# K254108: Jabra Enhance Select Self-fit (Jabra Enhance Select 550)

- Pathway: 510(k) (Traditional)
- Applicant: GN Hearing A/S
- Decided: Jun 25, 2026 after 188 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)
- K213424: Jabra Enhance Plus, GN Hearing A/S (2022) Summary page 5.

## Indications for use
The Jabra Enhance Select 550 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. 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/K254108
Methodology: https://510kreport.com/methodology