# Bose Corporation

- Location (FDA's records): Framingham, MA
- FDA decisions: 2 (2018–2021): 1 510(k) clearance and 1 De Novo grant
- Product codes: QDD (2)
- Predicates its devices cite: 1 (1 its own); citations of its devices by later devices: 11 (1 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms that cite its devices most
- Kaz USA, Inc., A Helen of Troy Company: 1 (https://510kreport.com/company/kaz-usa-a-helen-of-troy)
- Eargo, Inc.: 1 (https://510kreport.com/company/eargo)
- Mdhearingaid: 1 (https://510kreport.com/company/mdhearingaid)
- Sonova AG: 1 (https://510kreport.com/company/sonova)
- GN Hearing A/S: 1 (https://510kreport.com/company/gn-hearing-a-s)
- Nuheara Limited: 1 (https://510kreport.com/company/nuheara)
- Huizhou Jinghao Medical Technology Co., Ltd.: 1 (https://510kreport.com/company/huizhou-jinghao-medical-technology)
- Concha Labs: 1 (https://510kreport.com/company/concha-labs)

## Its most-cited devices
- K211008: Bose SoundControl Hearing Aids (2021), cited by 6
- DEN180026: Bose Hearing Aid (2018), cited by 5

## Recent decisions
- K211008: Bose SoundControl Hearing Aids (May 5, 2021)
- DEN180026: Bose Hearing Aid (Oct 5, 2018)

Source page: https://510kreport.com/company/bose