FDA.reportPublic FDA data

JIUYEE, Smart Bluetooth Hearing Aid (RIC)

Primary DI
06975925880089
Brand
JIUYEE, Smart Bluetooth Hearing Aid (RIC)
Company
Hunan JIUYEE Medical Technology Co., Ltd
Model
REAL P4, Jade White
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.
Published
2023-02-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
true

Product Codes#

Code, Name table
CodeName
OSMHearing Aid, Air-Conduction With Wireless Technology, Prescription
QUGHearing Aid, Air-Conduction With Wireless Technology, Over The Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OSMHearing Aid, Air-Conduction With Wireless Technology, PrescriptionEar, Nose, Throat2
QUGHearing Aid, Air-Conduction With Wireless Technology, Over The CounterEar, Nose, Throat2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16975925880086PackageGS110In Commercial Distribution
06975925880089PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697592588008616975925880086
06975925880089069759258800896975925880089

GMDN Terms#

Term, Definition table
TermDefinition
Air-conduction hearing aid, behind-the-earA 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.

Regulatory Flags#

DUNS number
699350218
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06975925880164JlUYEE, Smart Bluetooth Hearing Aid (RlC)REAL P3,Obsidian Black2024-07-30
16975925880161JlUYEE, Smart Bluetooth Hearing Aid (RlC)REAL P3,Obsidian Black2024-07-30
06975925880133JIUYEE, Smart Bluetooth Hearing Aid (ITE) Air C2, Emerald Black2023-07-30
06975925880140JIUYEE, Smart Bluetooth Hearing Aid (ITE) Air C2, Jade Gold2023-07-30
06975925880157JIUYEE, Smart Bluetooth Hearing Aid (ITE) Air C2, Pearl White2023-07-30
16975925880130JIUYEE, Smart Bluetooth Hearing Aid (ITE) Air C2, Emerald Black2023-07-30
16975925880147JIUYEE, Smart Bluetooth Hearing Aid (ITE) Air C2, Jade Gold2023-07-30
16975925880154JIUYEE, Smart Bluetooth Hearing Aid (ITE) Air C2, Pearl White2023-07-30
06975925880058JIUYEE, Smart Bluetooth Hearing Aid (RIC) REAL P3, Emerald Black2023-02-03
06975925880065JIUYEE, Smart Bluetooth Hearing Aid (RIC) REAL P3, Jade White2023-02-03
06975925880072JIUYEE, Smart Bluetooth Hearing Aid (RIC) REAL P4, Emerald Black2023-02-02
06975925880096JIUYEE, Smart Bluetooth Hearing Aid (RIC) REAL P3, Emerald Black, Left2023-04-17
06975925880102JIUYEE, Smart Bluetooth Hearing Aid (RIC) REAL P3, Emerald Black, Right2023-04-17
06975925880119JIUYEE, Smart Bluetooth Hearing Aid (RIC) REAL P3, Jade White, Left2023-04-17
06975925880126JIUYEE, Smart Bluetooth Hearing Aid (RIC) REAL P3, Jade White, Right2023-04-17
06975925880010JIUYEE, Smart Bluetooth Hearing Aid (RIC) REAL P1, Emerald Black2023-02-03
06975925880027JIUYEE, Smart Bluetooth Hearing Aid (RIC) REAL P1, Jade White2023-02-03
06975925880034JIUYEE, Smart Bluetooth Hearing Aid (RIC) REAL P2, Emerald Black2023-02-03
06975925880041JIUYEE, Smart Bluetooth Hearing Aid (RIC) REAL P2, Jade White2023-02-03
16975925880055JIUYEE, Smart Bluetooth Hearing Aid (RIC) REAL P3, Emerald Black2023-02-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06979809410003Hearing AidsShenzhen Anker Medical Devices Co., Ltd.QUG2026-09-22
05708296253166GN ReSoundGn Hearing A/SOSM2026-09-21
05708296253173GN ReSoundGn Hearing A/SOSM2026-09-21
05708296253180GN ReSoundGn Hearing A/SOSM2026-09-21
05708296253197GN ReSoundGn Hearing A/SOSM2026-09-21
05708296253203GN ReSoundGn Hearing A/SOSM2026-09-21
05708296253210GN ReSoundGn Hearing A/SOSM2026-09-21
05708296253227GN ReSoundGn Hearing A/SOSM2026-09-21
05708296253234GN ReSoundGn Hearing A/SOSM2026-09-21
05708296253241GN ReSoundGn Hearing A/SOSM2026-09-21
05708296257966GN ReSoundGn Hearing A/SOSM2026-09-21
05708296257973GN ReSoundGn Hearing A/SOSM2026-09-21
05708296257980GN ReSoundGn Hearing A/SOSM2026-09-21
05708296257997GN ReSoundGn Hearing A/SOSM2026-09-21
05708296258000GN ReSoundGn Hearing A/SOSM2026-09-21
05708296258017GN ReSoundGn Hearing A/SOSM2026-09-21
05708296258024GN ReSoundGn Hearing A/SOSM2026-09-21
05708296258031GN ReSoundGn Hearing A/SOSM2026-09-21
05708296258048GN ReSoundGn Hearing A/SOSM2026-09-21
05708296258321GN ReSoundGn Hearing A/SOSM2026-09-21
05708296258338GN ReSoundGn Hearing A/SOSM2026-09-21
05708296258345GN ReSoundGn Hearing A/SOSM2026-09-21
05708296258352GN ReSoundGn Hearing A/SOSM2026-09-21
05708296258369GN ReSoundGn Hearing A/SOSM2026-09-21
05708296258376GN ReSoundGn Hearing A/SOSM2026-09-21
05708296258383GN ReSoundGn Hearing A/SOSM2026-09-21
05708296258390GN ReSoundGn Hearing A/SOSM2026-09-21
05708296258406GN ReSoundGn Hearing A/SOSM2026-09-21
05708296434602GN HearingGn Hearing A/SOSM2026-09-21
05708296434770GN HearingGn Hearing A/SOSM2026-09-21