FDA.reportPublic FDA data

Signia Siemens

Primary DI
04056839036662
Brand
Signia Siemens
Company
Ws Audiology Usa, Inc.
Model
HA CELLION 2PX DBR
Catalog number
10949336
Device description
Signia Siemens HA CELLION 2PX DBR Hearing Aid
Published
2018-05-10
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
OSMHearing Aid, Air Conduction With Wireless Technology

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04056839036662PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04056839036662040568390366624056839036662

GMDN Terms#

Term, Definition table
TermDefinition
Behind-the-ear air-conduction hearing aidA 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
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
07613275596845PhonakSonova AGOSM2018-02-28
07613275596869PhonakSonova AGOSM2018-02-28
07613275596883PhonakSonova AGOSM2018-02-28
07613275596944PhonakSonova AGOSM2018-02-28
07613275596951PhonakSonova AGOSM2018-02-28
07613275596968PhonakSonova AGOSM2018-02-28
07613275596982PhonakSonova AGOSM2018-02-28
07613275596999PhonakSonova AGOSM2018-02-28
07613275597002PhonakSonova AGOSM2018-02-28
07613275597019PhonakSonova AGOSM2018-02-28
07613275597033PhonakSonova AGOSM2018-02-28
07613275601327PhonakSonova AGOSM2018-02-28
07613275601402PhonakSonova AGOSM2018-02-28
07613275601426PhonakSonova AGOSM2018-02-28
07613275601501PhonakSonova AGOSM2018-02-28
07613275601518PhonakSonova AGOSM2018-02-28
07613275601556PhonakSonova AGOSM2018-02-28
07613275601594PhonakSonova AGOSM2018-02-28
07613275601600PhonakSonova AGOSM2018-02-28
07613275601655PhonakSonova AGOSM2018-02-28
07613275601662PhonakSonova AGOSM2018-02-28
07613275601686PhonakSonova AGOSM2018-02-28
07613275601693PhonakSonova AGOSM2018-02-28
07613275602935PhonakSonova AGOSM2018-02-28
07613275602959PhonakSonova AGOSM2018-02-28
07613275603000PhonakSonova AGOSM2018-02-28
07613275603017PhonakSonova AGOSM2018-02-28
07613275603048PhonakSonova AGOSM2018-02-28
07613275603062PhonakSonova AGOSM2018-02-28