510(k) K212609
K212609 is an FDA 510(k) premarket notification submitted by Kaz USA, Inc., A Helen of Troy Company for the device "BHA100 Series Braun Clear Hearing Aid". The FDA issued a decision of Substantially Equivalent on January 5, 2022. The device falls under product code QDD (Self-Fitting Air-Conduction Hearing Aid, Prescription), a Class II device regulated under 21 CFR 874.3325. Kaz USA, Inc., A Helen of Troy Company has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 5, 2022
- Date Received
- August 17, 2021
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Self-Fitting Air-Conduction Hearing Aid, Prescription
- Device Class
- Class II
- Regulation Number
- 874.3325
- Review Panel
- EN
- Submission Type
A self-fitting air-conduction hearing aid is a wearable sound amplifying device that is intended to compensate for impaired hearing and incorporates technology, including software, that allows users to program their hearing aids. This technology integrates user input with a self-fitting strategy and enables users to independently derive and customize their hearing aid fitting and settings. This is a prescription hearing aid.