UCSF Medical Center Seeking Participants for 'Bionic Ear' Study

June 07, 2001
News Office: Twink Stern (415) 502-6397

Researchers at UCSF Medical Center are studying a "bionic ear" cochlear implant to help adults with profound hearing loss. The medical center's Douglas Grant Cochlear Implant Center is seeking participants who are unable to hear, even with state-of-the-art digital hearing aids.

The study involves the Clarion CII Bionic Ear cochlear implant, which uses electrical currents to stimulate hearing nerve fibers and send sound information from an external device to the cochlear implant, then on to the brain. The device is made by Advanced Bionics Corp., Valencia, Calif., and is approved by the U.S. Food and Drug Administration. It is designed to bypass damaged parts of the ear and directly stimulate the hearing nerve at very high speeds. The external part of the bionic ear system converts speech and sound into digital code, sending radio waves back to the surgically implanted bionic ear.

The team at UCSF Medical Center including Dr. Anil Lalwani, an ear, nose and throat specialist)and surgeon; Jan Larky, an audiologist and coordinator of the Douglas Grant Cochlear Implant Center; and audiologist Colleen Polite -- are screening adults for the clinical study.

Surgical placement of the implant generally takes three to four hours and requires an overnight hospital stay. Lalwani said, "The patient's head can be sore for a few days, but the results may change lives. 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."

Larky added, "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."

Lalwani is an expert in the field of cochlear implants, the genetics of deafness and the application of gene therapy for hearing disorders. He 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 processor, surgery, programming and follow-up office visits.

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 Clarion CII 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 Ear 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 (415) 353-2464.