FDA.reportPublic FDA data

TRUHEARING

Primary DI
05714880300123
Brand
TRUHEARING
Company
Ws Audiology Usa, Inc.
Model
TH Premium 7 IF ITC LI
Catalog number
21056558
Device description
S_ITE TH PREMIUM7IFITCLIR GNBLK
Published
2026-11-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
KLWMasker, Tinnitus
OSMHearing Aid, Air-Conduction With Wireless Technology, Prescription

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
05714880300123PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05714880300123057148803001235714880300123

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
05714880300116TRUHEARINGTH Premium 7 IF ITC LI210565572026-11-02
05714880300130TRUHEARINGTH Advanced 7 IF ITC LI210565602026-11-02
05714880300147TRUHEARINGTH Advanced 7 IF ITC LI210565592026-11-02
05714880299359AudioServiceIF ITC Li 8.12210564072026-10-28
05714880299403AudioServiceIF ITC Li 8.12210564202026-10-28
05714880299410AudioServiceIF ITC Li 8.12210564192026-10-28
05714880299427AudioServiceIF ITC Li 8.12210564082026-10-28
05714880299564REXTONReach IF ITC-Li BT 80210564602026-10-28
05714880299571REXTONReach IF ITC-Li BT 80210564622026-10-28
05714880299588REXTONReach IF ITC-Li BT 80210564632026-10-28
05714880299595REXTONReach IF ITC-Li BT 80210564652026-10-28
05714880299601REXTONReach IF ITC-Li BT 60210564682026-10-28
05714880299618REXTONReach IF ITC-Li BT 60210564692026-10-28
05714880299625REXTONReach IF ITC-Li BT 60210564702026-10-28
05714880299632REXTONReach IF ITC-Li BT 60210564712026-10-28
05714880299649REXTONReach IF ITC-Li BT 40210564722026-10-28
05714880299656REXTONReach IF ITC-Li BT 40210564732026-10-28
05714880299663REXTONReach IF ITC-Li BT 40210564742026-10-28
05714880299670REXTONReach IF ITC-Li BT 40210564752026-10-28
05714880299687REXTONReach IF ITC-Li BT SDemo210564762026-10-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05714880300116TRUHEARINGWs Audiology Usa, Inc.OSM2026-11-02
05714880300116TRUHEARINGWs Audiology Usa, Inc.KLW2026-11-02
05714880300130TRUHEARINGWs Audiology Usa, Inc.KLW2026-11-02
05714880300130TRUHEARINGWs Audiology Usa, Inc.OSM2026-11-02
05714880300147TRUHEARINGWs Audiology Usa, Inc.KLW2026-11-02
05714880300147TRUHEARINGWs Audiology Usa, Inc.OSM2026-11-02
05714880296181WidexWidex A/SKLW2026-10-30
05714880296181WidexWidex A/SOSM2026-10-30
05714880296198WidexWidex A/SKLW2026-10-30
05714880296198WidexWidex A/SOSM2026-10-30
05714880296204WidexWidex A/SKLW2026-10-30
05714880296204WidexWidex A/SOSM2026-10-30
05714880296211WidexWidex A/SKLW2026-10-30
05714880296211WidexWidex A/SOSM2026-10-30
05714880296228WidexWidex A/SOSM2026-10-30
05714880296228WidexWidex A/SKLW2026-10-30
05714880296235WidexWidex A/SKLW2026-10-30
05714880296235WidexWidex A/SOSM2026-10-30
05714880296242WidexWidex A/SKLW2026-10-30
05714880296242WidexWidex A/SOSM2026-10-30
05714880296259WidexWidex A/SKLW2026-10-30
05714880296259WidexWidex A/SOSM2026-10-30
05714880296266WidexWidex A/SKLW2026-10-30
05714880296266WidexWidex A/SOSM2026-10-30
05714880296273WidexWidex A/SKLW2026-10-30
05714880296273WidexWidex A/SOSM2026-10-30
05714880296280WidexWidex A/SKLW2026-10-30
05714880296280WidexWidex A/SOSM2026-10-30
05714880296297WidexWidex A/SKLW2026-10-30
05714880296297WidexWidex A/SOSM2026-10-30