Wednesday, September 09, 2009

Cochlear Americas Announces FDA Approval of the Nucleus(R) 5 System, the Newest and Most Advanced Cochlear Implant System Life-Changing Technology Restores Hearing in People with Severe-to-Profound Hearing Loss

Source Link - Cochlear Americas Announces FDA Approval of the Nucleus(R) 5 System, the
Newest and Most Advanced Cochlear Implant System Life-Changing Technology Restores Hearing in People with Severe-to-Profound Hearing Loss


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

Nucleus is a registered trademark, and SmartSound, Set It and Go, and
AutoPhone are trademarks of Cochlear Limited. Cochlear and the elliptical logo
are trademarks of Cochlear Limited. Baha is a registered trademark of
Cochlear Bone Anchored Solutions AB.

SOURCE Cochlear Americas

Teresa Adkins, +1-303-524-7103, tadkins@cochlear.com, or Anna Czene-Hallinan,
+1-303-200-5423, aczene-hallinan@cochlear.com, both of Cochlear Americas; or
Media, Stephanie DeViteri of Dorland Global, +1-215-928-2385,
sdeviteri@dorland.com