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
Rx
false
OTC
true
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
QUHSelf-Fitting Air-Conduction Hearing Aid, Over The Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QUHSelf-Fitting Air-Conduction Hearing Aid, Over The CounterEar, 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).

Contacts#

Phone, Email table
PhoneEmail
17325626600consumerrelations@sivantos.com

Regulatory Flags#

DUNS number
157412271
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05714880295719SIGNIAActive Mini 7IX210541382026-06-08
05714880295726SIGNIAActive Mini 7IX210541492026-06-08
05714880295733SIGNIAActive Mini 5IX210543862026-06-08
05714880295740SIGNIAActive Mini 5IX210543912026-06-08
05714880295788SIGNIAActive Mini 3IX210543872026-06-08
05714880295795SIGNIAActive Mini 3IX210543922026-06-08
05714880295849SIGNIAActive Mini 2IX210543882026-06-08
05714880295856SIGNIAActive Mini 2IX210543942026-06-08
05714880295900SIGNIAActive Mini 1IX210543892026-06-08
05714880295917SIGNIAActive Mini 1IX210543952026-06-08
05714880295986SIGNIAKit Active Mini 7IX210541502026-06-08
05714880296013SIGNIAKit Active Mini 5IX210543972026-06-08
05714880296044SIGNIAKit Active Mini 3IX210543982026-06-08
05714880296075SIGNIAKit Active Mini 2IX210543992026-06-08
05714880296105SIGNIAKit Active Mini 1IX210544002026-06-08
05714880199420SonySony | Hearing Control WA210263452023-08-31
05714880293531SIGNIAPortable Charger Active Mini210539262026-06-04
05714880297898SIGNIAPortable Charger Active Mini210558862026-06-04
05714880113778CONNEXXSmart Key109398752026-05-28
05714880214345Audio ServiceR Li T 8.8210250432026-05-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810153660323Lexie B3 Hearing AidsHEARX GROUP (PTY) LTDQUH2026-05-07
00850010429786Eargo 8Eargo, Inc.QUH2026-04-20
00850010429847Eargo SEEargo, Inc.QUH2026-04-20
06971094538561HARMONIXHuizhou Jinghao Medical Technology Co., LtdQUH2026-01-20
00850010429779Eargo SEEargo, Inc.QUH2025-10-22
00810153660811Lexie HearingHEARX GROUP (PTY) LTDQUH2025-07-31
00850010429304Eargo 8Eargo, Inc.QUH2025-05-13
00850010429328Eargo 8Eargo, Inc.QUH2025-05-13
00850010429540Eargo 8Eargo, Inc.QUH2025-05-13
00850010429687Eargo 8Eargo, Inc.QUH2025-05-13
00850010429694Eargo 8Eargo, Inc.QUH2025-05-13
00850010429700Eargo 8Eargo, Inc.QUH2025-05-13
00850010429717Eargo 8Eargo, Inc.QUH2025-05-13
00850010429724Eargo 8Eargo, Inc.QUH2025-05-13
00850010429793Eargo 8Eargo, Inc.QUH2025-05-13
00850010429809Eargo 8Eargo, Inc.QUH2025-05-13
00046838505065JVCNovidan, Inc.QUH2025-05-07
00850010429816Eargo SEEargo, Inc.QUH2025-04-07
00850010429731Eargo SEEargo, Inc.QUH2025-04-03
00850010429748Eargo SEEargo, Inc.QUH2025-04-03
00850010429755Eargo SEEargo, Inc.QUH2025-04-03
00850010429762Eargo SEEargo, Inc.QUH2025-04-03
06971094538097OXILINEHuizhou Jinghao Medical Technology Co., LtdQUH2025-03-24
16971094538094OXILINEHuizhou Jinghao Medical Technology Co., LtdQUH2025-03-24
06971094537991AudialnetHuizhou Jinghao Medical Technology Co., LtdQUH2025-02-25
16971094537998AudialnetHuizhou Jinghao Medical Technology Co., LtdQUH2025-02-25
00860010331033CeretoneAudicon CorporationQUH2024-09-04
10860010331030CeretoneAudicon CorporationQUH2024-09-04
06971094537793RETEKESSHuizhou Jinghao Medical Technology Co., LtdQUH2024-09-02
16971094537790RETEKESSHuizhou Jinghao Medical Technology Co., LtdQUH2024-09-02