Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015246392

FEI Number

3015246392

Entity Name

hearX USA

City/State/Country

Dekalb, IL, US

Establishment Address

320 Dietz Ave, Dekalb, IL 60115, US

Establishment Type(s)

Manufacture 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 Lexie B2 Plus Self-fitting OTC Hearing Aids, Powered by Bose Lexie B2 Self-fitting OTC Hearing Aids, Powered by Bose Lexie B1 Self-fitting OTC Hearing Aids, Powered by Bose hearScope hearTest OccHealth hearScreen USA hearTest STK hearScreen

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
QDD	Self-Fitting Air-Conduction Hearing Aid, Prescription	Ear, Nose, Throat	Class 2	874.3325	2022-07-05
QUH	Self-Fitting Air-Conduction Hearing Aid, Over The Counter	Ear, Nose, Throat	Class 2	874.3325	2022-07-05
ERA	Otoscope	Ear, Nose, Throat	Class 1	874.4770	2018-06-18
EWO	Audiometer	Ear, Nose, Throat	Class 2	874.1050	2018-07-12

Official Correspondent

Jade Blanchard

US Agent Details

No US Agent registered (Local establishment).

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
3014337591	HEARX SA	Pretoria Gauteng, ZA

Related 510(k) Records

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

Similar Registrations

Registration Number	Establishment Name	Location
3023339161	TUNED LTD	Gan Yoshiya Central, IL
3040068315	LUXSHARE ELECTRONIC TECHNOLOGY (KUNSHAN) LTD.	Kunshan Jiangsu, CN
3014337591	HEARX SA	Pretoria Gauteng, ZA
3015527983	SOUNDWAVE HEARING, LLC	Oak Brook, IL, US
3010841212	EARGO INC	San Jose, CA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015246392. Last updated year: 2026. Please use registration number 3015246392 when referencing this establishment in official correspondence.