Envoy Medical Announces First Patients Successfully Reaching 12-Month Endpoint in Pivotal Clinical Trial for Fully Implanted Cochlear Implant
Rhea-AI Summary
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.
Positive
- First three patients reached 12-month endpoint (implanted early 2025)
- Trial is fully enrolled, enabling primary endpoint data collection
- PMA submission planned after all 12-month evaluations are complete
- Breakthrough Device designation for Acclaim (2019)
- Esteem implant FDA-approved and commercial in U.S. since 2010
Negative
- No complete 12-month primary endpoint results currently available
- PMA timing depends on completion of all 12-month evaluations
News Market Reaction – COCH
In the Apr 1 session, COCH gained 6.00%, reflecting a notable positive market reaction. Argus tracked a peak move of +8.3% during that session. Our momentum scanner triggered 3 alerts that day, indicating moderate trading interest and price volatility.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Previous Clinical trial Reports
| Date | Event | Sentiment | 24h Move | Catalyst |
|---|---|---|---|---|
| Mar 11 | Enrollment completion | Positive | +9.1% | Announced implantation of the 56th and final patient in pivotal trial. |
| Feb 19 | Financing & trial update | Positive | -2.9% | Reported upsized financing and strong progress with 47 of 56 implants done. |
| Feb 17 | Enrollment progress | Positive | +14.8% | Highlighted 45 of 56 patients implanted and timeline toward PMA submission. |
| Dec 18 | Mid-enrollment milestone | Positive | -0.4% | Reached midway enrollment in pivotal Acclaim study with timeline reaffirmed. |
| Dec 10 | First activations | Positive | +3.1% | Completed first activations in final study stage with no serious adverse events. |
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Clinical trial milestones have often produced positive reactions, but there is a mixed record with several instances of negative or muted responses despite constructive updates.
Over the past year, Envoy Medical has repeatedly highlighted progress in its fully implanted Acclaim cochlear implant pivotal trial. Prior updates covered early activations, mid- and late-stage enrollment milestones, and confirmation of a path toward a potential PMA submission. Price reactions to these clinical headlines have ranged from modest declines to strong double‑digit gains, underscoring that while trial progress is a central driver, investor responses have not been uniformly positive. This 12‑month endpoint milestone fits into that ongoing trial completion narrative.
Key Terms
pivotal clinical trial medical
Premarket Approval (PMA) regulatory
FDA regulatory
Breakthrough Device Designation regulatory
sensorineural hearing loss medical
cochlear implant medical
AI-generated analysis. How Rhea-AI works. Not financial advice.
Company Remains on Schedule for PMA Submission to FDA
White Bear Lake, Minnesota--(Newsfile Corp. - April 1, 2026) - Envoy Medical®, Inc. (NASDAQ: COCH) ("Envoy Medical"), a hearing health company pioneering fully implanted hearing solutions, announced that the first three patients implanted in its pivotal clinical trial for the fully implanted Acclaim® cochlear implant have successfully completed their 12-month endpoint visit, marking a key milestone in the study's progress.
The first three pivotal trial patients implanted at the start of 2025 are now the first to reach the 12-month follow-up evaluation point. The primary endpoints for the trial are tied to 12-month data. Achieving this critical milestone on schedule underscores the Company's continued execution as it steadily marches towards commercialization.
"We are thrilled to highlight the first wave of trial participants successfully reaching and completing their 12-month endpoint," said Brent Lucas, CEO of Envoy Medical. "We believe our first-of-its-kind breakthrough technology has the potential to change the perception around how severe to profound hearing loss is treated and potentially increase adoption rates. Now that the trial has been fully enrolled and we are beginning to collect 12-month data, the future of hearing implants may be closer than you realize."
After all trial participants complete their 12-month evaluations, Envoy Medical plans to submit its Premarket Approval (PMA) application to the U.S. Food and Drug Administration (FDA).
The Acclaim® cochlear implant is an investigational, first-of-its-kind fully implanted device designed to address severe to profound sensorineural hearing loss without externally worn components. With Envoy Medical's proprietary sensor technology, the Acclaim® device design leverages the ear's natural anatomy to capture sound to support a smooth and discreet hearing experience.
Envoy Medical believes fully implanted hearing technology offers the potential to significantly expand adoption among patients unwilling or unable to use traditional hearing devices that rely on external hardware. Per the NIH, only six percent of eligible individuals receive cochlear implants, highlighting a substantial unmet need in the market.
The Company continues to build on its leadership in fully implanted hearing solutions, including its FDA-approved Esteem® fully implanted active middle ear implant, which has been commercially available in the United States since 2010.
The Acclaim® cochlear implant received Breakthrough Device Designation from the FDA in 2019 and is currently under investigation as part of a U.S. based pivotal clinical trial. For more information on the trial, visit www.envoymedical.com/acclaim-pivotal.
To be added to the Envoy Medical email distribution list, please email Envoy@kcsa.com with COCH in the subject line.
NIH Citation: Zhang L, Ding AS, Xie DX, Creighton FX. Understanding Public Perceptions Regarding Cochlear Implant Surgery in Adults. Otol Neurotol. 2022 Mar 1;43(3):e331-e336. doi: 10.1097/MAO.0000000000003439. PMID: 35147605; PMCID: PMC10368452.
About Envoy Medical, Inc.
Envoy Medical (NASDAQ: COCH) is a hearing health company focused on providing innovative technologies across the hearing loss spectrum. Envoy Medical has pioneered one-of-a-kind, fully implanted devices for hearing loss, including its fully implanted Esteem® active middle ear implant, commercially available in the U.S. since 2010, and the fully implanted Acclaim® cochlear implant, an investigational device. Envoy Medical is dedicated to pushing hearing technology beyond the status quo to improve access, usability, compliance, and ultimately quality of life.
