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 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.
Envoy Medical (NASDAQ: COCH) reported that 45 of 56 patients have been implanted in its pivotal trial of the fully implanted Acclaim cochlear implant, representing over 80% of enrollment. The company expects full enrollment by end of March 2026.
Envoy Medical said the trial remains on track for completion and a potential PMA submission in Q2 2027, and plans an update at an industry meeting in May. The Acclaim device uses an implanted piezoelectric sensor to capture sound without external components.
Envoy Medical (NASDAQ: COCH) closed an upsized public offering generating approximately $30.0 million of upfront gross proceeds, with up to an additional $48.0 million available if milestone-linked Series A-1 and A-2 warrants are exercised for cash at $0.40 per share.
The offering included 75,000,000 Class A shares (or pre-funded warrants) and attached warrants; lead investor was Nantahala Capital with participation from Broadfin, Glen Taylor, board members and management. Net proceeds extend projected cash runway into H2 2027, beyond expected PMA submission; full warrant exercise could extend runway past FDA approval and into the first full year of commercialization.
Envoy Medical (NASDAQ: COCH) priced an upsized public offering to raise approximately $30.0 million in gross proceeds at closing, plus up to $48.0 million additional gross proceeds if milestone-linked warrants are fully exercised for cash.
The deal covers 75,000,000 Class A shares (or pre-funded warrants) plus Series A-1 and A-2 warrants exercisable at $0.40 per share. Closing is expected on or about February 12, 2026. Net proceeds will fund working capital and operations during the company’s FDA pivotal clinical study for its Acclaim cochlear implant.
Envoy Medical (NASDAQ: COCH) announced its pivotal U.S. study of the fully implanted Acclaim cochlear implant has reached the midway point of target enrollment as of December 18, 2025. Sites report active screening and the company says full enrollment is on track to complete within the first half of Q1 2026 despite holiday and year‑end operating room constraints. The device uses a proprietary implanted piezoelectric sensor to capture sound and received FDA Breakthrough Device Designation in 2019. The company points investors to its trial page for more details.
Envoy Medical (NASDAQ: COCH) announced issuance of Australian Patent No. 2022229818 on October 16, 2025 for a "Cochlear Implant System with Improved Input Signal-To-Noise Ratio." The patent covers a sensor and powered signal modifier that amplifies the input at the source to reduce noise and interference.
The company highlighted its multi‑decade investment (about $300 million), prior FDA Breakthrough Device Designation for the Acclaim cochlear implant, and an ongoing U.S. pivotal clinical trial for the investigational fully implanted cochlear implant.