Mean CNC word recognition scores for Stage 1 cohort improved to 53.2% at 12 months from 15.2% pre-implantation, a 38.0 percentage point gain that continued to build on the 24.0 percentage point improvement reported at 6 months
White Bear Lake, Minnesota--(Newsfile Corp. - July 14, 2026) - Envoy Medical® Inc. (NASDAQ: COCH) ("Envoy Medical" or the "Company"), a hearing health company pioneering fully implanted hearing solutions, today announced positive 12-month data from the first 10 participants in Stage 1 of its pivotal clinical trial evaluating the investigational fully implanted Acclaim® cochlear implant.
The Stage 1 cohort demonstrated a mean Consonant-Nucleus-Consonant ("CNC") word recognition score of 53.2% at their 12-month visits, up from a mean pre-implantation baseline of 15.2% — a 38.0 percentage point improvement. This represents continued improvement over the 39.2% mean score (a 24.0 percentage point improvement from baseline) previously reported by the Company at the 6-month visits for the Stage 1 cohort. The primary efficacy endpoint for the Acclaim® cochlear implant pivotal clinical study will be assessed on 12-month data.
"We hope that our shareholders and investors are as encouraged as we are by the updated data readout from the first 10 participants in Stage 1 of the Acclaim® clinical study," said Brent Lucas, Chief Executive Officer of Envoy Medical. "While we believed the six-month data readout from Stage 1 was promising, we reasonably expected to see meaningful continued improvement through 12 months and are seeing objective evidence supporting that belief. While the study remains ongoing and these interim results are preliminary, these data reinforce our conviction that the future of cochlear implants is in fully implanted devices using Invisible Hearing® technology."
12-Month Data Highlights (Specific to 10 Participants in Stage 1)
CNC word recognition: mean scores continued to improve through the 12-month visits, increasing to 53.2% from a pre-implantation baseline of 15.2% — a 38.0 percentage point improvement. This improvement compares to a 39.2% mean score and 24.0 percentage point improvement reported after the 6-month visits.
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Of the 10 participants in the Stage 1 cohort, nine demonstrated a positive hearing response consistent with the overall trend, while one patient has been identified as a potential "non-responder." The Company is actively reviewing the underlying cause of this patient's outcome.
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In a supplementary analysis of 12-month visit data excluding this patient, the mean CNC word recognition score among the remaining nine responders was 59.1%, a 42.2 percentage point improvement from baseline, compared to the 53.2% mean score and 38.0 percentage point improvement reported across all 10 participants.
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Safety: Among the first 10 participants in Stage 1 of the pivotal trial through their 12-month visits, no serious adverse events ("SAEs") as defined by the study protocol were reported.
Other data including AzBio sentence scores, quality of life questionnaires, and other patient-reported outcome measures are being collected as part of the overall study protocol but are not part of this top-line data readout. Full data will be included as part of the Company's overall Premarket Approval ("PMA") submission to the United States Food and Drug Administration ("FDA").