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FDA Approves Technology Upgrade for Nucleus 22 Implant Recipients

Cochlear, the global leader in implantable hearing solutions, announced last week 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.

“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.

[1] Wolfe, J., et al (2015). The Benefits of Adaptive Signal Processing in a Commercially Available Cochlear Implant Sound Processor, Otology & Neurotology. (In press)

* With compact rechargeable battery option.

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