Envoy Medical Inc. (NASDAQ:COCH) announced on Tuesday that it has received U.S. Food and Drug Administration (FDA) approval to expand its pivotal clinical trial for the fully implanted Acclaim cochlear implant to the final stage, based on promising three-month data from the first 10 patients.
The FDA's approval of the expansion request removes a previously uncertain timing variable and allows the company to solidify its path toward regulatory approval.
