Device
Air-conduction hearing aid, behind-the-ear
Manufacturer
Xiamen Vienatone Medical Technology Co., Ltd.
Xiamen Vienatone Medical Technology Co., Ltd.
Model: Falcon CF430S
DI: 06973967150283
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: No
OTC: Yes
First Published: 2026-04-28
Current Version: 2026-05-06
Description
Air-conduction hearing aid, behind-the-ear
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
4d2a29c1-0b1e-4833-8d3b-f8083534d67b
Distribution Status:
In Commercial Distribution
DUNS Number:
554462731
Device Count:
1
DM Exempt:
No
Premarket Exempt:
Yes
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
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:
06973967150283
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
QUF
Hearing Aid, Air-Conduction, Over The Counter
Device Sizes
Item #1 - Size - @attributes - Unit:
Millimeter
Item #1 - Size - @attributes - Value:
37.14
Item #1 - Size Type:
Length
Item #2 - Size - @attributes - Unit:
Millimeter
Item #2 - Size - @attributes - Value:
34.33
Item #2 - Size Type:
Width
Item #3 - Size - @attributes - Unit:
Millimeter
Item #3 - Size - @attributes - Value:
28.02
Item #3 - Size Type:
Height