FDA Approves CLARION

Editor: Regular readers know that the CLARION HiFocus Electrode seems to significantly improve the performance of the CLARION Cochlear Implants. Available experimentally for some time, they are now approved by the FDA for postlingually deafened adults. Here are excerpts from the press release.

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California-based Advanced Bionics Corporation today announced that its new CLARION HiFocus Electrode has received approval from the U.S. Food and Drug Administration (FDA) for use in postlingually deafened adults.

"Scientists have attempted for many years to develop an electrode that can selectively stimulate targeted groups of hearing nerve fibers," announced Jeff Greiner, President of Advanced Bionics. "The HiFocus Electrode is the first FDA approved technology which is designed to achieve this goal," Mr. Greiner added.

The HiFocus Electrode is a critical component of the CLARION cochlear implant system and is responsible for delivering sound information in the form of electrical current to the deafened ear. The new technology allows, for the first time, focused directional coupling between a cochlear implant system and a deaf patient's auditory nerve, which may result in major performance benefits to deaf patients.

"Advanced Bionics is proud to be the first in the race to get this technology to market because patient performance results have exceeded our expectations," stated Albert Maltan, Vice President of Product Management.

"The HiFocus Electrode provides deaf adults with the ability to hear significantly better than they could with any other hearing device technology before surgical implantation," noted Dr. Mary Joe Osberger, Director of Clinical Research. Dr. Osberger further reported that "with the new electrode, less electrical current is required to elicit hearing in deaf adults, which is evidence that the electrode is positioned in close proximity to the auditory nerve. And, the clear majority of adults (> 90%) hear best when the HiFocus Electrode delivers information to multiple electrode contacts at the same time simultaneously, which suggests that the electrode is focusing stimulation on the targeted nerve fibers."

"During my junior year at Purdue I went completely deaf after contracting spinal meningitis," said Scott Hebl, a 23-year-old recipient of the CLARION Cochlear Implant with HiFocus Electrode. "It was the most frightening experience of my life. I couldn't hear my friends. I couldn't hear my professors. I couldn't hear a thing. I didn't know what the future would hold for me or if I could finish my degree and live my life normally," recalled Scott. "Getting my hearing back was amazing. I went from total silence to hearing and have since finished my degree, reconnected with friends and family, and returned to listening to music again. What a miracle!"

CLARION HiFocus Electrode Design Features

The HiFocus Electrode is designed to consistently deliver focused stimulation toward the auditory nerve as a result of the invention of special dielectric partitions and directionally focused electrode contacts. Dielectric partitions are "pillow-like" elevations less than 1 mm high that are engineered to prevent electrical current from spreading to un-targeted nerve fibers. The partitions are further designed to buffer the inner wall of the fragile cochlea from contact with the platinum iridium electrode contacts.

The 16 independent electrode contacts are spaced along the inner surface of the electrode array, and are oriented toward the neural elements. The electrode array has soft forward bending properties to facilitate easy surgical insertion into the pea-sized human cochlea, and is engineered to avoid constrictive pressure against the inner cochlear wall. The HiFocus Electrode is guided into position during surgery by the use of the patented Electrode Positioning System(TM) (Positioner). The Positioner is also designed to occupy the space in the human cochlea where scar (fibrous) tissue can form. This may be important for cochlear implant users, especially children, who will make use of future technologies in their lifetimes.

How a Cochlear Implant Works

Multichannel cochlear implants are a clinically proven treatment for severe to profound sensorineural hearing loss in both ears (nerve deafness) and have been in use since the 1980s. They consist of externally worn and surgically implanted components. The externally worn components capture sound in the environment and process it into digital code. The digital code is transmitted via radio waves to the surgically implanted electronics, which deliver electrical impulses via the electrode array. The electrode array is inserted into the inner ear and delivers electrical current to hearing nerve fibers. The nerve fibers then carry the electrical signals to the brain where they are heard as sound.

Candidates for Cochlear Implants

Deaf children as young as 12 months and adults of all ages are considered candidates for a cochlear implant if they have severe to profound sensorineural hearing loss (greater than 70 dB) in both ears. Cochlear implants are covered by most private health insurance carriers and Medicare, and are available at leading medical centers around the world.

Committed to Helping People Overcome Disabilities

Founded by noted philanthropist and businessman Alfred E. Mann, Advanced Bionics is committed to helping people overcome their disabilities and achieve independence through the use of innovative bionic devices. Advanced Bionics evolved from the world's second largest heart pacemaker manufacturer (Pacesetter Systems) and the largest manufacturer of external and implantable insulin pumps (MiniMed, Inc. (NASDAQ:MNMD) ). It is the only American manufacturer of multichannel cochlear implants and invests millions of dollars annually for product improvements, research and development and next generation products. The company employs over 350 scientists, engineers and professionals around the globe and is one of the fastest growing medical device manufacturers in the world. Its experience in implantable prostheses and miniaturization demonstrates the company's commitment to advanced technology for the disabled.