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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, implanted
Regulation Description Hearing Aid.
Product CodeMAH
Regulation Number 874.3300
Device Class 2


Premarket Reviews
ManufacturerDecision
COCHLEAR AMERICAS
  SUBSTANTIALLY EQUIVALENT 2
COCHLEAR BONE ANCHORED SYSTEMS AB
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
No code available 120
Failure to osseointegrate 110
Loss of osseointegration 58
Extrusion 17
Unknown (for use when the device problem is not known) 6
Implant breakage or physical damage 3
Explanted 3
Device remains implanted 3
No Information 3
Shelf life exceeded 1
Use of Device Issue 1
Expiration date error 1
Failure to separate 1
Malposition of device 1
Improper or incorrect procedure or method 1
No Known Device Problem 1
Osseointegration issue 1
Not Applicable 1
Total Device Problems 332

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