510(k) K212609
- Device
- BHA100 Series Braun Clear Hearing Aid
- Applicant
- Kaz USA, Inc., A Helen Of Troy Company
- 510(k) number
- K212609
- Product code
- QDD
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2022-01-05
- Date received
- 2021-08-17
- Regulation
- 874.3325
- Classification name
- Self-fitting Air-conduction Hearing Aid
- Medical specialty
- Ear Nose & Throat
- Review panel
- Ear Nose & Throat
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Matt J. Baun
- Address
- 400 Donald Lynch Blvd., Suite 300 Marlborough MA US 01752 01752
FDA Registration Numbers#
- 3026048380
- 3005019184
- 3003426343
- 3015246392
- 2182204
- 3019918054
- 3007344957
- 3030627827
- 3014337591
- 3013294311
- 3004871905
- 3005650109
- 3015651976
- 3011927597
- 3003303986
Source Documents#
Other 510(k) Records For Product Code QDD #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K223911 | Lumen 155-SF | Intricon Corporation | 2023-10-17 |
| K220403 | Vibe SF Self-Fitting Hearing Aid | Wsaud A/S | 2022-08-12 |
| K220303 | MDHearingAid app, MDHearingAid Smart hearing aids | Mdhearingaid | 2022-08-04 |
| K213424 | Jabra Enhance Plus | GN Hearing A/S | 2022-01-19 |
| K211008 | Bose SoundControl Hearing Aids | Bose Corporation | 2021-05-05 |
| DEN180026 | Bose Hearing Aid | Bose Corporation | 2018-10-05 |
Legacy Summary#
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FDA Review#
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