Thread View: alt.support.hearing-loss
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Started by Martin Eden
Thu, 02 Nov 2000 19:38
FDA approves next generation...
Author: Martin Eden
Date: Thu, 02 Nov 2000 19:38
Date: Thu, 02 Nov 2000 19:38
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This is the one that *I* want. It's funny, I called the company last week
inquiring as to when this device would be approved by the FDA. They had no
idea when the FDA would approve the Contour. What's below is from the
company website.
----------------------------------------------------------
FDA APPROVES NEXT GENERATION COCHLEAR IMPLANT SYSTEM
Nucleus 24 Contour Cochlear Implant System Significantly Broadens
Eligibility
Criteria For Severe-To-Profoundly Deaf Adults and Children
DENVER (November 1, 2000) - 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 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 Ear Level Speech
Processor, worn
behind the ear. The SPrint Speech Processor, a body-worn processor.
It is the only cochlear implant with Neural Response Telemetry
(NRT), a
technological breakthrough. NRT provides information concerning the
hearing nerves
response to stimulation by the implant.
Broadest choice of speech coding strategies (CIS, ACE and SPEAK),
the software
programs used to convert pitch, loudness and timing of sound into
useful electrical
signals.
More than forty 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 over 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 www.cochlear.com.
Re: FDA approves next generation...
Author: Dan Hildebrand
Date: Sat, 04 Nov 2000 03:14
Date: Sat, 04 Nov 2000 03:14
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Hmm, not sure what the CI24M is. Is it the Nucleus 24 that you have? Probably. The N24 is the "tried and true", well established version of the Nucleus CI. When I had the chance to go N24 or Contour for my son, I chose the N24. Don't worry about it. Remember, there are people doing very well with the N22, the predecessor of the N24. You got a very good CI ... In article <8tt4ak$31f$1@bob.news.rcn.net>, "David Glaser" <glaser@ma.ultranet.com> wrote: > Hmmm, > > I have a CI24M implant from nucleus. Does this have that fancy telemetry > the contour > feature? > > I can't tell from looking at the web site. > > -david > ============================ > "Martin Eden" <Martin-Edenn@home.com> wrote in message > news:FojM5.76140$hD4.17483446@news1.rdc1.mi.home.com... > > This is the one that *I* want. It's funny, I called the company last week > > inquiring as to when this device would be approved by the FDA. They had > no > > idea when the FDA would approve the Contour. What's below is from the > > company website. > > > > > > ---------------------------------------------------------- > > FDA APPROVES NEXT GENERATION COCHLEAR IMPLANT SYSTEM > > > > Nucleus 24 Contour Cochlear Implant System Significantly Broadens > > Eligibility > > Criteria For Severe-To-Profoundly Deaf Adults and Children > > > > DENVER (November 1, 2000) - 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 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 Ear Level Speech > > Processor, worn > > behind the ear. The SPrint Speech Processor, a body-worn > processor. > > > > It is the only cochlear implant with Neural Response Telemetry > > (NRT), a > > technological breakthrough. NRT provides information concerning > the > > hearing nerves > > response to stimulation by the implant. > > > > Broadest choice of speech coding strategies (CIS, ACE and SPEAK), > > the software > > programs used to convert pitch, loudness and timing of sound into > > useful electrical > > signals. > > > > > > More than forty 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 over 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 www.cochlear.com. > > > > > > > > > > -- ---------------------------------------- Dan, Tehetina, and David Abel Hildebrand Beating Deafness A Little More Every Day http://www.netcom.com/~danhilde ---------------------------------------- Sent via Deja.com http://www.deja.com/ Before you buy.
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