# K221698: Eargo 5 , Eargo 6

- Pathway: 510(k) (Traditional)
- Applicant: Eargo, Inc.
- Decided: Dec 21, 2022 after 191 days
- Product code: QUH (Self-Fitting Air-Conduction Hearing Aid, Over The Counter)
- 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.
No later device cites it as a predicate yet.
0 of 3 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.

## Indications for use
The Eargo Self-Fitting Hearing Aids are intended to amplify and transmit sound to the ear and thereby compensate for perceived mild to moderate hearing impairment in individuals 18 years of age or older. They are adjusted by the user to meet the user's hearing needs. No pre-programming or hearing test is necessary. The product is intended to be used without the assistance of a hearing care professional.

Source page: https://510kreport.com/device/K221698
Methodology: https://510kreport.com/methodology