510(k) K250215 ยท LXB Hearing Aid, Bone Conduction
Baha 7 Sound Processor; Baha Fitting Software 7 (P2121898); Baha Smart App (iOS) (P1646054); Baha Smart App (Android) (P1646035); Baha SoundBand
| Applicant | Cochlear, Lone Tree CO, US |
| Decision | Substantially Equivalent, May 29, 2025 |
| Received | Jan 24, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K250215
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.