Envoy Medical, Inc. develops hearing-health technologies focused on fully implanted hearing solutions. The company’s portfolio includes the Esteem FI-AMEI, an FDA-approved fully implanted active middle ear implant for adults with moderate to severe sensorineural hearing loss, and the investigational Acclaim cochlear implant, which uses a sensor designed to work with the ear’s natural anatomy rather than an external microphone.
Recurring company news covers Acclaim clinical-study updates, FDA-related development toward a Premarket Approval pathway, financial results, capital-structure actions, Nasdaq listing compliance, board and governance changes, and intellectual-property updates tied to its hearing segment.
Envoy Medical (NASDAQ: COCH) has moved its third-quarter 2026 financial results conference call to 8:00 A.M. ET on November 5, 2026. The company will release results for the quarter ended September 30, 2026, before the market opens that day. A call replay will be available through November 19, 2026.
Envoy Medical (NASDAQ: COCH) will report its third-quarter financial results on November 5, 2026, followed by a management conference call.
The results cover the quarter ended September 30, 2026. The call will begin at 4:30 P.M. ET that day, with a replay available through November 19, 2026.
Envoy Medical (COCH) will implement a 1-for-10 reverse stock split of its Class A common stock on October 26, 2026.
The split takes effect at 12:01 a.m. Eastern Time, with split-adjusted trading beginning at market open that day. The company intends the split to maintain compliance with Nasdaq's $1.00 minimum bid price requirement. Stockholders authorized it on October 12, 2026. Outstanding warrants, other convertible securities and shares issuable under stock incentive and compensation plans will receive proportionate adjustments under the applicable terms.
Envoy Medical (NASDAQ: COCH) has surpassed the six-month follow-up milestone in its pivotal trial of the investigational Acclaim cochlear implant. This marks the halfway point in the trial's final data-collection stage, with each participant followed for 12 months.
The company remains on track to complete 12-month visits by early Q2 2027 and expects to submit its final clinical module for FDA premarket approval by the end of Q2 2027. Two of four planned application modules have been submitted. Envoy sees potential for an FDA decision by the end of 2027 or the first part of 2028. Acclaim received FDA Breakthrough Device Designation in 2019 and remains investigational.
Envoy Medical (NASDAQ: COCH) submitted the second module of its FDA premarket approval application for the Acclaim cochlear implant. The submission primarily contained engineering information and follows the first module submitted on June 30, 2026. The modular process lets the FDA review submitted sections while clinical data collection continues.
Two of four planned modules are now submitted. Envoy Medical expects to submit the two remaining modules toward the end of the second quarter of 2027. The final module will contain final clinical trial data and complete the application, rather than constitute FDA approval. Acclaim received FDA Breakthrough Device Designation in 2019 and remains under investigation in a U.S.-based pivotal clinical trial. Submitted modules also provide opportunities for FDA feedback before the final submission.
Envoy Medical (COCH) announced the grant of two new international patents in Canada and Hong Kong, bringing its global portfolio to 97 granted patents and 35 pending applications. The Canadian patent (No. 3,130,978) covers technology for characterizing electrical conductors within an implantable cochlear system, supporting future integrated implantable hearing technology. The Hong Kong patent (No. HK40108431) covers systems and methods to compensate for variability in a middle ear sensor and normalize sensor signals, reinforcing Envoy Medical’s approach of using the ear’s natural anatomy instead of a microphone for sound capture.
The portfolio now includes 40 U.S. and 57 foreign granted patents, spanning sensing, signal processing, implantation and system integration for the company’s fully implanted hearing platform.
Envoy Medical (COCH) will present at the H.C. Wainwright 28th Annual Global Investment Conference at the Lotte New York Palace Hotel in New York City on September 14-16, 2026.
CEO Brent Lucas is scheduled to present on Tuesday, September 15, 2026 at 2:00 PM ET in the Kennedy II Room. A webcast will be accessible via Envoy Medical's investor relations website and available on demand for 90 days following the conference. Envoy develops fully implanted hearing devices, including the FDA-approved Esteem FI-AMEI and the investigational Acclaim cochlear implant.
Envoy Medical (NASDAQ: COCH) reported second quarter 2026 results and regulatory progress for its fully implanted Acclaim cochlear implant. The company submitted the first of four modules of its modular PMA application to the FDA and targets submission of the final, clinical-data module in Q2 2027.
According to Envoy Medical, 12‑month Stage 1 data from the first 10 pivotal trial participants showed mean CNC word recognition improving to 53.2% from a 15.2% pre‑implant baseline, and the full cohort has passed the three‑month follow‑up window. Net revenue for Q2 2026 was $51,000, with a net loss attributable to common stockholders of $7.3 million, or $0.07 per share. Envoy ended June 30, 2026 with $19.7 million in cash and positive stockholders’ equity of $3.3 million, aided by approximately $30.0 million of gross financing proceeds in the first half and new patents granted in Australia and Europe.
Envoy Medical (NASDAQ: COCH) reported that all 56 patients in its pivotal clinical trial of the investigational fully implanted Acclaim cochlear implant have surpassed the three-month visit milestone. The company continues collecting safety and other study measures for inclusion in a planned Premarket Approval (PMA) submission to the U.S. FDA.
According to Envoy Medical, the six-month visit milestone is anticipated by late 2026, with the 12-month visit milestone for the entire study expected by April 2027. The Acclaim CI, which leverages the ear’s natural anatomy instead of a microphone, holds FDA Breakthrough Device Designation and targets adults with severe to profound sensorineural hearing loss not adequately addressed by hearing aids.
Envoy Medical (NASDAQ: COCH) reported 12‑month interim results from the first 10 participants in Stage 1 of its pivotal trial of the investigational fully implanted Acclaim cochlear implant. Mean CNC word recognition improved to 53.2% from 15.2% pre‑implant, a 38.0 percentage point gain, versus a 39.2% mean score at six months.
Nine of 10 participants showed a positive hearing response; excluding one potential non‑responder, mean CNC scores reached 59.1%, a 42.2 percentage point increase. No protocol‑defined serious adverse events were reported through 12 months. Stage 2 of the trial is fully enrolled, with all 12‑month data expected by early Q2 2027 and a PMA submission to the FDA planned a few months thereafter.