Core Viewpoint - Envoy Medical has selected seven investigational sites for its pivotal clinical trial of the Acclaim® cochlear implant, with initial patient enrollment expected in Q1 2025 [2][3]. Company Overview - Envoy Medical, Inc. is a hearing health company focused on developing innovative solutions for hearing loss, specifically through its fully implanted Acclaim® cochlear implant [2][3]. Clinical Trial Details - The Investigational Device Exemption (IDE) for the Acclaim® cochlear implant study was approved by the FDA, which previously granted it Breakthrough Device Designation [3][10]. - The Acclaim CI is designed to be fully implanted without external components, utilizing the ear's natural anatomy for sound capture, allowing for all-day hearing with a multi-day rechargeable battery [3][9][10]. - The trial will involve seven cochlear implant centers, each with trained surgeons and audiologists dedicated to the study [5][6]. Study Sites - The selected investigational sites include: - Mayo Clinic, Rochester, Minnesota - Medical University of South Carolina, Charleston, South Carolina - University of Florida Health, Gainesville, Florida - Shohet Ear Associates, Seal Beach, California - Hearts for Hearing, Oklahoma City, Oklahoma - Center for Neurosciences, Tucson, Arizona - Cleveland Clinic Foundation, Cleveland, Ohio [6][7][8]. Product Differentiation - The Acclaim CI is positioned as a first-of-its-kind device aimed at addressing severe to profound sensorineural hearing loss, which is not sufficiently managed by traditional hearing aids [9][10].
Envoy Medical Names Seven Investigational Sites for Participation in Its Pivotal Clinical Study