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DENVER - June 17, 2002 - Cochlear
Americas announced today that the Food and Drug Administration
(FDA) approved the Nucleus® 24 Double Array cochlear
implant for use in patients with ossification (bone
growth) in their cochlea (inner ear). This bone growth
may block the space inside the cochlea preventing the
use of conventional cochlear implants, which consist
of a single array of electrodes.
The Nucleus 24 Double Array, developed in collaboration
with Professor Lenarz at the ORL Clinic, Medical University
Hannover, allows patients with significantly ossified
cochlea to gain the benefits of cochlear implantation
by offering two shorter electrode arrays. Unlike a single
electrode array, these shorter electrodes arrays are
surgically implanted into two different positions in
the cochlea bypassing ossification that may be obstructing
the passage way.
"The Nucleus 24 Double Array is an innovative
solution offering patients with ossified cochlea the
option to benefit from cochlear implants," said
Jim Miller, president, Cochlear Americas. "We are
delighted that the collaborative efforts of Cochlear
Americas and Professor Lenarz resulted in a product
that provides an alternative to patients who, due to
this disorder, could not normally benefit from a cochlear
implant."
Additional features of the Nucleus 24 Double Array:
* Two electrode arrays, providing 22 channels of stimulation.
* Compact arrays, each consisting of 11 electrodes,
designed to provide the most sound information over
the shortest distance.
* Thin and tapered electrode arrays for easy insertion.
* Supports SPEAK, CIS and ACE speech coding strategies
to help maximize hearing performance.
* Compatible with the ESPrit 3G™ and Sprint™
speech processors.
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 to the auditory system to the brain for
interpretation.
The Nucleus 24 Double Array cochlear implant will be
included in Cochlear Americas' newly introduced product
range - the Nucleus® 3 system. The Nucleus 3 system
is a state-of-the-art family of products launched this
year, which marks the 20th anniversary of the first
commercial cochlear implantation. The Nucleus 3 system
can be customized to meet the particular needs of recipients'
lifestyles and to maximize hearing performance.
Nucleus 3 Features
The Nucleus 3 system offers the following products:
* An internal component: Nucleus® 24 Contour™,
the only cochlear implant system approved for use in
infants as young as 12 months. The Nucleus® 24K,
a cochlear implant with a small implant body and straight
electrode array. The Nucleus® 24, the first implant
developed for the Nucleus 24 family. The Nucleus 24
Double Array, designed specifically for individuals
with ossified cochlea. The Nucleus® 24 ABI, designed
for those suffering from Neurofibromatosis Type II (NF2).
* A choice of two speech processors: ESPrit™
3G, a speech processor worn behind the ear. The SPrint™,
a body worn speech processor.
* Nucleus® NRT™ 3.0 (Neural Response Telemetry).
Third Generation Neural Response Telemetry which provides
information concerning the hearing nerves response to
stimulation by the implant, and is particularly useful
in very young children.
Denver-based Cochlear Americas is the
U.S. headquarters for Cochlear Limited, the world leader
in cochlear implant technology. Cochlear is a winner
of the 2001 Medical Design Excellence Awards for its
design of the Nucleus® 24 Contour™ cochlear
implant and the FDA Commissioner's Special Citation
for the development and commercialization of the Nucleus®
24 Multichannel Auditory Brainstem Implant. For more
information about Cochlear's products, call the Nucleus
Hotline at 800/458-4999 (Voice), or 800/483-3123 (TDD)
or visit their Web site at http://www.cochlear.com.
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