Lexie Hearing In-Store

GUDID 00850022464577

Lexie B1 Hearing Aids, powered by Bose. Self-fit, app-controlled hearing aids

HEARX GROUP (PTY) LTD

Air-conduction hearing aid, receiver-in-canal Air-conduction hearing aid, receiver-in-canal Air-conduction hearing aid, receiver-in-canal Air-conduction hearing aid, receiver-in-canal Air-conduction hearing aid, receiver-in-canal Air-conduction hearing aid, receiver-in-canal Air-conduction hearing aid, receiver-in-canal Air-conduction hearing aid, receiver-in-canal Air-conduction hearing aid, receiver-in-canal Air-conduction hearing aid, receiver-in-canal Air-conduction hearing aid, receiver-in-canal Air-conduction hearing aid, receiver-in-canal Air-conduction hearing aid, receiver-in-canal Air-conduction hearing aid, receiver-in-canal Air-conduction hearing aid, receiver-in-canal

• Primary Device ID: 00850022464577
• NIH Device Record Key: 8cbb8d69-50ff-408e-b6a8-fcdb7ebdc7d9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Lexie Hearing
• Version Model Number: Lexie B1 Self-fitting OTC Hearing Aids Powered by
• Catalog Number: In-Store
• Company DUNS: 539177681
• Company Name: HEARX GROUP (PTY) LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: (800) 499-1336
• Email: support@lexiehearing.com
• Phone: (800) 499-1336
• Email: support@lexiehearing.com
• Phone: (800) 499-1336
• Email: support@lexiehearing.com
• Phone: (800) 499-1336
• Email: support@lexiehearing.com
• Phone: (800) 499-1336
• Email: support@lexiehearing.com
• Phone: (800) 499-1336
• Email: support@lexiehearing.com
• Phone: (800) 499-1336
• Email: support@lexiehearing.com
• Phone: (800) 499-1336
• Email: support@lexiehearing.com
• Phone: (800) 499-1336
• Email: support@lexiehearing.com
• Phone: (800) 499-1336
• Email: support@lexiehearing.com
• Phone: (800) 499-1336
• Email: support@lexiehearing.com
• Phone: (800) 499-1336
• Email: support@lexiehearing.com
• Phone: (800) 499-1336
• Email: support@lexiehearing.com
• Phone: (800) 499-1336
• Email: support@lexiehearing.com
• Phone: (800) 499-1336
• Email: support@lexiehearing.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Handling Environment Temperature: between 0 and 45 degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Handling Environment Temperature: between 0 and 45 degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Handling Environment Temperature: between 0 and 45 degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Handling Environment Temperature: between 0 and 45 degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Handling Environment Temperature: between 0 and 45 degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Handling Environment Temperature: between 0 and 45 degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Handling Environment Temperature: between 0 and 45 degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Handling Environment Temperature: between 0 and 45 degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Handling Environment Temperature: between 0 and 45 degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Handling Environment Temperature: between 0 and 45 degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Handling Environment Temperature: between 0 and 45 degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Handling Environment Temperature: between 0 and 45 degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Handling Environment Temperature: between 0 and 45 degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Handling Environment Temperature: between 0 and 45 degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Handling Environment Temperature: between 0 and 45 degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850022464577 [Primary]
GS1	10850022464574 [Package]; Package: Case [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211008

FDA Product Code

• QDD: Self-Fitting Air-Conduction Hearing Aid

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-10-13
• Device Publish Date: 2022-10-05

On-Brand Devices [Lexie Hearing]

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