Clearance Summary
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 received FDA 510(k) clearance under submission number K260902, sponsored by Cochlear Americas. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ear, Nose, Throat review panel. The statutory decision date of record is 2026-07-10.
- Submission: K260902
- Applicant / Sponsor: Cochlear Americas
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class II
- Regulation citation: 21 CFR 874.3340
- Decision date: 2026-07-10
Classification & Regulation
This clearance is catalogued under FDA product code PFO and 21 CFR 874.3340, within the Ear, Nose, Throat review panel as a Class II device.