FDA.reportPublic FDA data

Lexie Hearing

Primary DI
10850022464642
Brand
Lexie Hearing
Company
HEARX GROUP (PTY) LTD
Model
Lexie B2 Self-fitting OTC Hearing Aids Powered by
Catalog number
In-Store
Device description
Lexie B2, Powered by Bose re-chargeable self-fitting hearing aid
Published
2022-10-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
false
OTC
true
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
QDDSelf-Fitting Air-Conduction Hearing Aid

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QDDSelf-Fitting Air-Conduction Hearing Aid, PrescriptionEar, Nose, Throat2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K211008000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K211008000Bose SoundControl Hearing AidsBose Corporation2021-05-05QDD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850022464642PackageGS16In Commercial Distribution
00850022464645PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085002246464210850022464642
00850022464645008500224646458500224646450850022464645

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Storage and handling temperature between 0 and 45 degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(800) 499-1336support@lexiehearing.com

Regulatory Flags#

DUNS number
539177681
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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
00850010429205Eargo RXEargo, Inc.QDD2024-06-17
00850010429274Eargo RXEargo, Inc.QDD2024-06-17
05708296231010GN HearingGn Hearing A/SQDD2024-04-12
05708296231027GN HearingGn Hearing A/SQDD2024-04-12
05708296231034GN HearingGn Hearing A/SQDD2024-04-12
05708296231041GN HearingGn Hearing A/SQDD2024-04-12
05708296237944GN HearingGn Hearing A/SQDD2024-04-12
05708296237951GN HearingGn Hearing A/SQDD2024-04-12
05708296237968GN HearingGn Hearing A/SQDD2024-04-12
05708296237975GN HearingGn Hearing A/SQDD2024-04-12
05714880199420SonyWs Audiology Usa, Inc.QDD2023-08-31
05714880182781SonyWs Audiology Usa, Inc.QDD2023-05-30
05714880189308SonyWs Audiology Usa, Inc.QDD2023-01-20
05714880182750SonyWs Audiology Usa, Inc.QDD2022-12-20
05708296260775GN HearingGn Hearing A/SQDD2022-12-08
05708296260782GN HearingGn Hearing A/SQDD2022-12-08
05708296260799GN HearingGn Hearing A/SQDD2022-12-08
00850022464645Lexie HearingHEARX GROUP (PTY) LTDQDD2022-10-05
00850022464577Lexie HearingHEARX GROUP (PTY) LTDQDD2022-10-05
05714880182743SonyWs Audiology Usa, Inc.QDD2022-09-12
00850022464638Lexie B2, Powered by BoseHEARX GROUP (PTY) LTDQDD2022-09-09
00850022464492Lexie B1, Powered by BoseHEARX GROUP (PTY) LTDQDD2022-08-01
05708296228706GN HearingGn Hearing A/SQDD2022-07-08
05708296228713GN HearingGn Hearing A/SQDD2022-07-08
05708296233656GN HearingGn Hearing A/SQDD2022-07-08
05708296237609GN HearingGn Hearing A/SQDD2022-07-08
05708296238040GN HearingGn Hearing A/SQDD2022-07-08
05708296238057GN HearingGn Hearing A/SQDD2022-07-08
05708296238064GN HearingGn Hearing A/SQDD2022-07-08
05708296238071GN HearingGn Hearing A/SQDD2022-07-08