Welcome to our dedicated page for Envoy Medical news (Ticker: COCH), a resource for investors and traders seeking the latest updates and insights on Envoy Medical stock.
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) 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.
Envoy Medical (NASDAQ: COCH) reported full‑year 2025 results and subsequent events on March 23, 2026. Key developments include FDA approval to expand its Acclaim pivotal clinical trial to the final stage, completion of enrollment of a 56‑patient U.S. pivotal trial, and extinguishing over $32 million of debt.
Financials: Net revenue $241 (dollars in thousands), increased R&D and G&A expenses, approximately $3.7 million cash at year‑end, and a post‑year capital raise of up to $78M (including $30M received).
Envoy Medical (NASDAQ: COCH) announced completion of enrollment in its U.S. pivotal clinical trial for the investigational fully implanted Acclaim cochlear implant with implantation of the 56th and final patient on March 11, 2026.
The device has FDA Breakthrough Device Designation (2019); the trial will continue scheduled follow-ups, with 12-month data for all patients to be analyzed and submitted in a PMA seeking FDA approval and potential U.S. commercialization.
Envoy Medical (NASDAQ: COCH) announced it has regained compliance with Nasdaq Listing Rule 5550(b) after demonstrating alternatives under the rule to meet the minimum Market Value of Listed Securities. The company said strategic financing initiatives substantially strengthened its balance sheet and enabled compliance.
Envoy noted it received a Nasdaq non-compliance notice on February 25, 2025 and believes it has an achievable plan to maintain continued listing on the Nasdaq Capital Market under the symbol COCH.
Envoy Medical (NASDAQ: COCH) announced issuance of three patents — one U.S. and two Hong Kong — strengthening its fully implanted cochlear implant IP portfolio.
The U.S. Patent No. 12,544,564 (Feb 10, 2026) covers improved input signal-to-noise ratio. Hong Kong patents HK40102155 and HK40107235 cover hearing-aid combination functionality and electrode impedance diagnostics. The company noted IP importance as it advances toward potential PMA submission; the Acclaim device holds FDA Breakthrough Device designation and is in a U.S. pivotal trial.
Envoy Medical (NASDAQ: COCH) announced an upsized financing and clinical progress for its fully implanted Acclaim cochlear implant. The company closed $30.0M in gross proceeds with up to $48.0M additional upon exercise of milestone warrants, and says this capital could fund commercialization into 2028–2029. The pivotal trial has 47 of 56 implants completed, with the nine remaining participants scheduled for surgery and enrollment expected to finish by end of March 2026. A fireside chat with Dr. Theodore McRackan is set for Feb 25, 2026 at 10:00 AM ET.