Model: IF CIC Li 8.16
Catalog: 21034914
DI: 05714880219463
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
S_ITE IF CIC LI 8.16SL MOC TBL
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
f78576c4-bd20-473e-956c-58cbb55756a1
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:
05714880219463
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 34672
Name: Air-conduction hearing aid, in-the-ear
Definition:
A battery-powered acoustic device intended to compensate for impaired hearing by transmitting amplified sound waves to the eardrum through air. It typically consists of a miniature microphone, amplifier, and speaker (receiver) contained in a case that fits completely inside the outer ear (concha) [in-the-ear (ITE)]. 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 severe 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