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) submitted the first module of its modular Premarket Approval (PMA) application to the FDA for its Breakthrough Device-designated Acclaim cochlear implant. The plan includes four modules, with the final clinical module targeted for Q2 2027, supporting ongoing FDA interaction and clearer investor milestones.
Envoy Medical (NASDAQ: COCH), a hearing health company focused on fully implanted hearing solutions, announced it has terminated its at-the-market equity facility.
The ATM facility had allowed the company to offer and sell up to $15 million of common stock and was terminated effective June 24, 2026. Envoy Medical indicated the termination reflects confidence in its current capital position.
Envoy Medical (NASDAQ: COCH) announced that CEO Brent Lucas will present at two investor events on June 25, 2026.
He will speak at the Life Sciences Virtual Investor Forum at 1:00 p.m. ET and the Biotech Webull Webinar Panel at 2:40 p.m. ET, both accessible via webcast links.
Envoy Medical (NASDAQ: COCH) announced that CEO Brent Lucas will present at the Planet MicroCap Conference Las Vegas 2026 from June 16-18 at the Bellagio Hotel & Casino.
The presentation is scheduled for Wednesday, June 17, 2026 at 11:00 A.M. PT in Track 7 - Donatello 3, with a webcast available.
Envoy Medical (NASDAQ: COCH) announced four newly granted patents in Australia and Europe and an additional European patent expected June 10, 2026. The intellectual property covers fully implanted cochlear implant platforms, removable earplug sensors, integrated signal analysis, implanted battery systems, and rechargeable battery safety and management.
Envoy Medical (NASDAQ: COCH) reported Q1 2026 results and key milestones advancing its investigational fully implanted Acclaim cochlear implant toward FDA PMA submission.
Highlights include completion of pivotal trial enrollment (56 patients), an upsized public offering of up to $78.0 million, promising interim clinical data, and cash of approximately $25,251 as of March 31, 2026.
- Interim data from first 10 patients showed improved word recognition and no study-defined serious adverse events.
- Global IP portfolio expanded to 47 patents.
- All 56 patients activated; first three reached 12‑month endpoint.
Envoy Medical (NASDAQ: COCH) presented interim six-month clinical data from the first 10 patients in its pivotal study of the investigational Acclaim cochlear implant. Key findings: no study-defined serious adverse events, mean CNC word recognition improved from 15.2% to 39.2%, median daily device wear time 24 hours, and quality-of-life and tinnitus scores improved.
Additional podium presentations are scheduled for May 8 and May 11, 2026, and a company fireside chat is set for April 29, 2026 at 4:30 PM ET.
Envoy Medical (NASDAQ: COCH) announced on April 22, 2026 that all 56 patients enrolled in its pivotal trial of the fully implanted Acclaim cochlear implant have completed their Activation Visits.
Following completion of 12-month follow-up for all patients, the company expects to analyze data and submit results to the U.S. Food and Drug Administration as part of a PMA application. The Acclaim device received FDA Breakthrough Device Designation in 2019.
Envoy Medical (NASDAQ: COCH) appointed Chas McKhann to its Board of Directors and Compensation Committee on April 16, 2026. McKhann brings commercial leadership from prior exits totaling over $1.775 billion and will advise commercialization for the Acclaim fully implanted cochlear implant.
The company reports pivotal trial enrollment for Acclaim is complete; Acclaim previously received FDA Breakthrough Device Designation.
Envoy Medical (NASDAQ: COCH) announced the first three pivotal trial patients implanted in early 2025 have successfully reached their 12-month endpoint, marking a key study milestone as the trial is now fully enrolled. The company plans a PMA submission to FDA after all 12-month evaluations are complete.
The investigational Acclaim fully implanted cochlear implant leverages proprietary sensor technology and holds Breakthrough Device designation (2019). Envoy also markets the FDA-approved Esteem implant, commercially available in the U.S. since 2010.