Lexie Hearing In-Store

GUDID 10850022464642

Lexie B2, Powered by Bose re-chargeable self-fitting hearing aid

HEARX GROUP (PTY) LTD

Air-conduction hearing aid, receiver-in-canal
Primary Device ID10850022464642
NIH Device Record Key8492c2ea-d9ac-46ef-9607-f690caf4831d
Commercial Distribution StatusIn Commercial Distribution
Brand NameLexie Hearing
Version Model NumberLexie B2 Self-fitting OTC Hearing Aids Powered by
Catalog NumberIn-Store
Company DUNS539177681
Company NameHEARX GROUP (PTY) LTD
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone(800) 499-1336
Emailsupport@lexiehearing.com
Phone(800) 499-1336
Emailsupport@lexiehearing.com
Phone(800) 499-1336
Emailsupport@lexiehearing.com
Phone(800) 499-1336
Emailsupport@lexiehearing.com
Phone(800) 499-1336
Emailsupport@lexiehearing.com
Phone(800) 499-1336
Emailsupport@lexiehearing.com
Phone(800) 499-1336
Emailsupport@lexiehearing.com
Phone(800) 499-1336
Emailsupport@lexiehearing.com
Phone(800) 499-1336
Emailsupport@lexiehearing.com
Phone(800) 499-1336
Emailsupport@lexiehearing.com
Phone(800) 499-1336
Emailsupport@lexiehearing.com
Phone(800) 499-1336
Emailsupport@lexiehearing.com
Phone(800) 499-1336
Emailsupport@lexiehearing.com
Phone(800) 499-1336
Emailsupport@lexiehearing.com
Phone(800) 499-1336
Emailsupport@lexiehearing.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Storage and handling temperature between 0 and 45 degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Storage and handling temperature between 0 and 45 degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Storage and handling temperature between 0 and 45 degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Storage and handling temperature between 0 and 45 degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Storage and handling temperature between 0 and 45 degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Storage and handling temperature between 0 and 45 degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Storage and handling temperature between 0 and 45 degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Storage and handling temperature between 0 and 45 degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Storage and handling temperature between 0 and 45 degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Storage and handling temperature between 0 and 45 degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Storage and handling temperature between 0 and 45 degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Storage and handling temperature between 0 and 45 degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Storage and handling temperature between 0 and 45 degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Storage and handling temperature between 0 and 45 degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Storage and handling temperature between 0 and 45 degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100850022464645 [Primary]
GS110850022464642 [Package]
Contains: 00850022464645
Package: Case [6 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

QDDSelf-Fitting Air-Conduction Hearing Aid

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-10-13
Device Publish Date2022-10-05

On-Brand Devices [Lexie Hearing]

00850022464263iOS Hearing Aid Programming App
00850022464256Android Hearing Aid Programming App
10860003469801Lexie Lumen self-fitting Beige hearing aid - Duo
10850022464000Lexie Lumen self-fitting Silver hearing aid - Duo
10850022464642Lexie B2, Powered by Bose re-chargeable self-fitting hearing aid
00850022464577Lexie B1 Hearing Aids, powered by Bose. Self-fit, app-controlled hearing aids
00850022464942Lexie B2 Self-fitting OTC Hearing Aids, Powered by Bose (BTE, Grey)
00850022464157Lexie Lumen OTC Hearing Aids - Beige Online
00860003469880Lexie Lumen Duo Metalic Black - Online
00860003469866Lexie Lumen Duo Bronze - Online
00860003469842Lexie Lumen Duo Light Gray - Online
00850022464171Lexie Lumen Duo Silver - Online
00850022464065Lexie Lumen OTC Hearing Aids - Gray Online
00810153660163Refurbished Lexie B2 Plus Powered by Bose
00810153660156Refurbished Lexie B2 Powered by Bose
00810153660149Refurbished Lexie B1 Powered by Bose

Trademark Results [Lexie Hearing]

Mark Image

Registration | Serial
Company
Trademark
Application Date
LEXIE HEARING
LEXIE HEARING
98220205 not registered Live/Pending
hearX USA Inc.
2023-10-12

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