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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
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
356
356
2024
166
166
Device Problems
MDRs with this Device Problem
Events in those MDRs
Appropriate Term/Code Not Available
3140
3140
Loss of Osseointegration
821
821
Adverse Event Without Identified Device or Use Problem
478
478
Patient Device Interaction Problem
380
380
Insufficient Information
191
191
Failure to Osseointegrate
76
76
Expulsion
43
43
Biocompatibility
20
20
Patient-Device Incompatibility
20
20
Extrusion
17
17
Inadequacy of Device Shape and/or Size
16
16
No Apparent Adverse Event
11
11
Osseointegration Problem
10
10
Device Appears to Trigger Rejection
7
7
Loosening of Implant Not Related to Bone-Ingrowth
7
7
Signal Artifact/Noise
6
6
Output Problem
6
6
Improper or Incorrect Procedure or Method
5
5
Device Dislodged or Dislocated
5
5
Therapeutic or Diagnostic Output Failure
4
4
Battery Problem
4
4
Device Operates Differently Than Expected
4
4
Missing Value Reason
4
4
Use of Device Problem
4
4
Migration
3
3
Migration or Expulsion of Device
3
3
Detachment of Device or Device Component
2
2
Contamination
2
2
Unexpected Therapeutic Results
2
2
Misassembly During Maintenance/Repair
2
2
Thermal Decomposition of Device
2
2
Failure to Deliver Shock/Stimulation
2
2
Loose or Intermittent Connection
2
2
Defective Component
2
2
Material Integrity Problem
2
2
Labelling, Instructions for Use or Training Problem
1
1
Material Protrusion/Extrusion
1
1
Component Missing
1
1
Break
1
1
Unintended Movement
1
1
Malposition of Device
1
1
Overheating of Device
1
1
Device Inoperable
1
1
Device Handling Problem
1
1
Device Issue
1
1
Disconnection
1
1
Noise, Audible
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Code Available
708
708
Unspecified Infection
662
662
Bacterial Infection
639
639
No Information
592
592
Pain
429
429
Patient Problem/Medical Problem
359
359
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
337
337
No Clinical Signs, Symptoms or Conditions
251
251
Host-Tissue Reaction
240
240
Skin Infection
174
174
Inadequate Osseointegration
159
159
Impaired Healing
151
151
Hearing Impairment
149
149
Head Injury
107
107
Swelling
81
81
Tissue Breakdown
79
79
Insufficient Information
75
75
Skin Inflammation/ Irritation
72
72
Inflammation
69
69
Discomfort
67
67
Cellulitis
49
49
Implant Pain
46
46
Skin Irritation
45
45
Deafness
43
43
Headache
40
40
Purulent Discharge
28
28
Necrosis Of Flap Tissue
27
27
Scar Tissue
27
27
Necrosis
23
23
Wound Dehiscence
21
21
Fluid Discharge
21
21
Hematoma
19
19
Post Operative Wound Infection
18
18
Irritation
18
18
Swelling/ Edema
15
15
Erythema
15
15
Skin Disorders
11
11
Foreign Body Reaction
11
11
Abscess
9
9
Seroma
9
9
No Consequences Or Impact To Patient
8
8
Discharge
8
8
No Known Impact Or Consequence To Patient
7
7
Skin Inflammation
7
7
Dizziness
7
7
Skin Erosion
6
6
Hemorrhage/Bleeding
6
6
Pressure Sores
6
6
Failure of Implant
6
6
Staphylococcus Aureus
5
5
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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