FDA.reportPublic FDA data

Vienatone

Primary DI
06973967150573
Brand
Vienatone
Company
Xiamen Vienatone Medical Technology Co., Ltd.
Model
LY230
Device description
Air-conduction hearing aid, behind-the-ear
Published
2026-04-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
QUFHearing Aid, Air-Conduction, Over The Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QUFHearing Aid, Air-Conduction, Over The CounterEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06973967150573PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06973967150573069739671505736973967150573

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height25.79Millimeter
Length33.43Millimeter
Width31.94Millimeter

Regulatory Flags#

DUNS number
554462731
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06973967150658EaraExplore Li +2026-05-19
06973967150276WuveeTY CN430S2026-04-28
06973967150283NebrooFalcon CF430S 2026-04-28
06973967150313VienatoneCN2232026-04-28
06973967150320VienatoneSamba R112026-04-28
06973967150351Audien Hearingion Pro 22026-04-28
06973967150368NebrooCN130S2026-04-28
06973967150177SoundbrightMini2025-05-27
06973967150207SoundbrightDiscovery2025-05-27
06973967150238Audien hearingion Pro2025-05-27
06973967150245Nano hearing aidsFirst Ear Plus CIC2025-05-27
06973967150252Nano hearing aidsFirst Ear Pro CIC2025-05-27
06973967150269nebrooJiaquan CN430S2025-05-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06971094538721KLARIQHuizhou Jinghao Medical Technology Co., LtdQUF2026-05-26
06971094538738KLARIQHuizhou Jinghao Medical Technology Co., LtdQUF2026-05-26
06971094538707XQYMHuizhou Jinghao Medical Technology Co., LtdQUF2026-05-08
06971094538691OricleHuizhou Jinghao Medical Technology Co., LtdQUF2026-04-30
06973967150276WuveeXiamen Vienatone Medical Technology Co., Ltd.QUF2026-04-28
06973967150283NebrooXiamen Vienatone Medical Technology Co., Ltd.QUF2026-04-28
06973967150313VienatoneXiamen Vienatone Medical Technology Co., Ltd.QUF2026-04-28
06973967150320VienatoneXiamen Vienatone Medical Technology Co., Ltd.QUF2026-04-28
06973967150368NebrooXiamen Vienatone Medical Technology Co., Ltd.QUF2026-04-28
06971094538622Savvy SmartHuizhou Jinghao Medical Technology Co., LtdQUF2026-03-25
06971094538639Spade & CoHuizhou Jinghao Medical Technology Co., LtdQUF2026-03-24
06971094538615GIATATHAHuizhou Jinghao Medical Technology Co., LtdQUF2026-03-20
06971094538592LITOULFHuizhou Jinghao Medical Technology Co., LtdQUF2026-03-18
06950715563090CofoeCofoe Medical Technology Co.,LtdQUF2026-02-24
06971094538585Bachgold Huizhou Jinghao Medical Technology Co., LtdQUF2026-02-05
06979053570034UltrotingShenzhen Magnet Technology Co., LtdQUF2026-01-21
06979053570041UltrotingShenzhen Magnet Technology Co., LtdQUF2026-01-21
06971094538530LITOULFHuizhou Jinghao Medical Technology Co., LtdQUF2025-12-19
06978898058011Viva HearShenzhen Cresendo Technology Co.,Ltd.QUF2025-12-12
06978898058028Viva HearShenzhen Cresendo Technology Co.,Ltd.QUF2025-12-12
06978898058035Viva HearShenzhen Cresendo Technology Co.,Ltd.QUF2025-12-12
06978898058042Xpect VisionShenzhen Cresendo Technology Co.,Ltd.QUF2025-12-12
06978898058059Xpect VisionShenzhen Cresendo Technology Co.,Ltd.QUF2025-12-12
06978898058066Xpect VisionShenzhen Cresendo Technology Co.,Ltd.QUF2025-12-12
06975958550010MirasingXiamen Mirasing Technology Co.,Ltd.QUF2025-12-09
06975958550119MirasingXiamen Mirasing Technology Co.,Ltd.QUF2025-12-09
06975958550225MirasingXiamen Mirasing Technology Co.,Ltd.QUF2025-12-09
06975958550232MirasingXiamen Mirasing Technology Co.,Ltd.QUF2025-12-09
06975958550249MirasingXiamen Mirasing Technology Co.,Ltd.QUF2025-12-09
06975958550256MirasingXiamen Mirasing Technology Co.,Ltd.QUF2025-12-09