# SCR: Air-Conduction Hearing Aid Software

- Device class: 2; regulation: 21 CFR 874.3335; FDA's rule: 510(k) required
- FDA decisions: 5
- 510(k) review time 2021–2025: median 142 days (middle half 133–152)
- 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)
- 2024: 1
- 2025: 2
- 2026: 2

## Most-cited predicates
- DEN230081: Hearing Aid Feature (HAF) (2024), cited by 4

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