# EWD: Protector, Hearing (Insert)

- Device class: U; regulation: 21 CFR —
- FDA decisions: 14
- 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)
- 1979: 1
- 1982: 1
- 1987: 1
- 1991: 1
- 1992: 1
- 1993: 1
- 1995: 1
- 1996: 2
- 1997: 2
- 2002: 1

## Most-cited predicates
- K781907: Ear Stopples for Noise Attention (1978), cited by 1

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