FDA.reportPublic FDA data

A&M

Primary DI
04046355206403
Brand
A&M
Company
Ws Audiology Usa, Inc.
Model
HA A&M AURORA 2 P BG
Catalog number
10299902
Device description
A&M HA A&M AURORA 2 P BG Hearing Aid
Published
2016-06-26
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ESDHearing Aid, Air Conduction

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04046355206403PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04046355206403040463552064034046355206403

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

Contacts#

Phone, Email table
PhoneEmail
17325626600consumerrelations@sivantos.com

Regulatory Flags#

DUNS number
157412271
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05714880288117SIGNIAD&C Charger RIC210518832026-07-16
05714880288124SIGNIAD&C Charger BTE SP210518842026-07-16
05714880288131SIGNIAD&C CHARGER BTE P210518852026-07-16
05714880288148SIGNIAD&C Charger slimRIC210518862026-07-16
05714880288155CONNEXXCharging+ Station B-HP210518882026-07-16
05714880288162CONNEXXCharging+ Station R210518872026-07-16
05714880288179CONNEXXCharging+ Station B-P210518892026-07-16
05714880288186CONNEXXCharging+ Station SR210518902026-07-16
05714880297508SIGNIACHARGER RIC210538802026-07-16
05714880297515CONNEXXCharging Station B-M210538872026-07-16
05714880297522CONNEXXCharging Station R210538862026-07-16
05714880297539CONNEXXCharging Station B-HP210538852026-07-16
05714880297546CONNEXXCharging Station B-P210538842026-07-16
05714880297553SIGNIACHARGER BTE M210538832026-07-16
05714880297560SIGNIACHARGER BTE P210538822026-07-16
05714880297577SIGNIACHARGER BTE SP210538812026-07-16
05714880297928SIGNIAD&C CHARGER BTE P210558932026-07-16
05714880297935SIGNIAD&C Charger BTE SP210558942026-07-16
05714880297942SIGNIAD&C Charger RIC210558952026-07-16
05714880297959SIGNIAD&C Charger slimRIC210558962026-07-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840388201145STARKEYStarkey Laboratories, Inc.ESD2025-06-25
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
16945936703773NewsoundXiamen New Sound Technology Co., Ltd.ESD2024-01-19
00810126191373AudinaAudina Hearing Instruments, Inc.ESD2023-01-31
00810126191380AudinaAudina Hearing Instruments, Inc.ESD2023-01-31
00810126191397AudinaAudina Hearing Instruments, Inc.ESD2023-01-31
00810126191403AudinaAudina Hearing Instruments, Inc.ESD2023-01-31
00810126191410AudinaAudina Hearing Instruments, Inc.ESD2023-01-31
00810126191427AudinaAudina Hearing Instruments, Inc.ESD2023-01-31
00810126191434AudinaAudina Hearing Instruments, Inc.ESD2023-01-31
00810126191441AudinaAudina Hearing Instruments, Inc.ESD2023-01-31
00810126191458AudinaAudina Hearing Instruments, Inc.ESD2023-01-31
00810126191465AudinaAudina Hearing Instruments, Inc.ESD2023-01-31
00810126191472AudinaAudina Hearing Instruments, Inc.ESD2023-01-31
00810126191489AudinaAudina Hearing Instruments, Inc.ESD2023-01-31
00810126191496AudinaAudina Hearing Instruments, Inc.ESD2023-01-31
00810126191502AudinaAudina Hearing Instruments, Inc.ESD2023-01-31
00810126191519AudinaAudina Hearing Instruments, Inc.ESD2023-01-31
00810126191526AudinaAudina Hearing Instruments, Inc.ESD2023-01-31
00810126191533AudinaAudina Hearing Instruments, Inc.ESD2023-01-31
00810126191540AudinaAudina Hearing Instruments, Inc.ESD2023-01-31
00810126191557AudinaAudina Hearing Instruments, Inc.ESD2023-01-31
00810126191564AudinaAudina Hearing Instruments, Inc.ESD2023-01-31
00810126191571AudinaAudina Hearing Instruments, Inc.ESD2023-01-31
00810126191588AudinaAudina Hearing Instruments, Inc.ESD2023-01-31
00810126191595AudinaAudina Hearing Instruments, Inc.ESD2023-01-31