Oticon Medical: FDA filings under this applicant name
FDA lists 0 510(k) clearances under the applicant name “Oticon Medical”, plus 1 PMA decision, across 1 product code in 1 review panel. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MCM | Implant, Cochlear | 1 | 0 |
Review panels
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P200021 | PMA | Neuro Cochlear Implant System | 2021-06-23 |
Recalls
openFDA lists no recalls under a recalling firm named Oticon Medical.
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 Oticon Medical is the lead sponsor of 28 device studies on ClinicalTrials.gov (3 active or recruiting). Most recent:
- NCT07294976: Evaluation of Actual Maximum Gain in Bone Anchored Devices (Recruiting, started 2025-12-04)
- NCT06930781: Evaluation of Clinical Outcomes of Ponto Procedures Performed in Settings Outside the Main Operating Room (i.e. Out-of-OR) (Recruiting, started 2025-05-07)
- NCT06976086: Pediatric Expansion Study of the Sentio System (Recruiting, started 2025-04-30)
- NCT06421766: Retrospective Study of Outcomes With 3 mm Implant for Percutaneous BAHS Procedures (Completed, started 2024-03-08)
- NCT05628285: Evaluation of a Hearing Device for Transmitting Sound to the Inner Ear (Completed, started 2022-11-15)
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Oticon Medical (a text match, not an official crosswalk):
- L8616 — Microphone for use with cochlear implant device, replacement (via MCM)
- L8628 — Cochlear implant, external controller component, replacement (via MCM)
- L8615 — Headset/headpiece for use with cochlear implant device, replacement (via MCM)
- L8617 — Transmitting coil for use with cochlear implant device, replacement (via MCM)
- L8627 — Cochlear implant, external speech processor, component, replacement (via MCM)
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Oticon Corp. (66 510(k)s)
- Oticon Medical AB (17 510(k)s)
- Oticon A/S (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Oticon Medical?
FDA lists 0 510(k) clearances under the applicant name “Oticon Medical”, plus 1 PMA decision, across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
Which FDA product codes appear under Oticon Medical?
The most frequent FDA product codes under this applicant name are MCM (Implant, Cochlear, 1).
Next steps
- See all 0 Oticon Medical clearances with predicates and recalls
- Run predicate analysis for product code MCM, Oticon Medical'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.