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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)
2019 2020 2021 2022 2023 2024
1 1 0 1 0 0

MDR Year MDR Reports MDR Events
2019 8 8
2020 9 9
2021 10 10
2022 15 15
2023 7 7
2024 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 34 34
Incomplete or Inadequate Connection 8 8
Premature Discharge of Battery 5 5
Electrical Shorting 2 2
Device Contamination with Body Fluid 1 1
Material Puncture/Hole 1 1
Insufficient Information 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Battery Problem 1 1
Labelling, Instructions for Use or Training Problem 1 1
Electrical /Electronic Property Problem 1 1
Intermittent Communication Failure 1 1
Output below Specifications 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Wound Dehiscence 26 26
Hearing Impairment 11 11
Partial Hearing Loss 9 9
Post Operative Wound Infection 7 7
Unspecified Infection 3 3
Post Traumatic Wound Infection 3 3
Total Hearing Loss 1 1
Failure of Implant 1 1
Unspecified Mental, Emotional or Behavioural Problem 1 1

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