Envoy Medical, Inc. is a clinical-stage and commercial medical technology company focused on advancing novel hearing health solutions across the hearing loss spectrum. The company's primary innovation is the development of fully implanted hearing prostheses that leverage the natural structure of the ear—specifically using a piezoelectric sensor affixed to the ossicular chain rather than an external microphone or external hardware. This design eliminates external microphones and sound processors, allowing recipients to shower, swim, and sleep without removing equipment.
Envoy Medical's product portfolio centers on two primary technologies: Esteem and Acclaim. The Esteem Fully Implanted Active Middle Ear Implant (FI-AMEI) received FDA Premarket Approval (PMA) in 2010 for adults with moderate to severe sensorineural hearing loss. Its pipeline candidate, the Acclaim Cochlear Implant, was granted FDA Breakthrough Device Designation in 2019 and is an investigational, fully implanted cochlear implant designed for severe-to-profound hearing loss, undergoing pivotal clinical trials in the United States.
The company operates as a single reportable operating segment, termed 'hearing.' Its commercial revenue is derived entirely from the sale of Esteem FI-AMEI devices, replacement sound processors, and replacement batteries (which typically require surgical replacement every several years). In fiscal years 2024 and 2025, annual revenues were modest ($225,000 and $241,000, respectively), with the overwhelming majority of capital directed toward research and development and the pivotal clinical study of Acclaim. Envoy Medical competes in the broader auditory implant market alongside major global players such as Cochlear Limited, MED-EL, and Sonova (Advanced Bionics).
