Envoy Medical develops implanted hearing devices that convert mechanical energy from the ear's natural structures into amplified sound signals. The company's first product, the Esteem FI-AMEI, is a fully implanted active hearing implant approved by the FDA but has seen limited adoption due to reimbursement barriers; its primary focus is on the Acclaim CI, an investigational fully implanted cochlear implant that enables continuous 24-hour use, water functionality, and reduced external components compared to traditional cochlear implants. Envoy addresses the approximately 2.8 million U.S. adults eligible for cochlear implants but not currently treated, operating in a market dominated by three major competitors with established relationships and substantially greater resources, while pursuing FDA approval as the foundation for broader commercialization through selective surgical centers and physician partnerships.