FDA.reportPublic FDA data

Lexie Hearing

Primary DI
00810153660811
Brand
Lexie Hearing
Company
HEARX GROUP (PTY) LTD
Model
Lexie B2 Powered by Bose (AARP Bundle)
Catalog number
LBS00001B2UF
Device description
Lexie B2 Powered by Bose (AARP)
Published
2025-07-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
OTC
true

Product Codes#

Code, Name table
CodeName
QUHSelf-Fitting Air-Conduction Hearing Aid, Over The Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QUHSelf-Fitting Air-Conduction Hearing Aid, Over The CounterEar, Nose, Throat2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810153660811PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810153660811008101536608118101536608110810153660811

GMDN Terms#

Term, Definition table
TermDefinition
Air-conduction hearing aid, receiver-in-canalA battery-powered acoustic device intended to compensate for impaired hearing by transmitting amplified sound waves to the eardrum through air. It consists of a microphone and an amplifier in a case behind-the-ear (BTE) connected, via a wire, to a receiver (speaker) in the ear canal [receiver-in-canal (RIC)]. 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 profound hearing loss; most types are programmable to enable computerized adjustments for a patient's hearing loss and related factors.

Sterilization Methods#

Method table
Method

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860003469828hearXhearScope2022-05-30
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
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
05708296422043GN HearingGn Hearing A/SQUH2026-08-21
05708296422050GN HearingGn Hearing A/SQUH2026-08-21
05708296422067GN HearingGn Hearing A/SQUH2026-08-21
05708296422074GN HearingGn Hearing A/SQUH2026-08-21
05708296422081GN HearingGn Hearing A/SQUH2026-08-21
05708296422098GN HearingGn Hearing A/SQUH2026-08-21
05708296422104GN HearingGn Hearing A/SQUH2026-08-21
05708296422111GN HearingGn Hearing A/SQUH2026-08-21
05708296422128GN HearingGn Hearing A/SQUH2026-08-21
05708296422135GN HearingGn Hearing A/SQUH2026-08-21
05708296422142GN HearingGn Hearing A/SQUH2026-08-21
05708296422159GN HearingGn Hearing A/SQUH2026-08-21
05708296422166GN HearingGn Hearing A/SQUH2026-08-21
05708296422173GN HearingGn Hearing A/SQUH2026-08-21
05708296422180GN HearingGn Hearing A/SQUH2026-08-21
05708296422197GN HearingGn Hearing A/SQUH2026-08-21
05708296422203GN HearingGn Hearing A/SQUH2026-08-21
05708296422210GN HearingGn Hearing A/SQUH2026-08-21
05708296422227GN HearingGn Hearing A/SQUH2026-08-21
05708296422234GN HearingGn Hearing A/SQUH2026-08-21
05708296422241GN HearingGn Hearing A/SQUH2026-08-21
05708296422258GN HearingGn Hearing A/SQUH2026-08-21
05708296422265GN HearingGn Hearing A/SQUH2026-08-21
05708296422272GN HearingGn Hearing A/SQUH2026-08-21
05708296422289GN HearingGn Hearing A/SQUH2026-08-21
05708296422296GN HearingGn Hearing A/SQUH2026-08-21
05708296422302GN HearingGn Hearing A/SQUH2026-08-21
05708296422319GN HearingGn Hearing A/SQUH2026-08-21
05708296422326GN HearingGn Hearing A/SQUH2026-08-21
05708296422333GN HearingGn Hearing A/SQUH2026-08-21