# K220403: Vibe SF Self-Fitting Hearing Aid

- Pathway: 510(k) (Traditional)
- Applicant: Wsaud A/S
- Decided: Aug 12, 2022 after 182 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.
1 later device descends from it; 1 cites it directly.
0 of 3 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 4.

## Most influential descendants
- K233464: WSA Self-Fitting Hearing Aid Gen 2 (2024), 0 descendants of its own

## Indications for use
The Vibe SF self-fitting 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 through software tools. The device is intended for direct-to-consumer sale and use without the assistance of a hearing care professional. The EasyFit self-fitting web application is intended to support self-fitting and fine-tuning of the Vibe SF hearing aid.

Source page: https://510kreport.com/device/K220403
Methodology: https://510kreport.com/methodology