Clearance Summary
WSA Self-Fitting Hearing Aid Gen 2 received FDA 510(k) clearance under submission number K233464, sponsored by Wsaud A/S. The device was reviewed via the Special premarket notification pathway and assigned to the Ear, Nose, Throat review panel. The statutory decision date of record is 2024-02-09.
- Submission: K233464
- Applicant / Sponsor: Wsaud A/S
- Clearance pathway: Special
- Review panel: Ear, Nose, Throat
- Device class: Class II
- Regulation citation: 21 CFR 874.3325
- Decision date: 2024-02-09
Classification & Regulation
This clearance is catalogued under FDA product code QUH and 21 CFR 874.3325, within the Ear, Nose, Throat review panel as a Class II device.