FDA.reportPublic FDA data

AUSTAR

Primary DI
06943786081020
Brand
AUSTAR
Company
Austar Hearing Science & Technology (Xiamen) Co., Ltd men) Co., Ltd.
Model
FHE510-B
Published
2024-08-29
Public version status
New
Distribution status
Not in Commercial Distribution
MRI safety
MR Conditional
Rx
true

Product Codes#

Code, Name table
CodeName
OSMHearing Aid, Air-Conduction With Wireless Technology, Prescription

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OSMHearing Aid, Air-Conduction With Wireless Technology, PrescriptionEar, Nose, Throat2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06943786081020PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06943786081020069437860810206943786081020

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
547919154
Device count
1
Premarket exempt
true
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06943786079911AUSTARATOM X2025-12-03
06943786093733AUSTARALD-L1A2025-09-15
06943786081013AUSTARFHE511-B2024-08-30
06943786081167AUSTARFHE406-B2024-08-30
06943786081198AUSTARFHE403-B2024-08-30
06943786081006AUSTARFHE512-B2024-08-29
06943786081037AUSTARFHE509-B2024-08-29
06943786081044AUSTARFHE508-B2024-08-29
06943786081051AUSTARFHE507-B2024-08-29
06943786081068AUSTARFHE506-B2024-08-29
06943786081075AUSTARFHE505-B2024-08-29
06943786081082AUSTARFHE504-B2024-08-29
06943786081099AUSTARFHE503-B2024-08-29
06943786081105AUSTARFHE412-B2024-08-29
06943786081112AUSTARFHE411-B2024-08-29
06943786081129AUSTARFHE410-B2024-08-29
06943786081136AUSTARFHE409-B2024-08-29
06943786081143AUSTARFHE408-B2024-08-29
06943786081150AUSTARFHE407-B2024-08-29
06943786081174AUSTARFHE405-B2024-08-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05714880293531SIGNIAWs Audiology Usa, Inc.OSM2026-06-04
05714880297898SIGNIAWs Audiology Usa, Inc.OSM2026-06-04
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07613389836332USB Phonak Target 12.0 USBSonova AGOSM2026-06-01
07613389836349Phonak Target 12.0Sonova AGOSM2026-06-01
07613389842388Phonak ChargerGo ITESonova AGOSM2026-06-01
07613389842395Phonak ChargerGo ITESonova AGOSM2026-06-01
07613389842401Phonak ChargerGo ITESonova AGOSM2026-06-01
07613389843026Phonak ChargerGo ITESonova AGOSM2026-06-01
07613389917024Phonak ChargerGo RIC I ESonova AGOSM2026-06-01
07613389917116Phonak ChargerGo RIC I ESonova AGOSM2026-06-01
07613389917123Phonak ChargerGo RIC I ESonova AGOSM2026-06-01
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