Trial Outcomes & Findings for Early Experience of a New Implant System for Bone Conduction Hearing in the Pediatric Population (NCT NCT03509974)
NCT ID: NCT03509974
Last Updated: 2021-10-22
Results Overview
Number, Type and Severity of Adverse Events will be tabulated and summarized.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
14 participants
Primary outcome timeframe
Surgery to 12 months post-operative
Results posted on
2021-10-22
Participant Flow
Participant milestones
| Measure |
Bone Anchored Hearing Device (OSIA)
All subjects will receive the Bone Anchored Hearing Device (OSIA)
Osseointegrated Steady State Implant: Bone anchored, bone conduction hearing system
|
|---|---|
|
Overall Study
STARTED
|
14
|
|
Overall Study
COMPLETED
|
14
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Bone Anchored Hearing Device (OSIA)
n=14 Participants
All subjects will receive the Bone Anchored Hearing Device (OSIA)
Osseointegrated Steady State Implant: Bone anchored, bone conduction hearing system
|
|---|---|
|
Age, Categorical
<=18 years
|
14 Participants
n=14 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=14 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=14 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=14 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=14 Participants
|
|
Type of Hearing Loss
Conductive
|
9 Participants
n=14 Participants
|
|
Type of Hearing Loss
Mixed Conductive
|
2 Participants
n=14 Participants
|
|
Type of Hearing Loss
Single-Sided-Deafness
|
3 Participants
n=14 Participants
|
PRIMARY outcome
Timeframe: Surgery to 12 months post-operativeNumber, Type and Severity of Adverse Events will be tabulated and summarized.
Outcome measures
| Measure |
Bone Anchored Hearing Device (OSIA)
n=14 Participants
All subjects will receive the Bone Anchored Hearing Device (OSIA)
Osseointegrated Steady State Implant: Bone anchored, bone conduction hearing system
|
|---|---|
|
Number of Participants Reporting Type and Severity of Adverse Events in the Pediatric Population Implanted With the Osia System
Not Serious - Redness at magnet site
|
1 Participants
|
|
Number of Participants Reporting Type and Severity of Adverse Events in the Pediatric Population Implanted With the Osia System
Not Serious - Ingrown hair near incision
|
1 Participants
|
|
Number of Participants Reporting Type and Severity of Adverse Events in the Pediatric Population Implanted With the Osia System
Not Serious - Red incision site with pus leaking
|
1 Participants
|
|
Number of Participants Reporting Type and Severity of Adverse Events in the Pediatric Population Implanted With the Osia System
Not Serious - Patient bumped magnet site in shower, pain and swelling
|
1 Participants
|
|
Number of Participants Reporting Type and Severity of Adverse Events in the Pediatric Population Implanted With the Osia System
Serious - Skin flap measurement >10mm prevented device connectio/activiation
|
1 Participants
|
|
Number of Participants Reporting Type and Severity of Adverse Events in the Pediatric Population Implanted With the Osia System
Not Serious - Pain and swelling at the tip of mastoid
|
1 Participants
|
|
Number of Participants Reporting Type and Severity of Adverse Events in the Pediatric Population Implanted With the Osia System
Not Serious - magnetitis and soe discomfort with pin skin
|
1 Participants
|
|
Number of Participants Reporting Type and Severity of Adverse Events in the Pediatric Population Implanted With the Osia System
Not Serious - right swelling at the tip of the mastoid
|
1 Participants
|
|
Number of Participants Reporting Type and Severity of Adverse Events in the Pediatric Population Implanted With the Osia System
Not Serious - Left side facial swelling at post-operative site
|
1 Participants
|
|
Number of Participants Reporting Type and Severity of Adverse Events in the Pediatric Population Implanted With the Osia System
Not Serious - some discomfort following surgery
|
1 Participants
|
|
Number of Participants Reporting Type and Severity of Adverse Events in the Pediatric Population Implanted With the Osia System
Not Serious - Pain and swelling at surgical sight
|
1 Participants
|
|
Number of Participants Reporting Type and Severity of Adverse Events in the Pediatric Population Implanted With the Osia System
Not Serious - Post-operative nausea and vomitting
|
1 Participants
|
|
Number of Participants Reporting Type and Severity of Adverse Events in the Pediatric Population Implanted With the Osia System
Not Serious - swelling post surgery
|
1 Participants
|
|
Number of Participants Reporting Type and Severity of Adverse Events in the Pediatric Population Implanted With the Osia System
Not Serious - Sensitivity post surgery
|
1 Participants
|
|
Number of Participants Reporting Type and Severity of Adverse Events in the Pediatric Population Implanted With the Osia System
Not Serious - discomfort post surgery for one week
|
1 Participants
|
Adverse Events
Bone Anchored Hearing Device (OSIA)
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Bone Anchored Hearing Device (OSIA)
n=14 participants at risk
All subjects will receive the Bone Anchored Hearing Device (OSIA)
Osseointegrated Steady State Implant: Bone anchored, bone conduction hearing system
|
|---|---|
|
Ear and labyrinth disorders
Prevention of Device Connection/Activation
|
7.1%
1/14 • Number of events 1 • 12 months
|
Other adverse events
| Measure |
Bone Anchored Hearing Device (OSIA)
n=14 participants at risk
All subjects will receive the Bone Anchored Hearing Device (OSIA)
Osseointegrated Steady State Implant: Bone anchored, bone conduction hearing system
|
|---|---|
|
Injury, poisoning and procedural complications
Ingrown hair near incision site
|
7.1%
1/14 • Number of events 1 • 12 months
|
|
Injury, poisoning and procedural complications
Red incision site with some pus leaking
|
7.1%
1/14 • Number of events 1 • 12 months
|
|
Product Issues
Pain and swelling at magnet site
|
7.1%
1/14 • Number of events 1 • 12 months
|
|
Product Issues
Pain and swelling at the tip of mastoid
|
7.1%
1/14 • Number of events 1 • 12 months
|
|
Product Issues
Magnetitis and discomfort
|
7.1%
1/14 • Number of events 1 • 12 months
|
|
Product Issues
Right swelling at the tip of the mastoid
|
7.1%
1/14 • Number of events 1 • 12 months
|
|
Injury, poisoning and procedural complications
Left-side facial swelling at post-operation
|
7.1%
1/14 • Number of events 1 • 12 months
|
|
Product Issues
Redness at magnet site
|
7.1%
1/14 • Number of events 1 • 12 months
|
|
Injury, poisoning and procedural complications
Some discomfort following surgery
|
7.1%
1/14 • Number of events 1 • 12 months
|
|
Injury, poisoning and procedural complications
Pain and swelling at surgical site
|
7.1%
1/14 • Number of events 1 • 12 months
|
|
Injury, poisoning and procedural complications
Post-operation nausea and vomitting
|
7.1%
1/14 • Number of events 1 • 12 months
|
|
Injury, poisoning and procedural complications
Swelling post surgery
|
7.1%
1/14 • Number of events 1 • 12 months
|
|
Injury, poisoning and procedural complications
Sensitivity post surgery
|
7.1%
1/14 • Number of events 1 • 12 months
|
|
Injury, poisoning and procedural complications
Discomfort post-surgery
|
7.1%
1/14 • Number of events 1 • 12 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Principal Investigators and Team at Sick Kids preparing a publication for peer review with sponsor coordination.
- Publication restrictions are in place
Restriction type: OTHER