Core Insights - Envoy Medical has completed enrollment for its pivotal clinical trial of the fully implanted Acclaim® cochlear implant, marking a significant milestone as the first cochlear implant company to achieve this in the U.S. [1][4] Company Overview - Envoy Medical, listed on NASDAQ as COCH, specializes in innovative hearing health technologies, including fully implanted devices for hearing loss [6]. - The company has previously launched the Esteem® active middle ear implant, which has been commercially available since 2010 [6]. Clinical Trial Details - The pivotal trial for the Acclaim cochlear implant received Breakthrough Device Designation from the FDA in 2019 and is currently under investigation [4][8]. - The trial involved 56 participants, with the final two patients implanted by Dr. Patrick Antonelli at the University of Florida [2][3]. - Following the completion of enrollment, the study will proceed with follow-up visits and data collection, with a PMA application to be submitted to the FDA after 12 months of data collection [3]. Product Features - The Acclaim cochlear implant is designed for adults with severe to profound sensorineural hearing loss and aims to provide a fully implanted solution without the need for an external processor [7][8]. - The device utilizes a sensor that leverages the natural anatomy of the ear to capture sound, representing a significant advancement over traditional cochlear implants [7].

As filed with the U.S. Securities and Exchange Commission on December 18, 2025. Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 Envoy Medical, Inc. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) (Primary Standard Industrial Classification Code Number) Delaware 3842 86-1369123 (IRS Employer Identification Number) 4875 White Bear ...

As filed with the U.S. Securities and Exchange Commission on December 18, 2025. Registration No. 333- (State or other jurisdiction of incorporation or organization) FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 Envoy Medical, Inc. (Exact name of registrant as specified in its charter) UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 (Primary Standard Industrial Classification Code Number) Delaware 3842 86-1369123 (IRS Employer Identification Number) 4875 White Bear ...

As filed with the U.S. Securities and Exchange Commission on December 1, 2025. Registration No. 333-290927 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 AMENDMENT NO. 1 TO FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 Envoy Medical, Inc. (Exact name of registrant as specified in its charter) Delaware 3842 86-1369123 (State or other jurisdiction of incorporation or organization) (Primary Standard Industrial Classification Code Number) (IRS Employer Identification ...

As filed with the U.S. Securities and Exchange Commission on December 1, 2025. Registration No. 333-290927 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 AMENDMENT NO. 1 TO FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 Envoy Medical, Inc. (Exact name of registrant as specified in its charter) Delaware 3842 86-1369123 (State or other jurisdiction of incorporation or organization) (Primary Standard Industrial Classification Code Number) (IRS Employer Identification ...

As filed with the U.S. Securities and Exchange Commission on October 17, 2025. Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 Envoy Medical, Inc. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) Delaware 3842 86-1369123 (Primary Standard Industrial Classification Code Number) (IRS Employer Identification Number) 4875 White Bear P ...