TruHearing 10961861

GUDID 04056839089408

TruHearing HA TH PREMIUM RIC+ 19 GNT Hearing Aid

SIVANTOS, INC.

Behind-the-ear air-conduction hearing aid
Primary Device ID04056839089408
NIH Device Record Key3033d7b3-ed95-428b-a77b-ca2bcef8b5bd
Commercial Distribution StatusIn Commercial Distribution
Brand NameTruHearing
Version Model NumberHA TH PREMIUM RIC+ 19 GNT
Catalog Number10961861
Company DUNS157412271
Company NameSIVANTOS, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone17325626600
Emailconsumerrelations@sivantos.com
Phone17325626600
Emailconsumerrelations@sivantos.com
Phone17325626600
Emailconsumerrelations@sivantos.com
Phone17325626600
Emailconsumerrelations@sivantos.com
Phone17325626600
Emailconsumerrelations@sivantos.com
Phone17325626600
Emailconsumerrelations@sivantos.com
Phone17325626600
Emailconsumerrelations@sivantos.com
Phone17325626600
Emailconsumerrelations@sivantos.com
Phone17325626600
Emailconsumerrelations@sivantos.com
Phone17325626600
Emailconsumerrelations@sivantos.com
Phone17325626600
Emailconsumerrelations@sivantos.com
Phone17325626600
Emailconsumerrelations@sivantos.com
Phone17325626600
Emailconsumerrelations@sivantos.com
Phone17325626600
Emailconsumerrelations@sivantos.com

Device Identifiers

Device Issuing AgencyDevice ID
GS104056839089408 [Primary]

FDA Product Code

OSMHearing Aid, Air Conduction With Wireless Technology

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-04-22
Device Publish Date2019-04-12

On-Brand Devices [TruHearing]

04056839095515TruHearing HA TH DEMO RIC 19 BG Hearing Aid
04056839095393TruHearing C_ITE TH PREMIUM 19 ITE Hearing Aid
04056839095386TruHearing C_ITE TH PREMIUM 19 CANAL ITC Hearing Aid
04056839095379TruHearing C_ITE TH PREMIUM 19 IIC Hearing Aid
04056839095348TruHearing C_ITE TH PREMIUM 19 CIC Hearing Aid
04056839095331TruHearing C_ITE TH ADVANCED 19 ITE Hearing Aid
04056839095324TruHearing C_ITE TH ADVANCED 19 CANAL ITC Hearing Aid
04056839095317TruHearing C_ITE TH ADVANCED 19 CIC Hearing Aid
04056839091517TruHearing S_ITE TH PREMIUM IF 19 L BLK Hearing Aid
04056839091500TruHearing S_ITE TH PREMIUM IF 19 R BLK Hearing Aid
04056839091494TruHearing S_ITE TH PREMIUM IF 19 L MOC Hearing Aid
04056839089583TruHearing HA TH PREMIUM RIC 19 BG Hearing Aid
04056839089576TruHearing HA TH PREMIUM RIC 19 DBR Hearing Aid
04056839089569TruHearing HA TH PREMIUM RIC 19 GNT Hearing Aid
04056839089552TruHearing HA TH PREMIUM RIC 19 BLK Hearing Aid
04056839089545TruHearing HA TH PREMIUM RIC 19 SB Hearing Aid
04056839089538TruHearing HA TH ADVANCED RIC 19 BG Hearing Aid
04056839089521TruHearing HA TH ADVANCED RIC 19 DBR Hearing Aid
04056839089514TruHearing HA TH ADVANCED RIC 19 GNT Hearing Aid
04056839089507TruHearing HA TH ADVANCED RIC 19 BLK Hearing Aid
04056839089491TruHearing HA TH ADVANCED RIC 19 SB Hearing Aid
04056839089484TruHearing SET TH CROS RIC 19 BG
04056839089477TruHearing SET TH CROS RIC 19 DBR
04056839089460TruHearing SET TH CROS RIC 19 GNT
04056839089453TruHearing SET TH CROS RIC 19 BLK
04056839089446TruHearing SET TH CROS RIC 19 SB
04056839089439TruHearing HA TH DEMO RIC 19 GNT Hearing Aid
04056839089422TruHearing HA TH PREMIUM RIC+ 19 BG Hearing Aid
04056839089415TruHearing HA TH PREMIUM RIC+ 19 DBR Hearing Aid
04056839089408TruHearing HA TH PREMIUM RIC+ 19 GNT Hearing Aid
04056839089392TruHearing HA TH PREMIUM RIC+ 19 BLK Hearing Aid
04056839089385TruHearing HA TH PREMIUM RIC+ 19 SB Hearing Aid
04056839089378TruHearing HA TH ADVANCED RIC+ 19 BG Hearing Aid
04056839089361TruHearing HA TH ADVANCED RIC+ 19 DBR Hearing Aid
04056839089354TruHearing HA TH ADVANCED RIC+ 19 GNT Hearing Aid
04056839089347TruHearing HA TH ADVANCED RIC+ 19 BLK Hearing Aid
04056839089330TruHearing HA TH ADVANCED RIC+ 19 SB Hearing Aid
04056839089323TruHearing HA TH PREMIUM RIC LI 19 BG Hearing Aid
04056839089316TruHearing HA TH PREMIUM RIC LI 19 DBR Hearing Aid
04056839089309TruHearing HA TH PREMIUM RIC LI 19 GNT Hearing Aid
04056839089293TruHearing HA TH PREMIUM RIC LI 19 BLK Hearing Aid
04056839089286TruHearing HA TH PREMIUM RIC LI 19 SB Hearing Aid
04056839089262TruHearing S_ITE TH PREMIUM IF 19 R MOC Hearing Aid
04056839089255TruHearing HA TH PREMIUM STD BTE 19 BG Hearing Aid
04056839089248TruHearing HA TH PREMIUM STD BTE 19 DBR Hearing Aid
04056839089231TruHearing HA TH PREMIUM STD BTE 19 GNT Hearing Aid
04056839089224TruHearing HA TH PREMIUM STD BTE 19 BLK Hearing Aid
04056839089217TruHearing HA TH PREMIUM STD BTE 19 SB Hearing Aid
04056839089200TruHearing HA TH ADVANCED STD BTE 19 BG Hearing Aid
04056839089194TruHearing HA TH ADVANCED STD BTE 19 DBR Hearing Aid

Trademark Results [TruHearing]

Mark Image

Registration | Serial
Company
Trademark
Application Date
TRUHEARING
TRUHEARING
86734603 4991682 Live/Registered
TruHearing, Inc.
2015-08-24
TRUHEARING
TRUHEARING
86550349 5101004 Live/Registered
TruHearing, Inc.
2015-03-02
TRUHEARING
TRUHEARING
78283036 2961127 Live/Registered
Truhearing, Inc
2003-08-04
TRUHEARING
TRUHEARING
78283032 2973590 Live/Registered
Truhearing, Inc.
2003-08-04

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.