K250215
- 510(k) number
- K250215
- Device name
- Baha 7 Sound Processor; Baha Fitting Software 7 (P2121898); Baha Smart App (iOS) (P1646054); Baha Smart App (Android) (P1646035); Baha SoundBand
- Applicant
- Cochlear CO · US
- Product code
- LXB — Hearing Aid, Bone Conduction
- Decision date
- 2025-05-29
- Date received
- 2025-01-24
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Ear, Nose, Throat
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K250215.pdf
Official FDA record: K250215
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.