WHITE BEAR LAKE, Minn., April 22, 2026

Envoy Medical, Inc. announced a major milestone in its pivotal clinical trial of the fully implanted Acclaim® cochlear implant, confirming that all 56 enrolled patients have successfully completed their Activation Visits, where the device is turned on for the first time. This achievement marks a critical step toward trial completion and regulatory submission, reinforcing the company’s leadership in next-generation hearing implant technology designed to transform care for patients with severe to profound hearing loss.

Pivotal Trial Progress Strengthens Regulatory Pathway

The completion of Activation Visits across all enrolled subjects provides increased confidence in the study timeline, allowing the company to proceed with scheduled follow-up evaluations and data collection milestones. The ongoing trial is evaluating the safety and performance of the fully implanted Acclaim cochlear implant, a first-of-its-kind investigational device that has already received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA).

Following completion of the 12-month follow-up period, Envoy Medical plans to analyze clinical data and submit a Premarket Approval (PMA) application to the FDA. This milestone is particularly significant as it brings the company closer to potential commercialization of a fully implanted cochlear implant solution, which could redefine treatment standards in hearing loss.

Innovative Fully Implanted Technology Redefines Hearing Care

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The Acclaim cochlear implant represents a novel advancement in auditory technology, utilizing a sensor that leverages the ear’s natural anatomy to capture sound, eliminating the need for external microphones or components. Unlike traditional cochlear implants and hearing aids, this fully implanted system is designed to provide continuous, 24/7 hearing capability, improving patient convenience, compliance, and overall quality of life.

The device specifically targets individuals with severe to profound sensorineural hearing loss who do not benefit adequately from conventional hearing aids. By offering a completely internal solution, Acclaim aims to overcome common limitations such as device visibility, maintenance challenges, and inconsistent usage, making it a potential breakthrough in hearing restoration technology.

Expanding Innovation Across Hearing Loss Spectrum

Envoy Medical continues to build on its expertise in fully implanted hearing devices, including its commercially available Esteem® active middle ear implant, which is currently the only FDA-approved fully implanted hearing device for adults with moderate to severe hearing loss. The success of the Acclaim trial further strengthens the company’s position as a pioneer in implantable hearing technologies, focused on delivering innovative solutions that improve accessibility and patient outcomes. The company’s approach emphasizes integration with natural auditory processes, enabling more seamless and effective hearing experiences.

The progress of the Acclaim cochlear implant trial highlights the growing importance of medical device innovation in addressing unmet clinical needs, particularly in conditions where existing solutions fall short. As the trial advances toward completion, the anticipated data will provide critical insights into device performance, safety, and long-term benefits, supporting regulatory evaluation and potential approval. If successful, the Acclaim implant could revolutionize hearing care by offering a discreet, continuous, and highly effective alternative to traditional devices, significantly enhancing the quality of life for patients with severe hearing impairment.

Source: Envoy Medical press release