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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 782
Loss of osseointegration 232
Failure to osseointegrate 72
No Information 39
Device remains implanted 17
No Known Device Problem 14
Extrusion 11
Component falling 10
Explanted 10
Dislodged or dislocated 9
Unknown (for use when the device problem is not known) 3
Osseointegration issue 3
Slippage of device or device component 3
Implant breakage or physical damage 2
Hermetic seal, loss of 1
Device operates differently than expected 1
Improper or incorrect procedure or method 1
Implant extrusion 1
Other (for use when an appropriate device code cannot be identified) 1
Loss of or failure to bond 1
Detachment of device component 1
Difficult to insert 1
Migration of device or device component 1
Total Device Problems 1216

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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