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

Substantially Equivalent

Hearx SA (Pty) , Ltd.

Clearance details

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

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.