Envoy Medical Inc (COCH)

Envoy Medical Submits First Module of Modular Premarket Approval Application to the U.S. Food and Drug Administration for Breakthrough-Designated DeviceJune 30, 2026 8:30 AM
NewsfileModular Regulatory Strategy Creates Defined Milestone Cadence, Enables Earlier FDA Engagement, and Supports Targeted Final Clinical Module Submission Planned for Q2 2027White Bear Lake, Minnesota--(Newsfile Corp. - June 30, 2026) - Envoy Medical® Inc. (NASDAQ: COCH) ("Envoy Medical" or the "Company"), a hearing health company pioneering fully implanted hearing solutions, today announced the submission of the first module of its Modular Premarket Approval ("PMA") application to the U.S. Food and Drug Administration ("FDA") for its FDA Breakthrough Device-designated product.The submission marks the first regulatory milestone in the Company's planned modular PMA strategy. Unlike a traditional PMA, which is submitted as a single comprehensive application, the modular PMA pathway allows the Company to submit completed sections to the FDA for review as they become available, rather than waiting to compile and submit the entire submission at once. Envoy Medical expects to submit a total of four modules, with the final module containing final clinical trial data targeted for submission in the second quarter of 2027. By utilizing the modular PMA pathway, the Company expects to engage with the FDA throughout the review process, allowing for earlier regulatory feedback while establishing a series of defined development milestones. Management believes this approach provides investors with greater visibility into the Company's progress and may reduce execution risk by identifying potential issues earlier in the review process."We believe the modular PMA approach is the right strategy for advancing our breakthrough-designated device through the FDA review process," said Brent Lucas, Chief Executive Officer of Envoy Medical." This submission represents the first of several milestones that we expect to achieve over the coming quarters. Rather than concentrating regulatory risk into a single binary event at the end of a multi-year process, this approach gives us a roadmap with meaningful accomplishments along the way. Each submitted module enables ongoing engagement with the FDA and creates a clearer framework for measuring our execution. We remain focused on advancing what we believe is a differentiated hearing solution for a large population of people interested in Invisible Hearing® technology."Key advantages of the modular PMA approach for Envoy Medical include:Earlier FDA Engagement: The FDA can begin reviewing submitted modules, such as nonclinical data and manufacturing information, while the clinical trial is ongoing, allowing the review process to progress in parallel with remaining data collection.Iterative Feedback and Risk Reduction: Receiving FDA input on individual modules allows the Company to address any questions or concerns proactively, reducing the chance of unanticipated issues or delays upon final submission. The Company believes this proactive approach reflects prudent use of capital and helps to reduce the risk profile of the overall regulatory process.A Structured Investor Roadmap: With four planned modules, Envoy Medical expects to have multiple opportunities to report meaningful progress to investors over the next year, providing investor visibility into the Company's advancement toward a potential approval decision.Aligned with Breakthrough Device Designation: As an FDA-designated Breakthrough Device, Envoy Medical's product is eligible for more intensive FDA interaction and guidance throughout the review process. The modular PMA structure, which requires FDA agreement and alignment on the submission framework in advance, is a natural fit for this level of ongoing collaboration with the FDA.The Acclaim® cochlear implant received Breakthrough Device Designation from the FDA in 2019 and is currently under investigation as part of a U.S. based pivotal clinical trial. For more information on the trial, visit www.envoymedical.com/acclaim-pivotal.To be added to the Envoy Medical email distribution list, please email Envoy@kcsa.com with COCH in the subject line.About Envoy Medical, Inc.
Envoy Medical (NASDAQ: COCH) is a hearing health company focused on providing innovative technologies across the hearing loss spectrum. Envoy Medical has pioneered one-of-a-kind, fully implanted devices for hearing loss, including its fully implanted Esteem® active middle ear implant, commercially available in the U.S. since 2010, and the fully implanted Acclaim® cochlear implant, an investigational device. Envoy Medical is dedicated to pushing hearing technology beyond the status quo to improve access, usability, compliance, and ultimately quality of life.About the Fully Implanted Acclaim® Cochlear Implant
We believe the fully implanted Acclaim Cochlear Implant ("Acclaim CI") is a first-of-its-kind hearing device. Envoy Medical's fully implanted technology includes a sensor designed to leverage the natural anatomy of the ear instead of a microphone to capture sound.The Acclaim CI is designed to address severe to profound sensorineural hearing loss that is not adequately addressed by hearing aids. The Acclaim CI is expected to be indicated for adults who have been deemed adequate candidates by a qualified physician.The Acclaim Cochlear Implant received the Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) in 2019.CAUTION The fully implanted Acclaim Cochlear Implant is an investigational device. Limited by Federal (or United States) law to investigational use.About the Esteem® Fully Implanted Active Middle Ear Implant (FI-AMEI)
The Esteem fully implanted active middle ear implant (FI-AMEI) is the only FDA-approved, fully implanted* hearing device for adults diagnosed with moderate to severe sensorineural hearing loss allowing for 24/7 hearing capability using the ear's natural anatomy. The Esteem FI-AMEI hearing implant is invisible and requires no externally worn components and nothing is placed in the ear canal for it to function. Unlike hearing aids, you never put it on or take it off. You can't lose it. You don't clean it. The Esteem FI-AMEI hearing implant offers true 24/7 hearing.*Once activated, the external Esteem FI-AMEI Personal Programmer is not required for daily use.Important safety information for the Esteem FI-AMEI can be found at: https://www.envoymedical.com/safety-information.Additional Information and Where to Find It
Copies of the documents filed by Envoy Medical with the SEC may be obtained free of charge at the SEC's website at www.sec.gov.Forward-Looking Statements
This press release includes "forward-looking statements" within the meaning of the "safe harbor" provisions of the United States Private Securities Litigation Reform Act of 1995. Forward-Looking statements may be identified by the use of words such as "estimate," "plan," "project," "forecast," "intend," "will," "expect," "anticipate," "believe," "seek," "target" or other similar expressions that predict or indicate future events or trends or that are not statements of historical matters, but the absence of these words does not mean that a statement is not forward-looking. Such statements may include, but are not limited to, statements regarding the expectations of Envoy Medical concerning the outlook for its business, productivity, plans and goals for future operations; the ability to obtain additional patents and develop future products or product improvements; the ability to maintain compliance with Nasdaq rules and requirements; the timing and future outcome of its FDA pivotal trial; the ability to raise capital and the amount of capital required to complete the FDA pivotal trial and early commercialization; the Acclaim CI being the first to market fully implanted cochlear implant; the timing and results of activations, enrollments, follow-up visits, data, and clinical trials of the Acclaim CI; performance of the Acclaim CI during clinical trials, including improvement of patient outcomes over time after implant; and the participation or any changes or delays in participation of any subjects, institutions, or healthcare professionals in such trials; the safety, performance, and market acceptance of the Acclaim CI; the timing and results of the Acclaim CI's PMA submissions to the FDA, including modular submissions and related feedback; the size of Envoy Medical's addressable market, operational performance, future market conditions or economic performance and developments in the capital and credit markets; and any information concerning possible or assumed future operations of Envoy Medical. The forward-looking statements contained in this press release reflect Envoy Medical's current views about future events and are subject to numerous known and unknown risks, uncertainties, assumptions and changes in circumstances that may cause its actual results to differ significantly from those expressed in any forward-looking statement. Envoy Medical does not guarantee that the events described will happen as described (or that they will happen at all). These forward-looking statements are subject to a number of risks and uncertainties, including, but not limited to changes in the market price of shares of Envoy Medical's Class A Common Stock; changes in or removal of Envoy Medical's shares inclusion in any index; Envoy Medical's success in retaining or recruiting, or changes required in, its officers, key employees or directors; unpredictability in the medical device industry, the regulatory process to approve medical devices, and the clinical development process of Envoy Medical products; the ability to engage competition in the medical device industry, and the failure to introduce new products and services in a timely manner or at competitive prices to compete successfully against competitors; disruptions in relationships with Envoy Medical's suppliers, or disruptions in Envoy Medical's own production capabilities for some of the key components and materials of its products; changes in the need for capital and the availability of financing and capital to fund these needs; changes in interest rates or rates of inflation; legal, regulatory and other proceedings could be costly and time-consuming to defend; changes in applicable laws or regulations, or the application thereof on Envoy Medical; a loss of any of Envoy Medical's key intellectual property rights or failure to adequately protect intellectual property rights; the effects of catastrophic events, including war, terrorism and other international conflicts; and other risks and uncertainties set forth in the section entitled "Risk Factors" and "Cautionary Note Regarding Forward-Looking Statements" in the Annual Report on Form 10-K filed by Envoy Medical on March 23, 2026, and in other reports Envoy Medical files, with the SEC. If any of these risks materialize or Envoy Medical's assumptions prove incorrect, actual results could differ materially from the results implied by these forward-looking statements. While forward-looking statements reflect Envoy Medical's good faith beliefs, they are not guarantees of future performance. Envoy Medical disclaims any obligation to publicly update or revise any forward-looking statement to reflect changes in underlying assumptions or factors, new information, data or methods, future events or other changes after the date of this press release, except as required by applicable law. You should not place undue reliance on any forward-looking statements, which are based only on information currently available to Envoy Medical.Investor Contact:
Phil Carlson
KCSA Strategic Communications
O: 212.896.1233
E: Envoy@kcsa.comTo view the source version of this press release, please visit https://www.newsfilecorp.com/release/303387 Original: Envoy Medical Submits First Module of Modular Premarket Approval Application to the U.S. Food and Drug Administration for Breakthrough-Designated Device

Envoy Medical Terminates At-the-Market (ATM) Equity FacilityJune 25, 2026 8:30 AM
NewsfileTermination Reflects Company's Confidence in Current Capital PositionWhite Bear Lake, Minnesota--(Newsfile Corp. - June 25, 2026) - Envoy Medical®, Inc. (NASDAQ: COCH) ("Envoy Medical"), a hearing health company pioneering fully implanted hearing solutions, today announced that it has formally terminated its at-the-market equity facility (the "ATM Facility").The ATM Facility, under which the Company was previously authorized to offer and sell up to $15 million worth of shares of its common stock from time to time, has been terminated effective June 24, 2026.To be added to the Envoy Medical email distribution list, please email Envoy@kcsa.com with COCH in the subject line.About Envoy Medical, Inc.
Envoy Medical (NASDAQ: COCH) is a hearing health company focused on providing innovative technologies across the hearing loss spectrum. Envoy Medical has pioneered one-of-a-kind, fully implanted devices for hearing loss, including its fully implanted Esteem® active middle ear implant, commercially available in the U.S. since 2010, and the fully implanted Acclaim® cochlear implant, an investigational device. Envoy Medical is dedicated to pushing hearing technology beyond the status quo to improve access, usability, compliance, and ultimately quality of life.About the Fully Implanted Acclaim® Cochlear Implant
We believe the fully implanted Acclaim Cochlear Implant ("Acclaim CI") is a first-of-its-kind hearing device. Envoy Medical's fully implanted technology includes a sensor designed to leverage the natural anatomy of the ear instead of a microphone to capture sound.The Acclaim CI is designed to address severe to profound sensorineural hearing loss that is not adequately addressed by hearing aids. The Acclaim CI is expected to be indicated for adults who have been deemed adequate candidates by a qualified physician.The Acclaim Cochlear Implant received the Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) in 2019.CAUTION The fully implanted Acclaim Cochlear Implant is an investigational device. Limited by Federal (or United States) law to investigational use.About the Esteem® Fully Implanted Active Middle Ear Implant (FI-AMEI)
The Esteem fully implanted active middle ear implant (FI-AMEI) is the only FDA-approved, fully implanted* hearing device for adults diagnosed with moderate to severe sensorineural hearing loss allowing for 24/7 hearing capability using the ear's natural anatomy. The Esteem FI-AMEI hearing implant is invisible and requires no externally worn components and nothing is placed in the ear canal for it to function. Unlike hearing aids, you never put it on or take it off. You can't lose it. You don't clean it. The Esteem FI-AMEI hearing implant offers true 24/7 hearing.*Once activated, the external Esteem FI-AMEI Personal Programmer is not required for daily use.Important safety information for the Esteem FI-AMEI can be found at: https://www.envoymedical.com/safety-information. Additional Information and Where to Find It
Copies of the documents filed by Envoy Medical with the SEC may be obtained free of charge at the SEC's website at www.sec.gov.Forward-Looking Statements
This press release includes "forward-looking statements" within the meaning of the "safe harbor" provisions of the United States Private Securities Litigation Reform Act of 1995. Forward-Looking statements may be identified by the use of words such as "estimate," "plan," "project," "forecast," "intend," "will," "expect," "anticipate," "believe," "seek," "target" or other similar expressions that predict or indicate future events or trends or that are not statements of historical matters, but the absence of these words does not mean that a statement is not forward-looking. Such statements may include, but are not limited to, statements regarding the expectations of Envoy Medical concerning the outlook for its business, productivity, plans and goals for future operations; the ability to obtain additional patents and develop future products or product improvements; the ability to maintain compliance with Nasdaq rules and requirements; the timing and future outcome of its FDA pivotal trial; the ability to raise capital and the amount of capital required to complete the FDA pivotal trial and early commercialization; the Acclaim CI being the first to market fully implanted cochlear implant; the timing and results of activations, enrollments, follow-up visits, data, and clinical trials of the Acclaim CI; and the participation or any changes or delays in participation of any subjects, institutions, or healthcare professionals in such trials; the safety, performance, and market acceptance of the Acclaim CI; the timing and results of the Acclaim CI's PMA submission to the FDA; the size of Envoy Medical's addressable market, operational performance, future market conditions or economic performance and developments in the capital and credit markets; and any information concerning possible or assumed future operations of Envoy Medical. The forward-looking statements contained in this press release reflect Envoy Medical's current views about future events and are subject to numerous known and unknown risks, uncertainties, assumptions and changes in circumstances that may cause its actual results to differ significantly from those expressed in any forward-looking statement. Envoy Medical does not guarantee that the events described will happen as described (or that they will happen at all). These forward-looking statements are subject to a number of risks and uncertainties, including, but not limited to changes in the market price of shares of Envoy Medical's Class A Common Stock; changes in or removal of Envoy Medical's shares inclusion in any index; Envoy Medical's success in retaining or recruiting, or changes required in, its officers, key employees or directors; unpredictability in the medical device industry, the regulatory process to approve medical devices, and the clinical development process of Envoy Medical products; the ability to engage competition in the medical device industry, and the failure to introduce new products and services in a timely manner or at competitive prices to compete successfully against competitors; disruptions in relationships with Envoy Medical's suppliers, or disruptions in Envoy Medical's own production capabilities for some of the key components and materials of its products; changes in the need for capital and the availability of financing and capital to fund these needs; changes in interest rates or rates of inflation; legal, regulatory and other proceedings could be costly and time-consuming to defend; changes in applicable laws or regulations, or the application thereof on Envoy Medical; a loss of any of Envoy Medical's key intellectual property rights or failure to adequately protect intellectual property rights; the effects of catastrophic events, including war, terrorism and other international conflicts; and other risks and uncertainties set forth in the section entitled "Risk Factors" and "Cautionary Note Regarding Forward-Looking Statements" in the Annual Report on Form 10-K filed by Envoy Medical on March 23, 2026, and in other reports Envoy Medical files, with the SEC. If any of these risks materialize or Envoy Medical's assumptions prove incorrect, actual results could differ materially from the results implied by these forward-looking statements. While forward-looking statements reflect Envoy Medical's good faith beliefs, they are not guarantees of future performance. Envoy Medical disclaims any obligation to publicly update or revise any forward-looking statement to reflect changes in underlying assumptions or factors, new information, data or methods, future events or other changes after the date of this press release, except as required by applicable law. You should not place undue reliance on any forward-looking statements, which are based only on information currently available to Envoy Medical.Investor Contact
Phil Carlson
KCSA Strategic Communications
O: 212.896.1233
E: Envoy@kcsa.comTo view the source version of this press release, please visit https://www.newsfilecorp.com/release/302819 Original: Envoy Medical Terminates At-the-Market (ATM) Equity Facility

