K260902
- 510(k) number
- K260902
- Device name
- Cochlear Osia® 3(I) Sound Processor;Cochlear Osia® 3 Sound Processor;Cochlear Osia® 3 Charger;Cochlear Osia® 3 Aqua+;Cochlear Osia® Fitting Software 3;Cochlear Osia® Smart App;Cochlear Osia® System
- Applicant
- Cochlear Americas CO · US
- Product code
- PFO — Active Implantable Bone Conduction Hearing System
- Decision date
- 2026-07-10
- Date received
- 2026-03-18
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Ear, Nose, Throat
510(k) Summary (official FDA PDF): K260902.pdf
Official FDA record: K260902
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.