BHA100 Series Braun Clear Hearing Aid
FDA 510(k) K212609 · Kaz USA, Inc., A Helen of Troy Company
Submission
- Device name
- BHA100 Series Braun Clear Hearing Aid
- Applicant
- Kaz USA, Inc., A Helen of Troy Company
Marlborough, MA, US - Received
- August 17, 2021
- Decision date
- January 5, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- QDD – Self-Fitting Air-Conduction Hearing Aid, Prescription
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 874.3325
- Specialty
- Ear, Nose, Throat
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…
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| K223911 | Lumen 155-SFQDD · Traditional | Intricon Corporation | 10/17/2023SE |
| K220403 | Vibe SF Self-Fitting Hearing AidQDD · Traditional | Wsaud A/S | 08/12/2022SE |
| K220303 | MDHearingAid app, MDHearingAid Smart hearing aidsQDD · Traditional | Mdhearingaid | 08/04/2022SE |
| K213424 | Jabra Enhance PlusQDD · Traditional | GN Hearing A/S | 01/19/2022SE |
| K211008 | Bose SoundControl Hearing AidsQDD · Special | Bose Corporation | 05/05/2021SE |
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Questions and answers
When was BHA100 Series Braun Clear Hearing Aid cleared by the FDA?
BHA100 Series Braun Clear Hearing Aid (K212609) received a 510(k) decision of Substantially Equivalent on January 5, 2022, 141 days after the submission was received.
What is the product code of K212609?
The FDA product code is QDD – Self-Fitting Air-Conduction Hearing Aid, Prescription, a Class II (moderate risk) device regulated under 21 CFR 874.3325.