# K233464: WSA Self-Fitting Hearing Aid Gen 2

- Pathway: 510(k) (Special)
- Applicant: Wsaud A/S
- Decided: Feb 9, 2024 after 109 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)
- K220403: Vibe SF Self-Fitting Hearing Aid, Wsaud A/S (2022) Summary page 4.

## Indications for use
The WSA Self-Fitting Hearing Aid Gen 2 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 through software tools. The device is intended for direct-to-consumer sale and use without the assistance of a hearing care professional. The SF-App is intended to support self-fitting and fine-tuning of the hearing aid.

Source page: https://510kreport.com/device/K233464
Methodology: https://510kreport.com/methodology