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Cochlear Implant Designed For Individuals With Ossified Cochlea
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. |