510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K223137Substantially Equivalent

Lexie Lumen Self-Fitting OTC Hearing Aids with Lexie Application

Hearx SA (Pty), Ltd., Pretoria, ZA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K223137 is the FDA 510(k) clearance record for Lexie Lumen Self-Fitting OTC Hearing Aids with Lexie Application, a class II device, cleared for Hearx SA (Pty) , Ltd. on under FDA product code QUH (Self-Fitting Air-Conduction Hearing Aid, Over The Counter). FDA's definition for product code QUH reads: "A self-fitting air-conduction hearing aid is a wearable sound amplifying device that is intended to compensate for impaired hearing and incorporates technology, including software, that allows users to program their hearing aids. This...". FDA records list 2 510(k) clearances for Hearx SA (Pty) , Ltd., from to . As of , FDA records show no recalls naming K223137.

Clearance record

Decision date
Received
(161 days to decision)
Product code
QUH Self-Fitting Air-Conduction Hearing Aid, Over The Counter
Regulation
21 CFR 874.3325
Device class
Class II
Review panel
Ear, Nose, Throat
Applicant
Hearx SA (Pty) , Ltd. Bldg. 2, Ashlea Gardens Office Park, 180 Garsfontein Rd., Pretoria, ZA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QUH

Trailing 12 months
1 clearance under product code QUH in the twelve months to October 2026, June 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code QUH, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20261
July 20260
August 20260
September 20260
October 20260