Quick Links: Skip to main page content
Skip to Search
Skip to Topics Menu
Skip to Common Links
U.S. Food & Drug Administration
Follow FDA
En Español
Search FDA
Home
Food
Drugs
Medical Devices
Radiation-Emitting Products
Vaccines, Blood & Biologics
Animal & Veterinary
Cosmetics
Tobacco Products
TPLC - Total Product Life Cycle
FDA Home
medical devices
databases
-
510(k)
|
DeNovo
|
Registration & Listing
|
Adverse Events
|
Recalls
|
PMA
|
HDE
|
Classification
|
Standards
CFR Title 21
|
Radiation-Emitting Products
|
X-Ray Assembler
|
Medsun Reports
|
CLIA
|
TPLC
New Search
show TPLC since
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
Back to Search Results
Device
masker, tinnitus
Product Code
KLW
Regulation Number
874.3400
Device Class
2
Premarket Reviews
Manufacturer
Decision
AMPLISOUND HEARING PRODUCTS & SERVICES
SUBSTANTIALLY EQUIVALENT
1
ANM ADAPTIVE NEUROMODULATION GMBH
SUBSTANTIALLY EQUIVALENT
1
AUDIFON GMBH & CO. KG
SUBSTANTIALLY EQUIVALENT
1
AUDIFON-USA INC.
SUBSTANTIALLY EQUIVALENT
3
AUDIOFON USA INC.
SUBSTANTIALLY EQUIVALENT
1
AURELIYM GMBH
SUBSTANTIALLY EQUIVALENT
1
DUEARITY AB
SUBSTANTIALLY EQUIVALENT
1
GN HEARING A/S
SUBSTANTIALLY EQUIVALENT
3
GN RESOUND A/S
SUBSTANTIALLY EQUIVALENT
2
GOLDENEAR COMPANY, INC.
SUBSTANTIALLY EQUIVALENT
1
HANSATON AKUSTIK GMBH
SUBSTANTIALLY EQUIVALENT
1
JIANGSU BETTERLIFE MEDICAL CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
KW EAR LAB, INC
SUBSTANTIALLY EQUIVALENT
1
MAGNATONE HEARING AID CORP. DBA PERSONA MEDICAL
SUBSTANTIALLY EQUIVALENT
1
NEUROTHERAPIES RESET GMBH.
SUBSTANTIALLY EQUIVALENT
1
OTICON A/S
SUBSTANTIALLY EQUIVALENT
1
OTOHARMONICS CORP
SUBSTANTIALLY EQUIVALENT
1
PHONAK LLC
SUBSTANTIALLY EQUIVALENT
1
PNQ HEALTH
SUBSTANTIALLY EQUIVALENT
1
SANUTHERA, INC.
SUBSTANTIALLY EQUIVALENT
1
SOUND OPTIONS TINNITUS TREATMENTS INC.
SUBSTANTIALLY EQUIVALENT
1
SOUNDCURE INC
SUBSTANTIALLY EQUIVALENT
1
SOUNDCURE, INC.
SUBSTANTIALLY EQUIVALENT
1
STARKEY LABORATORIES
SUBSTANTIALLY EQUIVALENT
1
STARKEY LABORATORIES, INC.
SUBSTANTIALLY EQUIVALENT
1
TURTLE BEACH CORPORATION
SUBSTANTIALLY EQUIVALENT
1
UNITRON HEARING
SUBSTANTIALLY EQUIVALENT
1
WIDEX USA
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2015
4
4
Device Problems
MDRs with this Device Problem
Events in those MDRs
Device Operates Differently Than Expected
2
2
Use of Incorrect Control/Treatment Settings
1
1
Therapeutic or Diagnostic Output Failure
1
1
Insufficient Information
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Tinnitus
2
2
Hearing Impairment
1
1
Sleep Dysfunction
1
1
Diarrhea
1
1
-
-