# Qualitone Hearing Aids and Audiometers

- Location (FDA's records): Minneapolis, MN
- FDA decisions: 1 (1991–1991): 1 510(k) clearance
- Product codes: EWO (1)
- 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
- K904622: Hearing Checker (TM), Desktop Model (Sep 17, 1991)

Source page: https://510kreport.com/company/qualitone-hearing-aids-and-audiometers