UCSF begins clinical trials for new bionic ear for profoundly deaf adults

June 06, 2001

UCSF researchers in the Department of Otolaryngology - Head and Neck Surgery will begin clinical trials this month of the Clarion® CII Bionic Earä cochlear implant to help adults with profound hearing loss to hear again.

The UCSF Douglas Grant Cochlear Implant Center is seeking patients eligible for the cochlear implant who are adults with severe-to-profound hearing loss and are unable to hear and understand speech, even with state-of-the-art digital hearing aids. An estimated 460,000 to 740,000 people in the United States are severely or profoundly hearing impaired and may benefit from cochlear implant surgery.

The clinical trials involve the use of new ways of processing speech designed to produce clear and recognizable speech using electrical currents to excite hearing nerve fibers and send the sound information from the outside device to the cochlear implant, then on to the brain.

The new speech processing strategies can be used only with the Clarion® CII Bionic Earä manufactured by Advanced Bionics Corporation, Valencia, Calif. The Clarion® CII Bionic Earä is approved by the U.S. Food and Drug Administration and is designed to bypass the damaged parts of the ear and directly stimulate the hearing nerve at very high speeds. The external part of the Clarion® CIIä Bionic Ear system converts speech and sound in the environment into digital code sending radio waves back to the surgically implanted bionic ear.

Anil Lalwani, MD, UCSF associate professor in the Department of Otolaryngology-Head and Neck Surgery, and colleagues Jan Larky, MA, CCC-A, coordinator of the UCSF Douglas Grant Cochlear Implant Center, and audiologist Colleen Polite, are screening adults with profound hearing loss for the clinical study.

Surgical placement of the implant generally takes three to four hours and requires an overnight stay. "The patient's head can be sore for a few days, but the results may change lives," Lalwani said. "When the outside device is turned on a month later, it is specifically programmed for each patient to hear sounds, perhaps for the first time. If a person has never heard the sound of a family member's voice, this is a phenomenon."

"Patients who have become isolated and depressed because of the inability to communicate with people around them find they have a new lease on life following the surgery," Larky added.

Lalwani is an expert in the field of cochlear implants, the genetics of deafness and the application of gene therapy for hearing disorders. Lalwani treats the full spectrum of otologic and neurotologic conditions in adults and children as chief of pediatric otology and neurotology, performing surgery for cochlear implants in both adults and children.

Most insurance companies including Medicare cover all or a percentage of the costs for the implant, externally worn processor, surgery, programming and follow-up office visits.

The Clarion® CIIä Bionic Ear took five years and $30 million to develop. Through electrical stimulation of the auditory nerve, the new device has an extremely high resolution which delivers sound information to the hearing nerve at a million times each second through 31 distinct stimulation audio channels. "The new equipment leads to better comprehension of speech because of the processing strategy of the cochlear implant," Lalwani said.

The new research options provided by use of the Clarion® CII Bionic Earä will foster the development of next-generation speech processors to improve speech understanding and sound quality for implant users, Lalwani said. More than 30 leading medical centers throughout North America are participating in clinical studies using the new system.
For questions about the study, please call Jan Larky at 415-353-2464. To contact researchers in the UCSF Department of Otolaryngology and Head and Neck Surgery, call Twink Stern at 415-476-2557.

University of California - San Francisco

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