# QUH: Self-Fitting Air-Conduction Hearing Aid, Over The Counter

- Device class: 2; regulation: 21 CFR 874.3325; FDA's rule: 510(k) required
- FDA decisions: 10
- 510(k) review time 2021–2025: median 161 days (middle half 114–202)
- 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)
- 2022: 2
- 2023: 5
- 2024: 2
- 2026: 1

## Most-cited predicates
- K221064: Nuheara IQbuds 2 PRO Hearing Aid (2022), cited by 1

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