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FDA Approves First Totally Implanted Hearing System
Date:3/17/2010

In a multicenter clinical study of Esteem versus pre-implant hearing aids, 93 percent of Esteem recipients scored equal to or better than their pre-implant hearing aids on a speech intelligibility test. Seven percent scored less than with their pre-implant hearing aids, and 56 percent scored better than with their pre-implant hearing aids.

Seven percent of participants experienced facial paralysis, and 42 percent experienced taste disturbance, both of which are results of the surgical procedure necessary to implant the device. The majority of these adverse events resolved during the one-year study period.

As a condition of FDA approval, Esteem manufacturer, Envoy Medical Corporation of St. Paul, Minn., must conduct two post-approval studies. In one study, Envoy must continue to follow-up on 61 subjects from the original study for five years to study safety and effectiveness. Another study of 120 newly enrolled subjects will include an evaluation of the incidence of facial paralysis at one month after implantation, and evaluate the effectiveness of Esteem five years after implantation.

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SOURCE U.S. Food and Drug Administration
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