Envoy Medical (COCH) FDA Approvals $0.69 +0.02 (+2.59%) As of 01:37 PM Eastern This is a fair market value price provided by Massive. Learn more. Add Compare Share Share FDA Events Stock AnalysisAnalyst ForecastsChartCompetitorsEarningsFDA EventsFinancialsHeadlinesInsider TradesOwnershipSEC FilingsTrendsBuy This Stock Envoy Medical's Drug in the FDA Approval ProcessThis section highlights FDA-related milestones and regulatory updates for drugs developed by Envoy Medical (COCH). Over the past two years, Envoy Medical has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as Acclaim. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend. Acclaim FDA Regulatory Timeline and Events Acclaim is a drug developed by Envoy Medical for the following indication: for Breakthrough Hearing Device. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy. Presentation - April 28,2026Presentation Drug: AcclaimAnnounced Date: April 28, 2026Indication: for Breakthrough Hearing DeviceAnnouncementEnvoy Medical 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.AI SummaryEnvoy Medical announced the first podium presentations of clinical data from the initial stage of its pivotal study of the investigational Acclaim® fully implanted cochlear implant. Preliminary 6‑month results from the first 10 patients were positive: no serious adverse events were reported, and side effects were mild or moderate and resolved with routine care or programming. Speech recognition improved notably, with mean CNC word scores rising from 15.2% before implantation to 39.2% at six months (a 24‑point gain). Participants reported a median device wear time of 24 hours a day, up from 15.5 hours with hearing aids. Quality‑of‑life scores improved on the CI‑QOL35 measure, and four patients with tinnitus showed mean THI scores falling from 24.5 to 6.25 at six months. Surveys showed many had previously declined traditional implants to avoid an external processor (80%), concern about attention (70%), or discomfort with size (60%); motivations for choosing Acclaim included hearing during water activities or exercise (100%), 24‑hour use (100%), and an invisible device (90%). Additional presentations are scheduled in early May, and a fireside chat is set for April 29, 2026 at 4:30 P.M. ET (webcast available).Read AnnouncementEnrollment Update - March 11,2026Enrollment Update Drug: AcclaimAnnounced Date: March 11, 2026Indication: for Breakthrough Hearing DeviceAnnouncementEnvoy Medical® announced completed enrollment of its pivotal clinical trial for the investigational fully implanted Acclaim® cochlear implant.AI SummaryEnvoy Medical announced it has finished enrolling its pivotal U.S. clinical trial for the investigational fully implanted Acclaim cochlear implant, reaching the 56th and final participant. With these implants complete, Envoy says it is the first cochlear implant company to fully enroll a U.S. pivotal trial for a fully implanted device seeking FDA approval. The final two participants were implanted by Dr. Patrick Antonelli at the University of Florida; Dr. Antonelli has implanted 11 of the 56 patients and is the trial’s second leading enroller. With enrollment closed, the study will move into scheduled follow-up visits and data collection. Once all patients reach 12-month follow-up, the results will be analyzed and submitted to the FDA as part of a PMA application seeking approval. The Acclaim device is investigational, intended for adults with severe to profound sensorineural hearing loss, and is designed as a fully implanted system that captures sound via a sensor using the ear’s natural anatomy.Read AnnouncementFDA approved - October 7,2025Fda Approved Drug: AcclaimAnnounced Date: October 7, 2025Indication: for Breakthrough Hearing DeviceAnnouncementEnvoy Medical, announced that it received approval from the U.S. Food and Drug Administration (FDA) to expand the Company's pivotal clinical trial for the fully implanted Acclaim® cochlear implant to the final stage based on promising three-month data from the first 10 patients.AI SummaryEnvoy Medical announced FDA approval to expand its pivotal clinical trial for the fully implanted Acclaim® cochlear implant into the final stage. This decision was based on promising three-month safety and effectiveness data from the first 10 patients, none of whom experienced serious adverse events or unanticipated device effects. With the expansion cleared, Envoy moved its development schedule up by three to six months and now expects to complete enrollment of all 56 participants by early 2026. The company plans