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Cochlear Corporation Nucleus CI

Cochlear Corporation, located in Australia, developed and pioneered the cochlear implant. Their CI is called the Nucleus.

December 2000 - The FDA has approved the newest Cochlear Implant from Cochlear Corporation. Called the Nucleus 24 Contour, this system places the electrode array closer to the auditory nerve for improved performance.

April 2001 - Cochlear Corporation announces that their Nucleus 24 implant will soon incorporate a Phonak FM System.

March 2002 - FDA Approves ESPrit(TM) 3G Behind The Ear Speech Processor

September 2003 - Cochlear announces their next generation implant.

November 2003 - Here's our report on the Cochlear presentation at ALDAcon 2003.

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FDA Approves Nucleus 24 Contour Cochlear Implant

Editor: The FDA has approved the newest Cochlear Implant from Cochlear Corporation. Called the Nucleus 24 Contour, this system places the electrode array closer to the auditory nerve for improved performance. Here are excerpts from the press release

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Cochlear Corporation announced today that the U.S. Food and Drug Administration (FDA) approved the Nucleus 24 Contour cochlear implant system. This system broadens the eligibility criteria for cochlear implant candidates to include infants as young as 12 months and individuals with more residual hearing. The device -- the latest development in cochlear implant technology -- provides closer contact with the hearing nerves for improvements in sound quality, speech recognition and power efficiency.

The Nucleus 24 Contour's unique self-curling electrode array matches the curvature of the average cochlea, allowing closer proximity of electrodes to the hearing nerve fibers. The device has the ability to stimulate 22 sites along the cochlea, allowing a broad pitch range of sound, which can enhance speech recognition. The small size of the device simplifies surgery and reduces pressure on cochlear structures making it well suited for very young children.

The Nucleus 24 Contour also offers the following additional features:

1. A choice of two speech processors: ESPrit(TM) Ear Level Speech Processor, worn behind the ear, or the SPrint(TM) Speech Processor, a body-worn processor.

2. It is the only cochlear implant with Neural Response Telemetry (NRT(TM)), a technological breakthrough. NRT provides information concerning the hearing nerves response to stimulation by the implant.

3. Broadest choice of speech coding strategies (CIS, ACE(TM) and SPEAK), the software programs used to convert pitch, loudness and timing of sound into useful electrical signals.

More than 40 medical centers across the United States participated in clinical trials for the Nucleus 24 Contour. To date, more than 450 people in the United States have been successfully implanted with the device with a total of 600 worldwide.

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 through the auditory system to the brain for interpretation.

Candidacy requirements

Candidates for the Nucleus 24 Contour cochlear implant system must meet the following criteria: age 12 months and older (no upper age limit); severe-to-profound sensorineural hearing loss in adults and profound sensorineural hearing loss in children in both ears; and no medical contraindications.

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Cochlear CI to Incorporate Phonak FM System

Editor: Cochlear Corporation and Phonak recently announced that they would work together to provide Phonak FM systems on Cochlear Corporation CIs. Hearing aid users who use these FM systems often rave about their effectiveness, so it seems like a natural extension for cochlear implants. Here's the press release.

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Phonak AG, Switzerland's number one manufacturer of technologically advanced hearing systems, recently signed an agreement for the global distribution of Phonak's miniaturized FM (Frequency Modulation) radio communication equipment via Cochlear Limited (Cochlear), the world's leading cochlear implant manufacturer.

"The collaboration between two world leaders in the race for optimum hearing solutions is a major step forward," said Peter Pfluger, CEO of the Phonak Group, "We firmly believe that a majority of cochlear implant patients could benefit greatly from FM technology and are delighted that we now offer that benefit as a team together with Cochlear Ltd.

"The agreement with Cochlear confirms our FM technology as the industry standard; it further raises its awareness in the ENT doctors' community and reinforces Phonak's position as the key player in this important segment," he said.

Mr Jack O'Mahony, President/Chief Executive Officer of Cochlear said this agreement demonstrates Cochlear's commitment to provide cutting edge technology for Nucleus recipients.

"As we continue to help more severely and profoundly hearing impaired children and adults, we know we must make it easier for them to lead a rich and fulfilling life in the hearing world. This agreement will provide benefits to our more than 30000 Nucleus recipients today and pave the way for successful outcomes for many more recipients in the future."

