BHA100 Series Braun Clear Hearing Aid
FDA 510(k) clearance K212609 · decided 2022-01-05
Clearance details
- K-number
- K212609
- Device name
- BHA100 Series Braun Clear Hearing Aid
- Applicant
- Kaz USA, Inc., A Helen of Troy Company
- Decision
- Substantially Equivalent
- Date received
- 2021-08-17
- Decision date
- 2022-01-05
- Days to decision
- 141 days
- Clearance type
- Traditional
- Product code
- QDD
- Device class
- 2
- Regulation number
- 874.3325
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Marlborough, MA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Lumen 155-SF (K223911) | Intricon Corporation | 2023-10-17 |
| Vibe SF Self-Fitting Hearing Aid (K220403) | Wsaud A/S | 2022-08-12 |
| MDHearingAid app, MDHearingAid Smart hearing aids (K220303) | Mdhearingaid | 2022-08-04 |
| Jabra Enhance Plus (K213424) | GN Hearing A/S | 2022-01-19 |
| Bose SoundControl Hearing Aids (K211008) | Bose Corporation | 2021-05-05 |
| Bose Hearing Aid (DEN180026) | Bose Corporation | 2018-10-05 |
Recalls involving this device
No recalls on record reference this clearance.