# DEN180026: Bose Hearing Aid

- Pathway: De Novo (Direct)
- Applicant: Bose Corporation
- Decided: Oct 5, 2018 after 147 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
No predicates in its family tree.
16 later devices descend from it; 5 cite it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K211008: Bose SoundControl Hearing Aids (2021), 8 descendants of its own
- K212609: BHA100 Series Braun Clear Hearing Aid (2022), 2 descendants of its own
- K221064: Nuheara IQbuds 2 PRO Hearing Aid (2022), 1 descendant of its own
- K220403: Vibe SF Self-Fitting Hearing Aid (2022), 1 descendant of its own
- K213424: Jabra Enhance Plus (2022), 1 descendant of its own

## Indications for use
The Bose Hearing Aid 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/DEN180026
Methodology: https://510kreport.com/methodology