510(k) K261142

Ponto 5 Mini; Ponto 5 Superpower by Oticon Medical AB — Product Code MAH

K261142 is an FDA 510(k) premarket notification submitted by Oticon Medical AB for the device "Ponto 5 Mini; Ponto 5 Superpower". The FDA issued a decision of Substantially Equivalent on August 26, 2026. The device falls under product code MAH (Hearing Aid, Bone Conduction, Implanted), a Class II device regulated under 21 CFR 874.3302. Oticon Medical AB has at least 10 other 510(k) clearances on record.