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 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.
- Drug:
- Acclaim
- Announced Date:
- October 7, 2025
- Indication:
- for Breakthrough Hearing Device
Announcement
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.
AI Summary
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.
Read Announcement- Drug:
- Acclaim
- Announced Date:
- September 24, 2025
- Indication:
- for Breakthrough Hearing Device
Announcement
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.
AI Summary
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.
Read Announcement
Envoy Medical FDA Events - Frequently Asked Questions
As of now, Envoy Medical (COCH) has not received any FDA approvals for its therapy in the last two years.
In the past two years, Envoy Medical (COCH) has reported FDA regulatory activity for Acclaim.
The most recent FDA-related event for Envoy Medical occurred on October 7, 2025, involving Acclaim. The update was categorized as "FDA approved," with the company reporting: "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."
Currently, Envoy Medical has one therapy (Acclaim) targeting the following condition: for Breakthrough Hearing Device.
More FDA Event Resources from MarketBeat
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
This page (NASDAQ:COCH) was last updated on 10/8/2025 by MarketBeat.com Staff