Envoy Medical to Present at Investor Conferences on June 25thJune 18, 2026 8:30 AM
NewsfileWhite Bear Lake, Minnesota--(Newsfile Corp. - June 18, 2026) - Envoy Medical® Inc. (NASDAQ: COCH) ("Envoy Medical" or the "Company"), a hearing health company pioneering fully implanted hearing solutions, today announced that Brent Lucas, CEO of Envoy Medical, will present at the Virtual Life Sciences Investor Forum and the Biotech Webull Webinar Panel on June 25, 2026.Life Sciences Virtual Investor Forum
Dates: June 24th & 25th
Presentation Day and Time: Thursday, June 25, 2026, at 1:00 p.m. ET
Webcast Link Biotech Webull Webinar Panel
Presentation Day and Time: Thursday, June 25, 2026, at 2:40 p.m. ET
Webcast LinkTo schedule a meeting with the Envoy Medicals management team, please contact KCSA Strategic Communications at Envoy@kcsa.com.To be added to the Envoy Medical email distribution list, please email Envoy@kcsa.com with COCH in the subject line.About Envoy Medical, Inc.
Envoy Medical (NASDAQ: COCH) is a hearing health company focused on providing innovative technologies across the hearing loss spectrum. Envoy Medical has pioneered one-of-a-kind, fully implanted devices for hearing loss, including its fully implanted Esteem® active middle ear implant, commercially available in the U.S. since 2010, and the fully implanted Acclaim® cochlear implant, an investigational device. Envoy Medical is dedicated to pushing hearing technology beyond the status quo to improve access, usability, compliance, and ultimately quality of life.About the Fully Implanted Acclaim® Cochlear Implant
We believe the fully implanted Acclaim Cochlear Implant ("Acclaim CI") is a first-of-its-kind hearing device. Envoy Medical's fully implanted technology includes a sensor designed to leverage the natural anatomy of the ear instead of a microphone to capture sound.The Acclaim CI is designed to address severe to profound sensorineural hearing loss that is not adequately addressed by hearing aids. The Acclaim CI is expected to be indicated for adults who have been deemed adequate candidates by a qualified physician.The Acclaim Cochlear Implant received the Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) in 2019.CAUTION The fully implanted Acclaim Cochlear Implant is an investigational device. Limited by Federal (or United States) law to investigational use.About the Esteem® Fully Implanted Active Middle Ear Implant (FI-AMEI)
The Esteem fully implanted active middle ear implant (FI-AMEI) is the only FDA-approved, fully implanted* hearing device for adults diagnosed with moderate to severe sensorineural hearing loss allowing for 24/7 hearing capability using the ear's natural anatomy. The Esteem FI-AMEI hearing implant is invisible and requires no externally worn components and nothing is placed in the ear canal for it to function. Unlike hearing aids, you never put it on or take it off. You can't lose it. You don't clean it. The Esteem FI-AMEI hearing implant offers true 24/7 hearing.*Once activated, the external Esteem FI-AMEI Personal Programmer is not required for daily use.Important safety information for the Esteem FI-AMEI can be found at: https://www.envoymedical.com/safety-information.Additional Information and Where to Find It
Copies of the documents filed by Envoy Medical with the SEC may be obtained free of charge at the SEC's website at www.sec.gov.Investor Contact:
Phil Carlson
KCSA Strategic Communications
O: 212.896.1233
E: Envoy@kcsa.com To view the source version of this press release, please visit https://www.newsfilecorp.com/release/301966 Original: Envoy Medical to Present at Investor Conferences on June 25th

Envoy Medical to Present at Planet MicroCap Conference Las Vegas on June 16th-18thJune 4, 2026 8:30 AM
NewsfileWhite Bear Lake, Minnesota--(Newsfile Corp. - June 4, 2026) - Envoy Medical® Inc. (NASDAQ: COCH), a hearing health company pioneering fully implanted hearing solutions, today announced that Brent Lucas, CEO of Envoy Medical, will present at the Planet MicroCap Conference on June 16-18, 2026, in Las Vegas, NV.Planet MicroCap Las Vegas 2026
Dates: June 16-18, 2026
Location: Bellagio Hotel & Casino, Las Vegas, NV
Booth: #410
Presentation Day and Time: Wednesday, June 17, 2026, at 11:00 A.M. PT
Presentation Location: Track 7 - Donatello 3
Webcast: Viewable hereThe Company will be participating in one-on-one investor meetings throughout the event. For more information about the conference, or to schedule a meeting with the Envoy Medical management team, please contact KCSA Strategic Communications at Envoy@kcsa.com.To be added to the Envoy Medical email distribution list, please email Envoy@kcsa.com with COCH in the subject line.About Envoy Medical, Inc.
Envoy Medical (NASDAQ: COCH) is a hearing health company focused on providing innovative technologies across the hearing loss spectrum. Envoy Medical has pioneered one-of-a-kind, fully implanted devices for hearing loss, including its fully implanted Esteem® active middle ear implant, commercially available in the U.S. since 2010, and the fully implanted Acclaim® cochlear implant, an investigational device. Envoy Medical is dedicated to pushing hearing technology beyond the status quo to improve access, usability, compliance, and ultimately quality of life.About the Fully Implanted Acclaim® Cochlear Implant
We believe the fully implanted Acclaim Cochlear Implant ("Acclaim CI") is a first-of-its-kind hearing device. Envoy Medical's fully implanted technology includes a sensor designed to leverage the natural anatomy of the ear instead of a microphone to capture sound.The Acclaim CI is designed to address severe to profound sensorineural hearing loss that is not adequately addressed by hearing aids. The Acclaim CI is expected to be indicated for adults who have been deemed adequate candidates by a qualified physician.The Acclaim Cochlear Implant received the Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) in 2019.CAUTION The fully implanted Acclaim Cochlear Implant is an investigational device. Limited by Federal (or United States) law to investigational use.About the Esteem® Fully Implanted Active Middle Ear Implant (FI-AMEI)
The Esteem fully implanted active middle ear implant (FI-AMEI) is the only FDA-approved, fully implanted* hearing device for adults diagnosed with moderate to severe sensorineural hearing loss allowing for 24/7 hearing capability using the ear's natural anatomy. The Esteem FI-AMEI hearing implant is invisible and requires no externally worn components and nothing is placed in the ear canal for it to function. Unlike hearing aids, you never put it on or take it off. You can't lose it. You don't clean it. The Esteem FI-AMEI hearing implant offers true 24/7 hearing.*Once activated, the external Esteem FI-AMEI Personal Programmer is not required for daily use.Important safety information for the Esteem FI-AMEI can be found at: https://www.envoymedical.com/safety-information.Additional Information and Where to Find It
Copies of the documents filed by Envoy Medical with the SEC may be obtained free of charge at the SEC's website at www.sec.gov.Investor Contact:
Phil Carlson
KCSA Strategic Communications
O: 212.896.1233
E: Envoy@kcsa.com To view the source version of this press release, please visit https://www.newsfilecorp.com/release/300016 Original: Envoy Medical to Present at Planet MicroCap Conference Las Vegas on June 16th-18th

Envoy Medical Reports Landmark Accomplishments, Advancing Toward FDA Approval of First-of-Its-Kind Fully Implanted Cochlear ImplantMay 11, 2026 8:00 AM
NewsfileCompany Completes Historic Trial Enrollment, Secures Transformational Financing, and Sees Promising Early Clinical Data Presented at Industry ConferencesWhite Bear Lake, Minnesota--(Newsfile Corp. - May 11, 2026) - Envoy Medical® Inc. (NASDAQ: COCH) ("Envoy Medical" or the "Company"), a hearing health company pioneering fully implanted hearing solutions, today reported first quarter 2026 results and landmark achievements that advance the Company another step closer toward commercialization of its investigational Acclaim® cochlear implant."The first quarter of 2026 marked a transformative period for Envoy Medical, highlighted by the completion of enrollment in our pivotal clinical trial and the successful execution of a significant financing," said Brent Lucas, Chief Executive Officer of Envoy Medical. "Achieving full enrollment in our pivotal clinical study represents a critical step. We continue to be encouraged by the trial's progress and remain focused on advancing toward PMA submission and, ultimately, commercialization. With a substantially strengthened balance sheet and the support of leading healthcare investors, we believe we are well positioned to execute on our strategic objectives and deliver on the roadmap ahead."Corporate and Financial Highlights for Q1 2026:Pivotal Trial Enrollment Complete — A First for the Industry

In a defining milestone for the hearing health sector, Envoy Medical became the first cochlear implant company to achieve full enrollment of a U.S. pivotal clinical trial evaluating a fully implanted cochlear implant seeking FDA approval. The 56th and final patient was successfully implanted on March 11, 2026, completing enrollment across U.S. sites. The Company is now collecting 12-month follow-up data from all participants, with a Premarket Approval (PMA) submission to the FDA to follow.Transformational Capital Raise

Envoy Medical closed an upsized public offering for up to $78.0 million, including $30.0 million in gross proceeds at closing with up to an additional $48.0 million of potential aggregate gross proceeds upon the exercise in full of milestone-linked warrants. The financing was led by Nantahala Capital and included healthcare-dedicated funds such as Broadfin Holdings, as well as existing shareholders including members of the Board and management team.Expanded Intellectual Property Portfolio

As of February 20, 2026, Envoy Medical has expanded its global IP portfolio to 47 patents across North America, Europe, Asia, and Australia. In February alone, the Company secured three new patents strengthening its competitive position in the fully implanted hearing space.Highlights Subsequent to Q1 2026:Promising Early Clinical Data Presented

Interim six-month clinical data from the first 10 patients in the pivotal study showed no study-defined serious adverse events, mean CNC word recognition improved from 15.2% to 39.2%, median daily device wear time of 24 hours, and improvements in quality-of-life and tinnitus scores. Initial safety and performance data for these 10 patients were presented at the American Academy of Audiology Annual Conference and the Combined Otolaryngology Spring Meetings.All 56 Pivotal Trial Patients Activated

Following the completion of enrollment, Envoy Medical confirmed that all 56 patients implanted in the pivotal clinical trial have been activated. This milestone validates that the full patient cohort is progressing through the study protocol on schedule, keeping the Company on track to collect the 12-month endpoint data required for its planned PMA submission to the FDA.Board StrengthenedEnvoy Medical appointed medical device veteran Chas McKhann to its Board of Directors in April 2026, further enhancing the Company's expertise as it prepares to conclude its pivotal clinical study and prepare for commercial launch.First Patients Reach 12-Month Endpoint

