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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
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)
2015 2016 2017 2018 2019 2020
2 3 4 1 1 1

Device Problems
Adverse Event Without Identified Device or Use Problem 39
Device Inoperable 13
Premature Discharge of Battery 13
Improper Device Output 2
Header 2
Fluid Leak 2
Device Damaged by Another Device 2
Physical Property Issue 2
Electrical Shorting 2
Intermittent Continuity 2
Electrical /Electronic Property Problem 2
Difficult to Insert 2
Device Damaged Prior to Use 1
Low Readings 1
Improper or Incorrect Procedure or Method 1
Device Contamination with Body Fluid 1
Device Operational Issue 1
Weld 1
Installation-Related Problem 1
Fitting Problem 1
Output below Specifications 1
Facilities Issue 1
Decoupling 1
Cut In Material 1
Low impedance 1
Device Issue 1
Blocked Connection 1
Total Device Problems 98

Recalls
Manufacturer Recall Class Date Posted
1 Envoy Medical Corporation II Aug-01-2018

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