FDA Approves Technology Upgrade for Recipients of First Commercially Available Cochlear Implant

June 24, 2015

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Kerri Lewandowski
Marketing Manager, Cochlear Americas
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FDA Approves Technology Upgrade for Recipients of First Commercially Available Cochlear Implant

Cochlear™ Nucleus® 22 Cochlear Implant users will have access to latest advancements in hearing with upgrade to the Nucleus 6 Sound Processor

Centennial, Colo., (June 24, 2015) – 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 René 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.


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  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.