FDA.reportPublic FDA data

Go Hearing

Primary DI
00850022464454
Brand
Go Hearing
Company
HEARX GROUP (PTY) LTD
Model
Go Prime (C600)
Device description
These hearing aids are for users age 18 and older to compensate for perceived mild-to-moderate hearing impairment.
Published
2022-04-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ESDHearing Aid, Air Conduction
QUFHearing Aid, Air-Conduction, Over The Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ESDHearing Aid, Air-Conduction, PrescriptionEar, Nose, Throat1
QUFHearing Aid, Air-Conduction, Over The CounterEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850022464454PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850022464454008500224644548500224644540850022464454

GMDN Terms#

Term, Definition table
TermDefinition
Air-conduction hearing aid, in-the-earA battery-powered acoustic device intended to compensate for impaired hearing by transmitting amplified sound waves to the eardrum through air. It typically consists of a miniature microphone, amplifier, and speaker (receiver) contained in a case that fits completely inside the outer ear (concha) [in-the-ear (ITE)]. The microphone receives sound waves and converts them into electrical signals which are increased by the amplifier and sent as sound waves, by the speaker, to the eardrum. The device is used for mild to severe hearing loss; most types are programmable to enable computerized adjustments for a patient's hearing loss and related factors.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Please keep device dry at all times

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1 302 754 3190support@gohearing.com

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810153660323Lexie B3 Hearing AidsLexie Hearing LBS00001B32026-05-07
00810153660408Lexie H1 Powered by BoseLexie HearingLBS00001H12025-10-01
00810153660828Lexie H1 OTC Hearing BudsLexie Hearing LBS00002H12025-10-01
00810153660811Lexie HearingLexie B2 Powered by Bose (AARP Bundle)LBS00001B2UF2025-07-31
00850022464621hearX GrouphearOAE2025-03-04
00810153660217Go Prime - BlackGo HearingGHPA00003BE2024-08-19
00810153660187Go Prime - BeigeGo Hearing GHPS00003BE2024-05-17
00850022464591Go Prime - BeigeGo Hearing2024-02-12
00810153660149Lexie HearingRefurbished Lexie B1 Powered by BoseR-LBS00001B12024-03-07
00810153660156Lexie HearingRefurbished Lexie B2 Powered by BoseR-LBS00001B22024-03-07
00810153660163Lexie HearingRefurbished Lexie B2 Plus Powered by BoseR-LBS00001B2PLS2024-03-07
00850022464973Lexie B2 Plus Powered by BoseLexie HearingLBS00001B2PLS2024-01-31
00810153660057Go HearingGo Ultra - Gray - BTE - WAG Online2024-01-15
10810153660054Go HearingGo Ultra - Gray - BTE - WAG Online - CASEGHUS00002CA2024-01-15
00810153660033Lexie B2 Plus Powered by BoseLexie HearingLBS00002B2PLS2024-01-08
00810153660040Go PrimeGo HearingGHPS00003BL2023-12-18
00850022464256Lexie HearingLexie Android AppLexie Android App2022-04-13
00850022464263Lexie HearingLexie iOS AppLexie iOS App2022-04-13
00850022464942Lexie HearingLexie B2 Self-fitting OTC Hearing Aids, Powered by2023-02-06
00850022464638Lexie B2, Powered by BoseLB2001LBO00001B22022-09-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06977171530008TECHMITechmi (HongKong) Co., LimitedQUF2026-06-03
06977171530015TECHMITechmi (HongKong) Co., LimitedQUF2026-06-03
06977171530022TECHMITechmi (HongKong) Co., LimitedQUF2026-06-03
06977171530039TECHMITechmi (HongKong) Co., LimitedQUF2026-06-03
00810153660408Lexie H1 Powered by BoseHEARX GROUP (PTY) LTDQUF2025-10-01
07613389772838ampli-mini I 3 5P CIC-10 NWL PHSonova AGESD2024-11-12
07613389772845ampli-mini I 2 5P CIC-10 NWL PHSonova AGESD2024-11-12
07613389772920MEMINI I 4 5P CIC-10 NWL PHSonova AGESD2024-11-12
07613389772937MEMINI I 3 5P CIC-10 NWL PHSonova AGESD2024-11-12
00311917052984WalgreensWALGREEN CO.QUF2024-05-06
16945936703773NewsoundXiamen New Sound Technology Co., Ltd.ESD2024-01-19
00197344013244MedlineMEDLINE INDUSTRIES, INC.QUF2023-11-28
69743465514172ELEHEAR AlphaElevoc Technology Co.,Ltd.QUF2023-09-30
00681066089583BrookstoneSakar International, Inc.QUF2023-09-27
00681066089613BrookstoneSakar International, Inc.QUF2023-09-27
00810126191373AudinaAudina Hearing Instruments, Inc.ESD2023-01-31
00810126191380AudinaAudina Hearing Instruments, Inc.ESD2023-01-31
00810126191397AudinaAudina Hearing Instruments, Inc.ESD2023-01-31
00810126191403AudinaAudina Hearing Instruments, Inc.ESD2023-01-31
00810126191410AudinaAudina Hearing Instruments, Inc.ESD2023-01-31
00810126191427AudinaAudina Hearing Instruments, Inc.ESD2023-01-31
00810126191434AudinaAudina Hearing Instruments, Inc.ESD2023-01-31
00810126191441AudinaAudina Hearing Instruments, Inc.ESD2023-01-31
00810126191458AudinaAudina Hearing Instruments, Inc.ESD2023-01-31
00810126191465AudinaAudina Hearing Instruments, Inc.ESD2023-01-31
00810126191472AudinaAudina Hearing Instruments, Inc.ESD2023-01-31
00810126191489AudinaAudina Hearing Instruments, Inc.ESD2023-01-31
00810126191496AudinaAudina Hearing Instruments, Inc.ESD2023-01-31
00810126191502AudinaAudina Hearing Instruments, Inc.ESD2023-01-31
00810126191519AudinaAudina Hearing Instruments, Inc.ESD2023-01-31