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| |  CLARION Cochlear Implant, New Bionic Ear Cleared by FDA SYLMAR, Calif., Aug. 20, 1996 -- A new bionic ear that allows deaf adults to hear again has received marketing clearance from the U.S. Food & Drug Administration. The CLARION(R) Cochlear Implant, developed by California-based Advanced Bionics(TM) Corporation, uses proprietary, advanced technology that can restore hearing to more than two million completely deaf adult Americans, and millions more worldwide. After a decade of development and clinical study at leading research centers nationwide, including the University of California San Francisco, University of Iowa, and the University of Miami -- surgeons can now offer CLARION to deaf adults throughout the United States. By combining advanced computer technology, electronic circuitry and sound processing strategies, CLARION transmits electrical signals directly to the auditory nerve which the brain can interpret as speech. The majority of deaf adult CLARION users are able to talk on the telephone and understand speech without lipreading. One hundred percent of adult users detect speech and sound at comfortable listening levels. "The CLARION cochlear implant gives profoundly deaf adults the chance to hear again," said Jeff Greiner, President and Chief Operating Officer of Advanced Bionics Corp. "For many people, deafness can be isolating and frightening. It weakens and damages the communicative function which is critical to both family interaction and productivity at work. With CLARION, deaf adults are able to return to leading more normal lives again both in the workplace and at home." "Getting a CLARION cochlear implant has given me the freedom to do whatever I want without having an interpreter with me 24-hours-a-day," said Angie Carranza, a third-year surgical resident at Baylor University Medical Center. "I am now able to pursue my dream of becoming a surgeon so that I can one day provide cochlear implants to other deaf people and give them the gift of hearing." Only Cochlear Implant Systems Manufactured in U.S. with FDA Clearance Advanced Bionics' pursuit of FDA clearance involved a significant investment in extensive research and development and pre-market testing. In August 1996, CLARION became the first cochlear implant cleared by the FDA in a decade and is the only FDA approved cochlear implant manufactured in the United States. CLARION has been approved for implantation in 26 countries worldwide, however, FDA approval standards are recognized as the highest in the world, reinforcing the fact that CLARION is safe, reliable and effective. "This is a labor of love, something that we've been working at for a long time," said Dr. Robert Schindler, a surgeon at the University of California San Francisco, who has been developing cochlear implants for more than 26 years. "This device has the potential for changing how deafness is dealt with worldwide. I'm thrilled that we are at a point where we can now make this technology available to everyone." Bypasses Damaged Parts of the Auditory System The CLARION cochlear implant is designed for profoundly deaf adults who are unable to understand speech with the use of hearing aids. Hearing aids simply amplify sound, while CLARION bypasses damaged parts of the inner ear and directly stimulates the auditory nerve. CLARION consists of both surgically implanted and externally worn components. The external components include a speech processor (usually worn on the belt like a pager), a headpiece (worn just behind the ear), and a thin cable that connects the two units. The internal parts include an implantable cochlear receiver/stimulator (ICS), and 16 tiny wires called an electrode array. Sound is picked up by a microphone in the headpiece and travels down a cable to the speech processor. The speech processor, which houses sophisticated computer programs, converts sound into electrical signals that travel back up the cable to the headpiece. Next, a small transmitter in the headpiece sends the signals to the receiver/stimulator that is surgically implanted under the skin. In turn, the receiver/stimulator delivers the signals to the electrode array located in the inner ear, thereby bypassing damaged parts of the auditory system and directly stimulating the auditory nerve. As in normal hearing, the auditory nerve carries the electrical signals to the brain where they are interpreted as sound. Customized for Individual Hearing Loss Because each person's hearing loss is different and can change over time, CLARION is designed for flexibility and individual customization. CLARION is the only cochlear implant with both digital and analog sound processing strategies, and with three user-defined computer programs to execute them. This flexibility provides users with the ability to maximize their hearing in different environments by simply flipping a switch on their speech processor. In addition, CLARION is designed to incorporate new technological advancements into its speech processor without having to replace internal or external components. 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. Advanced Bionics is a spin-off from the second largest heart pacemaker manufacturer in the world and in-vests millions of dollars annually for product improvements, research and development and next generation products. Its experience in implantable prostheses and miniaturization demonstrates the company's commitment to advanced technology for the disabled. Advanced Bionics is based in Sylmar, California.
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