FDA.reportPublic FDA data

OKB OTC Hearing Aid

Primary DI
00193169001602
Brand
OKB OTC Hearing Aid
Company
OK BIOTECH CO., LTD.
Model
GV-SA03.60
Catalog number
30-81-0300-0103
Device description
OTC Hearing Aid - Good Voice Everyday
Published
2025-07-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

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
00193169003606PackageGS11In Commercial Distribution
00193169001602PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00193169003606001931690036061931690036060193169003606
00193169001602001931690016021931690016020193169001602

GMDN Terms#

Term, Definition table
TermDefinition
Air-conduction hearing aid, in-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 miniature microphone, amplifier, and speaker (receiver) contained in a case that fits completely inside the outer ear (concha) [in-the-ear (ITE)]. 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. The device is used for mild to severe hearing loss; most types are programmable to enable computerized adjustments for a patient's hearing loss and related factors.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1 626-225-0621support@okbhearing.com

Regulatory Flags#

DUNS number
658796458
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00193169642300TruePoint64230642302018-09-28
00852169003015Perfect 3 Multi Blood Glucose Test StripsOK1M2023-08-23
00193169642324TruePoint64232642322018-12-03
00193169642331TruePoint64233642332018-12-03
00193169642348TruePoint64234642342018-12-03
00193169642362TruePoint64236642362018-12-03
00193169642409TruePoint64240642402018-12-03
00193169003507OKB OTC Hearing Aid - Bluetooth EarphonesHT00130-81-0300-03032025-07-01
00193169642003TruePoint64200642002025-06-05
04712803564141Smartest Persona II Multi Blood Glucose Monitoring System62762023-08-23
10193169642307TruePoint64230642302018-09-28

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