Envoy Medical, Inc.

Envoy Medical, Inc. is a hearing health company that develops innovative medical technologies for various types of hearing loss. The company aims to provide hearing devices that leverage the ear's natural anatomy, specifically by using an implanted sensor to capture sound energy from the ossicular chain (the three small hearing bones connecting the eardrum to the cochlea). This sensor converts mechanical energy into a signal that can be processed and amplified to meet a patient's specific hearing needs. Envoy Medical's initial product, the Esteem FI-AMEI, received FDA approval in 2010. It is the only FDA-approved fully implanted active hearing implant available. Despite its unique status, the Esteem FI-AMEI faced commercial challenges, primarily because the Centers for Medicaid and Medicare Services (CMS) classified it as a hearing aid, which limited coverage eligibility. The company continues to seek proper classification for the Esteem FI-AMEI as a Fully Implanted Active Middle Ear Implant. Globally, approximately 1,000 Esteem FI-AMEI devices have been implanted, including some during clinical trials in the early 2000s. This has provided Envoy Medical with over two decades of experience with its implantable sensor technology, which has demonstrated itself as a viable alternative to external or implanted microphones.