The first three patients implanted in the pivotal trial successfully completed their 12-month endpoint visit, marking a key milestone in the study's progress. The primary endpoints for the trial are tied to 12-month data, and achieving this critical milestone on schedule underscores the Company's continued execution as it steadily marches toward PMA submission and commercialization.Financial Results for the Quarter Ended March 31, 2026 (dollars in thousands):Net Revenue was $39 for the three months ended March 31, 2026.Cost of goods sold for the three months ended March 31, 2026, were $313, compared to $226. The $87 increase is primarily due to higher scrap and materials usage as well as increased fees for third-parties performing work related to our products.R&D expenses for the three months ended March 31, 2026, were $3,642 compared to $2,748 for the three months ended March 31, 2025. This increase of $894 mainly reflects additional clinical trial activity and related personnel costs during enrollment.Sales and marketing expenses for the three months ended March 31, 2026, were $164 compared to $358 for the three months ended March 31, 2025. The decrease of $194 is primarily due to the reallocation of resources to research and development activities in support of the clinical trial.General and administrative expenses are $1,879 for the three months ended March 31, 2026, compared to $1,821 for the three months ended March 31, 2025. The increase of $58 was primarily due to higher investor relations and legal expenses.As of March 31, 2026, cash was approximately $25,251.The Acclaim® cochlear implant received Breakthrough Device Designation from the FDA in 2019 and is currently under investigation as part of a U.S. based pivotal clinical trial. For more information on the trial, visit www.envoymedical.com/acclaim-pivotal.To be added to the Envoy Medical email distribution list, please email Envoy@kcsa.com with COCH in the subject line.About Envoy Medical, Inc.
Envoy Medical (NASDAQ: COCH) is a hearing health company focused on providing innovative technologies across the hearing loss spectrum. Envoy Medical has pioneered one-of-a-kind, fully implanted devices for hearing loss, including its fully implanted Esteem® active middle ear implant, commercially available in the U.S. since 2010, and the fully implanted Acclaim® cochlear implant, an investigational device. Envoy Medical is dedicated to pushing hearing technology beyond the status quo to improve access, usability, compliance, and ultimately quality of life.About the Fully Implanted Acclaim® Cochlear Implant
We believe the fully implanted Acclaim Cochlear Implant ("Acclaim CI") is a first-of-its-kind hearing device. Envoy Medical's fully implanted technology includes a sensor designed to leverage the natural anatomy of the ear instead of a microphone to capture sound.The Acclaim CI is designed to address severe to profound sensorineural hearing loss that is not adequately addressed by hearing aids. The Acclaim CI is expected to be indicated for adults who have been deemed adequate candidates by a qualified physician.The Acclaim Cochlear Implant received the Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) in 2019.CAUTION The fully implanted Acclaim Cochlear Implant is an investigational device. Limited by Federal (or United States) law to investigational use.About the Esteem® Fully Implanted Active Middle Ear Implant (FI-AMEI)
The Esteem fully implanted active middle ear implant (FI-AMEI) is the only FDA-approved, fully implanted* hearing device for adults diagnosed with moderate to severe sensorineural hearing loss allowing for 24/7 hearing capability using the ear's natural anatomy. The Esteem FI-AMEI hearing implant is invisible and requires no externally worn components and nothing is placed in the ear canal for it to function. Unlike hearing aids, you never put it on or take it off. You can't lose it. You don't clean it. The Esteem FI-AMEI hearing implant offers true 24/7 hearing.*Once activated, the external Esteem FI-AMEI Personal Programmer is not required for daily use.Important safety information for the Esteem FI-AMEI can be found at: https://www.envoymedical.com/safety-information.Additional Information and Where to Find It
Copies of the documents filed by Envoy Medical with the SEC may be obtained free of charge at the SEC's website at www.sec.gov.Forward-Looking Statements
This press release includes "forward-looking statements" within the meaning of the "safe harbor" provisions of the United States Private Securities Litigation Reform Act of 1995. Forward-Looking statements may be identified by the use of words such as "estimate," "plan," "project," "forecast," "intend," "will," "expect," "anticipate," "believe," "seek," "target" or other similar expressions that predict or indicate future events or trends or that are not statements of historical matters, but the absence of these words does not mean that a statement is not forward-looking. Such statements may include, but are not limited to, statements regarding the expectations of Envoy Medical concerning the outlook for its business, productivity, plans and goals for future operations; the ability to obtain additional patents and develop future products or product improvements; the ability to maintain compliance with Nasdaq rules and requirements; the timing and future outcome of its FDA pivotal trial; the ability to raise capital and the amount of capital required to complete the FDA pivotal trial and early commercialization; the Acclaim CI being the first to market fully implanted cochlear implant; the timing and results of activations, enrollments, follow-up visits, data, and clinical trials of the Acclaim CI; and the participation or any changes or delays in participation of any subjects, institutions, or healthcare professionals in such trials; the safety, performance, and market acceptance of the Acclaim CI; the timing and results of the Acclaim CI's PMA submission to the FDA; the size of Envoy Medical's addressable market, operational performance, future market conditions or economic performance and developments in the capital and credit markets; and any information concerning possible or assumed future operations of Envoy Medical. The forward-looking statements contained in this press release reflect Envoy Medical's current views about future events and are subject to numerous known and unknown risks, uncertainties, assumptions and changes in circumstances that may cause its actual results to differ significantly from those expressed in any forward-looking statement. Envoy Medical does not guarantee that the events described will happen as described (or that they will happen at all). These forward-looking statements are subject to a number of risks and uncertainties, including, but not limited to changes in the market price of shares of Envoy Medical's Class A Common Stock; changes in or removal of Envoy Medical's shares inclusion in any index; Envoy Medical's success in retaining or recruiting, or changes required in, its officers, key employees or directors; unpredictability in the medical device industry, the regulatory process to approve medical devices, and the clinical development process of Envoy Medical products; the ability to engage competition in the medical device industry, and the failure to introduce new products and services in a timely manner or at competitive prices to compete successfully against competitors; disruptions in relationships with Envoy Medical's suppliers, or disruptions in Envoy Medical's own production capabilities for some of the key components and materials of its products; changes in the need for capital and the availability of financing and capital to fund these needs; changes in interest rates or rates of inflation; legal, regulatory and other proceedings could be costly and time-consuming to defend; changes in applicable laws or regulations, or the application thereof on Envoy Medical; a loss of any of Envoy Medical's key intellectual property rights or failure to adequately protect intellectual property rights; the effects of catastrophic events, including war, terrorism and other international conflicts; and other risks and uncertainties set forth in the section entitled "Risk Factors" and "Cautionary Note Regarding Forward-Looking Statements" in the Annual Report on Form 10-K filed by Envoy Medical on March 23, 2026, and in other reports Envoy Medical files, with the SEC. If any of these risks materialize or Envoy Medical's assumptions prove incorrect, actual results could differ materially from the results implied by these forward-looking statements. While forward-looking statements reflect Envoy Medical's good faith beliefs, they are not guarantees of future performance. Envoy Medical disclaims any obligation to publicly update or revise any forward-looking statement to reflect changes in underlying assumptions or factors, new information, data or methods, future events or other changes after the date of this press release, except as required by applicable law. You should not place undue reliance on any forward-looking statements, which are based only on information currently available to Envoy Medical.Investor Contact:
Phil Carlson
KCSA Strategic Communications
O: 212.896.1233
E: Envoy@kcsa.comMedia Contact:
Anne Donohoe
KCSA Strategic Communications
O: 732-620-0033
E: Envoy@kcsa.comENVOY MEDICAL, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(UNAUDITED)
(In thousands, except share and per share amounts)

March 31,
December 31,


2026
2025






Current assets:




Cash
$25,251
$3,739
Accounts receivable, net

31

34
Other receivable

17

19
Inventories

1,490

1,546
Prepaid expenses and other current assets

893

941
Total current assets

27,682

6,279
Property and equipment, net

962

1,035
Operating lease right-of-use asset (related party)

853

886
Prepaid expenses and other assets

325

358
Total assets
$29,822
$8,558



 

 
Liabilities, mezzanine equity, and stockholders' equity (deficit)

 

 
Current liabilities:

 

 
Accounts payable
$1,700
$2,920
Accrued expenses

9,653

7,639
Forward purchase agreement warrant liability

37

24
Product warranty liability, current portion

264

287
Operating lease liability, current portion (related party)

178

174
Other current liabilities

379

518
Total current liabilities

12,211

11,562
Product warranty liability, net of current portion

1,550

1,605
Operating lease liability, net of current portion (related party)

711

745
Private warrant liability

3,830

5,835
Publicly traded warrant liability

941

551
Other liability

27

27
Total liabilities

19,270

20,325



 

 
Commitments and contingencies (see Note 13)

 

 



 

 
Mezzanine equity

 

 
Warrants issued to placement agent as part of the 2025 Offerings (see Note 9)

391

391



 

 
Stockholders' equity (deficit)

 

 
Series A Preferred Stock, $0.0001 par value; 100,000,000 shares authorized and 10,000,000 shares designated as of March 31, 2026 and December 31, 2025; 4,126,667 shares issued and outstanding as of March 31, 2026 and December 31, 2025

-

-
Class A Common Stock, $0.0001 par value; 400,000,000 shares authorized as of March 31, 2026 and December 31, 2025; 76,881,110 shares issued and outstanding as of March 31, 2026 and 28,934,960 shares issued and outstanding as of December 31, 2025

8

3
Additional paid-in capital

329,371

301,355
Accumulated deficit

(319,097)
(313,396)Accumulated other comprehensive loss

(121)
(120)Total stockholders' equity (deficit)

10,161

(12,158)Total liabilities, mezzanine equity, and stockholders' equity (deficit)
$29,822
$8,558
 ENVOY MEDICAL, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(UNAUDITED)
(In thousands, except share and per share amounts)

Three Months Ended


March 31,


2026
2025
Net revenues
$39
$46
Costs and operating expenses:

 

 
Cost of goods sold

313

226
Research and development

3,642

2,748
Sales and marketing

164

358
General and administrative

1,879

1,821
Total costs and operating expenses

5,998

5,153
Operating loss

(5,959)
(5,107)Other income (expense):

 

 
Change in fair value of forward purchase agreement warrant liability

(13)
421
Loss on offering and change in fair value of private warrant liability

2,005

-
Change in fair value of publicly traded warrant liability

(390)
194
Interest expense (related party)

-

(495)Other income (expense), net

6

(11)Total other income (expense), net

1,608

109
Net loss

(4,351)
(4,998)


 

 
Cumulative preferred dividends

(1,350)
(1,238)


 

 
Net loss attributable to common stockholders, basic and diluted
$(5,701)$(6,236)Net loss per share attributable to common stockholders, basic and diluted
$(0.08)$(0.29)Weighted-average Class A Common Stock and pre-funded warrants outstanding, basic and diluted

68,934,960

21,326,609
Other comprehensive (loss) income:

 

 
Foreign currency translation adjustment

(1)
6
Other comprehensive (loss) income

(1)
6
Comprehensive loss
$(4,352)$(4,992) ENVOY MEDICAL, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(UNAUDITED)
(Dollars in thousands)

Three Months Ended


March 31,


2026
2025
Cash flows from operating activities




Net loss
$(4,351)$(4,998)Adjustments to reconcile net loss to net cash used in operating activities:

 

 
Depreciation

73

61
Interest expense and amortization of debt discount on Term Loans (related party)

-

495
Stock-based compensation for services

44

-
Amortization of prepaid insurance

227

247
Stock-based compensation

239

160
Loss on offering and change in fair value of private warrant liability

(2,005)
-
Change in fair value of publicly traded warrant liability

390

(194)Change in fair value of forward purchase agreement warrant liability

13

(421)Net change in operating lease (related party)

55

26
Change in inventory reserve

12

(23)Changes in operating assets and liabilities:

 

 
Accounts receivable, net

3

(4)Other receivable

2

757
Inventories

44

74
Prepaid expenses and other current assets

(121)
(75)Accounts payable

(1,220)
10
Operating lease liability (related party)

(52)
(22)Accrued expenses

664

199
Product warranty liability

(78)
(17)Net cash used in operating activities

(6,061)
(3,725)


 

 
Cash flows from investing activities

 

 
Purchases of property and equipment

-

(6)Net cash used in investing activities

-

(6)


 

 
Cash flows from financing activities

 

 
Payments on insurance financing loans

(208)
(233)Proceeds from the issuance of Term Loans (related party)

-

5,000
Dividends paid to stockholders of Series A Preferred Stock

-

(1,213)Proceeds from the issuance of Class A Common Stock, Issued Pre-Funded Warrants, and Series A Warrants

29,997

-
Offering costs from the issuance of Class A Common Stock, Issued Pre-Funded Warrants, and Series A Warrants

(2,215)
-
Net cash provided by financing activities

27,574

3,554



 

 
Effect of exchange rate changes on cash

(1)
6
Net (decrease) increase in cash

21,512

(171)Cash, beginning of period

3,739

5,483
Cash, end of period
$25,251
$5,312



 

 
Supplemental disclosures of cash flow information:

 

 
Cash paid for interest
$11
$13
Non-cash investing and financing activities:

 

 
Accrued and unpaid dividends on Series A Preferred Stock
$1,350
$25
Financing of prepaid insurance
$69
$75
Issuance of Term Loan Warrants (related party)
$-
$688
Issuance of Placement Agent Warrants
$678
$-
 To view the source version of this press release, please visit https://www.newsfilecorp.com/release/296857 Original: Envoy Medical Reports Landmark Accomplishments, Advancing Toward FDA Approval of First-of-Its-Kind Fully Implanted Cochlear Implant

