FDA.reportPublic FDA data

HANSATON

Primary DI
04250185553136
Brand
HANSATON
Company
Hansaton Akustik GmbH
Model
050-5933-U4
Catalog number
050-5933-U4
Device description
Sound SHD 9-S13 (sterling silver)
Published
2018-12-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe

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
04250185553136PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250185553136042501855531364250185553136

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
+49402980110info@hansaton.de

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
05714880296440SIGNIAWs Audiology Usa, Inc.OSM2026-07-22
05714880296440SIGNIAWs Audiology Usa, Inc.KLW2026-07-22
05714880296464SIGNIAWs Audiology Usa, Inc.KLW2026-07-22
05714880296464SIGNIAWs Audiology Usa, Inc.OSM2026-07-22
05714880296488SIGNIAWs Audiology Usa, Inc.KLW2026-07-22
05714880296488SIGNIAWs Audiology Usa, Inc.OSM2026-07-22
05714880296501SIGNIAWs Audiology Usa, Inc.KLW2026-07-22
05714880296501SIGNIAWs Audiology Usa, Inc.OSM2026-07-22
05714880296525SIGNIAWs Audiology Usa, Inc.KLW2026-07-22
05714880296525SIGNIAWs Audiology Usa, Inc.OSM2026-07-22
05714880296549SIGNIAWs Audiology Usa, Inc.KLW2026-07-22
05714880296549SIGNIAWs Audiology Usa, Inc.OSM2026-07-22
05714880296563SIGNIAWs Audiology Usa, Inc.KLW2026-07-22
05714880296563SIGNIAWs Audiology Usa, Inc.OSM2026-07-22
05714880296587SIGNIAWs Audiology Usa, Inc.OSM2026-07-22
05714880296587SIGNIAWs Audiology Usa, Inc.KLW2026-07-22
05714880296600SIGNIAWs Audiology Usa, Inc.OSM2026-07-22
05714880296624SIGNIAWs Audiology Usa, Inc.OSM2026-07-22
05714880296648SIGNIAWs Audiology Usa, Inc.KLW2026-07-22
05714880296648SIGNIAWs Audiology Usa, Inc.OSM2026-07-22
05714880296679SIGNIAWs Audiology Usa, Inc.KLW2026-07-22
05714880296679SIGNIAWs Audiology Usa, Inc.OSM2026-07-22
05714880296709SIGNIAWs Audiology Usa, Inc.OSM2026-07-22
05714880296716SIGNIAWs Audiology Usa, Inc.OSM2026-07-22
05714880296747SIGNIAWs Audiology Usa, Inc.KLW2026-07-22
05714880296747SIGNIAWs Audiology Usa, Inc.OSM2026-07-22
05714880296754SIGNIAWs Audiology Usa, Inc.KLW2026-07-22
05714880296754SIGNIAWs Audiology Usa, Inc.OSM2026-07-22
05714880296853SIGNIAWs Audiology Usa, Inc.KLW2026-07-22
05714880296853SIGNIAWs Audiology Usa, Inc.OSM2026-07-22