Envoy Medical presents early data from cochlear implant trial
Envoy Medical presented early data from the first 10 patients in its pivotal trial of the Acclaim fully implanted cochlear implant, showing improved speech recognition, quality of life, and high device usage with no serious adverse events. Patients reported benefits including 24-hour hearing, invisibility, and use during water activities or exercise. The device has FDA Breakthrough Device Designation, with additional clinical data expected at upcoming conferences. Despite positive trial results, the company's stock has declined significantly over the past year.
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WHITE BEAR LAKE, Minn. - Envoy Medical Inc. (NASDAQ:COCH) presented initial clinical data from the first 10 patients in its pivotal trial of the investigational Acclaim cochlear implant, according to a press release statement. The planned interim analysis followed completion of six-month follow-up visits for the first patients. Data was presented by Dr. Elizabeth Camposeo at the American Academy of Audiology Annual Conference and Dr. Theodore McRackan at the Combined Otolaryngology Spring Meetings over the weekend. The company reported no serious adverse events as defined by the study protocol. Adverse events were described as mild or moderate and resolved with routine care or programming adjustments. Speech recognition scores showed improvement from baseline to six months.
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