Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014337591

FEI Number

3014337591

Entity Name

HEARX SA

City/State/Country

Pretoria Gauteng, ZA

Establishment Address

Building 2, Ashlea Gardens Office Park, 180 Garsfontein Road, Ashlea Gardens, Pretoria Gauteng 0081, ZA

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

hearX (Owner Number: 10057906)

Owner / Operator Contact Address

Ground Floor, Building 2, Ashlea Gardens Office Park,, 180 Garsfontein Road, Ashlea Gardens, Pretoria, ZA-GT 0081, ZA

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Lexie B3 Hearing Aids Lexie Lumen Self-Fitting OTC Hearing Aids with Lexie Application hearOAE hearTest OccHealth hearScreen USA hearTest STK hearScreen hearScope Lexie H1 OTC Hearing Buds Go Ultra OTC Hearing Aids

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QUH	Self-Fitting Air-Conduction Hearing Aid, Over The Counter	Ear, Nose, Throat	Class 2	874.3325	2023-03-22
EWO	Audiometer	Ear, Nose, Throat	Class 2	874.1050	2023-11-27
EWO	Audiometer	Ear, Nose, Throat	Class 2	874.1050	2018-07-12
ERA	Otoscope	Ear, Nose, Throat	Class 1	874.4770	2018-06-18
QUG	Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter	Ear, Nose, Throat	Class 2	874.3305	2022-10-24

Official Correspondent

Jade Blanchard

US Agent Details

Emily Matorin Business: FDAbasics Email: usagent@fdabasics.com Phone: (716) 7750533

Related Public Records

Same Entity

hearX

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3015246392	hearX USA	Dekalb, IL, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K780270	Maico Hearing Instruments, Inc.	COMPUTER AUDIOMETER - MA26	1978-02-27
K923074	Life-Tech Intl., Inc.	DANPLEX SCREENING AUDIOMETER	1992-09-23
K932506	Rudolf Riester GmbH & Co. KG	RI-SCOPE (S)	1993-10-08

Similar Registrations

Registration Number	Establishment Name	Location
3023339161	TUNED LTD	Gan Yoshiya Central, IL
3040068315	LUXSHARE ELECTRONIC TECHNOLOGY (KUNSHAN) LTD.	Kunshan Jiangsu, CN
3015527983	SOUNDWAVE HEARING, LLC	Oak Brook, IL, US
3010841212	EARGO INC	San Jose, CA, US
2182204	GN Hearing Care Corporation	Shakopee, MN, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014337591. Last updated year: 2026. Please use registration number 3014337591 when referencing this establishment in official correspondence.