FDA.reportPublic FDA data

Sony

Primary DI
05714880182743
Brand
Sony
Company
Ws Audiology Usa, Inc.
Model
CRE-C10
Catalog number
21022296
Device description
Sony CRE-C10 Hearing Aid
Published
2022-09-12
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
05714880182743PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05714880182743057148801827435714880182743

GMDN Terms#

Term, Definition table
TermDefinition
Air-conduction hearing aid, in-the-earA battery-powered acoustic device intended to compensate for impaired hearing by transmitting amplified sound waves to the eardrum through air. It typically consists of a miniature microphone, amplifier, and speaker (receiver) contained in a case that fits completely inside the outer ear (concha) [in-the-ear (ITE)]. 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 severe 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
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
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
05714880189308SonySony | Hearing Control210222962023-01-20
05714880199420SonySony | Hearing Control WA210263452023-08-31
05714880293531SIGNIAPortable Charger Active Mini210539262026-06-04
05714880297898SIGNIAPortable Charger Active Mini210558862026-06-04
05714880113778CONNEXXSmart Key109398752026-05-28

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
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
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
00328785002911BraunKAZ USA, INC.QDD2022-06-02
05708296237883GN HearingGn Hearing A/SQDD2022-04-04