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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)
2021 2022 2023 2024 2025 2026
0 1 0 0 0 0

MDR Year MDR Reports MDR Events
2021 10 10
2022 15 16
2023 7 7
2024 8 8
2025 11 11
2026 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 25 25
Incomplete or Inadequate Connection 10 10
Patient Device Interaction Problem 7 7
Premature Discharge of Battery 5 5
Patient-Device Incompatibility 4 4
Use of Device Problem 3 3
Improper or Incorrect Procedure or Method 3 3
Off-Label Use 3 3
Connection Problem 3 3
Material Split, Cut or Torn 2 2
Intermittent Loss of Power 2 2
Power Problem 2 2
Insufficient Information 2 2
Electrical /Electronic Property Problem 2 2
Loose or Intermittent Connection 2 2
Intermittent Communication Failure 1 1
Labelling, Instructions for Use or Training Problem 1 2
Material Puncture/Hole 1 1
Device Appears to Trigger Rejection 1 1
Material Perforation 1 1
Battery Problem 1 2
Manufacturing, Packaging or Shipping Problem 1 2
Material Integrity Problem 1 1
Output below Specifications 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Wound Dehiscence 28 28
Hearing Impairment 11 11
Partial Hearing Loss 11 11
Post Traumatic Wound Infection 7 7
Post Operative Wound Infection 4 4
Unspecified Infection 3 3
Failure of Implant 2 3
Total Hearing Loss 1 2
Unspecified Mental, Emotional or Behavioural Problem 1 2

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