Cochlear Announces the FDA Approval and U.S. Launch of the First of Its Kind Cochlear™ Nucleus® Hybrid Implant System

Hybrid hearing is a new way of hearing that combines the benefits of hearing aids and cochlear implants in one device to help give a more complete hearing experience

/ PRNewswire / — Cochlear Limited (ASX: COH), the global leader in implantable hearing solutions, announced the U.S. Food and Drug Administration (FDA) approval and launch of the Cochlear Nucleus® Hybrid Implant System, a revolutionary new hybrid hearing solution that helps people who may hear a little but are still missing a lot, even with their hearing aids. The Nucleus Hybrid System is a unique combination of proven solutions, which allows people to get back what they've been missing by amplifying the low-pitched hearing a person does have while restoring access to the high-pitched hearing they've lost. People who are candidates for the technology no longer have to worry about straining to hear with their hearing aids as the Nucleus Hybrid System will allow them to maximize their hearing in all frequencies.
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"The launch of the first of its kind Nucleus Hybrid System means that we have the opportunity to give people back what they've been missing with their hearing aids," said Chris Smith, President of Cochlear Americas. "By amplifying low-frequency hearing and restoring access to high-frequency hearing, this innovative new hybrid hearing solution will help people regain the sounds of life that had previously been lost, and ultimately empower them to connect with others and live a full life. We look forward to expanding access to hearing and instilling hope in those who may be suffering without an effective solution."

"Although I can hear many low-pitched sounds, my hearing loss is in the high frequencies, which makes hearing my children and grandchildren extremely difficult," said Ellen DeVoss, Nucleus Hybrid System recipient. "After years of wasting thousands of dollars on hearing aids and accessories and progressively retreating into a world of isolation due to my hearing loss, my audiologist told me I was a candidate for the Nucleus Hybrid System. I was skeptical at first, but now if I had to choose two words to describe the outcome of this experience they would be 'miraculous' and 'life changing.'"

The Nucleus Hybrid System is designed to deliver patients superior quality and clarity of sound in even the most difficult hearing situations, especially hearing in noisy environments. It is supported by robust clinical evidence which showed that Nucleus Hybrid System recipients heard on average two times better in both quiet and in noise than with hearing aids.1 Additionally, those recipients reported a ten times increase in their overall hearing satisfaction than with hearing aids.1

"The clinical data supporting the FDA approval of the Nucleus Hybrid System is very encouraging as it shows superior hearing performance compared to acoustic amplification alone," said J. Thomas Roland Jr., M.D., Lead Nucleus Hybrid System Clinical Investigator and Chair & Mendik Foundation Professor of Otolaryngology and Neurosurgery at NYU Langone Medical Center. "What this means is that we now have an effective solution that offers hybrid hearing to patients who may benefit from both electric and acoustic amplification, and that most patients will likely be very satisfied with the results."

Over 38 million Americans are reported to have hearing loss.2 However, only 8.4 million actually have hearing aids, the treatment considered to be the standard of care.3 For the over 75% who do not seek treatment, the reasons vary from awareness of need to cost of ownership. Of those who have purchased a hearing aid, over 1 million report never using the hearing aids due to dissatisfaction with overall benefit, comfort, and performance in noise. More severe levels of hearing loss are treated with cochlear implants, the standard of care for severe to profound sensorineural hearing loss. However, many people are unaware that cochlear implants exist or mistakenly believe that cochlear implants are only for the profoundly deaf. In fact, fewer than 6 percent of potential candidates actually have one.4-6 Neither hearing aids nor cochlear implants are ideal for individuals who demonstrate normal to moderate low frequency hearing loss with a severe to profound sensorineural hearing loss in the high frequencies, more commonly known as a "ski-slope" hearing loss. With the new Nucleus Hybrid System, the treatment criteria is expanded further to include adults with more hearing in the low frequencies who have difficulty hearing simple words and sentences in noise, even with the most advanced hearing aids.

"Since receiving my Nucleus Hybrid System, I was promoted to Office Manager at a very busy dental practice, I'm on and off the phone all day long and am in every hearing environment possible," DeVoss concluded. "I can't say enough about how the hybrid hearing solution from Cochlear has not only replaced a sense but given me my life back."

About Cochlear
Cochlear is the global leader in implantable hearing solutions. It has a dedicated global team of more than 2,700 people who deliver the gift of sound to those with hearing loss in over 100 countries. Its vision is to connect people, young and old, to a world of sound by offering life enhancing hearing solutions.

The Cochlear promise of "Hear now. And always" embodies the company's commitment to providing its recipients with their best possible hearing performance today and for the rest of their lives. For over 30 years Cochlear has helped hundreds of thousands of people either hear for the first time or reconnect them to their families, friends, workplaces and communities.

For more information, visit Cochlear.com.

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References
[1] FDA Panel Sponsor Executive Summary, Nucleus Hybrid L24 Implant System. September 27, 2013. Results presented in the Implant Ear Alone testing condition.
[2] Center for Hearing Communication. Facts About Hearing Loss. http://www.chchearing.org/about-hearing-loss/facts-about-hearing-loss. Accessed on November 4, 2013.
[3] Kochkin, S. (2009) MarkeTrak VIII: 25-Year Trends in the Hearing Health Market. The Hearing Review, October.
[4] National Institutes of Health. Hearing Aid Fact Sheet. http://report.nih.gov/nihfactsheets/viewfactsheet.aspx?csid=95. Accessed on November 4, 2013.
[5] 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.
[6] Internal Cochlear Data on File. June, 2009.