Envoy Medical (COCH) FDA Approvals

Envoy Medical's Drug in the FDA Approval Process

This 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 28,2026

• Drug: Acclaim
• Announced Date: April 28, 2026
• Indication: for Breakthrough Hearing Device

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.

Envoy 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).

Enrollment Update - March 11,2026

• Drug: Acclaim
• Announced Date: March 11, 2026
• Indication: for Breakthrough Hearing Device

Envoy Medical® announced completed enrollment of its pivotal clinical trial for the investigational fully implanted Acclaim® cochlear implant.

Envoy 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.

FDA approved - October 7,2025

• Drug: Acclaim
• Announced Date: October 7, 2025
• Indication: for Breakthrough Hearing Device

Envoy 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.

Envoy 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.

Provided Update - September 24,2025

• Drug: Acclaim
• Announced Date: September 24, 2025
• Indication: for Breakthrough Hearing Device

Envoy 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.

Envoy 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.