# K212609: BHA100 Series Braun Clear Hearing Aid

- Pathway: 510(k) (Traditional)
- Applicant: Kaz USA, Inc., A Helen of Troy Company
- Decided: Jan 5, 2022 after 141 days
- Product code: QDD (Self-Fitting Air-Conduction Hearing Aid, Prescription)
- Device class: 2
- Regulation: 21 CFR 874.3325
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to DEN180026 (2018). 2 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K211008: Bose SoundControl Hearing Aids, Bose Corporation (2021) Summary page 4.

## Most influential descendants
- K223848: Intrisound™ Tuned Lumen® 155 Hearing Aids (2023), 0 descendants of its own
- K223137: Lexie Lumen Self-Fitting OTC Hearing Aids with Lexie Application (2023), 0 descendants of its own

## Indications for use
The BHA100 Series Braun® Clear™ Hearing Aid is a self-fitting, air conduction hearing aid, intended to amplify sound for individuals 18 years of age or older with perceived mild to moderate hearing impairment. It is adjusted by the user to meet the user's hearing needs. The device is intended for direct-to-consumer sale and use without the assistance of a hearing health care professional.

Source page: https://510kreport.com/device/K212609
Methodology: https://510kreport.com/methodology