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Med-El Launches Electric-Acoustic System Clinical Trial

Editor: You may have heard of the "hybrid" cochlear implant and hearing aid, in which the hearing aid provides the low frequency sound and the cochlear implant provides the high frequency sound. Med-El is initiating a trial of their technology and are looking for subjects!

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July 2008

Med-El Corporation launched a U.S. Food and Drug Administration clinical trial for the study of the Electric-Acoustic System (EAS). This investigational device combines a cochlear implant system with hearing aid technology. EAS is designed to provide benefits in speech perception and sound quality to a population of people with residual low-frequency hearing who would not be considered as cochlear implant candidates.

Combined electric-acoustic stimulation uses hearing aid and cochlear implant (CI) technology in the same ear. The hearing aid acoustically amplifies low frequencies, while the CI electrically stimulates the middle and high frequencies. The inner ear processes acoustic and electric stimuli simultaneously.Results of international studies show a highly synergistic effect between hearing aid and cochlear implant technology. The clinical trial will demonstrate the safety and benefit of the new EAS system, as well as monitor residual hearing levels to ensure remaining hearing can be functionally maintained.

EAS uses the investigational electrode designed for atraumatic insertion so that residual hearing is preserved. In addition, special surgical techniques are employed to preserve remaining hearing in the ear receiving the implant. Approximately 55 subjects will be implanted with the EAS at approximately 15 study sites and will be involved with the investigation for 15 months.

Trial sites are still recruiting subjects, who must be adults with moderate sloping to severe/profound hearing loss in the ear to be implanted, and who have received minimal benefit from optimally fit hearing aid(s). Contact Med-El at 888-633-3524 or implants@medelus.com.