Envoy Medical Highlights First Clinical Data Presentations from Pivotal Clinical Study of Fully Implanted Acclaim(R) Cochlear Implant
Rhea-AI Summary
Envoy Medical (NASDAQ: COCH) presented interim six-month clinical data from the first 10 patients in its pivotal study of the investigational Acclaim cochlear implant. Key findings: no study-defined serious adverse events, mean CNC word recognition improved from 15.2% to 39.2%, median daily device wear time 24 hours, and quality-of-life and tinnitus scores improved.
Additional podium presentations are scheduled for May 8 and May 11, 2026, and a company fireside chat is set for April 29, 2026 at 4:30 PM ET.
AI-generated analysis. Not financial advice.
Positive
- CNC word recognition improved by 24 percentage points to 39.2% at six months
- No serious adverse events reported in the first 10 patients per study definition
- Median device wear time reported as 24 hours per day versus 15.5 hours pre-op
- Tinnitus scores (THI) fell from 24.5 to 6.25 in four affected patients
Negative
- Small interim sample: results reported for only 10 patients
- Limited follow-up: data reflect six-month outcomes only
- Study remains ongoing; interim findings are preliminary and not final
News Market Reaction – COCH
On the day this news was published, COCH declined 3.03%, reflecting a moderate negative market reaction. Argus tracked a peak move of +2.2% during that session. Our momentum scanner triggered 3 alerts that day, indicating moderate trading interest and price volatility. This price movement removed approximately $2M from the company's valuation, bringing the market cap to $53.05M at that time.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Market Reality Check
Peers on Argus
Momentum scans only flagged IINN moving up, with no broad moves across other medical device peers, indicating this Envoy update is stock-specific rather than a sector-wide shift.
Previous Clinical trial Reports
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Apr 22 | Trial activation milestone | Positive | -4.3% | All 56 pivotal trial patients completed Activation Visits, enabling full follow-up. |
| Apr 01 | 12-month endpoint data | Positive | +6.0% | First three patients reached 12-month endpoints in the pivotal Acclaim trial. |
| Mar 11 | Enrollment completion | Positive | +9.1% | Completion of enrollment with the 56th pivotal trial patient implanted. |
| Feb 19 | Financing and progress | Positive | -2.9% | Upsized financing and report of 47 of 56 implants completed in pivotal trial. |
| Feb 17 | Enrollment update | Positive | +14.8% | Reported 45 of 56 patients implanted, keeping pivotal trial on track. |
Clinical milestones often drew positive reactions, but there were notable sell-the-news divergences on similarly constructive trial updates.
Over recent months Envoy has repeatedly advanced its fully implanted Acclaim cochlear implant. Milestones included nearing full enrollment, reaching 45 of 56 and then all 56 patients implanted, activation visits completed, and the first patients hitting the 12-month endpoint. A February business update highlighted financing to support commercialization and trial progress. This article adds first-stage pivotal clinical data from the initial 10 patients with six-month follow-up, fitting into a steady stream of clinical trial de‑risking milestones.
Historical Comparison
Past clinical trial updates for Acclaim saw an average move of 4.54%, with reactions mixed between strong rallies and occasional sell-the-news pullbacks.
Clinical news has progressed from early enrollment milestones through majority implantation, financing to support the trial, completion of all 56 implants and activations, and first 12-month data. Today’s update adds six-month performance and quality-of-life data from the first 10 pivotal patients.
Market Pulse Summary
This announcement adds the first pivotal-stage performance and quality-of-life data for Acclaim, showing improved CNC scores from 15.2% to 39.2% and better tinnitus scores in select patients. It follows earlier milestones such as completion of enrollment of 56 patients and initial 12-month data. Investors may watch for larger patient datasets, durability beyond 6 months, and upcoming conference presentations in May for further validation.
Key Terms
cochlear implant medical
consonant-nucleus-consonant (cnc) medical
tinnitus handicap inventory (thi) medical
breakthrough device designation regulatory
pivotal clinical trial medical
AI-generated analysis. Not financial advice.
