Envoy Medical Reaches Enrollment Milestone in Pivotal Clinical Study of Fully Implanted Acclaim(R) Cochlear Implant
Rhea-AI Summary
Envoy Medical (NASDAQ: COCH) announced its pivotal U.S. study of the fully implanted Acclaim cochlear implant has reached the midway point of target enrollment as of December 18, 2025. Sites report active screening and the company says full enrollment is on track to complete within the first half of Q1 2026 despite holiday and year‑end operating room constraints. The device uses a proprietary implanted piezoelectric sensor to capture sound and received FDA Breakthrough Device Designation in 2019. The company points investors to its trial page for more details.
Positive
- Reached midway (≈50%) of pivotal study enrollment
- Company reports sites are actively screening numerous candidates
- Full enrollment on track for first half of Q1 2026
- Acclaim holds FDA Breakthrough Device Designation (2019)
Negative
- Holiday scheduling and year‑end OR constraints may slow enrollment
News Market Reaction
On the day this news was published, COCH declined 0.43%, reflecting a mild negative market reaction. Argus tracked a peak move of +3.5% during that session. Argus tracked a trough of -12.4% from its starting point during tracking. Our momentum scanner triggered 4 alerts that day, indicating moderate trading interest and price volatility. This price movement removed approximately $96K from the company's valuation, bringing the market cap to $22M at that time.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Market Reality Check
Peers on Argus
COCH is down 2.6% with mixed peer moves: VVOS, RBOT, IINN, MYO are negative while ADGM is positive, indicating stock-specific trading rather than a sector-wide move.
Historical Context
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Dec 16 | Patent issuance | Positive | -4.0% | New Australian patent for improved cochlear implant signal-to-noise ratio. |
| Dec 10 | Clinical trial update | Positive | +3.1% | First activations completed in final stage of pivotal Acclaim trial with no SAEs. |
| Dec 04 | Investor outreach | Positive | +4.5% | Announcement of fireside chat with CEO and first Acclaim implant patient. |
| Dec 02 | Patent milestone | Positive | -0.5% | Grant of 40th active U.S. patent and expansion of cochlear IP portfolio. |
| Nov 20 | Patent issuance | Positive | -1.8% | New U.S. patent for implant system with removable earplug sensor and battery. |
Recent news has been largely positive (patents, trial progress), but price reactions have been mixed, with several sell-offs on favorable IP updates.
Over the last few months, Envoy Medical has focused on building its Acclaim cochlear implant franchise, combining IP expansion with clinical progress. Since November 2025, it has secured new U.S. and Australian patents, hosted investor outreach events, and advanced its pivotal trial with initial activations and ongoing enrollment. Market reactions have alternated between gains and pullbacks, suggesting investors respond inconsistently to otherwise constructive technology and trial milestones.
Market Pulse Summary
This announcement highlights that Envoy Medical’s pivotal Acclaim cochlear implant study has reached the midway point to full enrollment, supporting the ongoing U.S. pivotal trial backed by FDA Breakthrough Device Designation from 2019. Prior clinical updates reported no serious adverse events and steady enrollment. Investors may watch for completion of full enrollment targeted for early Q1 2026, subsequent follow-up data, and how these milestones intersect with the company’s financial and Nasdaq compliance disclosures.
Key Terms
pivotal clinical study medical
cochlear implant medical
piezoelectric sensor medical
Breakthrough Device Designation regulatory
pivotal clinical trial medical
AI-generated analysis. Not financial advice.
Enrollment momentum accelerates as Company advances toward full enrollment
White Bear Lake, Minnesota--(Newsfile Corp. - December 18, 2025) - Envoy Medical® Inc. (NASDAQ: COCH) ("Envoy Medical" or the "Company"), a hearing health company pioneering fully implanted hearing solutions, today announced that its pivotal clinical study for the investigational fully implanted Acclaim® cochlear implant has achieved yet another milestone by reaching the midway point of the study's full enrollment target.
Despite holiday scheduling and year-end operating room constraints, enrollment is progressing at a steady pace. Sites report actively screening numerous potential candidates. Full enrollment is currently on track to be completed within the first half of Q1 2026.
"Reaching the midway point of the study's enrollment is another strong indication that our pivotal study continues to move forward efficiently," said Brent Lucas, Chief Executive Officer of Envoy Medical. "Even in a season that traditionally makes scheduling difficult, the investigational sites and our internal teams are performing exceptionally well."
The investigational fully implanted Acclaim® cochlear implant is designed to leverage the natural ear, rather than an external microphone, to capture sound using the Company's proprietary implanted piezoelectric sensor.
Lucas added, "We believe our fully implanted approach represents the future of hearing implants. The momentum in our pivotal study and the enthusiasm we are seeing from professionals in the field underscore the strong differentiation of our technology and our leadership as the industry shifts toward fully implanted solutions."
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 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/278490
FAQ
What enrollment milestone did Envoy Medical (COCH) announce on December 18, 2025?
When does Envoy expect full enrollment for the COCH Acclaim pivotal study?
What makes the Acclaim cochlear implant different for COCH investors?
Does Acclaim have any FDA designations that affect COCH's development timeline?
Could year‑end scheduling affect COCH trial timing?
Where can investors find details about the COCH pivotal trial?
