hearX Group

Primary DI
00850022464621
Brand
hearX Group
Company
HEARX GROUP (PTY) LTD
Model
hearOAE
Device description
The hearOAE (otoacoustic emission device) is a portable, handheld, battery-operated device that can detect hearing loss using Otoacoustic Emission technologies. The hearOAE device may be configured to support one or any combination of TEOAE (transient evoked otoacoustic emissions) or DPOAE (distortion product otoacoustic emissions).
Published
2025-03-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
EWOAudiometer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EWOAudiometerEar, Nose, Throat2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K231545000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K231545000hearOAEHearx SA (Pty) , Ltd.2023-10-27EWO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850022464621PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850022464621008500224646218500224646210850022464621

GMDN Terms#

Term, Definition table
TermDefinition
Otoacoustic emission system, battery-poweredAn assembly of battery-powered devices designed to record and analyse the faint sounds hair cells in the inner ear emit [otoacoustic emission (OAE)] in response to a stimulus (e.g., click, tone burst, pure-tone signals) to test for a deficiency of function in the ear during diagnostic evaluation and/or neonatal screening. It typically consists of a portable programmable unit, an OAE probe, and eartips. The stimulus signal is emitted via the probe inserted into the ear canal and the response is recorded via a microphone in the probe; OAEs are absent/reduced in patients with hearing loss. The system may be combined with other audiological devices (e.g., tympanometer, ABR device).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
539177681
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
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10810153660054Go HearingGo Ultra - Gray - BTE - WAG Online - CASEGHUS00002CA2024-01-15
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00810153660040Go PrimeGo HearingGHPS00003BL2023-12-18
00850022464256Lexie HearingLexie Android AppLexie Android App2022-04-13
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00850022464638Lexie B2, Powered by BoseLB2001LBO00001B22022-09-09
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