FDA.reportPublic FDA data

Amplifon

Primary DI
05714880150865
Brand
Amplifon
Company
Ws Audiology Usa, Inc.
Model
AMPLI-CROS R AX
Catalog number
21010029
Device description
CCK AMPLI-CROS R AX R BLK
Published
2024-01-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

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

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05714880150865PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05714880150865057148801508655714880150865

GMDN Terms#

Term, Definition table
TermDefinition
Contralateral hearing unitA passive (i.e., non-powered) acoustic device intended to compensate for total hearing loss in one ear, by transmitting sound received by a microphone from the deaf ear to an active (i.e., powered) hearing aid worn on the hearing ear. This contralateral routing of sound (CROS) technology is designed to improve awareness of sounds (e.g., traffic, speech) emanating from all directions. The device typically consists of a microphone contained in a case worn behind-the-ear (BTE) with a connection cable. The cable both transmits the power from, and the signal to, the active hearing aid.

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
05714880299359AudioServiceIF ITC Li 8.12210564072026-10-28
05714880299403AudioServiceIF ITC Li 8.12210564202026-10-28
05714880299410AudioServiceIF ITC Li 8.12210564192026-10-28
05714880299427AudioServiceIF ITC Li 8.12210564082026-10-28
05714880299564REXTONReach IF ITC-Li BT 80210564602026-10-28
05714880299571REXTONReach IF ITC-Li BT 80210564622026-10-28
05714880299588REXTONReach IF ITC-Li BT 80210564632026-10-28
05714880299595REXTONReach IF ITC-Li BT 80210564652026-10-28
05714880299601REXTONReach IF ITC-Li BT 60210564682026-10-28
05714880299618REXTONReach IF ITC-Li BT 60210564692026-10-28
05714880299625REXTONReach IF ITC-Li BT 60210564702026-10-28
05714880299632REXTONReach IF ITC-Li BT 60210564712026-10-28
05714880299649REXTONReach IF ITC-Li BT 40210564722026-10-28
05714880299656REXTONReach IF ITC-Li BT 40210564732026-10-28
05714880299663REXTONReach IF ITC-Li BT 40210564742026-10-28
05714880299670REXTONReach IF ITC-Li BT 40210564752026-10-28
05714880299687REXTONReach IF ITC-Li BT SDemo210564762026-10-28
05714880299694REXTONReach IF ITC-Li BT SDemo210564772026-10-28
05714880299991MIRACLE EARMEMINI I 5 5w ITC-R STD210565402026-10-27
05714880300000MIRACLE EARMEMINI I 5 5w ITC-R STD210565412026-10-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05714880299359AudioServiceWs Audiology Usa, Inc.OSM2026-10-28
05714880299359AudioServiceWs Audiology Usa, Inc.KLW2026-10-28
05714880299403AudioServiceWs Audiology Usa, Inc.KLW2026-10-28
05714880299403AudioServiceWs Audiology Usa, Inc.OSM2026-10-28
05714880299410AudioServiceWs Audiology Usa, Inc.KLW2026-10-28
05714880299410AudioServiceWs Audiology Usa, Inc.OSM2026-10-28
05714880299427AudioServiceWs Audiology Usa, Inc.KLW2026-10-28
05714880299427AudioServiceWs Audiology Usa, Inc.OSM2026-10-28
05714880299564REXTONWs Audiology Usa, Inc.KLW2026-10-28
05714880299564REXTONWs Audiology Usa, Inc.OSM2026-10-28
05714880299571REXTONWs Audiology Usa, Inc.KLW2026-10-28
05714880299571REXTONWs Audiology Usa, Inc.OSM2026-10-28
05714880299588REXTONWs Audiology Usa, Inc.KLW2026-10-28
05714880299588REXTONWs Audiology Usa, Inc.OSM2026-10-28
05714880299595REXTONWs Audiology Usa, Inc.OSM2026-10-28
05714880299595REXTONWs Audiology Usa, Inc.KLW2026-10-28
05714880299601REXTONWs Audiology Usa, Inc.KLW2026-10-28
05714880299601REXTONWs Audiology Usa, Inc.OSM2026-10-28
05714880299618REXTONWs Audiology Usa, Inc.KLW2026-10-28
05714880299618REXTONWs Audiology Usa, Inc.OSM2026-10-28
05714880299625REXTONWs Audiology Usa, Inc.KLW2026-10-28
05714880299625REXTONWs Audiology Usa, Inc.OSM2026-10-28
05714880299632REXTONWs Audiology Usa, Inc.KLW2026-10-28
05714880299632REXTONWs Audiology Usa, Inc.OSM2026-10-28
05714880299649REXTONWs Audiology Usa, Inc.KLW2026-10-28
05714880299649REXTONWs Audiology Usa, Inc.OSM2026-10-28
05714880299656REXTONWs Audiology Usa, Inc.KLW2026-10-28
05714880299656REXTONWs Audiology Usa, Inc.OSM2026-10-28
05714880299663REXTONWs Audiology Usa, Inc.KLW2026-10-28
05714880299663REXTONWs Audiology Usa, Inc.OSM2026-10-28