"Our mission is to be partners in hearing for life and this agreement is another improvement in the service we offer our recipients, their careers and teachers. As the application of FM technology for the hearing impaired is still evolving, we do not anticipate a significant material effect on revenues in the short term, but anticipate this technology will be a key element in future cochlear implant systems", he said.

Phonak FM products will be available via Cochlear's distribution network from the middle of 2001, and offered to cochlear implant patients to further enhance their hearing ability by means of state- of-the-art wireless communication technology.

The distribution agreement will provide Nucleus recipients with a proven integrated hearing solution, comprising implant, speech processor and wireless technology in more than 55 countries. Clinicians, hearing professionals and recipients will benefit by Cochlear providing a single reference point for technical support of this integrated system. In the future, Phonak's miniaturized MicroLink receivers will be directly integrated with Cochlear's speech processors - making the integrated solution even more attractive for cochlear recipients.

More than 30,000 people around the world already use a "Nucleus" cochlear implant, developed and manufactured by Cochlear and more than 6,000 new implant operations are performed each year. Over 50% of the candidates for a cochlear implantation are children.

As all hearing impaired individuals, cochlear recipients also struggle when they attempt to listen to competing conversations (for example in business meetings), in reverberating rooms (conference halls or restaurants) or when the speaker may be some distance away (for example, children in classrooms).

Phonak's range of wireless products (MicroVox, HandyMic transmitters and MicroLink receivers) helps overcome these challenges. These products improve the speech intelligibility by picking up the clearest possible signal directly at the source (i.e. the speaker's voice, a television, a phone etc.) and transmitting it wirelessly to a miniaturized receiver. This receiver delivers a high quality signal directly into the hearing instrument (for hearing-impaired people) or the speech processor (for cochlear implant recipients).

FM technology was traditionally used in special schools for hearing impaired children, where the teacher's voice is sent from a body-worn FM transmitter directly to a receiver clicked onto the child's hearing device. In this way the noise surrounding the teacher's voice is significantly decreased. The continuing improvements in this technology have made it possible that a large proportion of the hearing impaired children can now be educated in a normal mainstream school environment.

Similarly, children implanted with a Nucleus implant will now also benefit from this technology. The advent of FM technology and the trend to implant younger children means that more children with a Nucleus implant will now be educated in a normal classroom environment where they are learning with hearing peers.

The technology is also designed to provide improved understanding of speech for hearing-impaired adults. The HandyMic TX3 allows users to "zoom" in on individuals or groups of individuals in meetings or large settings. In the home environment, future products will allow a hearing impaired individual or a Nucleus recipient to receive high quality sound directly from the telephone or the television - fed into their hearing instrument or speech processor through the wireless FM link.

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FDA Approves ESPrit(TM) 3G Behind The Ear Speech Processor

March 2002

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.

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Cochlear Announces Next Generation Cochlear Implant

Editor: Cochlear Corporation has just announced its next-generation cochlear implant (CI). The big advantage over current CIs is an increased ability to upgrade the CI as technological improvements happen. In particular, the new CI will support upgrades in coding strategy, something current CIs can't do. Here are portions of the press release.

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DENVER - August 2003 - Cochlear Americas, manufacturer of the Cochlear Nucleus(r) line of implants and the world leader in cochlear implant technology, has forged yet another frontier in cochlear implant research - the percutaneous Contour AdvanceT cochlear implant. The percutaneous implant is a special type of cochlear implant that allows researchers to externally manipulate coding strategies. Coding strategies are the techniques used by the speech processor to translate sound into the signals the implant sends to the cochlea.

This new research platform is currently under clinical trials and not yet commercially available. The trials are designed to accelerate the development of new coding strategies to provide future patients with more advanced options. This type of research cannot be implemented with existing cochlear implants since the electronics are housed in the internal implant. The findings of the research will be applied to the design of Cochlear's future generations of cochlear implants. This research is being done in collaboration with the Research Triangle Institute and Duke University in Durham, North Carolina and Rocky Mountain Cochlear Implant Center in Denver, Colorado. The first patient to receive a cochlear implant with a percutaneous plug was implanted last month at Duke University.

[snip]

"We feel that the next major breakthrough in cochlear implant performance will be the result of advanced coding strategies," said Jim Miller, President, Cochlear Americas. "We are delighted that Dr. van den Honert will be leading us in this endeavor and hope that the research will result in future developments and opportunities for cochlear implant recipients."