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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device active implantable bone conduction hearing system
Definition An active implantable bone conduction hearing system is a prescription device consisting of an implanted transducer, implanted electronics components, and an audio processor. The active implantable bone conduction hearing system is intended to compensate for conductive or mixed hearing losses by conveying amplified acoustic signals to the cochlea via mechanical vibrations on the skull bone.
Product CodePFO
Regulation Number 874.3340
Device Class 2


Premarket Reviews
ManufacturerDecision
COCHLEAR
  SUBSTANTIALLY EQUIVALENT 1
COCHLEAR AMERICAS
  SUBSTANTIALLY EQUIVALENT 3
MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH
  SUBSTANTIALLY EQUIVALENT 4

MDR Year MDR Reports MDR Events
2019 25 25
2020 70 70
2021 237 237
2022 305 305
2023 475 475
2024 151 151

Device Problems MDRs with this Device Problem Events in those MDRs
Appropriate Term/Code Not Available 568 568
Expulsion 249 249
Adverse Event Without Identified Device or Use Problem 158 158
No Device Output 75 75
Output Problem 67 67
Insufficient Information 54 54
Device Appears to Trigger Rejection 52 52
Device Dislodged or Dislocated 36 36
Patient Device Interaction Problem 23 23
Loss of Osseointegration 16 16
Unexpected Therapeutic Results 12 12
Improper or Incorrect Procedure or Method 8 8
Migration 8 8
No Apparent Adverse Event 6 6
Signal Artifact/Noise 6 6
Inadequacy of Device Shape and/or Size 6 6
Positioning Failure 5 5
Malposition of Device 5 5
Migration or Expulsion of Device 4 4
Failure to Read Input Signal 3 3
Therapeutic or Diagnostic Output Failure 3 3
Lack of Effect 3 3
Material Protrusion/Extrusion 3 3
Device Handling Problem 2 2
Loose or Intermittent Connection 2 2
Noise, Audible 2 2
Microbial Contamination of Device 2 2
Activation, Positioning or Separation Problem 2 2
Intermittent Shock/Stimulation 2 2
Circuit Failure 1 1
Osseointegration Problem 1 1
Energy Output Problem 1 1
Device Damaged Prior to Use 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Unspecified Infection 338 338
Tissue Breakdown 237 237
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 175 175
Failure of Implant 140 140
Wound Dehiscence 138 138
Pain 85 85
No Clinical Signs, Symptoms or Conditions 66 66
Skin Infection 61 61
Post Operative Wound Infection 53 53
Insufficient Information 50 50
Necrosis 36 36
Hematoma 36 36
Swelling/ Edema 34 34
Bacterial Infection 29 29
Fluid Discharge 28 28
Implant Pain 26 26
Skin Inflammation/ Irritation 22 22
Impaired Healing 21 21
Abscess 20 20
Skin Tears 18 18
Discomfort 17 17
Drug Resistant Bacterial Infection 14 14
Headache 14 14
Inadequate Osseointegration 13 13
Head Injury 11 11
Patient Problem/Medical Problem 10 10
Seroma 9 9
Cellulitis 9 9
Purulent Discharge 9 9
Inflammation 9 9
Skin Erosion 8 8
Ulcer 7 7
Swelling 4 4
Hemorrhage/Bleeding 3 3
Hearing Impairment 3 3
No Code Available 3 3
Erosion 2 2
Meningitis 2 2
Electric Shock 1 1
No Information 1 1
Dizziness 1 1
No Consequences Or Impact To Patient 1 1
Ossification 1 1
Hemolysis 1 1
Laceration(s) 1 1
Nausea 1 1
Skin Disorders 1 1

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