to add seven U.S. trial sites and believes strong patient interest will speed recruitment. These efficiencies have allowed Envoy Medical to cut its projected capital needs by $10–$15 million, removing timing uncertainty and strengthening its path toward regulatory approval and eventual commercialization of the Acclaim® cochlear implant.Read AnnouncementProvided Update - September 24,2025Provided Update Drug: AcclaimAnnounced Date: September 24, 2025Indication: for Breakthrough Hearing DeviceAnnouncementEnvoy Medical® Inc announced it is scaling its commercialization planning for the company's breakthrough investigational Acclaim® fully implanted hearing device, as its pivotal clinical trial continues to build momentum.AI SummaryEnvoy Medical Inc. announced it is scaling its commercialization planning for its breakthrough investigational Acclaim fully implanted cochlear implant as its pivotal clinical trial gains momentum. The company is proactively training and engaging a network of clinical centers to build capacity for anticipated demand once regulatory approval is received. All patients in the trial’s first stage successfully completed their three-month follow-up visits with no serious adverse events or unanticipated device effects. Six-month follow-up visits have now begun, with more visits scheduled over the next two months. Envoy Medical is also preparing to launch the next enrollment phase at seven U.S. sites upon approval of its trial expansion request. By targeting 30–40 highly trained surgical and audiological centers, Envoy Medical aims for depth over breadth in its rollout strategy. The company believes this approach will unlock a significant underserved market segment and set the stage for rapid top-line growth following approval.Read Announcement Envoy Medical FDA Events - Frequently Asked Questions Has Envoy Medical received FDA approval? As of now, Envoy Medical (COCH) has not received any FDA approvals for its therapy in the last two years. What drugs has Envoy Medical submitted to the FDA? In the past two years, Envoy Medical (COCH) has reported FDA regulatory activity for Acclaim. What is the most recent FDA event for Envoy Medical? The most recent FDA-related event for Envoy Medical occurred on April 28, 2026, involving Acclaim. The update was categorized as "Presentation," with the company reporting: "Envoy Medical 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." What conditions do Envoy Medical's current drugs treat? Currently, Envoy Medical has one therapy (Acclaim) targeting the following condition: for Breakthrough Hearing Device. More FDA Event Resources from MarketBeat FDA Calendars Recent FDA Drug Approval Calendar Upcoming FDA Events & PDUFA Dates Calendar Companies With Recent FDA Events Acurx Pharmaceuticals FDA EventsAkebia Therapeutics FDA EventsAltimmune FDA EventsEstrella Immunopharma FDA EventsNiagen Bioscience FDA EventsOmeros FDA EventsOSR FDA EventsRocket Pharmaceuticals FDA EventsTonix Pharmaceuticals FDA EventsZai Lab FDA EventsEli Lilly and Company FDA EventsClearPoint Neuro FDA EventsMoleculin Biotech FDA EventsAprea Therapeutics FDA EventsCapricor Therapeutics FDA Events FDA Event Stage Terminology & Abbreviation Guide NDA: New Drug Application ANDA: Abbreviated New Drug Application sNDA: Supplemental New Drug Application BLA: Biologics License Application sBLA: Supplemental Biologics License Application FDA Approved: Approved by the FDA EMA: European Medicines Agency CE Mark: European Union Certification NMPA: China National Medical Products Administration MHLW: Japanese Ministry of Health FDA Meeting: Consultation with FDA Pre-IND: Pre-Investigational New Drug Meeting Breakthrough Therapy: Special FDA designation for promising therapies Fast Track: Accelerated FDA approval pathway Orphan Drug: Designation for rare disease treatments RPD: Rare Pediatric Disease Designation RMAT: Regenerative Medicine Advanced Therapy DSMB Review: Data Safety Monitoring Board Review IDMC Review: Independent Data Monitoring Committee MAA: MHRA Marketing Authorization Application RTF: Refusal to File (Rejected Application) 510(k): FDA Clearance for Medical Devices Rolling Submission: Staggered regulatory review process Related Companies KORU Medical Systems FDA Events Apyx Medical FDA Events Avita Medical FDA Events Microbot Medical FDA Events Inovio Pharmaceuticals FDA Events PolyPid FDA Events Nano-X Imaging FDA Events electroCore FDA Events Nyxoah FDA Events Stock Lists Biotechnology StocksCompare Biotech StocksCompare Healthcare StocksCompare Pharmaceutical StocksHealthcare