# K223137: Lexie Lumen Self-Fitting OTC Hearing Aids with Lexie Application

- Pathway: 510(k) (Traditional)
- Applicant: Hearx SA (Pty), Ltd.
- Decided: Mar 14, 2023 after 161 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: 3 generations back to DEN180026 (2018). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212609: BHA100 Series Braun Clear Hearing Aid, Kaz USA, Inc., A Helen of Troy Company (2022) Summary page 5.

## Indications for use
The Lexie Lumen Self-Fitting OTC Hearing Aid(s) with Lexie Application is a self-fitting air-conduction hearing aid, intended to amplify sound for individuals 18 years of age or older with perceived mild to moderate hearing impairment. The device is adjusted by the user to meet the user's hearing needs. The device is intended for use without the assistance of a hearing care professional.

Source page: https://510kreport.com/device/K223137
Methodology: https://510kreport.com/methodology