Envoy Medical Completes Enrollment of Pivotal Clinical Trial Evaluating First-Of-Its-Kind Fully Implanted Cochlear Implant

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].