WHITE BEAR LAKE, Minn., July 21, 2026
Envoy Medical announced that all 56 patients enrolled in its pivotal clinical trial evaluating the investigational Acclaim® fully implanted cochlear implant have successfully completed their three-month follow-up visits, marking an important milestone in the company’s progress toward U.S. regulatory approval. The study continues to collect safety and performance data that will support the company’s planned Premarket Approval (PMA) submission to the U.S. Food and Drug Administration (FDA). Envoy Medical expects to complete six-month patient follow-up visits by late 2026 and finalize 12-month evaluations for the entire study by April 2027.
Pivotal Trial Advances Toward FDA Premarket Approval
The Acclaim pivotal clinical trial is evaluating the safety and performance of Envoy Medical’s investigational fully implanted cochlear implant designed to provide hearing restoration without external sound processors. Completion of the three-month milestone across all enrolled participants represents continued progress toward generating the clinical evidence required for the company’s FDA PMA submission. The trial remains ongoing as investigators continue collecting long-term safety and clinical performance data through scheduled patient follow-up visits.
Fully Implanted Cochlear Implant Aims to Transform Hearing Care
Unlike conventional cochlear implant systems that rely on externally worn microphones and processors, the investigational Acclaim® cochlear implant is designed as a fully implanted hearing solution, potentially improving convenience, usability, and patient compliance. Envoy Medical believes the technology could expand treatment options for individuals with severe hearing loss by eliminating many of the limitations associated with external hearing devices while supporting continuous hearing performance.
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Company Targets Regulatory Submission Following Clinical Completion
Envoy Medical stated that successful execution of the pivotal trial keeps the company on track toward its goal of submitting a PMA application to the FDA. Company leadership emphasized that each completed clinical milestone strengthens the development program as Envoy Medical works to bring the first fully implanted cochlear implant to the U.S. market. In addition to the investigational Acclaim system, the company markets the Esteem® Active Middle Ear Implant, a fully implanted hearing device that has been commercially available in the United States since 2010.
Source: Envoy Medical press release
