K254296
- 510(k) number
- K254296
- Device name
- Ossiclear (Ossiclear System)
- Applicant
- Sounduct FR
- Product code
- LXB — Hearing Aid, Bone Conduction
- Decision date
- 2026-07-22
- Date received
- 2025-12-31
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Ear, Nose, Throat
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K254296.pdf
Official FDA record: K254296
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.