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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)
2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024
0 7 6 3 6 3 2 3 4 1 1 1 0 1 0 0

MDR Year MDR Reports MDR Events
2014 18 18
2015 9 9
2017 20 20
2018 36 36
2019 8 8
2020 9 9
2021 10 10
2022 15 15
2023 7 7
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 71 71
Premature Discharge of Battery 17 17
Device Inoperable 14 14
Electrical /Electronic Property Problem 9 9
Low impedance 7 7
Incomplete or Inadequate Connection 7 7
Impedance Problem 6 6
Difficult to Insert 2 2
Fluid/Blood Leak 2 2
Electrical Shorting 2 2
Device Damaged by Another Device 2 2
Improper Device Output 2 2
Improper or Incorrect Procedure or Method 2 2
Intermittent Continuity 2 2
Output below Specifications 2 2
Physical Property Issue 2 2
Material Puncture/Hole 1 1
Intermittent Communication Failure 1 1
Invalid Sensing 1 1
Battery Problem 1 1
Device Contamination with Body Fluid 1 1
Low Readings 1 1
Device Sensing Problem 1 1
Decoupling 1 1
Facilities Issue 1 1
Device Operational Issue 1 1
Device Operates Differently Than Expected 1 1
Installation-Related Problem 1 1
Device Issue 1 1
Fitting Problem 1 1
Blocked Connection 1 1
Insufficient Information 1 1
Labelling, Instructions for Use or Training Problem 1 1
Cut In Material 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Device Damaged Prior to Use 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Wound Dehiscence 49 49
Hearing Impairment 40 40
Post Operative Wound Infection 16 16
Unspecified Infection 10 10
Deafness 9 9
Partial Hearing Loss 8 8
Discomfort 8 8
Pain 7 7
No Known Impact Or Consequence To Patient 3 3
Post Traumatic Wound Infection 2 2
Vertigo 2 2
Dizziness 1 1
No Consequences Or Impact To Patient 1 1
No Code Available 1 1
Unspecified Mental, Emotional or Behavioural Problem 1 1
Fainting 1 1
Fistula 1 1
Nerve Damage 1 1
Hearing Loss 1 1
Failure of Implant 1 1
Total Hearing Loss 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Envoy Medical Corporation II Aug-01-2018
2 Envoy Medical Corporation II Jan-30-2013
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