Lexie Hearing

Basic Information

• Brand Name: Lexie Hearing
• Primary DI: 00850022464577
• Version / Model: Lexie B1 Self-fitting OTC Hearing Aids Powered by Bose
• Catalog Number: In-Store
• Company Name: HEARX GROUP (PTY) LTD
• Labeler DUNS: 539177681
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-10-05
• Public Version: 1
• Public Version Date: 2022-10-13
• Public Version Status: New
• Public Device Record Key: 8cbb8d69-50ff-408e-b6a8-fcdb7ebdc7d9

Device Description

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

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
QDD	Self-Fitting Air-Conduction Hearing Aid	Ear, Nose, Throat	874.3325	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47169	Air-conduction hearing aid, receiver-in-canal	A 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850022464577	GS1
Package	10850022464574	GS1	Case	6	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K211008	000

Storage Conditions

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