Envoy Medical Highlights First Clinical Data Presentations from Pivotal Clinical Study of Fully Implanted Acclaim(R) Cochlear ImplantApril 28, 2026 8:30 AM
NewsfilePositive Initial 6-Month Data from First 10 Patients and Improvements in Speech Understanding and Quality of Life Scores Presented; Additional Presentations Scheduled in Early MayDetails to be Discussed During Fireside Chat on April 29, 2026 at 4:30 pm ETWhite Bear Lake, Minnesota--(Newsfile Corp. - April 28, 2026) - Envoy Medical® Inc. (NASDAQ: COCH) ("Envoy Medical" or the "Company"), a hearing health company pioneering fully implanted hearing solutions, today announced the first podium presentations of clinical data from the first stage of its pivotal clinical study of the investigational Acclaim® cochlear implant, a first-of-its-kind, fully implanted cochlear implant system. The Company will host a Fireside Chat with Dr. Theodore McRackan, MD, MSCR and Dr. Elizabeth Camposeo, AuD from the Medical University of South Carolina (MUSC) on Wednesday April 29, 2026 at 4:30 pm ET to review the data and its clinical implications.A planned interim analysis of the clinical data for the first 10 patients was conducted following completion of their six-month follow-up visits. Initial safety and performance data were presented this past weekend by Dr. Camposeo at the American Academy of Audiology (AAA) Annual Conference and Dr. McRackan at the Combined Otolaryngology Spring Meetings (COSM). Additional podium presentations are scheduled for May including the American Cochlear Implant Alliance (ACIA) Conference on Friday, May 8, 2026, and the International Conference on Cochlear Implants and Other Implantable Technologies (CI2026) on Monday, May 11, 2026."We are encouraged by the initial data from the first stage of the investigational Acclaim® clinical study being presented across several industry conferences," said Brent Lucas, Chief Executive Officer of Envoy Medical. "In addition to promising early safety and performance signals, we are seeing evidence of a strong interest in a fully implanted solution. Many participants had previously declined traditional cochlear implants due to the required use of an external processor, underscoring the potential for the Acclaim cochlear implant to expand the addressable market. While the study remains ongoing and these interim results are preliminary, the data reinforces our belief in the clinical and commercial promise of a fully implanted approach." Envoy Fireside Chat Details
Event: Envoy Medical Fireside Chat
Date: Wednesday, April 29, 2026
Time: 4:30 P.M. ET
Webcast Link: https://ir.envoymedical.com/news-events/ir-calendarKey Takeaways from Investigator PresentationsPreliminary Safety Profile DataNo serious adverse events (SAEs) as defined by the study protocol were reported.Adverse events were mild or moderate and resolved with routine care or programming adjustments.Preliminary Hearing Performance DataSpeech recognition improved by 6 months: Consonant-Nucleus-Consonant (CNC) word recognition, mean scores increased from 15.2% pre-CI to 39.2% (24 percentage point improvement).Device UseParticipants reported a median daily hearing-device wear time of 24 hours a day. This was a noticeable increase from their pre-operative median of 15.5 hours a day with hearing aids.Drivers of Choice to ParticipateParticipants were surveyed to understand why they previously declined traditional cochlear implants. Top responses included:Not wanting to wear an external processor (80%).Concern that an external processor would draw unwanted attention (70%). Discomfort with external processor size (60%).Participants were surveyed to understand their motivations for choosing a fully implanted cochlear implant system. Top responses included:Wanted the ability to hear during water activities, exercise, or while wearing headgear (100%).Wanted to be able to hear 24-hours a day with device (100%).Wanted an invisible, fully implanted device (90%). Quality of LifePatients demonstrated improvements in quality-of-life scores as measured by the CI-QOL35, a validated cochlear implant-specific quality of life instrument.Tinnitus Handicap Inventory (THI)Four patients who reported having tinnitus prior to surgery experienced a reduction in tinnitus as assessed by the Tinnitus Handicap Instrument (THI). For these patients, mean THI scores decreased from 24.5 pre-implant to 6.25 in 6 months.Upcoming Conference PresentationsAmerican Cochlear Implant Alliance (ACIA) Conference - Friday, May 8, 2026International Conference on Cochlear Implants and Other Implantable Technologies (CI2026) - Monday, May 11, 2026The Acclaim® cochlear implant received Breakthrough Device Designation from the FDA in 2019 and is currently under investigation as part of a U.S. based pivotal clinical trial. For more information on the trial, visit www.envoymedical.com/acclaim-pivotal.To be added to the Envoy Medical email distribution list, please email Envoy@kcsa.com with COCH in the subject line.About Envoy Medical, Inc.
Envoy Medical (NASDAQ: COCH) is a hearing health company focused on providing innovative technologies across the hearing loss spectrum. Envoy Medical has pioneered one-of-a-kind, fully implanted devices for hearing loss, including its fully implanted Esteem® active middle ear implant, commercially available in the U.S. since 2010, and the fully implanted Acclaim® cochlear implant, an investigational device. Envoy Medical is dedicated to pushing hearing technology beyond the status quo to improve access, usability, compliance, and ultimately quality of life.About the Fully Implanted Acclaim® Cochlear Implant
We believe the fully implanted Acclaim Cochlear Implant ("Acclaim CI") is a first-of-its-kind hearing device. Envoy Medical's fully implanted technology includes a sensor designed to leverage the natural anatomy of the ear instead of a microphone to capture sound.The Acclaim CI is designed to address severe to profound sensorineural hearing loss that is not adequately addressed by hearing aids. The Acclaim CI is expected to be indicated for adults who have been deemed adequate candidates by a qualified physician.The Acclaim Cochlear Implant received the Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) in 2019.CAUTION The fully implanted Acclaim Cochlear Implant is an investigational device. Limited by Federal (or United States) law to investigational use.About the Esteem® Fully Implanted Active Middle Ear Implant (FI-AMEI)
The Esteem fully implanted active middle ear implant (FI-AMEI) is the only FDA-approved, fully implanted* hearing device for adults diagnosed with moderate to severe sensorineural hearing loss allowing for 24/7 hearing capability using the ear's natural anatomy. The Esteem FI-AMEI hearing implant is invisible and requires no externally worn components and nothing is placed in the ear canal for it to function. Unlike hearing aids, you never put it on or take it off. You can't lose it. You don't clean it. The Esteem FI-AMEI hearing implant offers true 24/7 hearing.*Once activated, the external Esteem FI-AMEI Personal Programmer is not required for daily use.Important safety information for the Esteem FI-AMEI can be found at: https://www.envoymedical.com/safety-information.Additional Information and Where to Find It
Copies of the documents filed by Envoy Medical with the SEC may be obtained free of charge at the SEC's website at www.sec.gov.Forward-Looking Statements
This press release includes "forward-looking statements" within the meaning of the "safe harbor" provisions of the United States Private Securities Litigation Reform Act of 1995. Forward-Looking statements may be identified by the use of words such as "estimate," "plan," "project," "forecast," "intend," "will," "expect," "anticipate," "believe," "seek," "target" or other similar expressions that predict or indicate future events or trends or that are not statements of historical matters, but the absence of these words does not mean that a statement is not forward-looking. Such statements may include, but are not limited to, statements regarding the expectations of Envoy Medical concerning the outlook for its business, productivity, plans and goals for future operations; the ability to obtain additional patents and develop future products or product improvements; the ability to maintain compliance with Nasdaq rules and requirements; the timing and future outcome of its FDA pivotal trial; the ability to raise capital and the amount of capital required to complete the FDA pivotal trial and early commercialization; the Acclaim CI being the first to market fully implanted cochlear implant; the timing and results of activations, enrollments, follow-up visits, data, and clinical trials of the Acclaim CI; performance of the Acclaim CI during clinical trials, including improvement of patient outcomes over time after implant; and the participation or any changes or delays in participation of any subjects, institutions, or healthcare professionals in such trials; the safety, performance, and market acceptance of the Acclaim CI; the timing and results of the Acclaim CI's PMA submission to the FDA; the size of Envoy Medical's addressable market, operational performance, future market conditions or economic performance and developments in the capital and credit markets; and any information concerning possible or assumed future operations of Envoy Medical. The forward-looking statements contained in this press release reflect Envoy Medical's current views about future events and are subject to numerous known and unknown risks, uncertainties, assumptions and changes in circumstances that may cause its actual results to differ significantly from those expressed in any forward-looking statement. Envoy Medical does not guarantee that the events described will happen as described (or that they will happen at all). These forward-looking statements are subject to a number of risks and uncertainties, including, but not limited to changes in the market price of shares of Envoy Medical's Class A Common Stock; changes in or removal of Envoy Medical's shares inclusion in any index; Envoy Medical's success in retaining or recruiting, or changes required in, its officers, key employees or directors; unpredictability in the medical device industry, the regulatory process to approve medical devices, and the clinical development process of Envoy Medical products; the ability to engage competition in the medical device industry, and the failure to introduce new products and services in a timely manner or at competitive prices to compete successfully against competitors; disruptions in relationships with Envoy Medical's suppliers, or disruptions in Envoy Medical's own production capabilities for some of the key components and materials of its products; changes in the need for capital and the availability of financing and capital to fund these needs; changes in interest rates or rates of inflation; legal, regulatory and other proceedings could be costly and time-consuming to defend; changes in applicable laws or regulations, or the application thereof on Envoy Medical; a loss of any of Envoy Medical's key intellectual property rights or failure to adequately protect intellectual property rights; the effects of catastrophic events, including war, terrorism and other international conflicts; and other risks and uncertainties set forth in the section entitled "Risk Factors" and "Cautionary Note Regarding Forward-Looking Statements" in the Annual Report on Form 10-K filed by Envoy Medical on March 23, 2026, and in other reports Envoy Medical files, with the SEC. If any of these risks materialize or Envoy Medical's assumptions prove incorrect, actual results could differ materially from the results implied by these forward-looking statements. While forward-looking statements reflect Envoy Medical's good faith beliefs, they are not guarantees of future performance. Envoy Medical disclaims any obligation to publicly update or revise any forward-looking statement to reflect changes in underlying assumptions or factors, new information, data or methods, future events or other changes after the date of this press release, except as required by applicable law. You should not place undue reliance on any forward-looking statements, which are based only on information currently available to Envoy Medical.Investor Contact:
Phil Carlson
KCSA Strategic Communications
O: 212.896.1233
E: Envoy@kcsa.comMedia Contact:
Anne Donohoe
KCSA Strategic Communications
O: 732-620-0033
E: Envoy@kcsa.comTo view the source version of this press release, please visit https://www.newsfilecorp.com/release/294479
Original: Envoy Medical Highlights First Clinical Data Presentations from Pivotal Clinical Study of Fully Implanted Acclaim(R) Cochlear Implant

April 2026 Presentation
seeing a potential for approval in late 2027.
Pretty much dead money until 1Q 2027 when the
data from the trial is released (??)
Disclaimer: only hold some 2028 Warrants

https://ir.envoymedical.com/_assets/_3be1639252c37e296aa34a6081785c06/envoymedical/db/919/9532/pdf/Envoy+Medical+IR+Deck+April+2026.pdf

The 12 month follow up post the PH 3 implants has started
for all of the participants. Means they could be looking at the PH 3
results in late April 2027.. then the Med Device submission phase
would kick in.. late 2027 run at the fda at best.. And to think they
got 'breakthru' designation from the fda back in 2019.. Ugh how long
these things take..

https://finance.yahoo.com/sectors/healthcare/articles/envoy-medical-reaches-critical-milestone-120000080.html

This looks like a good appointment. Not an expert in this field but I assume that this company is a little too small to launch by itself. Chas McKhann has attracted buyers to his previous ventures so I am assuming he can do the same thing here. If not a buyout then at least some partnering.

Whoever can find a way to eliminate TINNITUS would
make a fortune.. and then some...

