Envoy Medical Reaches Critical Milestone in Pivotal Clinical Trial of Fully Implanted Acclaim(R) Cochlear Implant
Rhea-AI Summary
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.
Positive
- All 56 enrolled patients completed Activation Visit
- Plans to analyze data after 12‑month follow-up completion
- PMA submission planned to the U.S. FDA upon data analysis
- Device holds FDA Breakthrough Device Designation (2019)
Negative
- No clinical efficacy or safety results reported yet
- PMA timing contingent on completion and analysis of 12‑month data
News Market Reaction – COCH
In the Apr 22 session, COCH declined 3.73%, reflecting a moderate negative market reaction. Argus tracked a trough of -3.5% from its starting point during tracking. Our momentum scanner triggered 4 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 |
|---|---|---|---|---|
| Apr 01 | Clinical milestone | Positive | +6.0% | First three pivotal trial patients reached 12‑month endpoint, enabling PMA planning. |
| Mar 11 | Trial enrollment complete | Positive | +9.1% | Completion of enrollment with the 56th Acclaim implant in pivotal U.S. trial. |
| Feb 19 | Financing and trial update | Positive | -2.9% | Upsized financing plus report of 47 of 56 implants completed in pivotal trial. |
| Feb 17 | Enrollment progress | Positive | +14.8% | Reported 45 of 56 patients implanted, over 80% enrollment, PMA timing outlined. |
| Dec 18 | Mid-enrollment update | Positive | -0.4% | Pivotal study reached midway enrollment, full enrollment targeted for early Q1 2026. |
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Clinical trial headlines have often coincided with upside moves, though not uniformly; positive trial updates have produced both strong rallies and occasional pullbacks.
Over the past few months, Envoy Medical has repeatedly updated progress on its fully implanted Acclaim cochlear implant. Clinical releases from Dec 18, 2025 through Apr 1, 2026 tracked enrollment from midway to completion, then to patients reaching the 12‑month endpoint. Price reactions to these clinical milestones ranged from modest declines to gains above 14%, indicating that trial progress has been a recurring, but variably rewarded, catalyst ahead of this latest activation‑visit milestone.
Key Terms
pivotal clinical trial medical
cochlear implant medical
activation visit medical
premarket approval (pma) regulatory
breakthrough device designation regulatory
AI-generated analysis. How Rhea-AI works. Not financial advice.
All 56 Enrolled Subjects Have Been Through Their Activation Visit Firming Up Study Timeline
White Bear Lake, Minnesota--(Newsfile Corp. - April 22, 2026) - Envoy Medical® Inc. (NASDAQ: COCH) ("Envoy Medical" or the "Company"), a hearing health company pioneering fully implanted hearing solutions, today announced that all 56 patients implanted and enrolled in its pivotal clinical trial evaluating the fully implanted Acclaim® cochlear implant have been through their "Activation Visits," when a patient's device is initially turned on for the first time.
"The conclusion of our trial studying the first-of-its-kind fully implanted Acclaim® cochlear implant is now within sight," said Brent Lucas, Chief Executive Officer of Envoy Medical. "We believe the future of hearing solutions for those with severe to profound hearing loss will be fully implanted devices, and we are excited to be on the leading edge of that revolution."
Now that all 56 patients are through their Activation Visit, the remaining follow-up visits and trial-related events can be scheduled providing increased confidence in timing of upcoming milestones. Upon completion of 12-month follow-up for all patients, the Company expects to analyze the data and submit results to the U.S. Food and Drug Administration (FDA) as part of a Premarket Approval (PMA) application.
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.
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/293673