Oticon Medical AB: FDA filings under this applicant name
FDA lists 17 510(k) clearances under the applicant name “Oticon Medical AB” (first 2008, latest 2026), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 112 days. Since 2017 the median was 70 days, against 136 days for all cleared 510(k)s in the same product codes. 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 | 1 | 137 |
| 2013 | 1 | 95 |
| 2014 | 1 | 99 |
| 2015 | 2 | 123 |
| 2016 | 2 | 110 |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 1 | 59 |
| 2020 | 0 | — |
| 2021 | 3 | 65 |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 1 | 127 |
| 2025 | 0 | — |
| 2026 | 1 | 141 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Oticon Medical AB took a median 70 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 136 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LXB | Hearing Aid, Bone Conduction | 8 | 8 |
| MAH | Hearing Aid, Bone Conduction, Implanted | 7 | 7 |
| KCT | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | 1 | 1 |
| PFO | Active Implantable Bone Conduction Hearing System | 1 | 1 |
Review panels
- Ear, Nose and Throat (16)
- General Hospital (1)
Most recent Oticon Medical AB 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K261142 | Ponto 5 Mini; Ponto 5 Superpower | MAH | 2026-08-26 | 141 |
| K240614 | Sentio Ti Implant Kit; Sentio 1 Mini; Genie Medical BAHS | PFO | 2024-07-10 | 127 |
| K213733 | Ponto 5 SuperPower | LXB | 2021-12-16 | 20 |
| K211640 | Ponto 5 Mini | LXB | 2021-08-10 | 75 |
| K203807 | Ponto Bone Anchored Hearing System, MONO Surgery Kit | MAH | 2021-03-03 | 65 |
| K190540 | Ponto 4 | LXB | 2019-05-02 | 59 |
| K161671 | Ponto 3, Ponto 3 Power and Ponto 3 SuperPower | LXB | 2016-09-29 | 105 |
| K152820 | Ponto Bone Anchored Hearing System | MAH | 2016-01-22 | 116 |
| K152067 | Ponto bone anchored hearing system | MAH | 2015-11-23 | 122 |
| K142678 | Ponto Bone Anchored Hearing system/ Abutment, 14mm. Ponto Bone Anchored Hearing System / Wide implant, 4mm, with abutment, 14 mm | MAH | 2015-01-21 | 124 |
7 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Oticon Medical AB.
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.
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 A/S (2 510(k)s)
- Oticon Medical (0 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Oticon Medical AB?
FDA lists 17 510(k) clearances under the applicant name “Oticon Medical AB” (first 2008, latest 2026), across 4 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Oticon Medical AB?
The median time from FDA receipt to decision across 510(k)s cleared under the name Oticon Medical AB is 112 days. Since 2017: 70 days, versus 136 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Oticon Medical AB?
The most frequent FDA product codes under this applicant name are LXB (Hearing Aid, Bone Conduction, 8); MAH (Hearing Aid, Bone Conduction, Implanted, 7); KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Accessories, 1).
Next steps
- See all 17 Oticon Medical AB clearances with predicates and recalls
- Run predicate analysis for product code LXB, Oticon Medical AB'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.