Envoy Medical Appoints Chas McKhann to Board of DirectorsApril 16, 2026 8:00 AM
NewsfileProven Med Tech Leader with an Established Track Record of Commercial Success and Optimizing Shareholder Value Leading to over $3.4 Billion in Successful ExitsWhite Bear Lake, Minnesota--(Newsfile Corp. - April 16, 2026) - Envoy Medical®, Inc. (NASDAQ: COCH) ("Envoy Medical"), a hearing health company pioneering fully implanted hearing solutions, today announced the appointment of Chas McKhann, a seasoned medical technology executive with documented success, to its Board of Directors.Mr. McKhann is a well-known and respected med tech leader with extensive experience creating and executing commercialization plans that have scaled into high-growth companies creating significant shareholder value. Most recently, he served as Chief Executive Officer of Silk Road Medical, which sold to Boston Scientific for $1.16 Billion, and Apollo Endosurgery, which also sold to Boston Scientific for approximately $615 million. Prior to those roles, Mr. McKhann served as the Chief Commercial Officer of Torax Medical and Intersect ENT prior to their acquisitors by Johnson and Johnson and Medtronic, respectively. "We are extremely excited to welcome Chas to our Board," said Brent Lucas, CEO of Envoy Medical. "Chas brings a proven track record of commercial success and delivering strong outcomes for investors. We look forward to benefitting from his deep industry knowledge and experience to advance our mission of bringing our first-of-its-kind fully implanted cochlear implant to the millions of patients who are not treating their hearing loss. Adding his experience and perspective will further strengthen our strategic positioning and visibility."Mr. McKhann currently serves as Executive Chair of Distalmotion SA, an independent director at Exagen Inc., and is a Senior Advisor to McKinsey & Company. Mr. McKhann holds an MBA from the Stanford University Graduate School of Business and a BA in Political Science from Stanford University."I am thrilled to be joining the Envoy Medical team," said Mr. McKhann. "As a first-of-its-kind fully implanted Cochlear implant, I believe the Acclaim® device has the ability to be a true game-changing advancement that has the potential to transform the lives of patients with hearing loss. With the pivotal trial enrollment now complete, I am excited to work with Brent and his team to develop a commercialization strategy and launch plan that maximizes the patient impact of this amazing technology."In addition to his role as an Independent Director, Mr. McKhann will also serve as a member of the Company's Compensation Committee. The Acclaim® cochlear implant received Breakthrough Device Designation from the FDA in 2019 and is currently under investigation as part of a U.S. based pivotal clinical trial. For more information on the trial, visit www.envoymedical.com/acclaim-pivotal.To be added to the Envoy Medical email distribution list, please email Envoy@kcsa.com with COCH in the subject line.About Envoy Medical, Inc.
Envoy Medical (NASDAQ: COCH) is a hearing health company focused on providing innovative technologies across the hearing loss spectrum. Envoy Medical has pioneered one-of-a-kind, fully implanted devices for hearing loss, including its fully implanted Esteem® active middle ear implant, commercially available in the U.S. since 2010, and the fully implanted Acclaim® cochlear implant, an investigational device. Envoy Medical is dedicated to pushing hearing technology beyond the status quo to improve access, usability, compliance, and ultimately quality of life.About the Fully Implanted Acclaim® Cochlear Implant
We believe the fully implanted Acclaim Cochlear Implant ("Acclaim CI") is a first-of-its-kind hearing device. Envoy Medical's fully implanted technology includes a sensor designed to leverage the natural anatomy of the ear instead of a microphone to capture sound.The Acclaim CI is designed to address severe to profound sensorineural hearing loss that is not adequately addressed by hearing aids. The Acclaim CI is expected to be indicated for adults who have been deemed adequate candidates by a qualified physician.The Acclaim Cochlear Implant received the Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) in 2019.CAUTION The fully implanted Acclaim Cochlear Implant is an investigational device. Limited by Federal (or United States) law to investigational use.About the Esteem® Fully Implanted Active Middle Ear Implant (FI-AMEI)
The Esteem fully implanted active middle ear implant (FI-AMEI) is the only FDA-approved, fully implanted* hearing device for adults diagnosed with moderate to severe sensorineural hearing loss allowing for 24/7 hearing capability using the ear's natural anatomy. The Esteem FI-AMEI hearing implant is invisible and requires no externally worn components and nothing is placed in the ear canal for it to function. Unlike hearing aids, you never put it on or take it off. You can't lose it. You don't clean it. The Esteem FI-AMEI hearing implant offers true 24/7 hearing.*Once activated, the external Esteem FI-AMEI Personal Programmer is not required for daily use.Important safety information for the Esteem FI-AMEI can be found at: https://www.envoymedical.com/safety-information. Additional Information and Where to Find It
Copies of the documents filed by Envoy Medical with the SEC may be obtained free of charge at the SEC's website at www.sec.gov.Forward-Looking Statements
This press release includes "forward-looking statements" within the meaning of the "safe harbor" provisions of the United States Private Securities Litigation Reform Act of 1995. Forward-Looking statements may be identified by the use of words such as "estimate," "plan," "project," "forecast," "intend," "will," "expect," "anticipate," "believe," "seek," "target" or other similar expressions that predict or indicate future events or trends or that are not statements of historical matters, but the absence of these words does not mean that a statement is not forward-looking. Such statements may include, but are not limited to, statements regarding the expectations of Envoy Medical concerning the outlook for its business, productivity, plans and goals for future operations; the ability to obtain additional patents and develop future products or product improvements; the ability to maintain compliance with Nasdaq rules and requirements; the timing and future outcome of its FDA pivotal trial; the ability to raise capital and the amount of capital required to complete the FDA pivotal trial and early commercialization; the Acclaim CI being the first to market fully implanted cochlear implant; the timing and results of activations, enrollments, follow-up visits, data, and clinical trials of the Acclaim CI; and the participation or any changes or delays in participation of any subjects, institutions, or healthcare professionals in such trials; the safety, performance, and market acceptance of the Acclaim CI; the timing and results of the Acclaim CI's PMA submission to the FDA; the size of Envoy Medical's addressable market, operational performance, future market conditions or economic performance and developments in the capital and credit markets; and any information concerning possible or assumed future operations of Envoy Medical. The forward-looking statements contained in this press release reflect Envoy Medical's current views about future events and are subject to numerous known and unknown risks, uncertainties, assumptions and changes in circumstances that may cause its actual results to differ significantly from those expressed in any forward-looking statement. Envoy Medical does not guarantee that the events described will happen as described (or that they will happen at all). These forward-looking statements are subject to a number of risks and uncertainties, including, but not limited to changes in the market price of shares of Envoy Medical's Class A Common Stock; changes in or removal of Envoy Medical's shares inclusion in any index; Envoy Medical's success in retaining or recruiting, or changes required in, its officers, key employees or directors; unpredictability in the medical device industry, the regulatory process to approve medical devices, and the clinical development process of Envoy Medical products; the ability to engage competition in the medical device industry, and the failure to introduce new products and services in a timely manner or at competitive prices to compete successfully against competitors; disruptions in relationships with Envoy Medical's suppliers, or disruptions in Envoy Medical's own production capabilities for some of the key components and materials of its products; changes in the need for capital and the availability of financing and capital to fund these needs; changes in interest rates or rates of inflation; legal, regulatory and other proceedings could be costly and time-consuming to defend; changes in applicable laws or regulations, or the application thereof on Envoy Medical; a loss of any of Envoy Medical's key intellectual property rights or failure to adequately protect intellectual property rights; the effects of catastrophic events, including war, terrorism and other international conflicts; and other risks and uncertainties set forth in the section entitled "Risk Factors" and "Cautionary Note Regarding Forward-Looking Statements" in the Annual Report on Form 10-K filed by Envoy Medical on March 23, 2026, and in other reports Envoy Medical files, with the SEC. If any of these risks materialize or Envoy Medical's assumptions prove incorrect, actual results could differ materially from the results implied by these forward-looking statements. While forward-looking statements reflect Envoy Medical's good faith beliefs, they are not guarantees of future performance. Envoy Medical disclaims any obligation to publicly update or revise any forward-looking statement to reflect changes in underlying assumptions or factors, new information, data or methods, future events or other changes after the date of this press release, except as required by applicable law. You should not place undue reliance on any forward-looking statements, which are based only on information currently available to Envoy Medical.Investor Contact
Phil Carlson
KCSA Strategic Communications
O: 212.896.1233
E: Envoy@kcsa.comMedia Contact
Anne Donohoe
KCSA Strategic Communications
O: 732-620-0033
E: Envoy@kcsa.comTo view the source version of this press release, please visit https://www.newsfilecorp.com/release/292772
Original: Envoy Medical Appoints Chas McKhann to Board of Directors

An anecdotal story of 1 but nonetheless a positive story.  He must feel it helps his hearing. Hopefully positive developments with this stock in 2026. 

Theres a guy on Reddit who was an early enrollee in their pivotal trial. Describes how they fine tuned it . Very happy with the device .
No adverse events .
Theres also a new discovery out of China where they used gene therapy to cure deafness . I think it only applies to those born deaf where as COCH is for those who have lost their hearing due to injury , regular loud noise etc

Kiwi

Ernie is just thinking of himself and Va Va Va Vooommmm 🤭

Thanks but I am not happy that they got in lower than me 🥲

Major Insider Purchases (February 2026)
Following a transformative financing round on February 12, 2026, several high-ranking insiders and the company’s largest shareholder made significant stock acquisitions at an average price of $0.40 per share:

Glen A. Taylor (Major Shareholder): Purchased 18,750,000 shares for a total value of $7.5 million.
Charles Brynelsen (Director): Acquired 1,000,000 shares worth $400,000.
Mona Chetan Patel (Director): Bought 312,500 shares valued at $125,000.
Robert Potashnick (Interim CFO): Purchased 212,500 shares for $85,000.
Susan Kantor (Director): Acquired 96,150 shares for $38,460.
Brent T. Lucas (CEO): Purchased 62,500 shares for $25,000.

Key Insider Trends
Alignment of Interests: Total insider ownership currently stands at approximately 34.5% ($26.56M value), suggesting strong alignment between management and shareholders.
Confidence Signal: Analysts at Simply Wall St noted that Taylor’s massive purchase increased his personal holding by 241%, signaling extreme confidence in the company's clinical trial progress.
Zero Selling: There have been no recorded insider sales in the past year, which is often viewed as a bullish indicator by investors.

----------------------
Kiwi

I always like when your big boys join me in my adventures.
I really never worry about being "too early" - it just means I got cheaper shares.

Re R/S

White Bear Lake, Minnesota--(Newsfile Corp. - February 24, 2026) - Envoy Medical® Inc. (NASDAQ: COCH) ("Envoy Medical" or the "Company"), a hearing health company pioneering fully implanted hearing solutions, today announced that it has received written notification from The Nasdaq Stock Market LLC ("Nasdaq") confirming that the Company has evidenced compliance with Nasdaq Listing Rule 5550(b)(2) through the alternatives permitted under Listing Rule 5550(b).

Kiwi

Re ICU Cash as of December 31, 2025, was $12.0 million, and they are losing $12.0m a yr ...so cash raise seems inevitable to complete the Adult trial ( now 50% enrolled ) Thursday run up maybe just short covering before a long weekend
I'll compare cash on hand with COCH

Cash on Hand: COCH
The company recently secured $30.0 million in gross proceeds through an upsized public offering in February 2026. This capital, combined with a $32 million debt reduction in 2025, is projected to provide a liquidity runway through 2028–2029.

The difference ..biotech specialist like Nanathala is backing COCH

Kiwi

Might of been me I took a stumblebum starter position before the close 🤫

Wasn't me, I added some the other day and will do so again if drops under .70 again.

Up 74% on warrants and will add under a nickel

ICU acting like news is gonna hit or something positive going to happen based on today's move.

Was that U wading in at the close Ernie :--)
Kiwi

Yeah I know, will have to do Sunday when I'm at my parents for Easter, hopefully.

You guys need to switch to Etrade

Fidelity is not my main broker so it really doesn't bother me that much, if Chuck and Fidelity won't take my orders I always have accounts with Etrade and they take just about anything I throw at them. I use Etrade for most of my foreign stocks since they don't hit me with the $50 fee just for buying thru Schwab or Fidelity and my commissions are $4.95 or free if big board stock.

Not sure if you mean with specific stocks but I have been able to place trades in both premarket and aftermarket. Now premarket at Fidelity only starts at 7 am ET. 

Fidelity is the only broker that does not allow pre and post market trading - at least I haven't found it. They also put stupid restrictions on how many shares can be purchased - no reason just like rolling dice to see if they will let me buy what and how much I want of valid tickers. Almost as bad as Chuckie Schwab and his BS which is extremely frustrating when he lets you buy different stocks and once you own them and want to add all of a sudden it "Place order with broker at 1800-we-suck" I get that message on about 40% of holdings - many of which are current Nasdaq stocks with not halts other than Chuckles doesn't believe in allowing trades for whatever bizarro reason which he refused to publicize.

I just went to my Fidelity account to place an order and there is a warning that says: "Deficient Issuer failed to meet NASDAQ continuing listing requirements". I wonder if that just hasn't been updated since I thought I saw something that they were in compliance now.????

My warrant entry was .035

Both

Ernie do you have stock or warrants in COCH

Think I will be joining you guys with a small starter position. RS off the table for now and we should hear results within a year.  

They had major institutions ( Cleveland Clinic , Stanford etc ) participating in enrollment ...always a good sign
More from Grok

No, there is no publicly available information indicating a planned or conducted interim analysis (e.g., for efficacy, futility, or sample size re-estimation) in Envoy Medical's (NASDAQ: COCH) pivotal trial for the Acclaim® fully implanted cochlear implant.



This is the relevant "COCH pivotal trial": a U.S.-based, prospective, interventional study (likely the one listed on ClinicalTrials.gov as evaluating the Acclaim® system, such as under identifiers associated with the fully implantable TICI/Acclaim device) assessing safety, performance, and clinical benefit in adults with sensorineural hearing loss. It targets enrollment of 56 implanted participants and focuses on 12-month follow-up data as the key dataset for a Premarket Approval (PMA) submission to the FDA.


Key Details on Trial Progress and AnalysisEnrollment status: Fully enrolled as of March 2026 (last patient implanted). The trial has progressed through follow-up visits, with the first patients reaching the 12-month endpoint recently (as of early April 2026 announcements).



Primary analysis timing: The protocol calls for data collection through scheduled follow-ups, with formal analysis only after all patients complete 12-month follow-up. This dataset will support the PMA submission (targeted around Q2 2027 based on earlier timelines). No early efficacy or futility stopping rules have been disclosed in press releases, company updates, or public trial descriptions.



Monitoring: Public sources (company press releases, trial page summaries) do not mention a Data Safety Monitoring Board (DSMB), independent data monitoring committee, or pre-specified interim analyses. Safety is monitored ongoing, as is standard for IDE/PMA device trials, but no adaptive elements or interim efficacy looks are referenced. The company has shared informal positive feedback from investigators ("encouraged by what we are hearing") and plans updates at meetings, but these are not formal interim analyses.



Why This MattersPivotal device trials like this often prioritize full follow-up for the primary endpoint (here, likely safety and performance metrics at 12 months) rather than early efficacy stops, especially for novel implants where long-term data strengthens the regulatory case. The Breakthrough Device Designation from the FDA (granted in 2019) may facilitate review but doesn't alter the lack of disclosed interim plans.If an interim analysis were planned (e.g., for safety or conditional power), it would typically be noted in the protocol on ClinicalTrials.gov or in regulatory filings/company disclosures—none appear in available sources.


