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FDA Approves New Bionic Ear Technology: |
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SYLMAR, CALIF., MARCH 21 -- California-based innovator of medial implants, Advanced Bionics Corporation (r), today announced that its Clarion (r) CII Bionic Ear (tm) System received U.S. Food and Drug Administration (FDA) approval for the treatment of deafness in children and adults. The new bionic ear technology, which took five years and $30 million to develop, is approved for use in children and adults with profound hearing loss in both ears. An estimated 460,000 TO 740,000 people in the United States who are severley or profoundly hearing impaired may benefit from bionic ear surgery. Benefits of the Bionic Ear Technology Platform Clinical studies demonstrate that current cochlear implant technology provides pediatric and adult users with significantly better hearing than can be achieved with any other hearing device technology prior to surgical implantation. The CII Bionic Ear hardware has the capability to provide deaf children and adults with over 10 times more sound information thatn the fastest conventional implant technology. This broadband sand information can process the audio signal through as many as 31 distinct channels for the representation of fine detains of sound in high fidelity. "A quarter century of clinical research with auditory prostheses clearly shows that delivering more sound information to the auditory nerve results in significantly better quality hearing and speech understanding for deaf children and adults," reported Dr. Gerald Loeb, M.D., Professor of Biomedical Engineering at the University of Southern California, a world renowned scientist who was one of the original developers of cochlear implants and whose research has been published in Science, Journal of Neuroscience, Annals of Otology, Rhinology and Laryngology, and Scientific American. "The electronic platform of the CLARION CII Bionic Ear provides the versatility required to implement many exciting advances from research on cochlear implants. Its extraordinary capability to deliver the fine details of sound in high resolution will provide the hearing health profession with a powerful tool to manage children and adults with severe to profound hearing loss. This is how deafness will be treated worldwide over the next decade," Dr. Loeb stated. Researchers Leap to Explore Bionic Ear Capability "The CII Bionic Ear is clearly a major leap forward in implant technology. The CII provides a host of new research options for the scientific community, which will foster the development of next-generation speech processors to improve speech understanding and sound quality for implant users" says Dr. Robert Shannon, Ph.D., Director of Auditory Implant Research at the House Ear Institute in Los Angeles and one of the world's leading authorities in the field of Auditory Perceptual Research. Leading medical research centers throughout North America -- including Johns Hopkins University, House Ear Institute, and the University of California, San Francisco, together with 30 other leading medical centers -- are participating in clinical studies exploring the advanced capabilities and associated benefits of the CLARION CII Bionic Ear System. CLARION CII Bionic Ear System Components THE CII BIONIC EAR ENABLES CHILDREN AND ADULTS TO HEAR BY DELIVERING ELECTRICAL STIMULATION DIRECTLY TO THE HEARING NERVE. THE EXTERNAL PART OF THE SYSTEM CONVERTS SPEECH AND SOUND IN THE ENVIRONMENT INTO DIGITAL CODE, WHICH IS SENT VIA RADIO WAVES TO THE SURGICALLY IMPLANTED BIONIC EAR. THE CII BIONIC EAR'S ELECTRODES (IMPLANTED IN THE INNER EAR) DELIVER THE SOUND INFORMATION IN THE FORM OF ELECTRICAL CURRENT TO HEARING NERVE FIBERS. THE ELECTRICAL CURRENT EXCITES HEARING NERVE FIBERS, WHICH CARRY THE SOUND INFORMATION TO THE BRAIN AND ARE HEARD. THE CII BIONIC EAR UTILIZES THE PATENTED HIFOCUS(r) ELECTRODE TECHNOLOGY TO DELIVER ELECTRICAL CURRENT TO THE HEARING NERVE FIBERS. FROM BEGINNING TO END, THE PROCESS TAKES ONLY A FEW MILLISECONDS AND IS PERCEIVED IN REAL-TIME TO THE CII BIONIC EAR USER. The external sound processing electronics, which digitize sound in the environment, include the revolutionary CII BTE(tm). The CII BTE is a low profile, convenient, miniature processor that is worn behind the ear like a hearing aid. The ultra low power requirements of the CII Bionic Ear enable the CII BTE to operate for nearly a full day with proprietary rechargeable battery technology -- a highly favorable alternative to disposable batteries, which may cost users up to $2,000 annually. An alternative external processor is the size of a small pager and can be worn on the belt and is ideal for those who wish to conceal or protect the external components. Costs and Insurance Reimbursement Most insurance companies, including Medicare, cover all or a percentage of the costs for the new technology, surgery, programming and follow-up office or rehabilitation visits. Programming upgrades for the CII Bionic Ear can be executed in a brief office visit; this provides users with easy access to newly developed sound processing technology in the future. This offers the potential to reduce costs, manage children's hearing as they mature, and adapt more easily to other users' changing needs. Advanced Bionics: History, and new Strategic Business Units Founded by noted philanthropist and businessman Alfred E. Mann, Advanced Bionics is a multi-faceted organization, 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 developer and manufacturer of bionic ear technology, and invests millions of dollars annually for product improvements, research and development and next generation products. Advanced Bionics is also actively developing several other Strategic Business Units. These business units are working on technologies that are intended to improve the lives of patients challenged by stroke, urinary incontinence, chronic pain, and other critical medical problems. The Company employs over 400 scientists, engineers and professionals around the globe and is the fastest growing bionic technology company in the world. To view a video describing how the CII Bionic Ear works, please visit http://www.videonewswire.com/ADVANCEDBIONICS/032001/ |
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