Model: R Li T 8.16
Catalog: 21025015
DI: 05714880214628
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: Yes
OTC: No
First Published: 2026-05-28
Current Version: 2026-06-05
Description
HA R LI T 8.16 BLK
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
49f87745-faaa-4ab9-a504-021f4f1ae8ea
Distribution Status:
In Commercial Distribution
DUNS Number:
157412271
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
No
Serial Number Tracked:
Yes
Manufacturing Date Tracked:
No
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
05714880214628
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
OSM
Hearing Aid, Air-Conduction With Wireless Technology, Prescription
KLW
Masker, Tinnitus