Lexie Lumen Self-Fitting OTC Hearing Aids with Lexie Application— 510(k) K223137

Name: FDA 510(k) clearance K223137
Creator: U.S. Food and Drug Administration
Published: 2023-03-14

Substantially Equivalent

Hearx SA (Pty) , Ltd.

FDA 510(k) clearance K223137 for Lexie Lumen Self-Fitting OTC Hearing Aids with Lexie Application, Substantially Equivalent on 2023-03-14. Applicant: Hearx SA (Pty) , Ltd.. Device class: 2.

Clearance details

Applicant: Hearx SA (Pty) , Ltd.
Product code: Code QUH
Device class: Class 2
Regulation: 21 CFR 874.3325
Advisory panel: Ear, Nose, Throat
Date received: 2022-10-04
Decision date: 2023-03-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pretoria, ZA

Download summary PDF View on FDA.gov ↗

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K254108 — Jabra Enhance Select Self-fit (Jabra Enhance Select 550)2026-06-25
K233747 — Concha Sol Hearing Aids (CL-1001)2024-03-15
K233464 — WSA Self-Fitting Hearing Aid Gen 22024-02-09
K231550 — Sontro® OTC Hearing Aids (AI)2023-10-26
K221052 — Self-Fitting hearing aids2023-09-25

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K231545 — hearOAE2023-10-27

Adverse events under product code QUH

product code QUH

Other: 1
Total: 1

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.