Core Insights - Envoy Medical's pivotal clinical trial for the fully implanted Acclaim® Cochlear Implant is progressing positively, with all 10 participants completing their one-month follow-up visits successfully [1][2][3] - The device allows participants to hear without externally worn devices, providing continuous hearing capability, and no serious adverse events have been reported [2][3] - The CEO of Envoy Medical expressed optimism about the trial's momentum and the potential for rapid market entry if the device receives approval [3] Company Overview - Envoy Medical, Inc. (NASDAQ: COCH) specializes in innovative hearing health technologies, focusing on fully implanted devices for hearing loss [5] - The company has previously launched the Esteem® active middle ear implant, which has been available in the U.S. since 2010, and is now advancing the Acclaim® cochlear implant [5] - The Acclaim CI is designed for individuals with severe to profound sensorineural hearing loss and has received Breakthrough Device Designation from the FDA [8] Product Details - The Acclaim CI utilizes a sensor that leverages the ear's natural anatomy instead of a microphone, powered by a rechargeable battery [6][7] - The device is intended for adults deemed suitable candidates by qualified physicians and aims to address hearing loss inadequately managed by traditional hearing aids [8] - The Esteem FI-AMEI is highlighted as the only FDA-approved fully implanted hearing device for moderate to severe sensorineural hearing loss, offering 24/7 hearing without external components [9]