FDA Approves Nucleus(R) 24 Double Array; Cochlear Implant Designed for Individuals With Ossified Cochlea

Jun 17, 2002, 01:00 ET from Cochlear Americas

    DENVER, June 17 /PRNewswire/ -- Cochlear Americas announced today that the
 Food and Drug Administration (FDA) approved the Nucleus(R) 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(TM) and Sprint(TM) 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(R) 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(R) 24 Contour(TM), the only cochlear
       implant system approved for use in infants as young as 12 months. The
       Nucleus(R) 24K, a cochlear implant with a small implant body and
       straight electrode array. The Nucleus(R) 24, the first implant developed
       for the Nucleus 24 family.  The Nucleus 24 Double Array, designed
       specifically for individuals with ossified cochlea.  The Nucleus(R) 24
       ABI, designed for those suffering from Neurofibromatosis Type II (NF2).
     * A choice of two speech processors: ESPrit(TM) 3G, a speech processor
       worn behind the ear.  The SPrint(TM), a body worn speech processor.
     * Nucleus(R) NRT(TM) 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(R) 24 Contour(TM) cochlear implant and the FDA Commissioner's Special
 Citation for the development and commercialization of the Nucleus(R) 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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SOURCE Cochlear Americas