FDA.reportPublic FDA data

Lexie B2 Plus Powered by Bose

Primary DI
00810153660033
Brand
Lexie B2 Plus Powered by Bose
Company
HEARX GROUP (PTY) LTD
Model
Lexie Hearing
Catalog number
LBS00002B2PLS
Device description
Lexie B2 Plus Powered by Bose-WAG Online
Published
2024-01-08
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
00810153660033PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810153660033008101536600338101536600330810153660033

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.

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
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
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
00850022464959Go HearingGo Ultra2023-03-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810153660323Lexie B3 Hearing AidsHEARX GROUP (PTY) LTDQUH2026-05-07
00850010429786Eargo 8Eargo, Inc.QUH2026-04-20
00850010429847Eargo SEEargo, Inc.QUH2026-04-20
06971094538561HARMONIXHuizhou Jinghao Medical Technology Co., LtdQUH2026-01-20
00850010429779Eargo SEEargo, Inc.QUH2025-10-22
00810153660811Lexie HearingHEARX GROUP (PTY) LTDQUH2025-07-31
00850010429304Eargo 8Eargo, Inc.QUH2025-05-13
00850010429328Eargo 8Eargo, Inc.QUH2025-05-13
00850010429540Eargo 8Eargo, Inc.QUH2025-05-13
00850010429687Eargo 8Eargo, Inc.QUH2025-05-13
00850010429694Eargo 8Eargo, Inc.QUH2025-05-13
00850010429700Eargo 8Eargo, Inc.QUH2025-05-13
00850010429717Eargo 8Eargo, Inc.QUH2025-05-13
00850010429724Eargo 8Eargo, Inc.QUH2025-05-13
00850010429793Eargo 8Eargo, Inc.QUH2025-05-13
00850010429809Eargo 8Eargo, Inc.QUH2025-05-13
00046838505065JVCNovidan, Inc.QUH2025-05-07
00850010429816Eargo SEEargo, Inc.QUH2025-04-07
00850010429731Eargo SEEargo, Inc.QUH2025-04-03
00850010429748Eargo SEEargo, Inc.QUH2025-04-03
00850010429755Eargo SEEargo, Inc.QUH2025-04-03
00850010429762Eargo SEEargo, Inc.QUH2025-04-03
06971094538097OXILINEHuizhou Jinghao Medical Technology Co., LtdQUH2025-03-24
16971094538094OXILINEHuizhou Jinghao Medical Technology Co., LtdQUH2025-03-24
06971094537991AudialnetHuizhou Jinghao Medical Technology Co., LtdQUH2025-02-25
16971094537998AudialnetHuizhou Jinghao Medical Technology Co., LtdQUH2025-02-25
00860010331033CeretoneAudicon CorporationQUH2024-09-04
10860010331030CeretoneAudicon CorporationQUH2024-09-04
06971094537793RETEKESSHuizhou Jinghao Medical Technology Co., LtdQUH2024-09-02
16971094537790RETEKESSHuizhou Jinghao Medical Technology Co., LtdQUH2024-09-02