Ponto 5 Mini; Ponto 5 Superpower— 510(k) K261142
Substantially EquivalentOticon Medical AB
FDA 510(k) clearance K261142 for Ponto 5 Mini; Ponto 5 Superpower, Substantially Equivalent on 2026-08-26. Applicant: Oticon Medical AB. Device class: 2.
Summary
Oticon Medical's submission lists the Ponto 5 Mini and the Ponto 5 Superpower. Both are filed under product code MAH, implanted bone conduction hearing aids.
Class II, 21 CFR 874.3302. Ear, Nose, Throat is both the classification panel and the review panel, and it came in as a Special 510(k).
Oticon filed from Askim, Sweden. The decision came 141 calendar days after FDA received it (April 7 to August 26, 2026), and it was substantially equivalent.
Clearance details
- Applicant
- Oticon Medical AB
- Product code
- Product code MAH
- Device class
- Class 2
- Regulation
- 21 CFR 874.3302
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Askim, SE
Recent devices under product code MAH
view allMore clearances from Oticon Medical AB
view allAdverse events under product code MAH
product code MAH- Injury
- 4,155
- Total
- 4,155
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.