Envoy Medical submits second FDA module for Acclaim implant

Envoy Medical (COCH) announced a 1-for-10 reverse stock split, effective October 26, 2026, to meet Nasdaq's $1.00 minimum price requirement. Shares fell 8% premarket.

Envoy Medical (NASDAQ: COCH) announced it has reached the six-month milestone in its pivotal clinical trial for the Acclaim® cochlear implant, the halfway point in data collection. The company expects to complete 12-month visits by early Q2 2027 and submit the final PMA module by the end of Q2 2027. Envoy Medical claims its device is the first of its kind in a U.S. pivotal trial and highlights its differentiated design.

Envoy Medical (COCH) submitted the second of four planned PMA modules to the FDA for its Acclaim cochlear implant, with the final clinical module targeted for Q2 2027. This follows the first module submission in June 2026, according to the company.

Envoy Medical (COCH) submitted the second module of its FDA PMA application for the Acclaim cochlear implant, which includes engineering details. The company plans to submit the final clinical trial data module in late Q2 2027, advancing its rolling review process.

Envoy Medical, Inc. (COCH) filed an SEC Form 8-K — Results of Operations and Financial Condition. Exhibit 99.1 Envoy Medical Reports Second Quarter 2026 Results and Achieves Key Regulatory and Clinical Milestones Submitted First Module of Modular PMA Application to FDA Subsequent to Quarter End, the Company Reported Positive 12-Month Stage 1 Data Showing Continued Improvement

Envoy Medical (NASDAQ: COCH) reported positive 12-month interim results from Stage 1 of its pivotal trial for the investigational fully implanted Acclaim cochlear implant. In 10 participants, mean CNC word recognition rose to 53.2% from a 15.2% baseline. No protocol-defined serious adverse events were reported. Stage 2 is fully enrolled.