MAH
- Product code
- MAH
- Device name
- Hearing Aid, Bone Conduction, Implanted
- Device class
- Class 2
- 21 CFR
- 21 CFR 874.3302
- Medical specialty
- Ear, Nose, Throat
- Marketing pathway
- 510(K)
- Flag
- Implant
- 510(k) clearances (last 3 years)
- 1
- Summaries archived here
- 1 (direct download)
- 510(k) clearances (all years, FDA)
- 12 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (1)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K261142 | 2026-08-26 | Oticon Medical AB | Ponto 5 Mini; Ponto 5 Superpower |
Official FDA classification page: MAH
Classification and pathway per current FDA publications. Data from openFDA (CC0).