FDA.reportPublic FDA data

TRUHEARING

Primary DI
05714880264685
Brand
TRUHEARING
Company
Ws Audiology Usa, Inc.
Model
TH Standard 7 IIC
Catalog number
21043117
Device description
C_ITE TH STANDARD 7 IIC
Published
2024-10-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
05714880264685PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05714880264685057148802646855714880264685

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
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05714880286342CONNEXXSlim-RIC Travel Charger 2 RB210488892026-10-01
05714880297584CONNEXXSlim-RIC Travel Charger 2 RB210543032026-10-01
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05714880270303WidexWidex A/SOSM2026-10-22
05708296447022GN HearingGn Hearing A/SOSM2026-10-21
05708296474998GN HearingGn Hearing A/SOSM2026-10-21
05708296475001GN HearingGn Hearing A/SOSM2026-10-21
05708296475025GN HearingGn Hearing A/SOSM2026-10-21
05708296475032GN HearingGn Hearing A/SOSM2026-10-21
05708296475049GN HearingGn Hearing A/SOSM2026-10-21
05708296485369GN HearingGn Hearing A/SOSM2026-10-21
05708296485529GN HearingGn Hearing A/SOSM2026-10-21
05708296249787BeltoneGn Hearing A/SKLW2022-08-24
05708296249787BeltoneGn Hearing A/SOSM2022-08-24
05708296249978BeltoneGn Hearing A/SOSM2022-08-24
05708296249978BeltoneGn Hearing A/SKLW2022-08-24
05708296226856GN HearingGn Hearing A/SKLW2021-06-11
05708296226856GN HearingGn Hearing A/SOSM2021-06-11
05708296226863GN HearingGn Hearing A/SOSM2021-06-11
05708296226863GN HearingGn Hearing A/SKLW2021-06-11
05708296227099GN HearingGn Hearing A/SOSM2021-06-11
05708296227099GN HearingGn Hearing A/SKLW2021-06-11
05708296220724GN HearingGn Hearing A/SKLW2021-06-07
05708296220724GN HearingGn Hearing A/SOSM2021-06-07
05708296221233GN HearingGn Hearing A/SOSM2021-06-07
05708296221233GN HearingGn Hearing A/SKLW2021-06-07
05708296221257GN HearingGn Hearing A/SKLW2021-06-07
05708296221257GN HearingGn Hearing A/SOSM2021-06-07
05708296221325GN HearingGn Hearing A/SKLW2021-06-07
05708296221325GN HearingGn Hearing A/SOSM2021-06-07
05708296221394GN HearingGn Hearing A/SKLW2021-06-07
05708296221394GN HearingGn Hearing A/SOSM2021-06-07
05708296221400GN HearingGn Hearing A/SKLW2021-06-07