# LEZ: Aids, Speech Training For The Hearing Impaired (Ac-Powered And Patient-Contact)

- Device class: U; regulation: 21 CFR —
- FDA decisions: 3
- Recalls: 1 (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)
- 1980: 1
- 1998: 1
- 2009: 1

## Most-cited predicates
- K982396: Visivox, Model V-2 (1998), cited by 1
- K802870: Rion Electro-Palatograph Model DP-01 (1980), cited by 1

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