OKB OTC Hearing Aid

Basic Information

• Brand Name: OKB OTC Hearing Aid
• Primary DI: 00193169001602
• Version / Model: GV-SA03.60
• Catalog Number: 30-81-0300-0103
• Company Name: OK BIOTECH CO., LTD.
• Labeler DUNS: 658796458
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-07-01
• Public Version: 1
• Public Version Date: 2025-07-09
• Public Version Status: New
• Public Device Record Key: d4dea434-ba0c-49a3-b12d-fa04fde1b5e9

Device Description

OTC Hearing Aid - Good Voice Everyday

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: No
• 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

GMDN Terms

Code	Name	Definition	Implantable	Status
34672	Air-conduction hearing aid, in-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 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00193169001602	GS1
Package	00193169003606	GS1	Kit	1	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]