K254044
- 510(k) number
- K254044
- Device name
- Hearing assist
- Applicant
- Meta Platform Technologies, LLC CA · US
- Product code
- SCR — Air-Conduction Hearing Aid Software
- Decision date
- 2026-07-13
- Date received
- 2025-12-17
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Ear, Nose, Throat
PDFDownload 510(k) SummaryArchived here · 0.8 MB · U.S. public domain
Also available from FDA: K254044.pdf
Official FDA record: K254044
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.