Envoy Medical Nears Completion of Enrollment in Pivotal Clinical Trial of Fully Implanted Acclaim(R) Cochlear Implant
Rhea-AI Summary
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.
Positive
- Enrollment 45 of 56 implanted (>80% complete)
- Expected full enrollment by end of March 2026
- PMA submission targeted in Q2 2027
Negative
- None.
News Market Reaction – COCH
In the Feb 17 session, COCH gained 14.82%, reflecting a significant positive market reaction. Argus tracked a peak move of +50.7% during that session. Our momentum scanner triggered 18 alerts that day, indicating notable 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 |
|---|---|---|---|---|
| Dec 18 | Enrollment milestone | Positive | -0.4% | Reached midway point of target enrollment in pivotal Acclaim trial. |
| Dec 10 | Activation progress | Positive | +3.1% | Completed first set of activations with no serious adverse events reported. |
| Nov 18 | Six‑month follow‑up | Positive | +17.5% | First 10 patients completed six‑month follow‑ups with no serious adverse events. |
| Nov 04 | Final‑stage enrollment | Positive | -5.0% | First three patients enrolled and implanted in final trial stage. |
| Sep 24 | Trial on track | Positive | -2.6% | Pivotal trial progressing with commercialization planning underway and milestones met. |
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Clinical trial updates have produced mixed reactions, with more instances of divergence than alignment between positive trial milestones and next-day price moves.
Over recent months, Envoy Medical has repeatedly updated investors on progress of its fully implanted Acclaim cochlear implant trial. Prior clinical milestones, such as first activations and reaching mid‑enrollment in Dec 2025, showed varied price reactions from -5.04% to +17.48%. Today’s news of nearing full enrollment continues this trajectory toward an expected PMA submission in 2027, building on earlier signs of trial advancement and safety.
Key Terms
pivotal clinical trial medical
Premarket Approval (PMA) regulatory
U.S. Food and Drug Administration (FDA) regulatory
cochlear implant medical
piezoelectric sensor medical
AI-generated analysis. How Rhea-AI works. Not financial advice.
45 of 56 Patients Implanted; Enrollment Completion Anticipated by End of March
White Bear Lake, Minnesota--(Newsfile Corp. - February 17, 2026) - Envoy Medical® Inc. (NASDAQ: COCH) ("Envoy Medical" or the "Company"), a hearing health company pioneering fully implanted hearing solutions, today announced continued progress in enrollment for its pivotal clinical trial of the investigational fully implanted Acclaim® cochlear implant.
To date, 45 patients have been successfully implanted and are officially enrolled in the study. The trial calls for a total of 56 implanted participants. In other words, Envoy Medical has completed over
Based on current enrollment trends and follow-up timelines, Envoy Medical believes the trial remains on track for completion and potential Premarket Approval (PMA) submission to the U.S. Food and Drug Administration (FDA) in the second quarter of 2027.
"We are extremely encouraged by the steady progress we've seen since receiving FDA approval to expand our pivotal study," said Brent Lucas, Chief Executive Officer of Envoy Medical. "Reaching 45 implanted patients and being approximately one month away from full enrollment is an exciting milestone for our entire organization. The journey to get to this point has been long, but we are now moving quickly and with great confidence."
Lucas added, "We remain encouraged by what we are hearing from the trial and look forward to sharing more as results are formally analyzed and published. We expect to provide an update at an industry meeting in May as we continue advancing toward our goal of redefining the standard of care with a fully implanted cochlear implant."
The investigational Acclaim® fully implanted cochlear implant is designed to leverage the natural ear, rather than an external microphone, to capture sound using Envoy Medical's proprietary implanted piezoelectric sensor technology. Unlike traditional cochlear implants, the Acclaim® device is designed without required externally worn components on or in the ear, representing a differentiated approach in the cochlear implant market.
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 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.
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 obtain and 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; 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 31, 2025, 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/283883