FDA.reportPublic FDA data

Audina

Primary DI
00810126190178
Brand
Audina
Company
Audina Hearing Instruments, Inc.
Model
CIC INTUITION 6
Device description
AUDINA CIC INTUITION 6
Published
2023-01-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Product Codes#

Code, Name table
CodeName
ESDHearing Aid, Air-Conduction, Prescription

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ESDHearing Aid, Air-Conduction, PrescriptionEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810126190178PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810126190178008101261901788101261901780810126190178

GMDN Terms#

Term, Definition table
TermDefinition
Air-conduction hearing aid, canalA 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) in a case that fits the ear canal [in-the-canal (ITC)] or in a case nearly hidden in the ear canal [completely-in-the-canal (CIC)]. 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. It is used for mild to moderately-severe hearing loss; most types are programmable to enable computerized adjustments for a patient's hearing loss and related factors.

Regulatory Flags#

DUNS number
606310522
Device count
1
DM exempt
true
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810126192066AudinaBTE Intuition 122024-10-28
00810126192059Audina1/2 SHELL INTUITION 122023-02-14
00810126191700AudinaRIC ARRO 62023-02-01
00810126191717AudinaRIC ARRO 2 2023-02-01
00810126191724AudinaRIC ARRO 12 2023-02-01
00810126191731AudinaOTE INTUITION 42023-02-01
00810126191748AudinaAUDINA GOHEAR 42023-02-01
00810126191755AudinaAUDINA GOHEAR 32023-02-01
00810126191762AudinaAUDINA GOHEAR 22023-02-01
00810126191779AudinaAUDINA GOHEAR 12023-02-01
00810126191786AudinaOTE ARRO 6 AD 2023-02-01
00810126191793AudinaOTE ARRO 6 2023-02-01
00810126191809AudinaOTE ARRO 2 2023-02-01
00810126191816AudinaOTE ARRO 12 2023-02-01
00810126191823AudinaBTE SIMPLEX 2 PROGRAM.+2023-02-01
00810126191830AudinaBTE SIMPLEX 22023-02-01
00810126191847AudinaBTE OCTANE HP T2023-02-01
00810126191854AudinaBTE OPTI-TRIM2023-02-01
00810126191861AudinaBTE OCTANE HP 6 WHEEL2023-02-01
00810126191878AudinaBTE OCTANE HP 4 WHEEL2023-02-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613389772838ampli-mini I 3 5P CIC-10 NWL PHSonova AGESD2024-11-12
07613389772845ampli-mini I 2 5P CIC-10 NWL PHSonova AGESD2024-11-12
07613389772920MEMINI I 4 5P CIC-10 NWL PHSonova AGESD2024-11-12
07613389772937MEMINI I 3 5P CIC-10 NWL PHSonova AGESD2024-11-12
EDET038421luxaprint 3D shell white 500gDETAX GmbHESD2024-08-28
06945936704070NanoXiamen New Sound Technology Co., Ltd.ESD2024-05-21
06945936704087NanoXiamen New Sound Technology Co., Ltd.ESD2024-05-21
16945936703773NewsoundXiamen New Sound Technology Co., Ltd.ESD2024-01-19
06945936703776NewsoundXiamen New Sound Technology Co., Ltd.ESD2024-01-19
00810126190000AudinaAudina Hearing Instruments, Inc.ESD2023-01-26
00810126190017AudinaAudina Hearing Instruments, Inc.ESD2023-01-26
00810126190024AudinaAudina Hearing Instruments, Inc.ESD2023-01-26
00810126190031AudinaAudina Hearing Instruments, Inc.ESD2023-01-26
00810126190048AudinaAudina Hearing Instruments, Inc.ESD2023-01-26
00810126190055AudinaAudina Hearing Instruments, Inc.ESD2023-01-26
00810126190062AudinaAudina Hearing Instruments, Inc.ESD2023-01-26
00810126190079AudinaAudina Hearing Instruments, Inc.ESD2023-01-26
00810126190086AudinaAudina Hearing Instruments, Inc.ESD2023-01-26
00810126190093AudinaAudina Hearing Instruments, Inc.ESD2023-01-26
00810126190109AudinaAudina Hearing Instruments, Inc.ESD2023-01-26
00810126190116AudinaAudina Hearing Instruments, Inc.ESD2023-01-26
00810126190123AudinaAudina Hearing Instruments, Inc.ESD2023-01-26
00810126190130AudinaAudina Hearing Instruments, Inc.ESD2023-01-26
00810126190147AudinaAudina Hearing Instruments, Inc.ESD2023-01-26
00810126190154AudinaAudina Hearing Instruments, Inc.ESD2023-01-26
00810126190161AudinaAudina Hearing Instruments, Inc.ESD2023-01-26
00810126190185AudinaAudina Hearing Instruments, Inc.ESD2023-01-26
00810126190192AudinaAudina Hearing Instruments, Inc.ESD2023-01-26
00810126190208AudinaAudina Hearing Instruments, Inc.ESD2023-01-26
00810126190215AudinaAudina Hearing Instruments, Inc.ESD2023-01-26