FDA.reportPublic FDA data

Sony

Primary DI
05714880199420
Brand
Sony
Company
Ws Audiology Usa, Inc.
Model
Sony | Hearing Control WA
Catalog number
21026345
Device description
Sony | Hearing Control App WA
Published
2023-08-31
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
05714880199420PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05714880199420057148801994205714880199420

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
true
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
05714880291278TRUHEARINGTH Premium 7 CIC LI210530542026-01-20
05714880291285TRUHEARINGTH Advanced 7 CIC LI210530562026-01-20
05714880291292TRUHEARINGTH Standard 7 CIC LI210530572026-01-20
05714880250695Audio ServiceR Li 4.6210388362026-09-18
05714880250701Audio ServiceR Li 4.6210388372026-09-18
05714880250718Audio ServiceR Li 4.6210388382026-09-18
05714880250725Audio ServiceR Li 4.6210388392026-09-18
05714880250732Audio ServiceR Li 4.6210388402026-09-18
05714880279580SIGNIAPortable Charger Styletto210488882026-08-21
05714880293951SIGNIAPortable Charger Styletto210543022026-08-21
05714880297461SIGNIARemote Control210524172026-08-21
05714880227154SonyCRE-C20210288712024-07-18
05714880215144SonyCRE-C20210288742024-07-01
05714880215151SonyCRE-C20210288752024-07-01
05714880182781SonyCRE-E10210223052023-05-30
05714880182743SonyCRE-C10210222962022-09-12
05714878800291MIRACLE EARMEMINI I 4 5W CIC-R210547572026-07-29
05714878800307MIRACLE EARMEMINI I 5 5W CIC-R210547562026-07-29
05714878800314MIRACLE EARMEMINI I 3 5W CIC-R210547582026-07-29
05714878800352MIRACLE EARMEMINI I 2 5W CIC-R210567122026-07-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05708296422043GN HearingGn Hearing A/SQUH2026-08-21
05708296422050GN HearingGn Hearing A/SQUH2026-08-21
05708296422067GN HearingGn Hearing A/SQUH2026-08-21
05708296422074GN HearingGn Hearing A/SQUH2026-08-21
05708296422081GN HearingGn Hearing A/SQUH2026-08-21
05708296422098GN HearingGn Hearing A/SQUH2026-08-21
05708296422104GN HearingGn Hearing A/SQUH2026-08-21
05708296422111GN HearingGn Hearing A/SQUH2026-08-21
05708296422128GN HearingGn Hearing A/SQUH2026-08-21
05708296422135GN HearingGn Hearing A/SQUH2026-08-21
05708296422142GN HearingGn Hearing A/SQUH2026-08-21
05708296422159GN HearingGn Hearing A/SQUH2026-08-21
05708296422166GN HearingGn Hearing A/SQUH2026-08-21
05708296422173GN HearingGn Hearing A/SQUH2026-08-21
05708296422180GN HearingGn Hearing A/SQUH2026-08-21
05708296422197GN HearingGn Hearing A/SQUH2026-08-21
05708296422203GN HearingGn Hearing A/SQUH2026-08-21
05708296422210GN HearingGn Hearing A/SQUH2026-08-21
05708296422227GN HearingGn Hearing A/SQUH2026-08-21
05708296422234GN HearingGn Hearing A/SQUH2026-08-21
05708296422241GN HearingGn Hearing A/SQUH2026-08-21
05708296422258GN HearingGn Hearing A/SQUH2026-08-21
05708296422265GN HearingGn Hearing A/SQUH2026-08-21
05708296422272GN HearingGn Hearing A/SQUH2026-08-21
05708296422289GN HearingGn Hearing A/SQUH2026-08-21
05708296422296GN HearingGn Hearing A/SQUH2026-08-21
05708296422302GN HearingGn Hearing A/SQUH2026-08-21
05708296422319GN HearingGn Hearing A/SQUH2026-08-21
05708296422326GN HearingGn Hearing A/SQUH2026-08-21
05708296422333GN HearingGn Hearing A/SQUH2026-08-21