Envoy Medical Completes First Set of Activations in Final Stage of Pivotal Clinical Study for its First-Of-Its-Kind Fully Implanted Acclaim(R) Cochlear Implant
Rhea-AI Summary
Envoy Medical (NASDAQ: COCH) announced completion of the first set of activations in the final stage of its pivotal clinical study for the investigational fully implanted Acclaim cochlear implant on December 10, 2025.
The company said activations occurred at two of seven investigational sites, reported no serious adverse events, and noted the study remains open with full enrollment expected in early 2026. The Acclaim device is fully implanted, uses an implanted piezoelectric sensor, has no external components or implanted magnet, and offers ~4–5 day battery between charges plus a removable battery pack.
Positive
- First set of final-stage activations completed on December 10, 2025
- No serious adverse events reported during these activations
- Full enrollment expected in early 2026
- Device offers ~4–5 day battery between charges
Negative
- No hearing outcomes disclosed until trial completion
- Activations reported at 2 of 7 investigational sites so far
Key Figures
Market Reality Check
Peers on Argus 1 Down
Peer moves in Medical Devices are mixed, with names like RBOT and IINN up and VVOS and MYO down, suggesting COCH’s reaction is more company-specific than sector-driven.
Historical Context
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Dec 04 | Investor event | Neutral | +4.5% | Announcement of fireside chat with CEO and first Acclaim patient. |
| Dec 02 | Patent grant | Positive | -0.5% | Grant of 40th U.S. patent covering cochlear implant calibration. |
| Nov 20 | Patent grant | Positive | -1.8% | New patent for cochlear system with removable earplug sensor and battery. |
| Nov 18 | Clinical milestone | Positive | +17.5% | First 10 pivotal trial patients completed six-month follow-up with no SAEs. |
| Nov 10 | Earnings & updates | Positive | -0.3% | Q3 results with debt extinguishment, patents, trial progress and financing. |
Positive IP and clinical milestones have often met with muted or negative next-day moves, while some clinical trial updates have produced stronger upside reactions.
Over the last six months, Envoy Medical has combined clinical milestones for its fully implanted Acclaim cochlear implant with balance sheet actions and IP expansion. Notable items include extinguishing $32 million of debt, multiple new U.S. patents, and a pivotal trial milestone where the first 10 patients reached six-month follow-up with no serious adverse events, which saw a 17.48% move. Other positive patents and financing updates drew modest or negative price reactions, underscoring inconsistent trading responses to good news.
Market Pulse Summary
This announcement reinforces steady advancement of Envoy Medical’s pivotal trial for its fully implanted Acclaim cochlear implant, highlighting first activations at 7 sites, no serious adverse events, and design features such as 4–5 day battery life and a removable battery pack. Prior clinical-trial updates with no serious adverse events and expanding enrollment frame this as continued execution. Investors may watch for full trial enrollment, top-line data, and subsequent regulatory milestones as key markers of progress.
Key Terms
adverse events medical
AI-generated analysis. Not financial advice.
Momentum continues to build for Company as series of clinical milestones are met, design choices cement differentiation from competition, and timeline comes into focus
White Bear Lake, Minnesota--(Newsfile Corp. - December 10, 2025) - Envoy Medical® Inc. (NASDAQ: COCH) ("Envoy Medical" or the "Company"), a hearing health company pioneering fully implanted hearing solutions, today announced the completion of the first set of activations in the final stage of the pivotal clinical study for the investigational fully implanted Acclaim® cochlear implant.
These activations were performed at Shohet Ear Associates in Seal Beach, California and the Center for Neurosciences Ear and Hearing Center in Tucson, Arizona, two of the seven investigational sites involved in the study. While specific hearing results from these activations cannot be publicly disclosed until the trial is completed, Envoy Medical notes that no serious adverse events were reported and that the team is pleased with how the activation appointments went.
"The steady progress of our pivotal clinical study is exceeding my initial expectations," said Brent Lucas, Chief Executive Officer of Envoy Medical. "Despite the holiday season and end of year crunch for surgical time, enrollment for the Study is moving along nicely. We continue to be encouraged by the high-level of interest from potential patients and professionals throughout the hearing industry and look forward to successfully completing the trial and preparing for robust commercial demand. "
The Acclaim® cochlear implant is an investigational first-of-its-kind cochlear implant designed to leverage the natural ear - not a microphone - to capture sound by using a combination of the Company's proprietary implanted piezoelectric sensor and the body's natural anatomy.
Unlike traditional, partially-implanted cochlear implants, the fully implanted Acclaim® cochlear implant does not require a bulky external component to function. In addition, the fully implanted Acclaim® cochlear implant also does not have an implanted magnet to attach external components to the side of the patient's head, as there are no external wearable components required to hear with the Acclaim® device.
Moreover, the design of the Acclaim® implant allows for several days approximately four to five days between any required recharging of the battery. The Acclaim® device design also has a removable battery pack that can be replaced by itself without requiring the full system to be explanted.
Continued Lucas, "I believe our amazing team has designed a cochlear implant for the future by putting the patient first and foremost with our design choices, and we look forward to bringing those with significant hearing loss a true breakthrough."
Full enrollment of the pivotal trial is expected in early 2026. For more information on the trial or the seven investigational sites conducting the trial, please visit the following link: https://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 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/277543
FAQ
What did Envoy Medical (COCH) announce on December 10, 2025 about the Acclaim pivotal study?
When does Envoy Medical expect full enrollment for the Acclaim (COCH) pivotal trial?
Which sites performed the Acclaim activations in the COCH pivotal study?
Does the investigational Acclaim cochlear implant require external components?
How long does the Acclaim device battery last between recharges according to Envoy Medical?
Are hearing outcome results from the Acclaim activations publicly available for COCH?
