Advanced Bionics Announces Approval of the High Resolution Clarion® CII Bionic Ear®System in the US and Canada

Valencia, CA - Advanced Bionics Corporation (Bionics) today announced it received approval from the U.S. Food & Drug Administration (FDA) and Health Canada to market its high resolution CLARION CII Bionic Ear' System.

"The FDA and Health Canada approvals of our high resolution system open the doors to a new level of sound fidelity for cochlear implant users," stated Jeff Greiner, President and Co-Chief Executive Officer.

Approval for New High Resolution Sound Processing
The FDA approval includes the new High Resolution Sound Processing software, which had been in clinical trials for the last year. High Resolution Sound Processing is designed to provide deaf adults and children the fine details of sound and a more natural hearing nerve response.

"Ninety six percent (96%) of patients in the clinical trial preferred High Resolution Sound Processing to other conventional sound processing strategies," said Mary Joe Osberger, Ph.D., Director of Clinical Research. "Clinical studies demonstrate that music sounds better and speech sounds more natural for the majority of patients," she added.
This new technology is already approved in Canada. Bionics will commercially release the software used to program High Resolution Sound Processing to U.S. and Canadian cochlear implant centers in 2003.

Approval for Children 12 Months of Age and Older
The FDA approval now lowers the age at implantation in the United States from 18-months down to 12-months. The system is already available to Canadian children 12 months of age and older.

System Availability
Bionics will begin distribution of the system immediately. The system configuration will not include the separate component called the Positioner, which had been used in previous models. Clinical data show that efficacy results are indistinguishable between systems configured with and without the Positioner.

Advanced Bionics
Advanced Bionics is a leading innovator of bionic technologies, and is developing a range of implantable devices to treat deafness, chronic pain and urinary incontinence. For more information, visit www.bionicear.com or www.advancedbionics.com.