# K211008: Bose SoundControl Hearing Aids

- Pathway: 510(k) (Special)
- Applicant: Bose Corporation
- Decided: May 5, 2021 after 30 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: 1 generation back to DEN180026 (2018). 1 ancestor in all.
8 later devices descend from it; 6 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN180026: Bose Hearing Aid, Bose Corporation (2018) Summary page 5.

## Most influential descendants
- K212609: BHA100 Series Braun Clear Hearing Aid (2022), 2 descendants of its own
- K233747: Concha Sol Hearing Aids (CL-1001) (2024), 0 descendants of its own
- K231550: Sontro® OTC Hearing Aids (AI) (2023), 0 descendants of its own
- K221052: Self-Fitting hearing aids (2023), 0 descendants of its own
- K223848: Intrisound™ Tuned Lumen® 155 Hearing Aids (2023), 0 descendants of its own

## Indications for use
The Bose SoundControl™ Hearing Aids is 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. No pre-programming or hearing test is necessary. The device is intended for direct-to-consumer sale and use without the assistance of a hearing care professional.

Source page: https://510kreport.com/device/K211008
Methodology: https://510kreport.com/methodology