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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 4
MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH
  SUBSTANTIALLY EQUIVALENT 4
OTICON MEDICAL AB
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 25 25
2020 70 70
2021 237 237
2022 305 305
2023 476 476
2024 365 365

Device Problems MDRs with this Device Problem Events in those MDRs
Appropriate Term/Code Not Available 679 679
Expulsion 292 292
Adverse Event Without Identified Device or Use Problem 181 181
No Device Output 89 89
Output Problem 71 71
Insufficient Information 63 63
Device Appears to Trigger Rejection 54 54
Device Dislodged or Dislocated 45 45
Patient Device Interaction Problem 29 29
Loss of Osseointegration 18 18
Unexpected Therapeutic Results 12 12
Improper or Incorrect Procedure or Method 8 8
Malposition of Device 8 8
Migration 8 8
No Apparent Adverse Event 8 8
Inadequacy of Device Shape and/or Size 6 6
Signal Artifact/Noise 6 6
Positioning Failure 5 5
Device Handling Problem 5 5
Lack of Effect 4 4
Loose or Intermittent Connection 4 4
Migration or Expulsion of Device 4 4
Failure to Read Input Signal 3 3
Therapeutic or Diagnostic Output Failure 3 3
Material Protrusion/Extrusion 3 3
Noise, Audible 2 2
Activation, Positioning or Separation Problem 2 2
Intermittent Shock/Stimulation 2 2
Microbial Contamination of Device 2 2
Device Damaged Prior to Use 1 1
Circuit Failure 1 1
Energy Output Problem 1 1
Osseointegration Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Unspecified Infection 402 402
Tissue Breakdown 278 278
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 212 212
Wound Dehiscence 157 157
Failure of Implant 157 157
No Clinical Signs, Symptoms or Conditions 100 100
Pain 94 94
Skin Infection 65 65
Post Operative Wound Infection 60 60
Insufficient Information 56 56
Necrosis 42 42
Hematoma 40 40
Swelling/ Edema 37 37
Fluid Discharge 31 31
Bacterial Infection 31 31
Implant Pain 27 27
Skin Inflammation/ Irritation 24 24
Impaired Healing 23 23
Abscess 20 20
Discomfort 19 19
Skin Tears 19 19
Drug Resistant Bacterial Infection 15 15
Inadequate Osseointegration 15 15
Headache 14 14
Cellulitis 13 13
Head Injury 13 13
Skin Erosion 11 11
Purulent Discharge 11 11
Inflammation 10 10
Patient Problem/Medical Problem 10 10
Seroma 9 9
Ulcer 7 7
Swelling 4 4
Hemorrhage/Bleeding 3 3
Hearing Impairment 3 3
No Code Available 3 3
Fever 2 2
Erosion 2 2
Meningitis 2 2
Post Traumatic Wound Infection 1 1
Dizziness 1 1
No Consequences Or Impact To Patient 1 1
Ossification 1 1
Erythema 1 1
Hemolysis 1 1
Laceration(s) 1 1
Nausea 1 1
Skin Disorders 1 1
Electric Shock 1 1
No Information 1 1

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