FDA.reportPublic FDA data

Hansaton

Primary DI
04250185545360
Brand
Hansaton
Company
Hansaton Akustik GmbH
Model
050-5613-U346
Catalog number
050-5613-U346
Device description
sound 5-13 (sandy beige)
Published
2016-09-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe

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
04250185545360PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250185545360042501855453604250185545360

GMDN Terms#

Term, Definition table
TermDefinition
Receiver-in-canal 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 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
+49402980110support@hansaton.com

Regulatory Flags#

DUNS number
316040146
Device count
1
DM exempt
true
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613389127225HANSATON088-5003088-50032019-01-16
07613389143225HANSATON058-5226058-52262018-12-10
07613389143232HANSATON058-5227058-52272018-12-10
04250185527595Hansaton71889718892016-09-23
04250185527601Hansaton71890718902016-09-23
04250185527618Hansaton71891718912016-09-23
04250185527625Hansaton71892718922016-09-23
04250185527632Hansaton71893718932016-09-23
04250185527656Hansaton71895718952016-09-23
04250185527670Hansaton71897718972016-09-23
04250185527687Hansaton71898718982016-09-23
04250185527694Hansaton71899718992016-09-23
04250185527700Hansaton71900719002016-09-23
04250185527717Hansaton71901719012016-09-23
04250185527731Hansaton71903719032016-09-23
04250185527755Hansaton71905719052016-09-23
04250185527762Hansaton71906719062016-09-23
04250185527779Hansaton71907719072016-09-23
04250185527786Hansaton71908719082016-09-23
04250185527793Hansaton71909719092016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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05714880297058SIGNIAWs Audiology Usa, Inc.OSM2026-07-22
05714880297065SIGNIAWs Audiology Usa, Inc.OSM2026-07-22
05714880297072SIGNIAWs Audiology Usa, Inc.OSM2026-07-22