FDA.reportPublic FDA data

Signia

Primary DI
05714880105490
Brand
Signia
Company
Ws Audiology Usa, Inc.
Model
Motion Charge&Go 7X
Catalog number
10970943
Device description
Motion Charge&Go 7X Sandy Brown
Published
2023-09-08
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

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
05714880105490PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05714880105490057148801054905714880105490

GMDN Terms#

Term, Definition table
TermDefinition
Air-conduction hearing aid, receiver-in-canalA battery-powered acoustic device intended to compensate for impaired hearing by transmitting amplified sound waves to the eardrum through air. It consists of a microphone and an amplifier in a case behind-the-ear (BTE) connected, via a wire, to a receiver (speaker) in the ear canal [receiver-in-canal (RIC)]. 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. 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
05714880295054SIGNIAActive Mini 7IX210540642026-05-22
05714880295061SIGNIAActive Mini 5IX210543622026-05-22
05714880295078SIGNIAActive Mini 5IX210543672026-05-22
05714880295689SIGNIAActive Mini 7IX210540692026-05-22
05714880295764SIGNIAActive Mini 3IX210543632026-05-22
05714880295771SIGNIAActive Mini 3IX210543682026-05-22
05714880295825SIGNIAActive Mini 2IX210543642026-05-22
05714880295832SIGNIAActive Mini 2IX210543692026-05-22
05714880295887SIGNIAActive Mini 1IX210543652026-05-22
05714880295894SIGNIAActive Mini 1IX210543702026-05-22
05714880295948SIGNIAActive Mini sDEMO DIX210543662026-05-22
05714880295955SIGNIAActive Mini sDEMO DIX210543712026-05-22
05714880295962SIGNIAKit Active Mini sDEMO DIX210543762026-05-22
05714880295979SIGNIAKit Active Mini 7IX210540742026-05-22
05714880296006SIGNIAKit Active Mini 5IX210543722026-05-22
05714880296037SIGNIAKit Active Mini 3IX210543732026-05-22
05714880296068SIGNIAKit Active Mini 2IX210543742026-05-22
05714880296099SIGNIAKit Active Mini 1IX210543752026-05-22
05714880288087CONNEXXIF CIC Travel Charger RB210518632026-04-30
05714880288100SIGNIAPortable Charger Silk210518652026-04-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613275596814PhonakSonova AGOSM2018-02-28
07613275596821PhonakSonova AGKLW2018-02-28
07613275596838PhonakSonova AGKLW2018-02-28
07613275596845PhonakSonova AGOSM2018-02-28
07613275596852PhonakSonova AGKLW2018-02-28
07613275596869PhonakSonova AGOSM2018-02-28
07613275596876PhonakSonova AGKLW2018-02-28
07613275596883PhonakSonova AGOSM2018-02-28
07613275596890PhonakSonova AGKLW2018-02-28
07613275596906PhonakSonova AGKLW2018-02-28
07613275596913PhonakSonova AGKLW2018-02-28
07613275596920PhonakSonova AGKLW2018-02-28
07613275596937PhonakSonova AGKLW2018-02-28
07613275596944PhonakSonova AGOSM2018-02-28
07613275596951PhonakSonova AGOSM2018-02-28
07613275596968PhonakSonova AGOSM2018-02-28
07613275596975PhonakSonova AGKLW2018-02-28
07613275596982PhonakSonova AGOSM2018-02-28
07613275596999PhonakSonova AGOSM2018-02-28
07613275597002PhonakSonova AGOSM2018-02-28
07613275597019PhonakSonova AGOSM2018-02-28
07613275597026PhonakSonova AGKLW2018-02-28
07613275597033PhonakSonova AGOSM2018-02-28
07613275601310PhonakSonova AGKLW2018-02-28
07613275601327PhonakSonova AGOSM2018-02-28
07613275601334PhonakSonova AGKLW2018-02-28
07613275601341PhonakSonova AGKLW2018-02-28
07613275601358PhonakSonova AGKLW2018-02-28
07613275601365PhonakSonova AGKLW2018-02-28
07613275601372PhonakSonova AGKLW2018-02-28