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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search Show TPLC since Back To Search Results
Device hearing aid, bone conduction
Regulation Description Hearing Aid.
Product CodeLXB
Regulation Number 874.3300
Device Class 2


Premarket Reviews
ManufacturerDecision
COCHLEAR AMERICAS
  SUBSTANTIALLY EQUIVALENT 5
MED-EL
  SUBSTANTIALLY EQUIVALENT 1
WILLIAM DEMANT HOLDING A/S
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Appropriate Term/Code Not Available 1526
Loss of Osseointegration 365
Insufficient Information 32
Magnet 26
Extrusion 16
Adverse Event Without Identified Device or Use Problem 14
Osseointegration Problem 9
Failure to Osseointegrate 7
Missing Value Reason 4
Migration or Expulsion of Device 3
Migration 3
Improper or Incorrect Procedure or Method 3
Battery 2
Material Integrity Problem 2
Use of Device Problem 2
Expulsion 2
Device Handling Problem 1
Device Issue 1
Unintended Movement 1
Receiver Stimulator Unit 1
Battery Problem 1
Total Device Problems 2021

Recalls
Manufacturer Recall Class Date Posted
1 Cochlear Americas Inc. II Jun-02-2014

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