JIUYEE, Smart Bluetooth Hearing Aid (RIC)

Basic Information

• Brand Name: JIUYEE, Smart Bluetooth Hearing Aid (RIC)
• Primary DI: 06975925880010
• Version / Model: REAL P1, Emerald Black
• Company Name: Hunan JIUYEE Medical Technology Co., Ltd
• Labeler DUNS: 699350218
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-02-03
• Public Version: 2
• Public Version Date: 2023-05-08
• Public Version Status: Update
• Public Device Record Key: 13796255-3f77-44a2-a2bf-50a81c26d109

Device Description

The hearing aid consists of the host and its accessories. The host comprises of the microphone, signal processor, battery, shell and receiver, and accessories, including the earplugs, cerumen baffle, charging box and charging cable. After inspection and fitting, the hearing aids is applicable for patients with air conduction hearing loss.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
QUG	Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter	Ear, Nose, Throat	874.3305	2
OSM	Hearing Aid, Air-Conduction With Wireless Technology, Prescription	Ear, Nose, Throat	874.3305	2

GMDN Terms

Code	Name	Definition	Implantable	Status
34671	Air-conduction hearing aid, behind-the-ear	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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	06975925880010	GS1
Package	16975925880017	GS1	Case	10	In Commercial Distribution