Positive Initial 6-Month Data from First 10 Patients and Improvements in Speech Understanding and Quality of Life Scores Presented; Additional Presentations Scheduled in Early May
Details to be Discussed During Fireside Chat on April 29, 2026 at 4:30 pm ET
White Bear Lake, Minnesota--(Newsfile Corp. - April 28, 2026) - Envoy Medical® Inc. (NASDAQ: COCH) ("Envoy Medical" or the "Company"), a hearing health company pioneering fully implanted hearing solutions, today announced the first podium presentations of clinical data from the first stage of its pivotal clinical study of the investigational Acclaim® cochlear implant, a first-of-its-kind, fully implanted cochlear implant system. The Company will host a Fireside Chat with Dr. Theodore McRackan, MD, MSCR and Dr. Elizabeth Camposeo, AuD from the Medical University of South Carolina (MUSC) on Wednesday April 29, 2026 at 4:30 pm ET to review the data and its clinical implications.
A planned interim analysis of the clinical data for the first 10 patients was conducted following completion of their six-month follow-up visits. Initial safety and performance data were presented this past weekend by Dr. Camposeo at the American Academy of Audiology (AAA) Annual Conference and Dr. McRackan at the Combined Otolaryngology Spring Meetings (COSM). Additional podium presentations are scheduled for May including the American Cochlear Implant Alliance (ACIA) Conference on Friday, May 8, 2026, and the International Conference on Cochlear Implants and Other Implantable Technologies (CI2026) on Monday, May 11, 2026.
"We are encouraged by the initial data from the first stage of the investigational Acclaim® clinical study being presented across several industry conferences," said Brent Lucas, Chief Executive Officer of Envoy Medical. "In addition to promising early safety and performance signals, we are seeing evidence of a strong interest in a fully implanted solution. Many participants had previously declined traditional cochlear implants due to the required use of an external processor, underscoring the potential for the Acclaim cochlear implant to expand the addressable market. While the study remains ongoing and these interim results are preliminary, the data reinforces our belief in the clinical and commercial promise of a fully implanted approach."
Envoy Fireside Chat Details
Event: Envoy Medical Fireside Chat
Date: Wednesday, April 29, 2026
Time: 4:30 P.M. ET
Webcast Link: https://ir.envoymedical.com/news-events/ir-calendar
Key Takeaways from Investigator Presentations
Preliminary Safety Profile Data
- No serious adverse events (SAEs) as defined by the study protocol were reported.
- Adverse events were mild or moderate and resolved with routine care or programming adjustments.
Preliminary Hearing Performance Data
- Speech recognition improved by 6 months: Consonant-Nucleus-Consonant (CNC) word recognition, mean scores increased from
15.2% pre-CI to39.2% (24 percentage point improvement).
Device Use
Participants reported a median daily hearing-device wear time of 24 hours a day. This was a noticeable increase from their pre-operative median of 15.5 hours a day with hearing aids.
Drivers of Choice to Participate
Participants were surveyed to understand why they previously declined traditional cochlear implants. Top responses included:
- Not wanting to wear an external processor (
80% ). - Concern that an external processor would draw unwanted attention (
70% ). - Discomfort with external processor size (
60% ).
Participants were surveyed to understand their motivations for choosing a fully implanted cochlear implant system. Top responses included:
- Wanted the ability to hear during water activities, exercise, or while wearing headgear (
100% ). - Wanted to be able to hear 24-hours a day with device (
100% ). - Wanted an invisible, fully implanted device (
90% ).
Quality of Life
- Patients demonstrated improvements in quality-of-life scores as measured by the CI-QOL35, a validated cochlear implant-specific quality of life instrument.
Tinnitus Handicap Inventory (THI)
- Four patients who reported having tinnitus prior to surgery experienced a reduction in tinnitus as assessed by the Tinnitus Handicap Instrument (THI). For these patients, mean THI scores decreased from 24.5 pre-implant to 6.25 in 6 months.
Upcoming Conference Presentations
- American Cochlear Implant Alliance (ACIA) Conference - Friday, May 8, 2026
- International Conference on Cochlear Implants and Other Implantable Technologies (CI2026) - Monday, May 11, 2026
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; 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 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/294479