The following data is part of a premarket notification filed by Kaz Usa, Inc., A Helen Of Troy Company with the FDA for Bha100 Series Braun Clear Hearing Aid.
| Device ID | K212609 |
| 510k Number | K212609 |
| Device Name: | BHA100 Series Braun Clear Hearing Aid |
| Classification | Self-fitting Air-conduction Hearing Aid |
| Applicant | Kaz USA, Inc., A Helen Of Troy Company 400 Donald Lynch Boulevard, Suite 300 Marlborough, MA 01752 |
| Contact | Matt J. Baun |
| Correspondent | Matt J. Baun Kaz USA, Inc., A Helen Of Troy Company 400 Donald Lynch Boulevard, Suite 300 Marlborough, MA 01752 |
| Product Code | QDD |
| CFR Regulation Number | 874.3325 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-08-17 |
| Decision Date | 2022-01-05 |