# EPF: Hearing Aid, Group And Auditory Trainer

- Device class: 2; regulation: 21 CFR 874.3320; FDA's rule: 510(k) exempt
- FDA decisions: 32
- Recalls: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 1988: 2
- 1989: 1
- 1991: 3
- 1992: 7
- 1994: 2
- 1995: 1
- 1996: 1
- 1997: 2
- 1998: 3
- 2014: 1

## Most-cited predicates
- K974287: FM Receiver - Auditory Trainer (1998), cited by 1
- K913495: Telex TDR-7AA Binaural Hear Aid/Wireless FM Rec (1991), cited by 1

Source page: https://510kreport.com/product-code/EPF
Data by year (CSV): https://510kreport.com/product-code/EPF.csv