FDA applicant

Oticon Corp.

Somerset, NJ66 decisions1978–19970 recalls

FDA records 66 decisions for Oticon Corp. (Somerset, NJ) from 1978 to 1997: 66 510(k) clearances. Most are in product codes ESD (Hearing Aid, Air-Conduction, Prescription) and ERA (Otoscope). No recall is linked to its devices.

FDA’s records also spell it “Oticon, Inc.”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, ear, nose and throat panel, where it files most

How often FDA has decided Oticon Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Oticon Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Oticon Corp. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Oticon”

FDA records each applicant name separately; these may or may not be the same firm.

Oticon Medical AB 18 Oticon A/S 2

Oticon Corp.

Which product codes does it file in?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Oticon”