FDA.reportPublic FDA data

JlUYEE, Smart Bluetooth Hearing Aid (RlC)

Primary DI
16975925880161
Brand
JlUYEE, Smart Bluetooth Hearing Aid (RlC)
Company
Hunan JIUYEE Medical Technology Co., Ltd
Model
REAL P3,Obsidian Black
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
2024-07-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
true
Sterile
false
Single use
false

Product Codes#

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

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16975925880161PackageGS110In Commercial Distribution
06975925880164PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697592588016116975925880161
06975925880164069759258801646975925880164

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
699350218
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06975925880164JlUYEE, 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
06975925880089JIUYEE, Smart Bluetooth Hearing Aid (RIC) REAL P4, Jade White2023-02-03
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
06973967150658EaraXiamen Vienatone Medical Technology Co., Ltd.QUG2026-05-19
06971094538677AntOkayHuizhou Jinghao Medical Technology Co., LtdQUG2026-05-01
06973967150351Audien HearingXiamen Vienatone Medical Technology Co., Ltd.QUG2026-04-28
00860015094803LegatoLEGATO AUDIO, INC.QUG2026-03-25
00860015094810LegatoLEGATO AUDIO, INC.QUG2026-03-25
00860015094827LegatoLEGATO AUDIO, INC.QUG2026-03-25
00860015094834LegatoLEGATO AUDIO, INC.QUG2026-03-25
00850080488249flysoundShenzhen Flysounds Medical Technology Co.,Ltd.QUG2026-03-06
16974308960209Retone, NebrooXiamen Retone Hearing Technology Co., LtdQUG2026-02-05
00850080488140flysoundShenzhen Flysounds Medical Technology Co.,Ltd.QUG2026-01-16
05714880290325hear.comWs Audiology Usa, Inc.QUG2026-01-12
05714880290332hear.comWs Audiology Usa, Inc.QUG2026-01-12
05714880290349hear.comWs Audiology Usa, Inc.QUG2026-01-12
05714880290356hear.comWs Audiology Usa, Inc.QUG2026-01-12
16974308960193Retone Xiamen Retone Hearing Technology Co., LtdQUG2026-01-08
06977352080438ELEHEARELEHEAR Inc.QUG2025-12-31
06943786079911AUSTARAustar Hearing Science & Technology (Xiamen) Co., Ltd men) Co., Ltd.QUG2025-12-03
06975958551277MirasingXiamen Mirasing Technology Co.,Ltd.QUG2025-11-03
00810153660828Lexie H1 OTC Hearing BudsHEARX GROUP (PTY) LTDQUG2025-10-01
06971094538486H-earrings Huizhou Jinghao Medical Technology Co., LtdQUG2025-10-01
05708296386239GN HearingGn Hearing A/SQUG2025-09-21
05708296386246GN HearingGn Hearing A/SQUG2025-09-21
05708296391240GN HearingGn Hearing A/SQUG2025-09-21
05708296386253GN HearingGn Hearing A/SQUG2025-09-19
05708296386260GN HearingGn Hearing A/SQUG2025-09-19
05708296386277GN HearingGn Hearing A/SQUG2025-09-19
05708296386284GN HearingGn Hearing A/SQUG2025-09-19
05708296386291GN HearingGn Hearing A/SQUG2025-09-19
05708296386307GN HearingGn Hearing A/SQUG2025-09-19
05708296386314GN HearingGn Hearing A/SQUG2025-09-19