FDA.reportPublic FDA data

SIGNIA

Primary DI
05714880246575
Brand
SIGNIA
Company
Ws Audiology Usa, Inc.
Model
Intuis M 4.3
Catalog number
21039953
Device description
HA INTUIS M 4.3 DKC
Published
2024-08-16
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
05714880246575PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05714880246575057148802465755714880246575

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
05714880288117SIGNIAWs Audiology Usa, Inc.OSM2026-07-16
05714880288124SIGNIAWs Audiology Usa, Inc.OSM2026-07-16
05714880288131SIGNIAWs Audiology Usa, Inc.OSM2026-07-16
05714880288148SIGNIAWs Audiology Usa, Inc.OSM2026-07-16
05714880288155CONNEXXWs Audiology Usa, Inc.OSM2026-07-16
05714880288162CONNEXXWs Audiology Usa, Inc.OSM2026-07-16
05714880288179CONNEXXWs Audiology Usa, Inc.OSM2026-07-16
05714880288186CONNEXXWs Audiology Usa, Inc.OSM2026-07-16
05714880297508SIGNIAWs Audiology Usa, Inc.OSM2026-07-16
05714880297515CONNEXXWs Audiology Usa, Inc.OSM2026-07-16
05714880297522CONNEXXWs Audiology Usa, Inc.OSM2026-07-16
05714880297539CONNEXXWs Audiology Usa, Inc.OSM2026-07-16
05714880297546CONNEXXWs Audiology Usa, Inc.OSM2026-07-16
05714880297553SIGNIAWs Audiology Usa, Inc.OSM2026-07-16
05714880297560SIGNIAWs Audiology Usa, Inc.OSM2026-07-16
05714880297577SIGNIAWs Audiology Usa, Inc.OSM2026-07-16
05714880297928SIGNIAWs Audiology Usa, Inc.OSM2026-07-16
05714880297935SIGNIAWs Audiology Usa, Inc.OSM2026-07-16
05714880297942SIGNIAWs Audiology Usa, Inc.OSM2026-07-16
05714880297959SIGNIAWs Audiology Usa, Inc.OSM2026-07-16
05714880297966CONNEXXWs Audiology Usa, Inc.OSM2026-07-16
05714880297973CONNEXXWs Audiology Usa, Inc.OSM2026-07-16
05714880297980CONNEXXWs Audiology Usa, Inc.OSM2026-07-16
05714880297997CONNEXXWs Audiology Usa, Inc.OSM2026-07-16
07613389915006SilentCloud Mobile AppSonova AGKLW2026-06-24
07613389938531SilentCloud Web AppSonova AGKLW2026-06-24
06945936705701QuietlyBoldXiamen New Sound Technology Co., Ltd.OSM2026-06-09
05714880295719SIGNIAWs Audiology Usa, Inc.OSM2026-06-08
05714880295719SIGNIAWs Audiology Usa, Inc.KLW2026-06-08
05714880295726SIGNIAWs Audiology Usa, Inc.KLW2026-06-08