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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 10
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 937
Loss of osseointegration 284
Failure to osseointegrate 73
No Information 38
Device remains implanted 17
No Known Device Problem 15
Extrusion 12
Component falling 10
Explanted 10
Dislodged or dislocated 9
Osseointegration issue 7
Unknown (for use when the device problem is not known) 3
Slippage of device or device component 3
Improper or incorrect procedure or method 3
Implant breakage or physical damage 2
Hermetic seal, loss of 1
Battery issue 1
Device operates differently than expected 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 1432

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 0 0 0 0 0
Class II 0 0 0 0 0 0 0 1 0 0 0
Class III 0 0 0 0 0 1 0 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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