Audien Hearing

Primary DI
00860003736135
Brand
Audien Hearing
Company
Budget Hearing Aids, LLC
Model
ion pro
Published
2025-07-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe

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
00860003736135PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860003736135008600037361358600037361350860003736135

GMDN Terms#

Term, Definition table
TermDefinition
Air-conduction hearing aid, receiver-in-canalA battery-powered acoustic device intended to compensate for impaired hearing by transmitting amplified sound waves to the eardrum through air. It consists of a microphone and an amplifier in a case behind-the-ear (BTE) connected, via a wire, to a receiver (speaker) in the ear canal [receiver-in-canal (RIC)]. 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 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
118027003
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850065060002Audien HearingAtom One2025-07-10
00850065060194Audien Hearingion pro 22025-07-10
00850065060880Audien HearingAtom X2025-07-10
00860003736128Audien HearingAtom One2023-06-16
00860009028036Audien HearingAtom 22023-03-10
00860009028043Audien HearingAtom Pro 22023-03-10
00860009028050Audien HearingAudien BTE2023-03-10
00860009028067Audien HearingAudien ion2023-03-10
00860003736142Audien HearingAtom2023-02-04
00860003736159Audien HearingAtom Pro2023-02-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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06980134820252n/aBlue Deer Medical Equipment (guangdong) Co., Ltd.QUG2026-06-09
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06980134820283n/aBlue Deer Medical Equipment (guangdong) Co., Ltd.QUG2026-06-09
06973967150658EaraXiamen Vienatone Medical Technology Co., Ltd.QUG2026-05-19
06971094538677AntOkayHuizhou Jinghao Medical Technology Co., LtdQUG2026-05-01