Model: Lexie Hearing
Catalog: LBS00001B3
DI: 00810153660323
Status: New
MRI: MR Unsafe
Single-use: No
Rx: No
OTC: Yes
First Published: 2026-05-07
Current Version: 2026-05-15
Description
Lexie B3 Hearing Aids
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
158c4914-76fa-4fd5-bf55-5f38d50207b9
Distribution Status:
In Commercial Distribution
DUNS Number:
539177681
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
Yes
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
00810153660323
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 47169
Name: Air-conduction hearing aid, receiver-in-canal
Definition:
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.
FDA Product Codes
QUH
Self-Fitting Air-Conduction Hearing Aid, Over The Counter
Premarket Submissions
Submission Number:
K223137
Supplement Number:
000