UCSF Begins Clinical Trials For New Bionic Ear For Profoundly Deaf Adults

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

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

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

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

Surgical placement of the implant generally takes three to four hours andrequires 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 isturned on a month later, it is specifically programmed for each patient to hearsounds, perhaps for the first time. If a person has never heard the sound of afamily member's voice, this is a phenomenon."

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

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

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

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

The new research options provided by use of the Clarion CII Bionic Ear willfoster the development of next-generation speech processors to improve speechunderstanding and sound quality for implant users, Lalwani said. More than 30leading medical centers throughout North America are participating in clinicalstudies using the new system.