FDA.reportPublic FDA data

Sony

Primary DI
05714880189308
Brand
Sony
Company
Ws Audiology Usa, Inc.
Model
Sony Hearing Control
Catalog number
21022296
Device description
Sony Hearing Control App
Published
2023-01-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
QDDSelf-Fitting Air-Conduction Hearing Aid

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QDDSelf-Fitting Air-Conduction Hearing Aid, PrescriptionEar, Nose, Throat2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05714880189308PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05714880189308057148801893085714880189308

GMDN Terms#

Term, Definition table
TermDefinition
Audiometric/hearing device softwareA software program intended to assist with the evaluation of a patient’s hearing capability and/or evaluate and adjust the settings of a hearing assistive device. It may be used by healthcare professionals in a healthcare facility or by the patient in the home, and intended to be used on a non-medical computerized device (e.g., smartphone, tablet).

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
17325626600consumerrelations@sivantos.com

Regulatory Flags#

DUNS number
157412271
Device count
1
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
00850010429205Eargo RXEargo, Inc.QDD2024-06-17
00850010429274Eargo RXEargo, Inc.QDD2024-06-17
05708296231010GN HearingGn Hearing A/SQDD2024-04-12
05708296231027GN HearingGn Hearing A/SQDD2024-04-12
05708296231034GN HearingGn Hearing A/SQDD2024-04-12
05708296231041GN HearingGn Hearing A/SQDD2024-04-12
05708296237944GN HearingGn Hearing A/SQDD2024-04-12
05708296237951GN HearingGn Hearing A/SQDD2024-04-12
05708296237968GN HearingGn Hearing A/SQDD2024-04-12
05708296237975GN HearingGn Hearing A/SQDD2024-04-12
05714880199420SonyWs Audiology Usa, Inc.QDD2023-08-31
05714880182781SonyWs Audiology Usa, Inc.QDD2023-05-30
05714880182750SonyWs Audiology Usa, Inc.QDD2022-12-20
05708296260775GN HearingGn Hearing A/SQDD2022-12-08
05708296260782GN HearingGn Hearing A/SQDD2022-12-08
05708296260799GN HearingGn Hearing A/SQDD2022-12-08
00850022464645Lexie HearingHEARX GROUP (PTY) LTDQDD2022-10-05
00850022464577Lexie HearingHEARX GROUP (PTY) LTDQDD2022-10-05
10850022464642Lexie HearingHEARX GROUP (PTY) LTDQDD2022-10-05
05714880182743SonyWs Audiology Usa, Inc.QDD2022-09-12
00850022464638Lexie B2, Powered by BoseHEARX GROUP (PTY) LTDQDD2022-09-09
00850022464492Lexie B1, Powered by BoseHEARX GROUP (PTY) LTDQDD2022-08-01
05708296228706GN HearingGn Hearing A/SQDD2022-07-08
05708296228713GN HearingGn Hearing A/SQDD2022-07-08
05708296233656GN HearingGn Hearing A/SQDD2022-07-08
05708296237609GN HearingGn Hearing A/SQDD2022-07-08
05708296238040GN HearingGn Hearing A/SQDD2022-07-08
05708296238057GN HearingGn Hearing A/SQDD2022-07-08
05708296238064GN HearingGn Hearing A/SQDD2022-07-08
05708296238071GN HearingGn Hearing A/SQDD2022-07-08