510(k) K260902 · PFO Active Implantable Bone Conduction Hearing System
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, Lone Tree CO, US |
| Decision | Substantially Equivalent, Jul 10, 2026 |
| Received | Mar 18, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K260902
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.