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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
Regulation Description Bone-conduction hearing aid.
Product CodeLXB
Regulation Number 874.3302
Device Class 2


Premarket Reviews
ManufacturerDecision
BHM-TECH PRODUKTIONSGESELLSCHAFT MBH
  SUBSTANTIALLY EQUIVALENT 1
COCHLEAR
  SUBSTANTIALLY EQUIVALENT 1
COCHLEAR AMERICAS
  SUBSTANTIALLY EQUIVALENT 2
OTICON MEDICAL AB
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2021 490 490
2022 387 401
2023 348 355
2024 232 233
2025 258 258

Device Problems MDRs with this Device Problem Events in those MDRs
Appropriate Term/Code Not Available 655 665
Patient Device Interaction Problem 502 516
Adverse Event Without Identified Device or Use Problem 252 253
Loss of Osseointegration 189 191
Insufficient Information 51 52
Expulsion 44 45
Inadequacy of Device Shape and/or Size 20 20
No Apparent Adverse Event 16 17
Signal Artifact/Noise 15 15
Output Problem 12 12
Therapeutic or Diagnostic Output Failure 11 11
Loosening of Implant Not Related to Bone-Ingrowth 8 8
Patient-Device Incompatibility 6 6
Failure to Osseointegrate 6 6
Detachment of Device or Device Component 6 6
Device Appears to Trigger Rejection 6 6
Unexpected Therapeutic Results 5 5
Fail-Safe Did Not Operate 2 2
Misassembly During Maintenance/Repair 2 2
Device Handling Problem 2 2
Device Dislodged or Dislocated 2 2
Failure to Deliver Shock/Stimulation 2 2
Biocompatibility 2 2
Migration or Expulsion of Device 1 1
Difficult to Open or Remove Packaging Material 1 1
Defective Component 1 1
Battery Problem 1 1
Material Protrusion/Extrusion 1 1
Overheating of Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 341 341
No Clinical Signs, Symptoms or Conditions 294 297
Skin Infection 227 234
Unspecified Infection 176 182
Inadequate Osseointegration 166 168
Impaired Healing 143 145
Pain 130 134
Insufficient Information 77 77
Skin Inflammation/ Irritation 67 67
Tissue Breakdown 67 68
Discomfort 60 60
Implant Pain 52 52
Head Injury 23 23
Cellulitis 23 25
Headache 21 21
Purulent Discharge 18 20
Necrosis 15 15
Bacterial Infection 14 14
Swelling/ Edema 14 18
Erythema 13 15
Fluid Discharge 12 13
Scar Tissue 11 11
Wound Dehiscence 10 10
Hemorrhage/Bleeding 10 10
Hearing Impairment 6 6
Skin Burning Sensation 6 6
Post Operative Wound Infection 6 6
Drug Resistant Bacterial Infection 4 4
Hematoma 4 4
Burning Sensation 4 4
Fistula 3 3
Dizziness 3 3
Pressure Sores 3 3
Tinnitus 3 3
Increased Sensitivity 2 2
Ulcer 2 2
Balance Problems 2 2
Fall 2 2
Osteomyelitis 2 2
Skin Erosion 2 2
Seroma 2 2
Skin Disorders 2 2
Inflammation 2 2
Failure of Implant 2 2
Solid Tumour 2 2
Electric Shock 2 2
Autoimmune Disorder 1 1
Meningitis 1 1
Cancer 1 1
Granuloma 1 1

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