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FDA Approves Nucleus 24 Double Array

Cochlear Implant Designed For Individuals With Ossified Cochlea

DENVER 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 Commissioners Special Citation for the development and commercialization of the Nucleus 24 Multichannel Auditory Brainstem Implant.

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