510(k) Report

FDA applicant

Oticon A/S

Smorum, DK2 decisions1995–20140 recalls

FDA records 2 decisions for Oticon A/S (Smorum, DK) from 1995 to 2014: 2 510(k) clearances. Most are in product codes KLW (Masker, Tinnitus) and ESD (Hearing Aid, Air-Conduction, Prescription). Its devices cite 2 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

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 A/S’s devices, and how often a recall has named them.

FDA decisions per year

1in 2014

2014: 1
2007high 1 (2014) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

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Which product codes does it file in?

  • KLWMasker, Tinnitus1decision
  • ESDHearing Aid, Air-Conduction, Prescription1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K133308Tinnitus SoundsupportOticon A/S · 20141cites it

What has FDA decided for it lately?

  • K133308Tinnitus SoundsupportOticon A/S · 2014
  • K951002Amendments to MultifocusOticon A/S · 1995

All 2 as Oticon A/S →

Other applicant names beginning “Oticon”

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

Oticon Corp. 66Oticon Medical AB 18