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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 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 32 32
Incomplete or Inadequate Connection 7 7
Premature Discharge of Battery 4 4
Electrical Shorting 2 2
Manufacturing, Packaging or Shipping Problem 1 1
Output below Specifications 1 1
Insufficient Information 1 1
Electrical /Electronic Property Problem 1 1
Labelling, Instructions for Use or Training Problem 1 1
Material Puncture/Hole 1 1
Device Contamination with Body Fluid 1 1
Battery Problem 1 1
Intermittent Communication Failure 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Wound Dehiscence 24 24
Hearing Impairment 10 10
Partial Hearing Loss 8 8
Post Operative Wound Infection 7 7
Unspecified Infection 3 3
Post Traumatic Wound Infection 2 2
Unspecified Mental, Emotional or Behavioural Problem 1 1
Failure of Implant 1 1
Total Hearing Loss 1 1

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