Envoy Medical Surpasses Three-Month Visit Milestone for All 56 Patients in Pivotal Clinical Trial
Rhea-AI Summary
Envoy Medical (NASDAQ: COCH) reported that all 56 patients in its pivotal clinical trial of the investigational fully implanted Acclaim cochlear implant have surpassed the three-month visit milestone. The company continues collecting safety and other study measures for inclusion in a planned Premarket Approval (PMA) submission to the U.S. FDA.
According to Envoy Medical, the six-month visit milestone is anticipated by late 2026, with the 12-month visit milestone for the entire study expected by April 2027. The Acclaim CI, which leverages the ear’s natural anatomy instead of a microphone, holds FDA Breakthrough Device Designation and targets adults with severe to profound sensorineural hearing loss not adequately addressed by hearing aids.
Positive
- All 56 pivotal-trial patients passed three-month visit milestone
- Pivotal trial supports planned PMA submission to U.S. FDA
- Acclaim cochlear implant holds FDA Breakthrough Device Designation since 2019
- Envoy already markets FDA-approved Esteem fully implanted middle ear implant
Negative
- Acclaim cochlear implant remains investigational, limited to investigational use by U.S. law
- Full 12-month pivotal study milestone not expected until April 2027 for all patients
News Market Reaction – COCH
In the Jul 21 session, COCH gained 1.42%, reflecting a mild positive market reaction. Argus tracked a peak move of +9.7% during that session. Our momentum scanner triggered 14 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 |
|---|---|---|---|---|
| Apr 28 | Six-month clinical data | Positive | -3.0% | Interim data showed improved speech recognition and no serious adverse events. |
| Apr 22 | Activation visit milestone | Positive | -4.3% | All 56 pivotal-trial patients completed their activation visits. |
| Apr 01 | Twelve-month endpoint | Positive | +6.0% | The first three patients successfully reached their twelve-month endpoints. |
| Mar 11 | Trial enrollment completion | Positive | +9.1% | The pivotal trial enrolled its 56th and final patient. |
| Feb 19 | Financing and trial progress | Neutral | -2.9% | The company reported financing alongside progress toward full trial enrollment. |
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Tag-matched clinical-trial announcements produced mixed reactions, with three divergences and two aligned outcomes.
Key Terms
pma regulatory
premarket approval regulatory
breakthrough device designation regulatory
sensorineural hearing loss medical
AI-generated analysis. How Rhea-AI works. Not financial advice.
White Bear Lake, Minnesota--(Newsfile Corp. - July 21, 2026) - Envoy Medical® Inc. (NASDAQ: COCH) ("Envoy Medical" or the "Company"), a hearing health company pioneering fully implanted hearing solutions, today announced that it has surpassed the three-month milestone for all 56 patients enrolled in the Company's pivotal clinical trial evaluating the investigational fully implanted Acclaim® cochlear implant. This marks another important clinical trial milestone as the Company continues to build momentum with the hearing industry.
"Envoy Medical continues to demonstrate its ability to execute," said Brent Lucas, Chief Executive Officer of Envoy Medical. "Each milestone achieved brings us one big step closer to our next major goal – submission of our PMA application to the FDA. We are steadily advancing toward our ultimate objective of bringing fully implanted cochlear implants to market in the United States."
The Company is continuing to collect safety and other study measures as part of its ongoing pivotal trial, with full data to be included as part of Envoy Medical's planned Premarket Approval ("PMA") submission to the U.S. Food and Drug Administration ("FDA").
The Company anticipates achieving its six-month visit milestone by late 2026 and its 12-month visit milestone for the entire study by April 2027.
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, outcomes, and results of activations, enrollments, follow-up visits, data, and clinical trials of the Acclaim CI, including data from Stage 2 (which may differ from Stage 1); the results of the safety and efficacy data from Stage 2 participants and the effect on its pooling with Stage 1 data, performance of the Acclaim CI during clinical trials, including improvement of patient outcomes over time after implant; 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 submissions to the FDA, including modular submissions and related feedback; 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
To view the source version of this press release, please visit https://www.newsfilecorp.com/release/305827