CENTENNIAL, Colo., Nov. 11, 2013 /PRNewswire/ -- Cochlear
Limited (ASX: COH), the global leader in implantable hearing
solutions, announced today that an advisory committee to the US
Food and Drug Administration (FDA) voted favorably on the Cochlear™
Nucleus® Hybrid™ L24 Implant System. This is a first of its kind
system designed for the treatment of adults with severe to profound
sensorineural hearing loss in the high frequencies and normal to
only mild hearing loss in the low frequencies, often referred to as
"ski-slope" hearing loss. The panel, comprised of leading
physicians and researchers, voted in favor of the new Hybrid device
based on substantial clinical evidence demonstrating the safety and
efficacy of the Nucleus Hybrid System in patients who met the
candidacy criteria. The FDA is not bound by the recommendations of
its advisory committees, but will consider the guidance during the
final review of the new Hybrid device.
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"We are pleased with the panel's vote for the Nucleus Hybrid
System," said Chris Smith, President
of Cochlear Americas. "The notion of hybrid hearing is truly a
novel one that addresses an unmet need for people with hearing loss
by bridging the gap between hearing aids and cochlear implants.
This first-of-its-kind technology consists of a unique combination
of solutions to overcome high frequency hearing loss, which impairs
a person's ability to hear voices clearly and understand speech in
noise. This positive recommendation is an important first step to
giving thousands of patients the opportunity to hear much better
than was possible even with the most advanced hearing aids."
The Nucleus Hybrid System combines the natural hearing via
acoustic amplification of low frequencies with the electrical
stimulation of a cochlear implant for high frequencies in one
device. It is designed to deliver patients superior quality and
clarity of sound in even the most difficult hearing situations,
especially hearing in noisy environments.
"The Nucleus Hybrid System is a technological breakthrough when
it comes to treating patients with hearing loss," said Bruce J. Gantz, M.D., Head of the Department of
Otolaryngology – Head and Neck Surgery at the University of Iowa Carver College of Medicine and
Hybrid System clinical investigator. "This device will open the
doors to a whole new way of hearing both acoustically and
electrically for those patients who cannot be treated effectively
today with hearing aids."
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.
SOURCE Cochlear Limited