Model: Sonix 107
DI: 06972665720958
Status: Update
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: No
OTC: No
First Published: 2026-05-08
Current Version: 2026-05-20
Description
Sonix 107
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
2
Record Key:
87a0c1e2-08a1-46e7-aee7-a20e15401cf9
Distribution Status:
In Commercial Distribution
DUNS Number:
551745815
Device Count:
1
DM Exempt:
No
Premarket Exempt:
Yes
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
06972665720958
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 34671
Name: Air-conduction hearing aid, behind-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 microphone, an amplifier, and a speaker (receiver) contained in a case worn behind-the-ear (BTE). 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 through an earmould that fits inside the outer ear or a tube in the ear canal. 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
ESD
Hearing Aid, Air-Conduction, Prescription