K231550
- 510(k) number
- K231550
- Device name
- Sontro® OTC Hearing Aids (AI)
- Applicant
- Soundwave Hearing, LLC IL · US
- Product code
- QUH — Self-Fitting Air-Conduction Hearing Aid, Over The Co
- Decision date
- 2023-10-26
- Date received
- 2023-05-30
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Ear, Nose, Throat
PDFDownload 510(k) SummaryArchived here · 1.5 MB · U.S. public domain
Also available from FDA: K231550.pdf
Official FDA record: K231550
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.