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Thread View: alt.support.hearing-loss
2 messages
2 total messages Started by Martin Eden Thu, 02 Nov 2000 19:38
FDA approves next generation...
#162
Author: Martin Eden
Date: Thu, 02 Nov 2000 19:38
125 lines
6179 bytes
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...
#161
Author: Dan Hildebrand
Date: Sat, 04 Nov 2000 03:14
216 lines
7869 bytes
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
----------------------------------------


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