Advanced Bionics Announces CII

March 2001

Editor: Advanced Bionics recently announced that its CLARION(r) CII Bionic Ear(tm) System received limited U.S. Food and Drug Administration (FDA) approval for the treatment of deafness in children and adults. The limitation is that it must be operated in the "conventional" (emulation) mode for now. The complete capabilities of the CII will not revealed until this restriction is lifted, hopefully in the next year. Here are portions of the press release.

~~~~~~~~~~~~~~~~~~~

Introducing the CLARION(r) CII Bionic Ear(tm) System*

. FDA APPROVED when operating in software restricted conventional cochlear implant mode**

. Available April 2001 at all CLARION Implant Centers

. Internal memory banks support powerful BROADBAND capabilities

. More than 10 times FASTER than any other conventional cochlear implant for high resolution signal delivery

. Up to 31 stimulation channels deliver the HIGHEST FIDELITY sound signal possible

. Innovative HIGH RESOLUTION software upgrade will allow users to take advantage of future technological developments

. Smart Control Electronics provide POWER efficiency for extended operating times with the CII BTE(tm)

Advancements in cochlear implant technology over the past twenty years have demonstrated that the ability to provide more sound information to the hearing nerve has resulted in increased user PERFORMANCE. Conventional cochlear implants have been limited in their ability to deliver a full or complete sound signal. The newly FDA APPROVED CLARION(r) CII Bionic Ear(tm) is a new generation cochlear implant with vastly increased performance capability never before seen in the industry. The CII Bionic Ear is designed to increase user performance through both powerful and INNOVATIVE technology.

"The CII Bionic Ear is clearly a major leap forward in implant technology. The CII provides a host of new research options for the scientific community, which will foster the development of next-generation speech processors to improve speech understanding and sound quality for implant users"
Dr. Robert Shannon, Ph.D., Director of Auditory Implant Research at the House Ear Institute in Los Angeles and one of the world's leading authorities in the field of Auditory Perceptual Research.

In high resolution mode, the CLARION(r) CII Bionic Ear(tm) can deliver sound information to the hearing nerve up to 1,000,000 times per second through 31 distinct audio processing channels. Special state- of-the-art safeguard electronics are designed to ensure that the high resolution CII Bionic Ear delivers the full broadband sound information to the hearing nerve safely and effectively. The system also utilizes the latest advances in focusing electrode technology and powerful miniature sound processor electronics to provide the HIGHEST FIDELITY to its users.*

Alternatively, the CII Bionic Ear can also operate in EMULATION mode where its high resolution functions are limited by software to that of the proven and leading conventional CLARION cochlear implant.

"The electronic platform of the CLARION CII Bionic Ear provides the versatility required to implement many exciting advances from research on cochlear implants. Its extraordinary capability to deliver the fine details of sound in high resolution will provide the hearing health profession with a powerful tool to manage children and adults with severe and profound hearing loss. This is how deafness will be treated worldwide over the next decade."
Dr. Gerald Loeb, M.D., Professor of Biomedical Engineering at USC, a world renowned scientist who was one of the original developers of cochlear implants and whose research has been published in Science, Journal of Neuroscience, Annals of Otology, Rhinology and Laryngology, and Scientific American.

In emulation mode, the CII Bionic Ear is restricted to the implementation of sound processing strategies such as CIS, MPS, and SAS, and is fully commercially approved for use in both adults and children 18 months or older.

The CII Bionic Ear electronics are also designed for optimal POWER efficiency. The rechargeable battery module of the full capability CII BTE(tm) (Behind-the-Ear) sound processor provides extended operating times between recharge cycles and results in low battery replacement cost. The CII BTE (for use with the CII Bionic Ear System) and the Platinum BTE(tm) (for use with current users) are fully FDA approved. Users who receive the CII Bionic Ear in emulation mode (available at all CLARION cochlear implant centers) can switch to high resolution broadband sound delivery mode at a later date through a simple software upgrade that does not require any surgery. HIGH RESOLUTION mode software is being evaluated as part of clinical trials in a limited number of clinics and is expected to receive regulatory clearance from the FDA within the next year.

* CAUTION: High Resolution broadband information sound delivery is limited to investigational use only.

** Approved for use in both adults and children 18 months or older.