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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device implant, hearing, active, middle ear, totally implanted
Definition Intended to provide useful hearing to persons with sensorineural hearing loss. Indicated for adults with mild to severe sensorineural hearing loss who have a speech discrimination score greater than or equal to 60%.
Product CodeOAF
Device Class 3

Premarket Approvals (PMA)
2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
0 0 0 7 6 3 6 3 2 1

Device Problems
No Known Device Problem 13
Electrical issue 5
Low impedance 5
Impedance issue 5
Device inoperable 4
Premature discharge of battery 3
Decoupling 1
Difficult to insert 1
Improper or incorrect procedure or method 1
Fitting problem 1
Total Device Problems 39

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 1 0 0 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Envoy Medical Corporation II Jan-30-2013

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