# QDD: Self-Fitting Air-Conduction Hearing Aid, Prescription

- Device class: 2; regulation: 21 CFR 874.3325; FDA's rule: 510(k) required
- FDA decisions: 7
- 510(k) review time 2021–2025: median 162 days (middle half 103–183)
- 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)
- 2018: 1
- 2021: 1
- 2022: 4
- 2023: 1

## Most-cited predicates
- K211008: Bose SoundControl Hearing Aids (2021), cited by 6
- DEN180026: Bose Hearing Aid (2018), cited by 5
- K212609: BHA100 Series Braun Clear Hearing Aid (2022), cited by 2
- K213424: Jabra Enhance Plus (2022), cited by 1
- K220403: Vibe SF Self-Fitting Hearing Aid (2022), cited by 1

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