08:46 AM EDT, 11/01/2024 (MT Newswires) -- Envoy Medical ( COCH ) said Friday the US Food and Drug Administration approved its investigational device exemption application to start a pivotal clinical trial of the Acclaim Cochlear Implant hearing device.

The Acclaim technology has an implanted sensor designed for the natural anatomy of the ear to capture sound, the company said.

The Acclaim Cochlear Implant received the FDA's breakthrough device designation in 2019, the hearing health company said.

Envoy shares were nearly 12% higher in recent premarket trading.