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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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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 9
COCHLEAR BONE ANCHORED SYSTEMS AB
  SUBSTANTIALLY EQUIVALENT 1
EAR TECHNOLOGY CORP.
  SUBSTANTIALLY EQUIVALENT 1
STARKEY LABORATORIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
XOMED, INC.
  SUBSTANTIALLY EQUIVALENT 6

Device Problems
No code available 710
Loss of osseointegration 214
Failure to osseointegrate 72
No Information 36
Device remains implanted 17
Component falling 10
Explanted 10
Dislodged or dislocated 9
Extrusion 9
No Known Device Problem 8
Osseointegration issue 3
Slippage of device or device component 3
Unknown (for use when the device problem is not known) 3
Implant breakage or physical damage 2
Hermetic seal, loss of 1
Device operates differently than expected 1
Loss of or failure to bond 1
Detachment of device component 1
Difficult to insert 1
Migration of device or device component 1
Implant extrusion 1
Other (for use when an appropriate device code cannot be identified) 1
Total Device Problems 1114

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 0 0 0
Class II 0 0 0 0 0 0 0 1 0 0
Class III 0 0 0 0 0 1 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Cochlear Americas Inc. II Jun-02-2014
2 Sonitus Medical Inc. III Mar-07-2012

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