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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
AUDIFON-USA INC.
  SUBSTANTIALLY EQUIVALENT 1
COCHLEAR AMERICAS
  SUBSTANTIALLY EQUIVALENT 11
COCHLEAR BONE ANCHORED SYSTEMS AB
  SUBSTANTIALLY EQUIVALENT 1
MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH
  SUBSTANTIALLY EQUIVALENT 1
OTICON MEDICAL AB
  SUBSTANTIALLY EQUIVALENT 7
SONITUS MEDICAL INC
  SUBSTANTIALLY EQUIVALENT 1
SONITUS MEDICAL INC
  SUBSTANTIALLY EQUIVALENT 1
SOPHONO INC.
  SUBSTANTIALLY EQUIVALENT 1
SOPHONO, INC
  SUBSTANTIALLY EQUIVALENT 4

MDR Year MDR Reports MDR Events
2014 544 544
2015 824 824
2016 694 694
2017 379 379
2018 336 336
2019 497 497
2020 547 547
2021 490 490
2022 387 387
2023 355 355
2024 65 65

Device Problems MDRs with this Device Problem Events in those MDRs
Appropriate Term/Code Not Available 3107 3107
Loss of Osseointegration 809 809
Adverse Event Without Identified Device or Use Problem 467 467
Patient Device Interaction Problem 344 344
Insufficient Information 188 188
Failure to Osseointegrate 76 76
Expulsion 35 35
Patient-Device Incompatibility 20 20
Biocompatibility 20 20
Extrusion 17 17
Inadequacy of Device Shape and/or Size 16 16
Osseointegration Problem 10 10
No Apparent Adverse Event 8 8
Device Appears to Trigger Rejection 7 7
Signal Artifact/Noise 6 6
Improper or Incorrect Procedure or Method 5 5
Output Problem 5 5
Device Dislodged or Dislocated 5 5
Loosening of Implant Not Related to Bone-Ingrowth 4 4
Missing Value Reason 4 4
Therapeutic or Diagnostic Output Failure 4 4
Use of Device Problem 4 4
Device Operates Differently Than Expected 4 4
Battery Problem 4 4
Migration or Expulsion of Device 3 3
Migration 3 3
Misassembly During Maintenance/Repair 2 2
Thermal Decomposition of Device 2 2
Contamination 2 2
Failure to Deliver Shock/Stimulation 2 2
Defective Component 2 2
Loose or Intermittent Connection 2 2
Unexpected Therapeutic Results 2 2
Detachment of Device or Device Component 2 2
Material Integrity Problem 2 2
Material Protrusion/Extrusion 1 1
Unintended Movement 1 1
Malposition of Device 1 1
Device Inoperable 1 1
Component Missing 1 1
Device Issue 1 1
Disconnection 1 1
Labelling, Instructions for Use or Training Problem 1 1
Overheating of Device 1 1
Break 1 1
Device Handling Problem 1 1
Noise, Audible 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Code Available 708 708
Unspecified Infection 660 660
Bacterial Infection 639 639
No Information 592 592
Pain 420 420
Patient Problem/Medical Problem 359 359
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 313 313
Host-Tissue Reaction 240 240
No Clinical Signs, Symptoms or Conditions 233 233
Skin Infection 154 154
Hearing Impairment 148 148
Impaired Healing 146 146
Inadequate Osseointegration 144 144
Head Injury 102 102
Swelling 81 81
Skin Inflammation/ Irritation 72 72
Insufficient Information 72 72
Tissue Breakdown 70 70
Inflammation 69 69
Discomfort 65 65
Cellulitis 47 47
Implant Pain 46 46
Skin Irritation 45 45
Deafness 43 43
Headache 40 40
Necrosis Of Flap Tissue 27 27
Scar Tissue 26 26
Purulent Discharge 26 26
Fluid Discharge 21 21
Hematoma 19 19
Irritation 18 18
Post Operative Wound Infection 18 18
Necrosis 18 18
Wound Dehiscence 17 17
Swelling/ Edema 15 15
Erythema 14 14
Foreign Body Reaction 11 11
Skin Disorders 11 11
Abscess 9 9
Seroma 9 9
No Consequences Or Impact To Patient 8 8
Discharge 8 8
Skin Inflammation 7 7
Dizziness 7 7
No Known Impact Or Consequence To Patient 7 7
Skin Erosion 6 6
Hemorrhage/Bleeding 6 6
Failure of Implant 6 6
Staphylococcus Aureus 5 5
Ulcer 5 5
Pressure Sores 5 5
Burning Sensation 4 4
Erosion 4 4
Fistula 3 3
Edema 3 3
Hearing Loss 3 3
Scar Excision 3 3
Missing Value Reason 3 3
Osteomyelitis 2 2
Increased Sensitivity 2 2
Skin Burning Sensation 2 2
No Patient Involvement 2 2
Solid Tumour 2 2
Injury 2 2
Electric Shock 2 2
Therapeutic Response, Decreased 2 2
Meningitis 2 2
Tissue Damage 2 2
Granuloma 2 2
Death 2 2
Fall 2 2
Cerebrospinal Fluid Leakage 1 1
Cyst(s) 1 1
Autoimmune Disorder 1 1
Ossification 1 1
Nausea 1 1
Hemorrhage, Subarachnoid 1 1
Hypersensitivity/Allergic reaction 1 1
Bone Fracture(s) 1 1
Tinnitus 1 1
Scarring 1 1
Device Overstimulation of Tissue 1 1
Rash 1 1
Reaction 1 1
Numbness 1 1
Blood Loss 1 1
Device Embedded In Tissue or Plaque 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Cochlear Americas Inc. II Jan-24-2020
2 Cochlear Americas Inc. II Jun-02-2014
3 Sonitus Medical Inc. III Mar-07-2012
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