# Bernafon, Inc.

- Location (FDA's records): Mountainside, NJ
- FDA decisions: 16 (1983–1988): 16 510(k) clearances
- Product codes: ESD (16)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 0 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Recent decisions
- K880349: Model 759 Custom in-the-Ear Hearing Aid (Mar 7, 1988)
- K874589: Bernafon Colibri, C-2H Hearing Aids (Dec 4, 1987)
- K864823: Behind the Ear Hearing Aids, Bernafon Colibri, C1 (Jan 6, 1987)
- K864180: Integra, Custom in-the-Ear Hearing Aid (Nov 5, 1986)
- K860759: Charisma Hearing Aid (Apr 11, 1986)
- K855240: Behind the Ear Hearing Aids Model (Mar 12, 1986)
- K851547: Behind the Ear Hearing Aid Model Bernafon T-82 (May 29, 1985)
- K844985: IN the Ear Model X-Ite 84 (Jan 23, 1985)

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