FDA applicant
Oticon Medical AB
FDA records 18 decisions for Oticon Medical AB (Askim, SE) from 2008 to 2026: 17 510(k) clearances and 1 original PMA approval. Most are in product codes LXB (Hearing Aid, Bone Conduction) and MAH (Hearing Aid, Bone Conduction, Implanted). Since 2016 its 510(k)s took a median of 75 days from receipt to decision, against 79 for FDA’s reviews in the same codes and years. Its devices cite 30 predicates, 21 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Oticon Medical”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Oticon Medical AB’s devices, and how often a recall has named them.
FDA decisions per year
1in 2024
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2008.
Planning a device like Oticon Medical AB’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) ReportOther applicant names beginning “Oticon”
FDA records each applicant name separately; these may or may not be the same firm.