Stocks FDA progress for NASDAQ:COCH last updated on 4/28/2026 by MarketBeat.com Staff. We continuously monitor for new FDA events and market data. From Our PartnersPorter flew 3,300 miles to investigate this systemPorter Stansberry flew the Porter and Co. team 3,300 miles to Dublin to investigate a 17-year investing experi...Porter & Company | SponsoredYour $29.97 book is free todayWhy Some Traders Skip Stocks Entirely You don't need a big account to trade options. In fact, options ca...Profits Run | Sponsored“The unseen winner of the AI race” is not SpaceXMarc Chaikin - the analyst who called Nvidia before its historic run - says a tech firm labeled 'the unseen wi...Chaikin Analytics | SponsoredWhat's the Best Way to Lower RMD Taxes?Once you turn 73, the IRS requires you to take distributions from your IRA, 401(k), and other retirement accou...SmartAsset | SponsoredBlackRock, JPMorgan, and Goldman are all stock piling the same asset… are you?BlackRock, JPMorgan, Goldman Sachs, Fidelity, ARK Invest and Andreessen Horowitz are all buying the same asset...Awesomely | SponsoredThe $15 Gold Fund That Pays Up to $1,152/MonthGold is hitting record highs, but most investors are leaving income on the table. A $15 fund is quietly paying...Investors Alley | SponsoredHere’s the stock symbol I’ve promisedWhitney Tilson of Stansberry Research has long recommended Berkshire Hathaway as a core retirement holding - b...Stansberry Research | SponsoredRickards Predicts: Trump to buy tiny $2 stock?Jim Rickards believes the Trump administration is about to take a direct stake in a $2 stock sitting on the la...Paradigm Press | Sponsored Adding Choose a watchlist: Watchlist Adding You have already added ten stocks to your watchlist. Upgrade to MarketBeat All Access to add more stocks to your watchlist. Adding Envoy Medical, Inc. Please log in to your account or sign up in order to add this asset to your watchlist. Share Envoy Medical With A Colleague Link copied to clipboard. Unlock superior investment research and tools. Sign up for MarketBeat All Access to gain access to MarketBeat's full suite of research tools and reports. Get MarketBeat All Access MarketBeat All Access Features Best-in-Class Portfolio Monitoring Get personalized stock ideas. Compare portfolio to indices. Check stock news, ratings, SEC filings, and more. Stock Ideas and Recommendations See daily stock ideas from top analysts. Receive short-term trading ideas from MarketBeat. Identify trending stocks on social media. Advanced Stock Screeners and Research Tools Use our seven stock screeners to find suitable stocks. Stay informed with MarketBeat's real-time news. Export data to Excel for personal analysis. Sign in to your free account to enjoy these benefits In-depth profiles and analysis for 20,000 public companies. Real-time analyst ratings, insider transactions, earnings data, and more. Our daily ratings and market update email newsletter. Sign in to your free account to enjoy all that MarketBeat has to offer. Sign In Create Account Your Email Address: Email Address Required Your Password: Password Required Log In Email Me a Login Link or Sign in with Facebook Sign in with Google Forgot your password? Your Email Address: Please enter your email address. Please enter a valid email address Choose a Password: Please enter your password. Your password must be at least 8 characters long and contain at least 1 number, 1 letter, and 1 special character. Create My Account (Free) or Sign in with Facebook Sign in with Google By creating a free account, you agree to our terms of service. This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
Presentation - April 28,2026Presentation Drug: AcclaimAnnounced Date: April 28, 2026Indication: for Breakthrough Hearing DeviceAnnouncementEnvoy Medical 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.AI SummaryEnvoy Medical announced the first podium presentations of clinical data from the initial stage of its pivotal study of the investigational Acclaim® fully implanted cochlear implant. Preliminary 6‑month results from the first 10 patients were positive: no serious adverse events were reported, and side effects were mild or moderate and resolved with routine care or programming. Speech recognition improved notably, with mean CNC word scores rising from 15.2% before implantation to 39.2% at six months (a 24‑point gain). Participants reported a median device wear time of 24 hours a day, up from 15.5 hours with hearing aids. Quality‑of‑life scores improved on the CI‑QOL35 measure, and four patients with tinnitus showed mean THI scores falling from 24.5 to 6.25 at six months. Surveys showed many had previously declined traditional implants to avoid an external processor (80%), concern about attention (70%), or discomfort with size (60%); motivations for choosing Acclaim included hearing during water activities or exercise (100%), 24‑hour use (100%), and an invisible device (90%). Additional presentations are scheduled in early May, and a fireside chat is set for April 29, 2026 at 4:30 P.M. ET (webcast available).Read Announcement
