Envoy Medical Corporation: FDA filings under this applicant name
FDA lists 1 510(k) clearance under the applicant name “Envoy Medical Corporation” (first 2008, latest 2008), plus 1 PMA decision, across 2 product codes in 1 review panel. Median 510(k) review time under this name: 52 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| NEA | Cement, Ear, Nose And Throat | 1 | 1 |
| OAF | Implant, Hearing, Active, Middle Ear, Totally Implanted | 1 | 0 |
Review panels
Most recent Envoy Medical Corporation 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K080032 | ENVOYCEM, MODEL 1640 | NEA | 2008-02-28 | 52 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P090018 | PMA | ESTEEM TOTALLY IMPLANTABLE HEARING SYSTEM | 2010-03-17 |
Recalls
2 product recalls in 2 recall events; 0 initiated in the last five years. Most recent: 2018-06-28.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Envoy Medical Corporation is the lead sponsor of 4 device studies on ClinicalTrials.gov (1 active or recruiting). Most recent:
- NCT06699797: Pivotal Clinical Trial Evaluating the Safety and Efficacy of the Fully Implanted Acclaim Cochlear Implant (Active not recruiting, started 2025-02-06)
- NCT02689349: Esteem New Subject Enrollment Post Approval Study (Completed, started 2010-08)
- NCT02666222: The Esteem® Hearing Implant Post Approval Study (Completed, started 2010-08)
- NCT01092910: Esteem Totally Implantable Hearing System (Completed, started 2008-01)
SEC filings
Envoy Medical, Inc. (COCH, COCHW): EDGAR filings, CIK 1840877. An SEC registrant with the same name, matched by name only.
Frequently asked questions
How many FDA 510(k) clearances are listed under Envoy Medical Corporation?
FDA lists 1 510(k) clearance under the applicant name “Envoy Medical Corporation” (first 2008, latest 2008), plus 1 PMA decision, across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Envoy Medical Corporation?
The median time from FDA receipt to decision across 510(k)s cleared under the name Envoy Medical Corporation is 52 days.
Which FDA product codes appear under Envoy Medical Corporation?
The most frequent FDA product codes under this applicant name are NEA (Cement, Ear, Nose And Throat, 1); OAF (Implant, Hearing, Active, Middle Ear, Totally Implanted, 1).
Next steps
- See all 1 Envoy Medical Corporation clearances with predicates and recalls
- Run predicate analysis for product code NEA, Envoy Medical Corporation's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.