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:
- 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.
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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 September 24, 2025, involving Acclaim. The update was categorized as "Provided Update," with the company reporting: "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."
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 9/25/2025 by MarketBeat.com Staff
