FDA Approves ESPrit

Editor: The Cochlear ESPrit (TM) 3G behind the ear (BTE) speech processor has been approved for use in the US by the FDA. Cochlear Corp says that the new processor is intended to help users hear more clearly in all environments. Here are portions of the press release.

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Cochlear Americas announced today that the U.S. Food and Drug Administration (FDA) cleared the ESPrit (TM) 3G behind the ear (BTE) speech processor for sale in the U.S.

The ESPrit 3G is a breakthrough in performance, comfort, convenience and design for cochlear implant recipients. It is designed to help recipients hear clearly in all environments. The ESPrit 3G is compatible with all Nucleus(R) 24 cochlear implants, including the revolutionary Nucleus(R) 24 Contour(TM).

The ESPrit 3G is the only BTE in the cochlear implant industry to offer:

* A built-in telecoil that allows recipients wireless access to hearing-aid compatible telephones. The built-in telecoil also allows listeners to connect to sound systems in public venues with assistive listening devices, which minimize background noise and help recipients to fully experience activities such as movies, concerts and lectures.

* The Whisper setting, which improves the audibility of soft and moderate speech. Ideal for use during dinner parties, watching television, listening to soft speakers or someone in the distance.

* An unprecedented average of fifty-four hours of battery life, allowing recipients to go all day without changing batteries.

* All three Nucleus digital speech coding strategies -- ACE(TM), CIS and SPEAK -- designed to allow users to hear clearly in all environments.

* Sleek, stylish design in a range of twelve brilliant colors. With a weight of only 15 grams with batteries and an adjustable earhook, it is suitable for both adults and children.

"The ESPrit 3G is a significant breakthrough in this technology because it is the first speech processor designed to allow recipients to concentrate on their lives instead of their hearing loss," said Jim Miller, president, Cochlear Americas. "The built-in telecoil, extended battery life and novel Whisper Setting allow recipients to participate in activities that they enjoy without the difficulties associated with conventional external devices."

The ESPrit 3G BTE speech processor will be included in Cochlear Americas' newly introduced product range -- the Nucleus(R) 3 system. The Nucleus 3 system can be customized to meet the particular needs of recipients' lifestyles and to maximize hearing performance.

The Nucleus 3 system offers the following products:

* Nucleus 24 Contour cochlear implant system. The only cochlear implant system approved for use in infants as young as 12 months.

* A choice of two speech processors: ESPrit 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.