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TPLC
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show TPLC since
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Device
hearing aid, bone conduction
Product Code
LXB
Regulation Number
874.3302
Device Class
2
Premarket Reviews
Manufacturer
Decision
COCHLEAR AMERICAS
SUBSTANTIALLY EQUIVALENT
2
OTICON MEDICAL AB
SUBSTANTIALLY EQUIVALENT
3
MDR Year
MDR Reports
MDR Events
2019
497
497
2020
547
547
2021
490
490
2022
387
387
2023
356
356
2024
166
166
Device Problems
MDRs with this Device Problem
Events in those MDRs
Appropriate Term/Code Not Available
1131
1131
Adverse Event Without Identified Device or Use Problem
459
459
Patient Device Interaction Problem
380
380
Loss of Osseointegration
304
304
Insufficient Information
75
75
Expulsion
41
41
Biocompatibility
20
20
Patient-Device Incompatibility
18
18
Failure to Osseointegrate
17
17
Inadequacy of Device Shape and/or Size
16
16
No Apparent Adverse Event
11
11
Loosening of Implant Not Related to Bone-Ingrowth
7
7
Device Appears to Trigger Rejection
7
7
Output Problem
6
6
Signal Artifact/Noise
6
6
Device Dislodged or Dislocated
4
4
Therapeutic or Diagnostic Output Failure
4
4
Misassembly During Maintenance/Repair
2
2
Thermal Decomposition of Device
2
2
Failure to Deliver Shock/Stimulation
2
2
Use of Device Problem
2
2
Material Integrity Problem
2
2
Migration
2
2
Unexpected Therapeutic Results
2
2
Malposition of Device
1
1
Osseointegration Problem
1
1
Battery Problem
1
1
Defective Component
1
1
Detachment of Device or Device Component
1
1
Material Protrusion/Extrusion
1
1
Overheating of Device
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Unspecified Infection
379
379
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
337
337
No Clinical Signs, Symptoms or Conditions
251
251
No Code Available
203
203
Pain
199
199
Skin Infection
174
174
Inadequate Osseointegration
151
151
Patient Problem/Medical Problem
125
125
Impaired Healing
117
117
Host-Tissue Reaction
101
101
Insufficient Information
73
73
Skin Inflammation/ Irritation
72
72
Tissue Breakdown
67
67
Discomfort
54
54
Bacterial Infection
49
49
Implant Pain
46
46
Cellulitis
33
33
Hearing Impairment
31
31
No Information
28
28
Head Injury
28
28
Scar Tissue
25
25
Headache
23
23
Skin Irritation
22
22
Purulent Discharge
21
21
Necrosis
18
18
Fluid Discharge
18
18
Wound Dehiscence
16
16
Swelling/ Edema
15
15
Post Operative Wound Infection
14
14
Swelling
14
14
Inflammation
12
12
Erythema
12
12
Skin Disorders
11
11
Necrosis Of Flap Tissue
8
8
Hemorrhage/Bleeding
6
6
Skin Inflammation
6
6
Failure of Implant
5
5
Foreign Body Reaction
5
5
No Consequences Or Impact To Patient
4
4
Burning Sensation
4
4
No Known Impact Or Consequence To Patient
4
4
Hematoma
4
4
Missing Value Reason
3
3
Dizziness
3
3
Pressure Sores
3
3
Osteomyelitis
2
2
No Patient Involvement
2
2
Injury
2
2
Fall
2
2
Skin Erosion
2
2
Recalls
Manufacturer
Recall Class
Date Posted
1
Cochlear Americas Inc.
II
Jan-24-2020
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