K261142
- 510(k) number
- K261142
- Device name
- Ponto 5 Mini; Ponto 5 Superpower
- Applicant
- Oticon Medical AB SE
- Product code
- MAH — Hearing Aid, Bone Conduction, Implanted
- Decision date
- 2026-08-26
- Date received
- 2026-04-07
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Ear, Nose, Throat
PDFDownload 510(k) SummaryArchived here · 3.2 MB · U.S. public domain
Also available from FDA: K261142.pdf
Official FDA record: K261142
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.