About the Fully Implanted Acclaim® Cochlear Implant
We believe the fully implanted Acclaim Cochlear Implant ("Acclaim CI") is a first-of-its-kind hearing device. Envoy Medical's fully implanted technology includes a sensor designed to leverage the natural anatomy of the ear instead of a microphone to capture sound.
The Acclaim CI is designed to address severe to profound sensorineural hearing loss that is not adequately addressed by hearing aids. The Acclaim CI is expected to be indicated for adults who have been deemed adequate candidates by a qualified physician.
The Acclaim Cochlear Implant received the Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) in 2019.
CAUTION The fully implanted Acclaim Cochlear Implant is an investigational device. Limited by Federal (or United States) law to investigational use.
About the Esteem® Fully Implanted Active Middle Ear Implant (FI-AMEI)
The Esteem fully implanted active middle ear implant (FI-AMEI) is the only FDA-approved, fully implanted* hearing device for adults diagnosed with moderate to severe sensorineural hearing loss allowing for 24/7 hearing capability using the ear's natural anatomy. The Esteem FI-AMEI hearing implant is invisible and requires no externally worn components and nothing is placed in the ear canal for it to function. Unlike hearing aids, you never put it on or take it off. You can't lose it. You don't clean it. The Esteem FI-AMEI hearing implant offers true 24/7 hearing.
*Once activated, the external Esteem FI-AMEI Personal Programmer is not required for daily use.
Important safety information for the Esteem FI-AMEI can be found at: https://www.envoymedical.com/safety-information.
Additional Information and Where to Find It
Copies of the documents filed by Envoy Medical with the SEC may be obtained free of charge at the SEC's website at www.sec.gov.
Forward-Looking Statements
This press release includes "forward-looking statements" within the meaning of the "safe harbor" provisions of the United States Private Securities Litigation Reform Act of 1995. Forward-Looking statements may be identified by the use of words such as "estimate," "plan," "project," "forecast," "intend," "will," "expect," "anticipate," "believe," "seek," "target" or other similar expressions that predict or indicate future events or trends or that are not statements of historical matters, but the absence of these words does not mean that a statement is not forward-looking. Such statements may include, but are not limited to, statements regarding the expectations of Envoy Medical concerning the outlook for its business, productivity, plans and goals for future operations; the ability to obtain additional patents and develop future products or product improvements; the ability to maintain compliance with Nasdaq rules and requirements; the timing and future outcome of its FDA pivotal trial; the ability to raise capital and the amount of capital required to complete the FDA pivotal trial and early commercialization; the Acclaim CI being the first to market fully implanted cochlear implant; the timing and results of activations, enrollments, follow-up visits, data, and clinical trials of the Acclaim CI; and the participation or any changes or delays in participation of any subjects, institutions, or healthcare professionals in such trials; the safety, performance, and market acceptance of the Acclaim CI; the timing and results of the Acclaim CI's PMA submission to the FDA; the size of Envoy Medical's addressable market, operational performance, future market conditions or economic performance and developments in the capital and credit markets; and any information concerning possible or assumed future operations of Envoy Medical. The forward-looking statements contained in this press release reflect Envoy Medical's current views about future events and are subject to numerous known and unknown risks, uncertainties, assumptions and changes in circumstances that may cause its actual results to differ significantly from those expressed in any forward-looking statement. Envoy Medical does not guarantee that the events described will happen as described (or that they will happen at all). These forward-looking statements are subject to a number of risks and uncertainties, including, but not limited to changes in the market price of shares of Envoy Medical's Class A Common Stock; changes in or removal of Envoy Medical's shares inclusion in any index; Envoy Medical's success in retaining or recruiting, or changes required in, its officers, key employees or directors; unpredictability in the medical device industry, the regulatory process to approve medical devices, and the clinical development process of Envoy Medical products; the ability to engage competition in the medical device industry, and the failure to introduce new products and services in a timely manner or at competitive prices to compete successfully against competitors; disruptions in relationships with Envoy Medical's suppliers, or disruptions in Envoy Medical's own production capabilities for some of the key components and materials of its products; changes in the need for capital and the availability of financing and capital to fund these needs; changes in interest rates or rates of inflation; legal, regulatory and other proceedings could be costly and time-consuming to defend; changes in applicable laws or regulations, or the application thereof on Envoy Medical; a loss of any of Envoy Medical's key intellectual property rights or failure to adequately protect intellectual property rights; the effects of catastrophic events, including war, terrorism and other international conflicts; and other risks and uncertainties set forth in the section entitled "Risk Factors" and "Cautionary Note Regarding Forward-Looking Statements" in the Annual Report on Form 10-K filed by Envoy Medical on March 23, 2026, and in other reports Envoy Medical files, with the SEC. If any of these risks materialize or Envoy Medical's assumptions prove incorrect, actual results could differ materially from the results implied by these forward-looking statements. While forward-looking statements reflect Envoy Medical's good faith beliefs, they are not guarantees of future performance. Envoy Medical disclaims any obligation to publicly update or revise any forward-looking statement to reflect changes in underlying assumptions or factors, new information, data or methods, future events or other changes after the date of this press release, except as required by applicable law. You should not place undue reliance on any forward-looking statements, which are based only on information currently available to Envoy Medical.
Investor Contact
Phil Carlson
KCSA Strategic Communications
O: 212.896.1233
E: Envoy@kcsa.com
Media Contact
Anne Donohoe
KCSA Strategic Communications
O: 732-620-0033
E: Envoy@kcsa.com
To view the source version of this press release, please visit https://www.newsfilecorp.com/release/290776