# Oticon Corp.

- Location (FDA's records): Somerset, NJ
- FDA decisions: 66 (1978–1997): 66 510(k) clearances
- Names in FDA's records: Oticon Corp. (57); Oticon, Inc. (9)
- Product codes: ESD (63), ERA (2), FSD (1)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 2 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms that cite its devices most
- Miracle-Ear, Inc.: 2 (https://510kreport.com/company/miracle-ear)

## Its most-cited devices
- K961059: Digifocus Compact (1996), cited by 1
- K964683: Digifocus Ite (1996), cited by 1

## Recent decisions
- K973886: Oticon Digisound Compact (Nov 4, 1997)
- K973885: Oticon Digisound Ite (Nov 4, 1997)
- K964683: Digifocus Ite (Dec 12, 1996)
- K963788: Primofocus Compact (Nov 27, 1996)
- K961059: Digifocus Compact (May 7, 1996)
- K960284: Oticon /Primofocus (PF) (Mar 7, 1996)
- K954794: Oticon (Nov 13, 1995)
- K950381: Oticon/Logic (Feb 27, 1995)

Source page: https://510kreport.com/company/oticon