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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
  GRANTED 1
OTICON MEDICAL AB
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 2 2
2019 25 25
2020 70 70
2021 237 237
2022 305 305
2023 477 477
2024 474 474

Device Problems MDRs with this Device Problem Events in those MDRs
Appropriate Term/Code Not Available 743 743
Expulsion 320 320
Adverse Event Without Identified Device or Use Problem 190 190
No Device Output 95 95
Output Problem 74 74
Insufficient Information 65 65
Device Appears to Trigger Rejection 55 55
Device Dislodged or Dislocated 45 45
Patient Device Interaction Problem 29 29
Loss of Osseointegration 19 19
Unexpected Therapeutic Results 12 12
No Apparent Adverse Event 11 11
Improper or Incorrect Procedure or Method 9 9
Signal Artifact/Noise 8 8
Migration 8 8
Malposition of Device 8 8
Inadequacy of Device Shape and/or Size 6 6
Positioning Failure 5 5
Device Handling Problem 5 5
Loose or Intermittent Connection 4 4
Migration or Expulsion of Device 4 4
Lack of Effect 4 4
Microbial Contamination of Device 3 3
Failure to Read Input Signal 3 3
Therapeutic or Diagnostic Output Failure 3 3
Material Protrusion/Extrusion 3 3
Noise, Audible 3 3
Activation, Positioning or Separation Problem 2 2
Intermittent Shock/Stimulation 2 2
Circuit Failure 1 1
Device Damaged Prior to Use 1 1
Energy Output Problem 1 1
Osseointegration Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Unspecified Infection 446 446
Tissue Breakdown 303 303
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 222 222
Wound Dehiscence 174 174
Failure of Implant 169 169
No Clinical Signs, Symptoms or Conditions 111 111
Pain 100 100
Skin Infection 67 67
Post Operative Wound Infection 62 62
Insufficient Information 56 56
Necrosis 44 44
Hematoma 40 40
Swelling/ Edema 37 37
Bacterial Infection 36 36
Fluid Discharge 33 33
Implant Pain 30 30
Skin Inflammation/ Irritation 24 24
Abscess 24 24
Impaired Healing 23 23
Skin Tears 21 21
Discomfort 19 19
Headache 18 18
Inadequate Osseointegration 16 16
Drug Resistant Bacterial Infection 15 15
Cellulitis 13 13
Purulent Discharge 13 13
Head Injury 13 13
Seroma 11 11
Skin Erosion 11 11
Inflammation 10 10
Patient Problem/Medical Problem 10 10
Ulcer 8 8
Swelling 4 4
No Code Available 3 3
Hemorrhage/Bleeding 3 3
Hearing Impairment 3 3
Post Traumatic Wound Infection 2 2
Fever 2 2
Erosion 2 2
Meningitis 2 2
Skin Disorders 1 1
Ossification 1 1
Erythema 1 1
No Information 1 1
Laceration(s) 1 1
Dizziness 1 1
Nausea 1 1
Hemolysis 1 1
Electric Shock 1 1
No Consequences Or Impact To Patient 1 1

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