FDA Approves Cochlear's Nucleus(R) 5 System

September 2009

Editor: Here's Cochlear's announcement that their new Nucleus(R) 5 Cochlear Implant System has received FDA approval for sales in the US.

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Cochlear, the global leader in implantable hearing solutions, announced today that the U.S. Food and Drug Administration (FDA) has approved the Nucleus((R) )5 System for adults and children with severe-to-profound hearing loss. Working with leading surgeons and audiologists worldwide, Cochlear has developed the most advanced technology including a smaller and thinner device with an unparalleled capability to deliver superior hearing performance and better user comfort. The Nucleus 5 System is the only one of its kind on the market today that offers the smallest, most water resistant sound processor, the thinnest titanium cochlear implant, two-way remote assistant, SmartSound((TM)) 2 technology and AutoPhone((TM)) capability.

Cochlear implants have the ability to restore hearing for individuals who are severely hard of hearing or profoundly deaf and who receive limited to no benefit from hearing aids. The new Nucleus 5 System is the most advanced cochlear implant system on the market for all ages*, which includes powerful features designed to restore hearing in deaf children so that they have the greatest potential to develop the spoken language skills necessary for school. Adults will benefit from advanced features that deliver the best listening options for phone use, communication in noisy environments and music enjoyment.

"Cochlear has reached a significant milestone with the introduction of the Nucleus 5 System. We have built upon our industry-leading hearing performance and reliability record with new, unique features designed to give users greater flexibility and help them hear better in difficult situations. We celebrate this milestone with the dedicated clinicians who have helped us positively impact the lives of so many people," said Chris Smith, President of Cochlear Americas.

Nucleus 5 System Delivers the Best Hearing Performance

Built on the industry benchmark set by Cochlear's previous generation system, preliminary research shows that the Nucleus 5 System outperforms other cochlear implant systems with higher speech performance results than reported for other systems. The new system is the result of several years of development and input from clinicians worldwide. It delivers new functionality while leveraging the existing stellar technology that the hearing healthcare industry has come to expect from the market leader.

"Advancements in cochlear implant technology give users greater opportunities to participate in the hearing world," said Jace Wolfe, PhD., Audiologist at Hearts for Hearing Foundation. "After having been involved in the global clinical validation of the new Nucleus 5 Sound Processor, I have seen first-hand how it will enable users to more fully experience everyday hearing activities like talking on the telephone, conversing in school and work settings, and going to concerts."

The Nucleus 5 System's hearing performance record is achieved through a combination of exclusive features that have been perfected over the last 25 years. This includes a unique patented( (1)) electrode array design that delivers a richer, more true-to life sound; the industry's only SmartSound 2 technology with the new Set It and Go(TM) program for everyday listening; and the world's only fully-integrated dual microphones for directionality and better sound quality in noisy situations. It also features AutoPhone, the industry's first and only automatic phone detection through an automatic telecoil for optimized phone use.

"What makes this new implant so remarkable is that it is significantly smaller than Cochlear's previous implant and any others, resulting in a more natural fit for adults and children," said Bruce Gantz, M.D., Professor and Head of the University of Iowa Department of Otolaryngology, Head and Neck Surgery.

About Cochlear Implants

Cochlear implants are a proven medical option for children as young as 12 months old with profound hearing loss in both ears and for individuals who are two years or older with severe-to-profound hearing loss in both ears whom obtain little or no benefit from hearing aids. They are electronic devices, which bypass damaged hair cells in the inner ear, or cochlea, and stimulate the hearing nerve directly. Cochlear implants are designed to restore hearing, giving users the best possible hearing experience possible and are becoming the standard of care with approximately 400 institutions in the United States providing this technology.

About Cochlear

Cochlear is the world leader in implantable hearing solutions. Since launching the first multichannel cochlear implant system more than 25 years ago, Cochlear Limited has brought the miracle of sound to more than 180,000 individuals with hearing loss across the globe. Cochlear Americas markets number one selling products -- the Baha((R)) implantable bone-anchored hearing device and Nucleus cochlear implant technology. For more information about Cochlear Americas' products, call the Cochlear Hotline at 800/523-5798 (Voice) or visit www.cochlearamericas.com.

* Cochlear implants are a proven medical option for children as young as 12 months old with profound hearing loss in both ears and for children and adults who are two years or older with severe-to-profound hearing loss in both ears who have not demonstrated benefit from wearing a hearing aid.

(1) US patent 7, 184, 843. [On file] 2007 Feb 27