CENTENNIAL, Colo., June 24, 2015 /PRNewswire/ -- Cochlear
Limited (ASX: COH), the global leader in implantable hearing
solutions, announced today that the U.S. Food and Drug
Administration (FDA) has approved the Cochlear™
Nucleus® 6 Sound Processor for use with the
Nucleus 22 Cochlear Implant, giving those who have worn cochlear
implants from the beginning (over 20 years in some cases) access to
the latest breakthroughs in true wireless and automatic hearing.
Released in 1985, the Nucleus 22 Implant was the first commercially
available multi-channel cochlear implant in the world. The Nucleus
6 Sound Processor is the sixth sound processor upgrade available to
Nucleus 22 Implant recipients.
Click here to see Cochlear's history of innovation in sound
processors.
"We know that choosing a cochlear implant is an incredibly
important decision, which is why we are committed to supporting our
recipients throughout their lifetime," said Rene Courtney, Vice President of Recipient
Services, Cochlear Americas. "The FDA approval of the Nucleus 6
Sound Processor for Nucleus 22 Implant users is especially
significant because it means we are fulfilling our founding promise
of helping people 'hear now and always.' We are so pleased, and
proud that this momentous day has come."
The market-leading Nucleus 6 Sound Processor is built on a new
microchip platform with five times the processing power of the
previous generation, providing users with a more comfortable
listening experience and improved hearing in noise.1 As
the industry's smallest sound processor*, it delivers more smart
features than ever before, including true 2.4 GHz wireless
connectivity and a proprietary signal processing platform that
automatically adapts to different acoustic environments. These
features are not only intended to help make listening easier, they
are designed to help users hear their best in all listening
situations.
FDA approval is the first of many steps in launching a new
upgrade. Cochlear is finalizing the necessary measures to bring
this exciting upgrade to market, with the goal of beginning orders
on or around October 1, 2015.
Eligible Nucleus 22 Implant recipients will receive an email update
outlining next steps toward upgrading to the Nucleus 6 Sound
Processor in September/October.
Visit www.Cochlear.com/US/N6Upgrade to learn more.
About Cochlear Implants
Cochlear implants are a proven
medical option for infants as young as 12 months old with profound
hearing loss in both ears, children aged two and older with
severe-to-profound hearing loss, and adults with
moderate-to-profound hearing loss in both ears. They are electronic
devices that bypass damaged hair cells in the inner ear, or
cochlea, and stimulate the hearing nerve directly.
According to the National Institute on Deafness and Other
Communication Disorders, approximately 58,000 adults and 38,000
children have received cochlear implants in the United States.2 Nearly two
million Americans could be candidates for cochlear implant
technology, but only 5 percent of patients who can benefit have
been treated.3,4
About Cochlear Limited (ASX: COH)
Cochlear is the
global leader in implantable hearing solutions. The company has a
global workforce of 2,700 people and invests more than AUS$100
million a year in research and development. Products include
hearing systems for cochlear, bone conduction and acoustic
implants.
Over 400,000 people of all ages, across more than 100 countries,
now hear because of Cochlear.
www.cochlear.com
References
[1] Wolfe, J., et al (2015). The Benefits
of Adaptive Signal Processing in a Commercially Available Cochlear
Implant Sound Processor, Otology & Neurotology. (In press)
[2] National Institute on Deafness and Other Communication
Disorders. Cochlear Implants [Internet] 2014 Aug 18 [cited 2015 Apr
13]. Available:
http://www.nidcd.nih.gov/health/hearing/coch.asp
[3] Blanchfield, B.B., et. al. (2001). The severely to
profoundly hearing-impaired population in the United States: Prevalence estimates and
demographics. JAAA. 12, 183-189.
[4] Internal Cochlear Data on File. June, 2009.
*With compact rechargeable battery option.
Photo - http://photos.prnewswire.com/prnh/20150624/225430
Logo - http://photos.prnewswire.com/prnh/20130531/LA23942
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/fda-approves-technology-upgrade-for-recipients-of-first-commercially-available-cochlear-implant-300104317.html
SOURCE Cochlear Limited
