FDA.reportPublic FDA data

Audina

Primary DI
00810126190789
Brand
Audina
Company
Audina Hearing Instruments, Inc.
Model
10AS INTUITION 12 MODULE
Device description
AUDINA 10AS INTUITION 12 MODULE
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
LRBFace Plate Hearing Aid

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LRBFace Plate Hearing AidEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810126190789PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810126190789008101261907898101261907890810126190789

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
05714464167012BirdsongSbo Hearing A/SLRB2026-03-26
05714464167029BirdsongSbo Hearing A/SLRB2026-03-26
05714464167036BirdsongSbo Hearing A/SLRB2026-03-26
05714464167043BirdsongSbo Hearing A/SLRB2026-03-26
05714464167050BirdsongSbo Hearing A/SLRB2026-03-26
05714464167067BirdsongSbo Hearing A/SLRB2026-03-26
05714464167074BirdsongSbo Hearing A/SLRB2026-03-26
05714464167081BirdsongSbo Hearing A/SLRB2026-03-26
05714464167098BirdsongSbo Hearing A/SLRB2026-03-26
05714464167104BirdsongSbo Hearing A/SLRB2026-03-26
05714464167111BirdsongSbo Hearing A/SLRB2026-03-26
05714464167128BirdsongSbo Hearing A/SLRB2026-03-26
05714464167135BirdsongSbo Hearing A/SLRB2026-03-26
05714464167142BirdsongSbo Hearing A/SLRB2026-03-26
05714464167159BirdsongSbo Hearing A/SLRB2026-03-26
05714464148103PhilipsSbo Hearing A/SLRB2025-02-10
05714464148110PhilipsSbo Hearing A/SLRB2025-02-10
05714464148202OticonSbo Hearing A/SLRB2025-02-10
05714464148219OticonSbo Hearing A/SLRB2025-02-10
05714464148226OticonSbo Hearing A/SLRB2025-02-10
05714464148233OticonSbo Hearing A/SLRB2025-02-10
05714464148240OticonSbo Hearing A/SLRB2025-02-10
05714464148257OticonSbo Hearing A/SLRB2025-02-10
05714464148264OticonSbo Hearing A/SLRB2025-02-10
05714464148271OticonSbo Hearing A/SLRB2025-02-10
05714464148288BernafonSbo Hearing A/SLRB2025-02-10
05714464148295BernafonSbo Hearing A/SLRB2025-02-10
05714464148301BernafonSbo Hearing A/SLRB2025-02-10
05714464148318BernafonSbo Hearing A/SLRB2025-02-10
05714464148325BernafonSbo Hearing A/SLRB2025-02-10