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.