Envoy Medical reported third-quarter 2026 results and an update on its investigational, fully implanted Acclaim cochlear implant. The main developments were continued progress in the pivotal clinical trial and a second submission in the company’s planned four-part application for FDA approval.
The announcement did not include revenue, cash, or earnings figures in the material provided here. Its operating update focused on clinical milestones, regulatory progress and intellectual property.
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Early trial participants showed further improvement in speech perception. The first 10 participants in Stage 1 had an average CNC word-recognition score of 53.2% at their 12-month visits, compared with 15.2% before implantation—an improvement of 38 percentage points. That was a larger gain than the 24-point improvement reported at six months. The trial’s primary efficacy endpoint will be assessed using 12-month data.
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The full cohort passed a three-month follow-up milestone during the quarter. After quarter-end, the company said the cohort had also passed the six-month mark. Envoy expects all participants to complete their 12-month visits by early in the second quarter of 2027.
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The FDA review process is advancing in stages. After quarter-end, Envoy submitted the second of four planned modules for its application for premarket approval. The final module is expected to include the final clinical-trial data. The company expects Stage 2 participants to complete 12-month data collection by early in the second quarter of 2027, with the final module submission planned a few months later.
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The implant remains investigational. The Acclaim device has FDA Breakthrough Device designation, but the announcement describes it as investigational and says the company is still pursuing premarket approval.
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Envoy added patents in Canada and Hong Kong. The grants relate to cochlear-system design and middle-ear sensor signal processing. The company said its portfolio now comprises 97 granted patents—40 in the United States and 57 abroad—with 35 applications pending.
The clearest near-term milestones are completion of the trial participants’ 12-month visits and submission of the final application module. The 12-month results are central because they will be used to evaluate the trial’s primary efficacy endpoint.