Initial Clinical Trial Results with New Bionic Ear Released

Editor: You've probably heard that the new "Bionic Ear" - also called the CII - from Advanced Bionics seems to offer significant improvement over previous CIs. Here are excerpts from the Advanced Bionics press release announcing the initial results of their clinical trials. The article is actually from August; I managed to lose it in my "highly sophisticated" <grin> filing system. The results are sufficiently interesting that I decided to publish the article now, anyway.

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Advanced Bionics Corporation released preliminary results from the North American clinical trial studying the high resolution Bionic Ear Mode* software for the CLARION CII Bionic Ear System.

"After just 3 days experience listening with the high resolution Bionic Ear Mode, study patients heard an average of 15 times better than they could before receiving the bionic ear," reported Mary Joe Osberger, Ph.D., Director of Clinical Research. "The first 8 patients programmed in the investigational Bionic Ear Mode scored, on average, 60% correct on the most difficult single syllable word tests without lipreading. The most recent clinical trial with conventional Cochlear Implant technology demonstrated that mean scores did not reach this level even after a full 3 months of listening experience. While the results are preliminary due to the small sample size, it is clear that these patients derived benefit from the new bionic ear technology," Dr. Osberger added.

CLARION CII Bionic Ear System

"The CLARION CII Bionic Ear System is designed to deliver vastly more sound information to the hearing nerve than conventional Cochlear Implants," stated Edward Overstreet, Ph.D., Clinical Engineer and neuroscientist. "When programmed in the investigational Bionic Ear Mode, sound information can be delivered up to 1,000,000 times each second, compared to under 20,000 times each second with other Cochlear Implant technology."

"The Bionic Ear differs from conventional Cochlear Implant technology in that it delivers substantially more sound information to the auditory nerve. It is expected that deaf and hard of hearing children and adults will have significantly improved hearing with the Bionic Ear," reported Dr. Franklin Rizer, M.D., a leading surgeon and researcher at the Lippy Group for ENT in Warren, Ohio.

There are an estimated 740,000 deaf adults and children in the United States who may benefit from this new medical breakthrough. Adults with severe-to-profound bilateral nerve deafness may participate in the clinical trial. Deaf children and adults who are not candidates for the clinical trial, yet want to receive the CLARION CII Bionic Ear System, may be implanted with the technology and have it programmed in FDA-approved Cochlear Implant Mode software. These adults and children will have access to full sound for better hearing when the Bionic Ear Mode software is approved and commercially released.