FDA.reportPublic FDA data

Lexie H1 Powered by Bose

Primary DI
00810153660408
Brand
Lexie H1 Powered by Bose
Company
HEARX GROUP (PTY) LTD
Model
Lexie Hearing
Catalog number
LBS00001H1
Device description
Lexie H1 Powered by Bose
Published
2025-10-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
OTC
true

Product Codes#

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

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810153660408PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810153660408008101536604088101536604080810153660408

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.

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
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
00850022464959Go HearingGo Ultra2023-03-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06971094538721KLARIQHuizhou Jinghao Medical Technology Co., LtdQUF2026-05-26
06971094538738KLARIQHuizhou Jinghao Medical Technology Co., LtdQUF2026-05-26
06971094538707XQYMHuizhou Jinghao Medical Technology Co., LtdQUF2026-05-08
06971094538691OricleHuizhou Jinghao Medical Technology Co., LtdQUF2026-04-30
06973967150276WuveeXiamen Vienatone Medical Technology Co., Ltd.QUF2026-04-28
06973967150283NebrooXiamen Vienatone Medical Technology Co., Ltd.QUF2026-04-28
06973967150313VienatoneXiamen Vienatone Medical Technology Co., Ltd.QUF2026-04-28
06973967150320VienatoneXiamen Vienatone Medical Technology Co., Ltd.QUF2026-04-28
06973967150368NebrooXiamen Vienatone Medical Technology Co., Ltd.QUF2026-04-28
06973967150573VienatoneXiamen Vienatone Medical Technology Co., Ltd.QUF2026-04-28
06971094538622Savvy SmartHuizhou Jinghao Medical Technology Co., LtdQUF2026-03-25
06971094538639Spade & CoHuizhou Jinghao Medical Technology Co., LtdQUF2026-03-24
06971094538615GIATATHAHuizhou Jinghao Medical Technology Co., LtdQUF2026-03-20
06971094538592LITOULFHuizhou Jinghao Medical Technology Co., LtdQUF2026-03-18
06950715563090CofoeCofoe Medical Technology Co.,LtdQUF2026-02-24
06971094538585Bachgold Huizhou Jinghao Medical Technology Co., LtdQUF2026-02-05
06979053570034UltrotingShenzhen Magnet Technology Co., LtdQUF2026-01-21
06979053570041UltrotingShenzhen Magnet Technology Co., LtdQUF2026-01-21
06971094538530LITOULFHuizhou Jinghao Medical Technology Co., LtdQUF2025-12-19
06978898058011Viva HearShenzhen Cresendo Technology Co.,Ltd.QUF2025-12-12
06978898058028Viva HearShenzhen Cresendo Technology Co.,Ltd.QUF2025-12-12
06978898058035Viva HearShenzhen Cresendo Technology Co.,Ltd.QUF2025-12-12
06978898058042Xpect VisionShenzhen Cresendo Technology Co.,Ltd.QUF2025-12-12
06978898058059Xpect VisionShenzhen Cresendo Technology Co.,Ltd.QUF2025-12-12
06978898058066Xpect VisionShenzhen Cresendo Technology Co.,Ltd.QUF2025-12-12
06975958550010MirasingXiamen Mirasing Technology Co.,Ltd.QUF2025-12-09
06975958550119MirasingXiamen Mirasing Technology Co.,Ltd.QUF2025-12-09
06975958550225MirasingXiamen Mirasing Technology Co.,Ltd.QUF2025-12-09
06975958550232MirasingXiamen Mirasing Technology Co.,Ltd.QUF2025-12-09
06975958550249MirasingXiamen Mirasing Technology Co.,Ltd.QUF2025-12-09