Enrollment Update - March 11,2026Enrollment Update Drug: AcclaimAnnounced Date: March 11, 2026Indication: for Breakthrough Hearing DeviceAnnouncementEnvoy Medical® announced completed enrollment of its pivotal clinical trial for the investigational fully implanted Acclaim® cochlear implant.AI SummaryEnvoy Medical announced it has finished enrolling its pivotal U.S. clinical trial for the investigational fully implanted Acclaim cochlear implant, reaching the 56th and final participant. With these implants complete, Envoy says it is the first cochlear implant company to fully enroll a U.S. pivotal trial for a fully implanted device seeking FDA approval. The final two participants were implanted by Dr. Patrick Antonelli at the University of Florida; Dr. Antonelli has implanted 11 of the 56 patients and is the trial’s second leading enroller. With enrollment closed, the study will move into scheduled follow-up visits and data collection. Once all patients reach 12-month follow-up, the results will be analyzed and submitted to the FDA as part of a PMA application seeking approval. The Acclaim device is investigational, intended for adults with severe to profound sensorineural hearing loss, and is designed as a fully implanted system that captures sound via a sensor using the ear’s natural anatomy.Read Announcement
FDA approved - October 7,2025Fda Approved Drug: AcclaimAnnounced Date: October 7, 2025Indication: for Breakthrough Hearing DeviceAnnouncementEnvoy Medical, announced that it received approval from the U.S. Food and Drug Administration (FDA) to expand the Company's pivotal clinical trial for the fully implanted Acclaim® cochlear implant to the final stage based on promising three-month data from the first 10 patients.AI SummaryEnvoy Medical announced FDA approval to expand its pivotal clinical trial for the fully implanted Acclaim® cochlear implant into the final stage. This decision was based on promising three-month safety and effectiveness data from the first 10 patients, none of whom experienced serious adverse events or unanticipated device effects. With the expansion cleared, Envoy moved its development schedule up by three to six months and now expects to complete enrollment of all 56 participants by early 2026. The company plans to add seven U.S. trial sites and believes strong patient interest will speed recruitment. These efficiencies have allowed Envoy Medical to cut its projected capital needs by $10–$15 million, removing timing uncertainty and strengthening its path toward regulatory approval and eventual commercialization of the Acclaim® cochlear implant.Read Announcement
Provided Update - September 24,2025Provided Update Drug: AcclaimAnnounced Date: September 24, 2025Indication: for Breakthrough Hearing DeviceAnnouncementEnvoy Medical® Inc announced it is scaling its commercialization planning for the company's breakthrough investigational Acclaim® fully implanted hearing device, as its pivotal clinical trial continues to build momentum.AI SummaryEnvoy Medical Inc. announced it is scaling its commercialization planning for its breakthrough investigational Acclaim fully implanted cochlear implant as its pivotal clinical trial gains momentum. The company is proactively training and engaging a network of clinical centers to build capacity for anticipated demand once regulatory approval is received. All patients in the trial’s first stage successfully completed their three-month follow-up visits with no serious adverse events or unanticipated device effects. Six-month follow-up visits have now begun, with more visits scheduled over the next two months. Envoy Medical is also preparing to launch the next enrollment phase at seven U.S. sites upon approval of its trial expansion request. By targeting 30–40 highly trained surgical and audiological centers, Envoy Medical aims for depth over breadth in its rollout strategy. The company believes this approach will unlock a significant underserved market segment and set the stage for rapid top-line growth following approval.Read Announcement
