# MAH: Hearing Aid, Bone Conduction, Implanted

- Device class: 2; regulation: 21 CFR 874.3302; FDA's rule: 510(k) required
- FDA decisions: 12
- 510(k) review time 2021–2025: median 65 days (middle half 65–65)
- 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)
- 1999: 1
- 2008: 1
- 2011: 1
- 2012: 2
- 2015: 3
- 2016: 1
- 2018: 1
- 2021: 1
- 2026: 1

## Most-cited predicates
- K080363: Baha Cordelle II (2008), cited by 4
- K112053: Obc Bone Anchored Hearing System (2011), cited by 3
- K984162: Branemark Bone-Anchored Hearing Aid (Baha) System for Pediatric Use (1999), cited by 2
- K121228: Ponto Bone Anchored Hearing System (2012), cited by 2
- K142678: Ponto Bone Anchored Hearing system/ Abutment, 14mm. Ponto Bone Anchored Hearing System / Wide implant, 4mm, with abutment, 14 mm (2015), cited by 2
- K152067: Ponto bone anchored hearing system (2015), cited by 1
- K121317: Cochlear Baha Implant System (2012), cited by 1

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