Oticon Medical’s Sentio™ System Receives Regulatory Clearance in the US
2024年7月12日 - 9:16PM
ビジネスワイヤ(英語)
Oticon Medical announced today the U.S. Food and Drug
Administration (FDA) clearance of its first active transcutaneous
bone conduction hearing system, the Sentio System. Sentio System
delivers the proven benefits of the Ponto™ System – and more – in a
transcutaneous option.
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the full release here:
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The Sentio System includes an external
Sentio 1 Mini sound processor and a Sentio Ti Implant placed under
the skin. (Photo: Business Wire)
The system includes Sentio 1 Mini, an external sound processor,
and Sentio Ti Implant, placed under the skin. It is the smallest
transcutaneous system available to date1.
While Ponto and other percutaneous bone-anchored hearing systems
use skin-protruding abutments, the Sentio System provides an
alternative keeping the skin intact. The Sentio System offers an
additional solution for patients and supports our commitment to
"freedom of choice."
“With the launch of Sentio System, we provide best-in-class and
the smallest active transcutaneous system. More importantly, Oticon
Medical now offers a complete portfolio of bone-anchored hearing
systems. This portfolio meets the needs of patients and customers,
and fits diverse clinical settings and global reimbursement schemes
for the treatment. We strongly believe that offering a broad
portfolio is the path to achieving our mission to "Help more
people" and give more potential users the quality of life
improvements these systems offer”, says René Govaerts, President
& General Manager, Oticon Medical.
The Sentio 1 Mini is designed with a focus on user comfort and
ease of use. The device's design and slim profile make it 26%
lighter than an alternative1. It gives access to a 360-degree sound
experience and offers the widest bandwidth of 9.5kHz.
Sentio Ti is a SuperPowerful implant developed to support
patient’s progressive hearing loss, without the need for additional
surgeries. Sentio Ti is designed and verified for a higher maximum
force output, so that patients can rely on its ability to handle
more powerful sound processors2. From a surgeon’s perspective, the
implant is designed for surgical flexibility, ensuring a
straightforward procedure.
Sentio System is indicated for candidates aged 12 and older who
have been diagnosed with conductive hearing loss, mixed hearing
loss, or single-sided deafness.
This launch marks a significant milestone for Oticon Medical, as
it continues to deliver the innovative hearing solutions that help
people live life to the fullest.
For more information visit www.oticonmedical.com.
Not all products are available in all markets. Product
availability and indications are subject to regulatory approval and
may vary depending on the market.
About Oticon Medical
Oticon Medical is a global company in implantable hearing
solutions, dedicated to bringing the power of sound to people at
every stage of life. For more than a decade, we have made bone
anchored hearing systems more accessible by simplifying the
treatment for physicians, audiologists, and patients alike.
We believe that patients and hearing care professionals should
be able to choose the best possible solution at any time along the
patient journey. We call it “Freedom of Choice” and it has always
been paramount to Oticon Medical. This is the reason why our
solutions are designed to be compatible whenever possible. As a
result, an implant from Oticon Medical stands as a true testament
to our unwavering lifelong support.
We work collaboratively with professionals to ensure that every
solution we create is designed with our users’ needs in mind. We
have a strong passion to provide innovative solutions and support
that enhance quality of life and help people live life to the
fullest – now and in the future.
Because we know how much sound matters.
References 1 Sentio implant and sound processor physical
features and comparison to other devices (Doc-00123204) 2 275144en
Product Information Sentio 1 Mini
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version on businesswire.com: https://www.businesswire.com/news/home/20240712765107/en/
Erik Lund Marketing Director, Oticon Medical E-mail:
erld@oticonmedical.com Mobile: +46 76 304 4482