Kiwi
Ps by the way ..the battery being charged is placed on / in your chest area like a pace maker ...not next to your brain ...from a Quick Look

Next major catalyst likely to be the KOL presentation in May at a conference

I'm starting to like what Grok has to say.

Re potential reverse split ...from Grok


No, Envoy Medical (COCH) does not appear to need a reverse stock split in the near term as of early April 2026.Here's the current situation:Bid Price Compliance: Nasdaq's primary minimum bid price rule requires a closing bid price of at least $1.00 for 10 consecutive trading days. As of late March/early April 2026, COCH has been trading well below $1.00 (recent closes around $0.65–$0.70, with a 52-week range showing lows near $0.36).



However, the company has not received (or at least not publicly disclosed) a deficiency notice specifically for the minimum bid price rule in 2026 so far. Earlier non-compliance issues were related to the Market Value of Listed Securities (MVLS) requirement (minimum $35 million), which they regained compliance with in February 2026 following the $30M (upsized to potential $78M) public offering and balance sheet improvements.



The large February 2026 offering significantly diluted the share count (adding 75 million shares plus warrants), which helped boost market capitalization and resolve the MVLS issue. It also provided substantial cash runway.
In the offering documents, the company explicitly agreed not to undertake a reverse or forward stock split for one year after the February 12, 2026 closing (i.e., until mid-February 2027), absent certain exceptions. This contractual restriction further reduces the likelihood of an immediate reverse split.



Kiwi

I always start small and increase holding on dips to build on ones I like. This one seems like a no brainer it is just a matter of when not if their implant is approved.

I'm an optimist until something makes me a pessimist.

Hi Ernie. They have a KOL presentation in May and the final 12 mth data on all subjects enrolled ...starting in 12 mths from now.
Question is will they do a reverse split ...6 mths under $1 or apply for an extension .
I'll probably start a small position since Nanathala is involved
thx
Kiwi

In today's PR - 1st 3 patients have implanted and coming up on 12 month follow up evaluations.

The first three pivotal trial patients implanted at the start of 2025 are now the first to reach the 12-month follow-up evaluation point. The primary endpoints for the trial are tied to 12-month data. Achieving this critical milestone on schedule underscores the Company's continued execution as it steadily marches towards commercialization.

Envoy Medical Announces First Patients Successfully Reaching 12-Month Endpoint in Pivotal Clinical Trial for Fully Implanted Cochlear ImplantApril 1, 2026 8:00 AM
NewsfileCompany Remains on Schedule for PMA Submission to FDAWhite Bear Lake, Minnesota--(Newsfile Corp. - April 1, 2026) - Envoy Medical®, Inc. (NASDAQ: COCH) ("Envoy Medical"), a hearing health company pioneering fully implanted hearing solutions, announced that the first three patients implanted in its pivotal clinical trial for the fully implanted Acclaim® cochlear implant have successfully completed their 12-month endpoint visit, marking a key milestone in the study's progress.The first three pivotal trial patients implanted at the start of 2025 are now the first to reach the 12-month follow-up evaluation point. The primary endpoints for the trial are tied to 12-month data. Achieving this critical milestone on schedule underscores the Company's continued execution as it steadily marches towards commercialization."We are thrilled to highlight the first wave of trial participants successfully reaching and completing their 12-month endpoint," said Brent Lucas, CEO of Envoy Medical. "We believe our first-of-its-kind breakthrough technology has the potential to change the perception around how severe to profound hearing loss is treated and potentially increase adoption rates. Now that the trial has been fully enrolled and we are beginning to collect 12-month data, the future of hearing implants may be closer than you realize."After all trial participants complete their 12-month evaluations, Envoy Medical plans to submit its Premarket Approval (PMA) application to the U.S. Food and Drug Administration (FDA).The Acclaim® cochlear implant is an investigational, first-of-its-kind fully implanted device designed to address severe to profound sensorineural hearing loss without externally worn components. With Envoy Medical's proprietary sensor technology, the Acclaim® device design leverages the ear's natural anatomy to capture sound to support a smooth and discreet hearing experience. Envoy Medical believes fully implanted hearing technology offers the potential to significantly expand adoption among patients unwilling or unable to use traditional hearing devices that rely on external hardware. Per the NIH, only six percent of eligible individuals receive cochlear implants, highlighting a substantial unmet need in the market.The Company continues to build on its leadership in fully implanted hearing solutions, including its FDA-approved Esteem® fully implanted active middle ear implant, which has been commercially available in the United States since 2010.The Acclaim® cochlear implant received Breakthrough Device Designation from the FDA in 2019 and is currently under investigation as part of a U.S. based pivotal clinical trial. For more information on the trial, visit www.envoymedical.com/acclaim-pivotal.To be added to the Envoy Medical email distribution list, please email Envoy@kcsa.com with COCH in the subject line.NIH Citation: Zhang L, Ding AS, Xie DX, Creighton FX. Understanding Public Perceptions Regarding Cochlear Implant Surgery in Adults. Otol Neurotol. 2022 Mar 1;43(3):e331-e336. doi: 10.1097/MAO.0000000000003439. PMID: 35147605; PMCID: PMC10368452.About Envoy Medical, Inc.
Envoy Medical (NASDAQ: COCH) is a hearing health company focused on providing innovative technologies across the hearing loss spectrum. Envoy Medical has pioneered one-of-a-kind, fully implanted devices for hearing loss, including its fully implanted Esteem® active middle ear implant, commercially available in the U.S. since 2010, and the fully implanted Acclaim® cochlear implant, an investigational device. Envoy Medical is dedicated to pushing hearing technology beyond the status quo to improve access, usability, compliance, and ultimately quality of life.About the Fully Implanted Acclaim® Cochlear Implant
We believe the fully implanted Acclaim Cochlear Implant ("Acclaim CI") is a first-of-its-kind hearing device. Envoy Medical's fully implanted technology includes a sensor designed to leverage the natural anatomy of the ear instead of a microphone to capture sound.The Acclaim CI is designed to address severe to profound sensorineural hearing loss that is not adequately addressed by hearing aids. The Acclaim CI is expected to be indicated for adults who have been deemed adequate candidates by a qualified physician.The Acclaim Cochlear Implant received the Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) in 2019.CAUTION The fully implanted Acclaim Cochlear Implant is an investigational device. Limited by Federal (or United States) law to investigational use.About the Esteem® Fully Implanted Active Middle Ear Implant (FI-AMEI)
The Esteem fully implanted active middle ear implant (FI-AMEI) is the only FDA-approved, fully implanted* hearing device for adults diagnosed with moderate to severe sensorineural hearing loss allowing for 24/7 hearing capability using the ear's natural anatomy. The Esteem FI-AMEI hearing implant is invisible and requires no externally worn components and nothing is placed in the ear canal for it to function. Unlike hearing aids, you never put it on or take it off. You can't lose it. You don't clean it. The Esteem FI-AMEI hearing implant offers true 24/7 hearing.*Once activated, the external Esteem FI-AMEI Personal Programmer is not required for daily use.Important safety information for the Esteem FI-AMEI can be found at: https://www.envoymedical.com/safety-information. Additional Information and Where to Find ItCopies of the documents filed by Envoy Medical with the SEC may be obtained free of charge at the SEC's website at www.sec.gov.Forward-Looking Statements
This press release includes "forward-looking statements" within the meaning of the "safe harbor" provisions of the United States Private Securities Litigation Reform Act of 1995. Forward-Looking statements may be identified by the use of words such as "estimate," "plan," "project," "forecast," "intend," "will," "expect," "anticipate," "believe," "seek," "target" or other similar expressions that predict or indicate future events or trends or that are not statements of historical matters, but the absence of these words does not mean that a statement is not forward-looking. Such statements may include, but are not limited to, statements regarding the expectations of Envoy Medical concerning the outlook for its business, productivity, plans and goals for future operations; the ability to obtain additional patents and develop future products or product improvements; the ability to maintain compliance with Nasdaq rules and requirements; the timing and future outcome of its FDA pivotal trial; the ability to raise capital and the amount of capital required to complete the FDA pivotal trial and early commercialization; the Acclaim CI being the first to market fully implanted cochlear implant; the timing and results of activations, enrollments, follow-up visits, data, and clinical trials of the Acclaim CI; and the participation or any changes or delays in participation of any subjects, institutions, or healthcare professionals in such trials; the safety, performance, and market acceptance of the Acclaim CI; the timing and results of the Acclaim CI's PMA submission to the FDA; the size of Envoy Medical's addressable market, operational performance, future market conditions or economic performance and developments in the capital and credit markets; and any information concerning possible or assumed future operations of Envoy Medical. The forward-looking statements contained in this press release reflect Envoy Medical's current views about future events and are subject to numerous known and unknown risks, uncertainties, assumptions and changes in circumstances that may cause its actual results to differ significantly from those expressed in any forward-looking statement. Envoy Medical does not guarantee that the events described will happen as described (or that they will happen at all). These forward-looking statements are subject to a number of risks and uncertainties, including, but not limited to changes in the market price of shares of Envoy Medical's Class A Common Stock; changes in or removal of Envoy Medical's shares inclusion in any index; Envoy Medical's success in retaining or recruiting, or changes required in, its officers, key employees or directors; unpredictability in the medical device industry, the regulatory process to approve medical devices, and the clinical development process of Envoy Medical products; the ability to engage competition in the medical device industry, and the failure to introduce new products and services in a timely manner or at competitive prices to compete successfully against competitors; disruptions in relationships with Envoy Medical's suppliers, or disruptions in Envoy Medical's own production capabilities for some of the key components and materials of its products; changes in the need for capital and the availability of financing and capital to fund these needs; changes in interest rates or rates of inflation; legal, regulatory and other proceedings could be costly and time-consuming to defend; changes in applicable laws or regulations, or the application thereof on Envoy Medical; a loss of any of Envoy Medical's key intellectual property rights or failure to adequately protect intellectual property rights; the effects of catastrophic events, including war, terrorism and other international conflicts; and other risks and uncertainties set forth in the section entitled "Risk Factors" and "Cautionary Note Regarding Forward-Looking Statements" in the Annual Report on Form 10-K filed by Envoy Medical on March 23, 2026, and in other reports Envoy Medical files, with the SEC. If any of these risks materialize or Envoy Medical's assumptions prove incorrect, actual results could differ materially from the results implied by these forward-looking statements. While forward-looking statements reflect Envoy Medical's good faith beliefs, they are not guarantees of future performance. Envoy Medical disclaims any obligation to publicly update or revise any forward-looking statement to reflect changes in underlying assumptions or factors, new information, data or methods, future events or other changes after the date of this press release, except as required by applicable law. You should not place undue reliance on any forward-looking statements, which are based only on information currently available to Envoy Medical.Investor Contact
Phil Carlson
KCSA Strategic Communications
O: 212.896.1233
E: Envoy@kcsa.comMedia Contact
Anne Donohoe
KCSA Strategic Communications
O: 732-620-0033
E: Envoy@kcsa.comTo view the source version of this press release, please visit https://www.newsfilecorp.com/release/290776
Original: Envoy Medical Announces First Patients Successfully Reaching 12-Month Endpoint in Pivotal Clinical Trial for Fully Implanted Cochlear Implant

