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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device hearing aid, bone conduction
Product CodeLXB
Regulation Number 874.3302
Device Class 2


Premarket Reviews
ManufacturerDecision
COCHLEAR AMERICAS
  SUBSTANTIALLY EQUIVALENT 2
OTICON MEDICAL AB
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2020 547 547
2021 490 490
2022 387 387
2023 356 356
2024 236 236

Device Problems MDRs with this Device Problem Events in those MDRs
Appropriate Term/Code Not Available 832 832
Adverse Event Without Identified Device or Use Problem 410 410
Patient Device Interaction Problem 402 402
Loss of Osseointegration 240 240
Insufficient Information 58 58
Expulsion 47 47
Inadequacy of Device Shape and/or Size 18 18
Biocompatibility 16 16
Failure to Osseointegrate 11 11
No Apparent Adverse Event 11 11
Patient-Device Incompatibility 10 10
Loosening of Implant Not Related to Bone-Ingrowth 7 7
Device Appears to Trigger Rejection 7 7
Signal Artifact/Noise 6 6
Output Problem 6 6
Therapeutic or Diagnostic Output Failure 6 6
Detachment of Device or Device Component 3 3
Misassembly During Maintenance/Repair 2 2
Unexpected Therapeutic Results 2 2
Failure to Deliver Shock/Stimulation 2 2
Migration or Expulsion of Device 1 1
Malposition of Device 1 1
Defective Component 1 1
Battery Problem 1 1
Material Protrusion/Extrusion 1 1
Overheating of Device 1 1
Osseointegration Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 358 358
Unspecified Infection 284 284
No Clinical Signs, Symptoms or Conditions 256 256
Skin Infection 187 187
Inadequate Osseointegration 153 153
Pain 143 143
Impaired Healing 124 124
No Code Available 83 83
Skin Inflammation/ Irritation 74 74
Insufficient Information 73 73
Tissue Breakdown 61 61
Patient Problem/Medical Problem 60 60
Discomfort 51 51
Implant Pain 50 50
Host-Tissue Reaction 42 42
Cellulitis 31 31
Bacterial Infection 28 28
Head Injury 27 27
Headache 21 21
Necrosis 20 20
Fluid Discharge 18 18
Purulent Discharge 17 17
Swelling/ Edema 15 15
Scar Tissue 13 13
Hearing Impairment 12 12
Wound Dehiscence 12 12
Skin Irritation 12 12
Erythema 12 12
Skin Disorders 11 11
No Information 9 9
Inflammation 8 8
Post Operative Wound Infection 8 8
Hemorrhage/Bleeding 6 6
Swelling 6 6
Necrosis Of Flap Tissue 5 5
Failure of Implant 5 5
Burning Sensation 4 4
Skin Erosion 4 4
Foreign Body Reaction 4 4
Hematoma 4 4
Dizziness 3 3
Drug Resistant Bacterial Infection 3 3
Pressure Sores 3 3
Seroma 2 2
Skin Inflammation 2 2
Osteomyelitis 2 2
Fall 2 2
Abscess 2 2
Ulcer 2 2
Scar Excision 2 2

Recalls
Manufacturer Recall Class Date Posted
1 Cochlear Americas Inc. II Jan-24-2020
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