Clearance Summary
BHA100 Series Braun Clear Hearing Aid received FDA 510(k) clearance under submission number K212609, sponsored by Kaz USA, Inc., A Helen of Troy Company. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ear, Nose, Throat review panel. The statutory decision date of record is 2022-01-05.
- Submission: K212609
- Applicant / Sponsor: Kaz USA, Inc., A Helen of Troy Company
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class II
- Regulation citation: 21 CFR 874.3325
- Decision date: 2022-01-05
Classification & Regulation
This clearance is catalogued under FDA product code QDD and 21 CFR 874.3325, within the Ear, Nose, Throat review panel as a Class II device.