Envoy Medical Reports Full Year 2025 Financial ResultsMarch 23, 2026 8:30 AM
NewsfileReceived FDA approval to expand fully implanted Acclaim® Cochlear Implant Pivotal Clinical Trial to final stageStrengthened balance sheet by extinguishing $32 million in debtSubsequent to year-end, closed on transformational capital raise led by established institutional healthcare investors and completed enrollment of Pivotal Clinical Trial for first-of-its-kind fully implanted cochlear implantWhite Bear Lake, Minnesota--(Newsfile Corp. - March 23, 2026) - Envoy Medical® Inc. (NASDAQ: COCH) ("Envoy Medical" or the "Company"), a hearing health company pioneering fully implanted hearing solutions, today announced its corporate and financial results for the full year ended December 31, 2025, as well as other subsequent events. Corporate and Financial Highlights for 2025:Received FDA Approval to Expand Its Pivotal Clinical Trial to Final Stage Based on Submission of Promising Three-Month DataExtinguished over $32 Million in Debt, Strengthening Balance SheetCompleted First Set of Activations in Final Stage of Pivotal Clinical Study for its First-Of-Its-Kind Fully Implanted Acclaim(R) Cochlear ImplantAchieved Six-Month Milestone with First 10 Patients in Acclaim(R) Cochlear Implant Clinical TrialHighlights Subsequent to 2025 Year End:Completed enrollment of a 56-patient U.S. pivotal trial for the fully implanted Acclaim® Cochlear ImplantStrengthened balance sheet with up to $78M public offering ($30M received, $48M potential from warrants)Expanded IP portfolio to 47 patents across North America, Europe, Asia, and Australia as of Feb. 20, 2026Brent Lucas, CEO of Envoy Medical, commented: "We are extremely proud of the significant progress we made as a company in 2025, which included the FDA approval to expand our pivotal clinical trial to its final stage. "We were also, on the financial side, able to extinguish over $32 million in debt to create a much stronger balance sheet. In addition, we continued to further expand our global patent portfolio as a leading fully implanted hearing technology company."The momentum from 2025 has set the stage for an exceptional start to 2026. In February, we closed a transformational capital raise that included established institutional healthcare investors and existing shareholders. In March, we announced complete enrollment of our pivotal clinical trial for investigational fully implanted Acclaim cochlear implant. We are now in a strengthened position as we continue to gather data and look forward to submitting our PMA application to the FDA. "The future is bright for Envoy Medical as we aim to revolutionize hearing health by providing fully implanted solutions to address the unmet needs of millions of individuals worldwide. We hope you join us on this meaningful and exciting journey."Financial Results for the Year Ended December 31, 2025 (dollars in thousands):Net Revenue was $241 as of December 31, 2025 compared to $225 for year ended December 31, 2024. The increase of $16 was primarily driven by the sales of the Esteem® FI-AMEI implant and related replacement components.Cost of goods sold increased $132 compared to the year ended December 31, 2024. The increase is primarily due to an increase in scrap and non-recurring expenses of $190, which was partially offset by lower fees for third-parties performing work related to our products of $77.R&D expenses, which include expenses related to the Acclaim pivotal clinical trial, increased by $2,307 for the year ended December 31, 2025 compared to the year ended December 31, 2024. This increase mainly reflects additional clinical trial expense during enrollment. Sales and marketing expenses of December 31, 2025 were $1,220 compared to $1,734 for the year ended December 31, 2024 a decrease of $514. The decrease is primarily due to a reduction of legal fees associated with reimbursement work for the Esteem FI-AMEI product.General and administrative expenses increased $1,105 to $7,931 for the year ended December 31, 2025 compared to $6,826 for the year ended December 31, 2024. The increase was primarily due to severance costs associated with the former Chief Financial Officer and increased consulting expenses.As of December 31, 2025, cash was approximately $3.7 million.The Acclaim® cochlear implant received Breakthrough Device Designation from the FDA in 2019 and is currently under investigation as part of a U.S. based pivotal clinical trial. For more information on the trial, visit www.envoymedical.com/acclaim-pivotal.To be added to the Envoy Medical email distribution list, please email Envoy@kcsa.com with COCH in the subject line.About Envoy Medical, Inc.
Envoy Medical (NASDAQ: COCH) is a hearing health company focused on providing innovative technologies across the hearing loss spectrum. Envoy Medical has pioneered one-of-a-kind, fully implanted devices for hearing loss, including its fully implanted Esteem® active middle ear implant, commercially available in the U.S. since 2010, and the fully implanted Acclaim® cochlear implant, an investigational device. Envoy Medical is dedicated to pushing hearing technology beyond the status quo to improve access, usability, compliance, and ultimately quality of life.About the Fully Implanted Acclaim® Cochlear Implant
We believe the fully implanted Acclaim Cochlear Implant ("Acclaim CI") is a first-of-its-kind hearing device. Envoy Medical's fully implanted technology includes a sensor designed to leverage the natural anatomy of the ear instead of a microphone to capture sound.The Acclaim CI is designed to address severe to profound sensorineural hearing loss that is not adequately addressed by hearing aids. The Acclaim CI is expected to be indicated for adults who have been deemed adequate candidates by a qualified physician.The Acclaim Cochlear Implant received the Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) in 2019.CAUTION The fully implanted Acclaim Cochlear Implant is an investigational device. Limited by Federal (or United States) law to investigational use.About the Esteem® Fully Implanted Active Middle Ear Implant (FI-AMEI)
The Esteem fully implanted active middle ear implant (FI-AMEI) is the only FDA-approved, fully implanted* hearing device for adults diagnosed with moderate to severe sensorineural hearing loss allowing for 24/7 hearing capability using the ear's natural anatomy. The Esteem FI-AMEI hearing implant is invisible and requires no externally worn components and nothing is placed in the ear canal for it to function. Unlike hearing aids, you never put it on or take it off. You can't lose it. You don't clean it. The Esteem FI-AMEI hearing implant offers true 24/7 hearing.*Once activated, the external Esteem FI-AMEI Personal Programmer is not required for daily use.Important safety information for the Esteem FI-AMEI can be found at: https://www.envoymedical.com/safety-information.Additional Information and Where to Find It
Copies of the documents filed by Envoy Medical with the SEC may be obtained free of charge at the SEC's website at www.sec.gov.Forward-Looking Statements
This press release includes "forward-looking statements" within the meaning of the "safe harbor" provisions of the United States Private Securities Litigation Reform Act of 1995. Forward-Looking statements may be identified by the use of words such as "estimate," "plan," "project," "forecast," "intend," "will," "expect," "anticipate," "believe," "seek," "target" or other similar expressions that predict or indicate future events or trends or that are not statements of historical matters, but the absence of these words does not mean that a statement is not forward-looking. Such statements may include, but are not limited to, statements regarding the expectations of Envoy Medical concerning the outlook for its business, productivity, plans and goals for future operations; the ability to obtain additional patents and develop future products or product improvements; the ability to maintain compliance with Nasdaq rules and requirements; the timing and future outcome of its FDA pivotal trial; the ability to raise capital and the amount of capital required to complete the FDA pivotal trial and early commercialization; the Acclaim CI being the first to market fully implanted cochlear implant; the timing and results of activations, enrollments, follow-up visits, data, and clinical trials of the Acclaim CI; and the participation or any changes or delays in participation of any subjects, institutions, or healthcare professionals in such trials; the safety, performance, and market acceptance of the Acclaim CI; the timing and results of the Acclaim CI's PMA submission to the FDA; the size of Envoy Medical's addressable market, operational performance, future market conditions or economic performance and developments in the capital and credit markets; and any information concerning possible or assumed future operations of Envoy Medical. The forward-looking statements contained in this press release reflect Envoy Medical's current views about future events and are subject to numerous known and unknown risks, uncertainties, assumptions and changes in circumstances that may cause its actual results to differ significantly from those expressed in any forward-looking statement. Envoy Medical does not guarantee that the events described will happen as described (or that they will happen at all). These forward-looking statements are subject to a number of risks and uncertainties, including, but not limited to changes in the market price of shares of Envoy Medical's Class A Common Stock; changes in or removal of Envoy Medical's shares inclusion in any index; Envoy Medical's success in retaining or recruiting, or changes required in, its officers, key employees or directors; unpredictability in the medical device industry, the regulatory process to approve medical devices, and the clinical development process of Envoy Medical products; the ability to engage competition in the medical device industry, and the failure to introduce new products and services in a timely manner or at competitive prices to compete successfully against competitors; disruptions in relationships with Envoy Medical's suppliers, or disruptions in Envoy Medical's own production capabilities for some of the key components and materials of its products; changes in the need for capital and the availability of financing and capital to fund these needs; changes in interest rates or rates of inflation; legal, regulatory and other proceedings could be costly and time-consuming to defend; changes in applicable laws or regulations, or the application thereof on Envoy Medical; a loss of any of Envoy Medical's key intellectual property rights or failure to adequately protect intellectual property rights; the effects of catastrophic events, including war, terrorism and other international conflicts; and other risks and uncertainties set forth in the section entitled "Risk Factors" and "Cautionary Note Regarding Forward-Looking Statements" in the Annual Report on Form 10-K filed by Envoy Medical on March 23, 2026, and in other reports Envoy Medical files, with the SEC. If any of these risks materialize or Envoy Medical's assumptions prove incorrect, actual results could differ materially from the results implied by these forward-looking statements. While forward-looking statements reflect Envoy Medical's good faith beliefs, they are not guarantees of future performance. Envoy Medical disclaims any obligation to publicly update or revise any forward-looking statement to reflect changes in underlying assumptions or factors, new information, data or methods, future events or other changes after the date of this press release, except as required by applicable law. You should not place undue reliance on any forward-looking statements, which are based only on information currently available to Envoy Medical.Investor Contact:
Phil Carlson
KCSA Strategic Communications
O: 212.896.1233
E: Envoy@kcsa.comMedia Contact:
Anne Donohoe
KCSA Strategic Communications
O: 732-620-0033
E: Envoy@kcsa.comENVOY MEDICAL, INC.
CONSOLIDATED BALANCE SHEETS
(In thousands, except share and per share amounts)
December 31,
December 31,

2025
2024
Current assets:





Cash$3,739
$5,483
Accounts receivable, net
34

38
Other receivable
19

780
Inventories
1,546

1,708
Prepaid expenses and other current assets
941

887
Total current assets
6,279

8,896
Property and equipment, net
1,035

1,275
Operating lease right-of-use asset (related party)
886

879
Prepaid expenses and other assets
358

488
Total assets$8,558
$11,538
 
 

 
Liabilities, mezzanine equity, and stockholders' deficit
 

 
Current liabilities:
 

 
Accounts payable$2,920
$1,652
Accrued expenses
7,639

3,713
Accrued interest (related party)
-

703
Other current liabilities
518

573
Forward purchase agreement warrant liability
24

472
Product warranty liability, current portion
287

282
Operating lease liability, current portion (related party)
174

143
Total current liabilities
11,562

7,538
Term loans payable (related party)
-

18,716
Product warranty liability, net of current portion
1,605

1,771
Operating lease liability, net of current portion (related party)
745

802
Private warrant liability
5,835

-
Publicly traded warrant liability
551

662
Other liability
27

891
Total liabilities
20,325

30,380
  
 

 
Commitments and contingencies
 

 
  
 

 
Mezzanine equity
 

 
Warrants issued to placement agent
391

-
  
 

 
Stockholders' deficit
 

 
Series A Preferred Stock, $0.0001 par value; 100,000,000 shares authorized and 10,000,000 shares designated as of December 31, 2025 and December 31, 2024; 4,126,667 shares issued and outstanding as of December 31, 2025 and December 31, 2024
-

-
Class A Common Stock, $0.0001 par value; 400,000,000 shares authorized as of December 31, 2025 and December 31, 2024; 28,934,960 shares issued and outstanding as of December 31, 2025 and 21,326,609 shares issued and outstanding as of December 31, 2024
3

2
Additional paid-in capital
301,355

266,013
Accumulated deficit
(313,396)
(284,734)Accumulated other comprehensive loss
(120)
(123)Total stockholders' deficit
(12,158)
(18,842)Total liabilities, mezzanine equity, and stockholders' deficit$8,558
$11,538
 ENVOY MEDICAL, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(In thousands, except share and per share amounts)
Year Ended

December 31,

2025
2024
Net revenues$241
$225
Costs and operating expenses:
 

 
Cost of goods sold
874

742
Research and development
12,486

10,179
Sales and marketing
1,220

1,734
General and administrative
7,931

6,826
Total costs and operating expenses
22,511

19,481
Operating loss
(22,270)
(19,256)Other income (expense):
 

 
Change in fair value of forward purchase agreement put option liability
-

103
Change in fair value of forward purchase agreement warrant liability
534

411
Change in fair value of forward purchase agreement warrant liability due to extension
(24)
(881)Loss on offering and change in fair value of private warrant liability
(494)
-
Change in fair value of publicly traded warrant liability
111

(330)Interest expense, related party
(1,590)
(816)Other expense, net
(23)
(26)Total other income (expense), net
(1,486)
(1,539)Net loss
(23,756)
(20,795)  
 

 
Induced conversion of Series A Preferred Stock into Class A Common Stock
-

(1,162)Deemed dividend on waiver of restriction on Class A Common Stock
-

(495)Cumulative preferred dividends
(4,906)
(5,521)  
 

 
Net loss attributable to common stockholders, basic and diluted$(28,662)$(27,973)Net loss per share attributable to common stockholders, basic and diluted$(1.23)$(1.49)Weighted-average Class A Common Stock outstanding, basic and diluted
23,259,598

18,790,448
Other comprehensive income (loss):
 

 
Foreign currency translation adjustment
3

(5)Other comprehensive income (loss)
3

(5)Comprehensive loss$(23,753)$(20,800) ENVOY MEDICAL, INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS
(Dollars in thousands)
Year Ended

December 31,

2025
2024
Cash flows from operating activities



Net loss$(23,756)$(20,795)Adjustments to reconcile net loss to net cash used in operating activities:
 

 
Depreciation
302

173
Interest expense and amortization of debt discount on Term Loans (related party)
1,590

816
Stock-based compensation for services
88

-
Amortization of prepaid insurance
964

1,047
Stock-based compensation
657

562
Loss on offering and change in fair value of private warrant liability
494

-
Change in fair value of publicly traded warrant liability
(111)
330
Change in fair value of forward purchase agreement warrant liability
(534)
(411)Change in fair value of forward purchase agreement put option liability
-

(103)Change in fair value of forward purchase agreement warrant liability due to extension
24

881
Net change in operating lease right-of-use assets and liability (related party)
206

113
Change in inventory reserve
36

76
Changes in operating assets and liabilities:
 

 
Accounts receivable, net
4

32
Other receivable
761

(604)Inventories
126

(380)Prepaid expenses and other current assets
(8)
9
Accounts payable
1,385

(19)Operating lease liability (related party)
(239)
(145)Accrued expenses
839

(241)Product warranty liability
(161)
(181)Other liability
(868)
891
Net cash used in operating activities
(18,201)
(17,949)  
 

 
Cash flows from investing activities
 

 
Purchases of property and equipment
(179)
(980)Net cash used in investing activities
(179)
(980)  
 

 
Cash flows from financing activities
 

 
Payments on insurance financing loans
(827)
(916)Proceeds from the issuance of Term Loans (related party)
10,000

20,000
Dividends paid to stockholders of Series A Preferred Stock
(1,819)
(2,447)Payment made for extinguishment of Term Loans (related party)
(100)
-
Proceeds from the issuance of Class A Common Stock from ATM offering
414

-
Proceeds from issuance of Class A Common Stock under employee stock purchase plan
184

63
Proceeds from exercise of forward purchase agreement warrants
3,111

1,815
Proceeds from the issuance of Class A Common Stock and Investor Warrants from registered direct offering
6,500

-
Offering costs from the issuance of Class A Common Stock and Investor Warrants from registered direct offering
(768)
 
Deferred offering costs
(62)
-
Proceeds from the issuance of Class A Common Stock associated with forward purchase agreement, net of transaction costs
-

1,683
Net cash provided by financing activities
16,633

20,198


 

 
Effect of exchange rate changes on cash
3

(5)Net (decrease) increase in cash
(1,744)
1,264
Cash, beginning of year
5,483

4,219
Cash, end of year$3,739
$5,483


 

 
Supplemental disclosures of cash flow information:
 

 
Cash paid for interest$36
$41
Non-cash investing and financing activities:
 

 
Accrued and unpaid dividends on Series A Preferred Stock$3,087
$3,074
Financing of prepaid insurance$772
$843
Issuance of Term Loan Warrants (related party)$1,570
$1,397
Accrued interest capitalized into term loans payable (related party)$800
$-
Modification of forward purchase agreement warrant$62
$94
Lease liabilities arising from obtaining right-of-use assets$121
$528
Extinguishment of excess warrant liability upon exercise of forward purchase agreement warrant$-
$96
Waiver of accrued dividends associated with Sponsor Support Agreement$-
$3,733
Deemed dividend on waiver of restriction on Class A Common Stock$-
$495
Induced conversion of Series A Preferred Stock to Class A Common Stock$-
$1,162
Property and equipment purchased on account$-
$117
Modification of Term Loan Warrants (related party)$1,455
$-
Deemed capital contribution associated with the extinguishment of Term Loans (related party)$27,883
$-
Issuance of Placement Agent Warrants$391
$-
 To view the source version of this press release, please visit https://www.newsfilecorp.com/release/289507
Original: Envoy Medical Reports Full Year 2025 Financial Results

Figured it had to be in there 'someplace' given
you buy and can hold them for years (smile)

Funny, PATIENCE is my middle name.

