FDA
Approves Nucleus 24 Contour Cochlear Implant
Editor: The FDA has approved the newest Cochlear Implant from
Cochlear Corporation. Called the Nucleus 24 Contour, this system places
the electrode array closer to the auditory nerve for improved
performance. Here are excerpts from the press release
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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 also offers the following additional features:
1. A choice of two speech processors: ESPrit(TM) Ear Level Speech
Processor, worn behind the ear, or the SPrint(TM) Speech Processor, a
body-worn processor.
2. 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.
3. 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.
