Envoy Medical, Inc.

Envoy Medical, Inc. (Nasdaq: ENVOY) is a hearing health company focused on developing and commercializing innovative medical technologies for patients across the hearing loss spectrum. The company's website is www.envoyhearing.com.

The company's primary product candidate is the Acclaim CI, a fully implanted cochlear implant designed to treat severe to profound sensorineural hearing loss. Unlike traditional partially implanted cochlear implants that require external components worn on or behind the ear, the Acclaim CI features no external hardware and leverages a piezoelectric sensor implanted in the middle ear to capture sound naturally. The device includes an implanted sound processor and rechargeable battery designed to last several days between wireless charges. The Acclaim CI received FDA Breakthrough Device Designation in 2019 and is currently in pivotal clinical trials, with the company anticipating FDA approval in late 2027 or early 2028.

Envoy Medical also maintains the Esteem FI-AMEI, a fully implanted active middle ear implant that received FDA approval in 2010 and remains the only FDA-approved fully implanted active hearing implant on the market. Though this product has not achieved significant commercial traction due to Medicare classification as a hearing aid rather than a prosthetic device, the company continues exploring potential reimbursement pathway changes through legislative efforts.

The company was formed through a business combination between Anzu Special Acquisition Corp I and Legacy Envoy Medical Corporation, which closed in late 2023. The transaction was completed with support from the Meteora FPA Parties and other investors.

Envoy Medical operates in a competitive market dominated by three major cochlear implant manufacturers: Cochlear Ltd., Advanced Bionics, and Med-El. The company's addressable market includes approximately 2.8 million adults in the United States who could qualify for cochlear implants, representing a potential market opportunity exceeding $80 billion based on estimated annual implantation rates of 25,000 to 30,000 procedures. The company is an early-stage medical device developer with a history of losses and has not yet generated significant revenue from product sales.