I'll buy more if my position turns negative, currently up 40% on commons and 109% on warrants

Naw, PATIENCE..

Be a year now (unless they do a data release
mid way thru this PH 3) before they have anything
meaningful to say to the masses (the end of the PH 3
for the last enrollees).

Then the next meaningful phase begins, 6-9 months long
to see if they can get an approval decision...

So folks need PATIENCE, and a lot of it (smile)

Makes a solid move up today and crickets????

Maybe investors need implants

I expect that IF they give a good trial readout, the share price
will react.

Biggest concern is dilution (and there is always that threat of a
reverse split with these 'youngsters") IF a cash shortage develops

Want to see how the warrants react to the share price moves, may add more.

And as far as playing warrants goes? Going to be judicious in my selection of
which ones I decide to participate in due to:
-do they really have something someone will 'want/need' vs a good idea
-stage they are in vs cash needed to bring the product to market
-potential for reverse splits due to the stage they are in

I bought mine in Oct 2025 at .035 and I'm in for the approval.

First warrants I have bought. And only because it is a medical device, and they already know
whether or not it 'works'. Only questions/concerns for me is, how much dilution in the next 12-18
months. And will the fda allow an energy source that close to the brain.
So figure I will hold them up to around the approval decision, see whats being said along the way..



And yes, have had some before, but not intention on my part. Got some several years
ago when a company called ANV decided to screw shareholders
over and declare an unexpected bankruptcy. Company was 'instantly' bought out by
HYMC. So as 'compensation', they gave us warrants for the shares. and then did nothing
to generate any value in the warrants. Ended up selling them for very little, exasperating the loss on the shares..

Once the common break and hold over a buck the warrants should go above .15 - .20 IMO

First warrants ever for you or just the first for COCHW?

1st warrant trade: 10,000 of the Sept 2028s at .0648/

Could have had them at .-055 or so, but hesitated. Suspect the chart
is showing some 'reaction' to the news of full enrollment

Hoping they give a 'mid-trial' readout, don't dilute too much (78 Mil shares
current, inst 5%, Market Cap of $58 Mil)

Not looking for a lot, but $2 at the current numbers above should add some value
to the warrants.

Only concern is, will the fda approve an 'implanted' energy source that near to the brain
that is rechargeable given the concerns over EMF and cell phones for example.

Envoy Medical Completes Enrollment of Pivotal Clinical Trial Evaluating First-Of-Its-Kind Fully Implanted Cochlear ImplantMarch 11, 2026 8:00 AM
NewsfileFirst Cochlear Implant Company to Announce Completed Enrollment of a U.S. Pivotal Clinical Trial for a Fully Implanted Cochlear Implant seeking FDA ApprovalWhite Bear Lake, Minnesota--(Newsfile Corp. - March 11, 2026) - Envoy Medical® Inc. (NASDAQ: COCH) ("Envoy Medical" or the "Company"), a hearing health company pioneering fully implanted hearing solutions, today announced completed enrollment of its pivotal clinical trial for the investigational fully implanted Acclaim® cochlear implant. With the successful implantation of the 56th and final patient, Envoy Medical is the first cochlear implant company to achieve full enrollment of a U.S. pivotal clinical trial to evaluate a fully implanted cochlear implant seeking FDA approval. "Completing enrollment of a pivotal clinical trial that is evaluating a breakthrough-designated medical device that has the potential to bring about generational change to an entire industry is a very big deal," said Brent Lucas, Chief Executive Officer of Envoy Medical, "We strongly believe in our device design and look forward to gathering additional data throughout the trial as we substantially differentiate ourselves from the competition. We believe today brings us significantly closer to redefining the standard of care for adults with severe to profound hearing loss and potentially growing the overall cochlear implant user base to include those patients who could benefit from a cochlear implant but have sat on the sidelines waiting for a fully implanted solution."The final two study participants were both implanted yesterday by Dr. Patrick Antonelli at the University of Florida. With these procedures, Dr. Antonelli became the second leading enroller in the trial, having implanted 11 of the 56 participants."Participating in the Acclaim Cochlear Implant Pivotal Trial has been an eye opener for me," Dr. Antonelli shared, "I've been placing traditional cochlear implants for so long-over 30 years-and these devices evolved so little over that time that I didn't give much thought to how dramatically they could be improved. The Acclaim changed that." Dr. Antonelli continued, "People with profound hearing loss desperately want to be able to hear 24 x 7 without having to wear an external processor. Others have been reluctant to get a cochlear implant because of the stigma they feel with an external processor. I think just about every Acclaim recipient that we've enrolled in this study said, often tearfully, 'you've really made my day,' when I told them they were cleared to get the Acclaim. Tears of joy followed activation as well. It's been a real privilege to be able to offer the Acclaim cochlear implant to our patients in this clinical trial. I am delighted that completion of study enrollment brings us a step closer to FDA approval and hopefully being able to offer the Acclaim to all of our properly qualified patients." With enrollment completed, the study will now progress through scheduled follow-up visits and data collection in accordance with the trial protocol. Once 12-month follow up data has been collected for all patients, the data will then be analyzed and submitted to the FDA as part of a PMA application seeking FDA approval. Subject to FDA review and approval, commercialization in the United States would follow.Envoy Medical believes it is the first cochlear implant manufacturer to complete enrollment in a U.S. pivotal trial for a fully implanted cochlear implant, positioning the Company at the forefront of this next generation of hearing technology. The Acclaim® cochlear implant received Breakthrough Device Designation from the FDA in 2019 and is currently under investigation as part of a U.S. based pivotal clinical trial. For more information on the trial, visit www.envoymedical.com/acclaim-pivotal.To be added to the Envoy Medical email distribution list, please email Envoy@kcsa.com with COCH in the subject line.About Envoy Medical, Inc.
Envoy Medical (NASDAQ: COCH) is a hearing health company focused on providing innovative technologies across the hearing loss spectrum. Envoy Medical has pioneered one-of-a-kind, fully implanted devices for hearing loss, including its fully implanted Esteem® active middle ear implant, commercially available in the U.S. since 2010, and the fully implanted Acclaim® cochlear implant, an investigational device. Envoy Medical is dedicated to pushing hearing technology beyond the status quo to improve access, usability, compliance, and ultimately quality of life.About the Fully Implanted Acclaim® Cochlear Implant
We believe the fully implanted Acclaim Cochlear Implant ("Acclaim CI") is a first-of-its-kind hearing device. Envoy Medical's fully implanted technology includes a sensor designed to leverage the natural anatomy of the ear instead of a microphone to capture sound.The Acclaim CI is designed to address severe to profound sensorineural hearing loss that is not adequately addressed by hearing aids. The Acclaim CI is expected to be indicated for adults who have been deemed adequate candidates by a qualified physician.The Acclaim Cochlear Implant received the Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) in 2019.CAUTION The fully implanted Acclaim Cochlear Implant is an investigational device. Limited by Federal (or United States) law to investigational use.About the Esteem® Fully Implanted Active Middle Ear Implant (FI-AMEI)
The Esteem fully implanted active middle ear implant (FI-AMEI) is the only FDA-approved, fully implanted* hearing device for adults diagnosed with moderate to severe sensorineural hearing loss allowing for 24/7 hearing capability using the ear's natural anatomy. The Esteem FI-AMEI hearing implant is invisible and requires no externally worn components and nothing is placed in the ear canal for it to function. Unlike hearing aids, you never put it on or take it off. You can't lose it. You don't clean it. The Esteem FI-AMEI hearing implant offers true 24/7 hearing.*Once activated, the external Esteem FI-AMEI Personal Programmer is not required for daily use.Important safety information for the Esteem FI-AMEI can be found at: https://www.envoymedical.com/safety-information.Additional Information and Where to Find It
Copies of the documents filed by Envoy Medical with the SEC may be obtained free of charge at the SEC's website at www.sec.gov.Forward-Looking Statements
This press release includes "forward-looking statements" within the meaning of the "safe harbor" provisions of the United States Private Securities Litigation Reform Act of 1995. Forward-Looking statements may be identified by the use of words such as "estimate," "plan," "project," "forecast," "intend," "will," "expect," "anticipate," "believe," "seek," "target" or other similar expressions that predict or indicate future events or trends or that are not statements of historical matters, but the absence of these words does not mean that a statement is not forward-looking. Such statements may include, but are not limited to, statements regarding the expectations of Envoy Medical concerning the outlook for its business, productivity, plans and goals for future operations; the ability to obtain additional patents and develop future products or product improvements; the ability to maintain compliance with Nasdaq rules and requirements; the timing and future outcome of its FDA pivotal trial; the ability to raise capital and the amount of capital required to complete the FDA pivotal trial and early commercialization; the Acclaim CI being the first to market fully implanted cochlear implant; the timing and results of activations, enrollments, follow-up visits, data, and clinical trials of the Acclaim CI; and the participation or any changes or delays in participation of any subjects, institutions, or healthcare professionals in such trials; the safety, performance, and market acceptance of the Acclaim CI; the timing and results of the Acclaim CI's PMA submission to the FDA; the size of Envoy Medical's addressable market, operational performance, future market conditions or economic performance and developments in the capital and credit markets; and any information concerning possible or assumed future operations of Envoy Medical. The forward-looking statements contained in this press release reflect Envoy Medical's current views about future events and are subject to numerous known and unknown risks, uncertainties, assumptions and changes in circumstances that may cause its actual results to differ significantly from those expressed in any forward-looking statement. Envoy Medical does not guarantee that the events described will happen as described (or that they will happen at all). These forward-looking statements are subject to a number of risks and uncertainties, including, but not limited to changes in the market price of shares of Envoy Medical's Class A Common Stock; changes in or removal of Envoy Medical's shares inclusion in any index; Envoy Medical's success in retaining or recruiting, or changes required in, its officers, key employees or directors; unpredictability in the medical device industry, the regulatory process to approve medical devices, and the clinical development process of Envoy Medical products; the ability to engage competition in the medical device industry, and the failure to introduce new products and services in a timely manner or at competitive prices to compete successfully against competitors; disruptions in relationships with Envoy Medical's suppliers, or disruptions in Envoy Medical's own production capabilities for some of the key components and materials of its products; changes in the need for capital and the availability of financing and capital to fund these needs; changes in interest rates or rates of inflation; legal, regulatory and other proceedings could be costly and time-consuming to defend; changes in applicable laws or regulations, or the application thereof on Envoy Medical; a loss of any of Envoy Medical's key intellectual property rights or failure to adequately protect intellectual property rights; the effects of catastrophic events, including war, terrorism and other international conflicts; and other risks and uncertainties set forth in the section entitled "Risk Factors" and "Cautionary Note Regarding Forward-Looking Statements" in the Annual Report on Form 10-K filed by Envoy Medical on March 31, 2025, and in other reports Envoy Medical files, with the SEC. If any of these risks materialize or Envoy Medical's assumptions prove incorrect, actual results could differ materially from the results implied by these forward-looking statements. While forward-looking statements reflect Envoy Medical's good faith beliefs, they are not guarantees of future performance. Envoy Medical disclaims any obligation to publicly update or revise any forward-looking statement to reflect changes in underlying assumptions or factors, new information, data or methods, future events or other changes after the date of this press release, except as required by applicable law. You should not place undue reliance on any forward-looking statements, which are based only on information currently available to Envoy Medical.Investor Contact:
Phil Carlson
KCSA Strategic Communications
O: 212.896.1233
E: Envoy@kcsa.comMedia Contact:
Anne Donohoe
KCSA Strategic Communications
O: 732-620-0033
E: Envoy@kcsa.comTo view the source version of this press release, please visit https://www.newsfilecorp.com/release/287997
Original: Envoy Medical Completes Enrollment of Pivotal Clinical Trial Evaluating First-Of-Its-Kind Fully Implanted Cochlear Implant