Skip to content
FDA.report
Public FDA data
NDC
RxNorm
DailyMed
Applications
GUDID
GMDN
PMA
PMN
MAUDE
Recalls
Search FDA.report
Search
Home
MAUDE
MDR
4895179
MAUDE MDR 4895179
MDR report key
4895179
Report number
MW5043596
Event key
0
Event type
3
Date received
2015-06-30
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
305
Health professional
0
Initial report to FDA
3
Event location
0
Related Records
#
Product code KLW
Manufacturer Contact
#
Report source
P
Manufacturer link flag
N
Devices
#
Seq, Brand, Generic table
Seq
Brand
Generic
Manufacturer
Product code
Model
Catalog
Lot
PMA
510(k)
Implant
Evaluated
Availability
1
PHONAK "HEARING AID MASKERS"
PHONAK "HEARING AID MASKERS"
PHONAK
KLW
Patients
#
Sequence, Received, Treatment table
Sequence
Received
Treatment
Outcome
1
2015-06-30
0
1. S
Event Narratives
#
D
Patient 1
SLEEPLESSNESS, INSOMNIA, DIARRHEA.
Related GUDID Devices By Product Code
#
Primary DI, Brand, Company table
Primary DI
Brand
Company
Product code
Published
05714880295719
SIGNIA
Ws Audiology Usa, Inc.
KLW
2026-06-08
05714880295726
SIGNIA
Ws Audiology Usa, Inc.
KLW
2026-06-08
05714880295733
SIGNIA
Ws Audiology Usa, Inc.
KLW
2026-06-08
05714880295740
SIGNIA
Ws Audiology Usa, Inc.
KLW
2026-06-08
05714880295788
SIGNIA
Ws Audiology Usa, Inc.
KLW
2026-06-08
05714880295795
SIGNIA
Ws Audiology Usa, Inc.
KLW
2026-06-08
05714880295849
SIGNIA
Ws Audiology Usa, Inc.
KLW
2026-06-08
05714880295856
SIGNIA
Ws Audiology Usa, Inc.
KLW
2026-06-08
05714880295900
SIGNIA
Ws Audiology Usa, Inc.
KLW
2026-06-08
05714880295917
SIGNIA
Ws Audiology Usa, Inc.
KLW
2026-06-08
05714880295986
SIGNIA
Ws Audiology Usa, Inc.
KLW
2026-06-08
05714880296013
SIGNIA
Ws Audiology Usa, Inc.
KLW
2026-06-08
05714880296044
SIGNIA
Ws Audiology Usa, Inc.
KLW
2026-06-08
05714880296075
SIGNIA
Ws Audiology Usa, Inc.
KLW
2026-06-08
05714880296105
SIGNIA
Ws Audiology Usa, Inc.
KLW
2026-06-08
05714880214345
Audio Service
Ws Audiology Usa, Inc.
KLW
2026-05-28
05714880214369
Audio Service
Ws Audiology Usa, Inc.
KLW
2026-05-28
05714880214376
Audio Service
Ws Audiology Usa, Inc.
KLW
2026-05-28
05714880214383
Audio Service
Ws Audiology Usa, Inc.
KLW
2026-05-28
05714880214390
Audio Service
Ws Audiology Usa, Inc.
KLW
2026-05-28
05714880214413
Audio Service
Ws Audiology Usa, Inc.
KLW
2026-05-28
05714880214420
Audio Service
Ws Audiology Usa, Inc.
KLW
2026-05-28
05714880214543
Audio Service
Ws Audiology Usa, Inc.
KLW
2026-05-28
05714880214567
Audio Service
Ws Audiology Usa, Inc.
KLW
2026-05-28
05714880214574
Audio Service
Ws Audiology Usa, Inc.
KLW
2026-05-28
05714880214581
Audio Service
Ws Audiology Usa, Inc.
KLW
2026-05-28
05714880214598
Audio Service
Ws Audiology Usa, Inc.
KLW
2026-05-28
05714880214611
Audio Service
Ws Audiology Usa, Inc.
KLW
2026-05-28
05714880214628
Audio Service
Ws Audiology Usa, Inc.
KLW
2026-05-28
05714880219425
Audio Service
Ws Audiology Usa, Inc.
KLW
2026-05-28
Related PMN/PMA Records By Product Code
#
Type, Submission, Product code table
Type
Submission
Product code
Device
Applicant
Decision date
510(k)
K233435
KLW
Peace N Quiet (0.7.0)
Pnq Health
2024-02-27
510(k)
K223694
KLW
Tinearity G1 (6103); Tinearity G1 Adapters x3 (6042)
Duearity AB
2023-06-30
510(k)
K221168
KLW
Tinnitogram Signal Generator
Goldenear Company, Inc.
2023-02-01
510(k)
K221125
KLW
SilentCloud
Aureliym GmbH
2023-01-04
510(k)
K201370
KLW
Multiflex Tinnitus Technology
Starkey Laboratories, Inc.
2020-06-19