Wednesday November 1, 4:36 pm Eastern Time
Press Release

SOURCE: Cochlear Corporation

FDA Approves Next Generation Cochlear Implant System

Nucleus(R) 24 Contour(TM) Cochlear Implant System Significantly
Broadens Eligibility Criteria for Severe-To-Profoundly Deaf Adults and Children

DENVER, Nov. 1 /PRNewswire/ -- Cochlear Corporation announced today that the U.S. Food and Drug Administration (FDA) approved the Nucleus 24 Contour cochlear implant system. This system broadens the eligibility criteria for cochlear implant candidates to include infants as young as 12 months and individuals with more residual hearing. The device -- the latest development in cochlear implant technology -- provides closer contact with the hearing nerves for improvements in sound quality, speech recognition and power efficiency.

The Nucleus 24 Contour's unique self-curling electrode array matches the curvature of the average cochlea, allowing closer
proximity of electrodes to the hearing nerve fibers. The device has the ability to stimulate 22 sites along the cochlea, allowing a
broad pitch range of sound, which can enhance speech recognition. The small size of the device simplifies surgery and reduces pressure on cochlear structures making it well suited for very young children.

``The Nucleus 24 Contour cochlear implant system is a significant advance in the field of cochlear implant technology because it
broadens the candidacy criteria allowing younger children and those with more residual hearing to restore or experience the
sense of hearing,'' said Ron West, President, Cochlear Corporation. ``Early implantation is important because research has shown that it allows auditory and verbal development at rates comparable to the child's hearing peers.''

``The unique design of the Nucleus® 24 Contour(TM) places the electrodes closer to the hearing nerves,'' said Noel Cohen, M.D., Professor and Chairman, Department of Otolaryngology, New York University Medical Center. ``The device is smaller than the previous design, making it appropriate for younger children. The new electrode is much simpler to insert thus decreasing the likelihood of trauma to the cochlea.''


Additional Nucleus 24 Contour Design Features


The Nucleus 24 Contour also offers the following additional features:
A choice of two speech processors: ESPrit(TM) Ear Level Speech Processor, worn behind the ear. The SPrint(TM) Speech
Processor, a body-worn processor. 

-- It is the only cochlear implant with Neural Response Telemetry
(NRT(TM)), a technological breakthrough. NRT provides information
concerning the hearing nerves response to stimulation by the implant.

-- Broadest choice of speech coding strategies (CIS, ACE(TM) and SPEAK), the software programs used to convert pitch, loudness and timing of sound into useful electrical signals.


More than 40 medical centers across the United States participated in clinical trials for the Nucleus 24 Contour. To date, more than 450 people in the United States have been successfully implanted with the device with a total of 600 worldwide.


How a cochlear implant works

A cochlear implant bypasses damaged hair cells and directly stimulates the hearing nerve fibers in the cochlea (inner ear). A
small, directional microphone located in the headset at the ear picks up sounds. Sound is carried through a cord to the speech
processor, which is a powerful miniaturized computer that filters, analyzes and digitizes sounds into coded signals and sends
them to the transmitting coil. The transmitting coil sends them as FM radio signals to the cochlear implant located under the
skin. Appropriate electrical energy is delivered to the array of electrodes, which has been inserted into the cochlea, stimulating
the auditory nerve fibers. Sound is sent through the auditory system to the brain for interpretation.


Candidacy requirements

Candidates for the Nucleus 24 Contour cochlear implant system must meet the following criteria: age 12 months and older (no
upper age limit); severe-to-profound sensorineural hearing loss in adults and profound sensorineural hearing loss in children in
both ears; and no medical contraindications.

Denver-based Cochlear Corporation is the U.S. headquarters of Cochlear Limited, the world leader in cochlear implant
technology.

For more information about the Nucleus 24 Contour cochlear implant system call the Cochlear Implant Information Center at
800-458-4999 (voice), 800-483-3123 (TDD) or visit their website at http://www.cochlear.com.