Trial Outcomes & Findings for Osia 2 Pediatric Expansion Study (NCT NCT05000931)
NCT ID: NCT05000931
Last Updated: 2024-12-11
Results Overview
Adverse events were reported from the time of implantation through 6-months.
COMPLETED
NA
50 participants
From implantation to 6 months post-surgery
2024-12-11
Participant Flow
Participants were recruited at seven US-based sites. The first participant was enrolled on 26 January 2022 and the last participant completed the study on 14 March 2024.
Participant milestones
| Measure |
Implanted With the Osia 2 System
Osia 2 System in a pediatric population aged 5 - 11 years.
|
|---|---|
|
Overall Study
STARTED
|
50
|
|
Overall Study
COMPLETED
|
49
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Implanted With the Osia 2 System
Osia 2 System in a pediatric population aged 5 - 11 years.
|
|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
Baseline Characteristics
Osia 2 Pediatric Expansion Study
Baseline characteristics by cohort
| Measure |
Implanted With the Osia 2 System
n=50 Participants
Osia 2 System in a pediatric population aged 5 - 11 years.
|
|---|---|
|
Age, Continuous
|
7 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
19 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
30 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
2 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Asian
|
4 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
2 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
White
|
33 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Other
|
6 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Unknown or Not Reported
|
3 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
50 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: From implantation to 6 months post-surgeryPopulation: 1 participant withdrew after the 4-week follow-up visit.
Adverse events were reported from the time of implantation through 6-months.
Outcome measures
| Measure |
Implanted With the Osia 2 System
n=49 Participants
Osia 2 System in a pediatric population aged 5 - 11 years.
|
|---|---|
|
Number of Adverse Events Quantified by Type and Severity Between Implantation and 6-months Post-surgery.
Mild Events
|
73 Number of events
|
|
Number of Adverse Events Quantified by Type and Severity Between Implantation and 6-months Post-surgery.
Adverse Device Effects
|
32 Number of events
|
|
Number of Adverse Events Quantified by Type and Severity Between Implantation and 6-months Post-surgery.
Serious Adverse Events
|
8 Number of events
|
|
Number of Adverse Events Quantified by Type and Severity Between Implantation and 6-months Post-surgery.
Serious Adverse Device Effects
|
3 Number of events
|
|
Number of Adverse Events Quantified by Type and Severity Between Implantation and 6-months Post-surgery.
Unanticipated Adverse Device Effects
|
0 Number of events
|
|
Number of Adverse Events Quantified by Type and Severity Between Implantation and 6-months Post-surgery.
Moderate Events
|
10 Number of events
|
|
Number of Adverse Events Quantified by Type and Severity Between Implantation and 6-months Post-surgery.
Sever Events
|
4 Number of events
|
SECONDARY outcome
Timeframe: Baseline before surgery, 6 months post-surgeryPopulation: One participant withdrew prior to the 6-month visit. One participant was unable to complete the questionnaire during the 6-month visit.
Measuring change of speech, spatial, quality and conversational uses of hearing (27 items in 4 sections). Each item is scored by the parent on a scale of 0 to 10 where 0 corresponds to "not at all" and 10 to "perfectly" when rating their child's ability to hear and listen in everyday situations. The score of a participant is determined as the mean of the scores for the 4 different sections. Higher scores indicate less hearing disability.
Outcome measures
| Measure |
Implanted With the Osia 2 System
n=48 Participants
Osia 2 System in a pediatric population aged 5 - 11 years.
|
|---|---|
|
Change From Baseline to 6-months Post-surgery in SSQ (Speech, Spatial and Qualities of Hearing Scale) Parent Questionnaire
|
1.63 score on a scale
Standard Deviation 1.53
|
SECONDARY outcome
Timeframe: Baseline before surgery, 4 weeks post-surgeryPopulation: 3 participants were unable to be included due to improper testing pre- and post-operatively.
The Pure Tone Average (PTA) is calculated as an average of the bone conduction thresholds collected at 500, 1000, 2000, and 4000 Hz. This measure was collected unaided both pre- and post-operatively to ensure no shift in bone conduction hearing as a result of the surgery.
Outcome measures
| Measure |
Implanted With the Osia 2 System
n=47 Participants
Osia 2 System in a pediatric population aged 5 - 11 years.
|
|---|---|
|
Change From Baseline to 4-weeks Post-surgery in Unaided Bone Conduction Thresholds.
|
0.1 dB HL (decibel Hearing Level)
Standard Deviation 5.1
|
SECONDARY outcome
Timeframe: Baseline before surgery, 6 months post-surgeryPopulation: One participant withdrew prior to the 6-month visit. One participant was unable to complete the CNC word test during the baseline visit.
The CNC Words test consists of 10 recorded lists of 50 monosyllabic words. For this study, one list is administered per test condition at 60 dBA in sound field and scored as the number of phonemes and words correct, which will be expressed as a percentage correct when analyzed. The CNC word test has a score range of 0-100% with higher values indicating better scores.
Outcome measures
| Measure |
Implanted With the Osia 2 System
n=48 Participants
Osia 2 System in a pediatric population aged 5 - 11 years.
|
|---|---|
|
Change in Word Recognition Using Consonant Nucleus Consonant (CNC) Words Presented in Quiet From Unaided Baseline to Aided 6-months Post-surgery.
|
63.7 percentage of correct words
Standard Deviation 24.6
|
SECONDARY outcome
Timeframe: Baseline before surgery, 6 months post-surgeryPopulation: One participant withdrew prior to the 6-month visit. One participant was unable to complete the BKB-SIN testing during the baseline visit.
The Bamford-Kowal-Bench Sentence in Noise test (BKB-SIN) consists of 36 paired lists. List of sentences are presented at 65 dBA with the level of noise varied stepwise at fixed signal to noise ratio to obtain a Speech Reception Threshold (SRT) where participants are able to repeat key words 50% of the time. Score range is not specified as metric is adaptive; lower scores indicate better performance.
Outcome measures
| Measure |
Implanted With the Osia 2 System
n=48 Participants
Osia 2 System in a pediatric population aged 5 - 11 years.
|
|---|---|
|
Change in Sentence Recognition in Noise Using the Bramford Kowal Bench Speech-In-Noise (BKB-SIN) From Unaided Baseline to Aided 6-months Post-surgery.
|
10.1 db SNR (decibel Speech to Noise Ratio)
Standard Deviation 7.8
|
Adverse Events
Implanted With the Osia 2 System
Serious adverse events
| Measure |
Implanted With the Osia 2 System
n=49 participants at risk
Osia 2 System in a pediatric population aged 5 - 11 years.
|
|---|---|
|
Ear and labyrinth disorders
Ear Infection
|
2.0%
1/49 • 12 months
Adverse events were reported from the time of implantation through 12-months post-op.
|
|
General disorders
Wound dehiscence
|
2.0%
1/49 • 12 months
Adverse events were reported from the time of implantation through 12-months post-op.
|
|
Injury, poisoning and procedural complications
Tissue Breakdown
|
2.0%
1/49 • 12 months
Adverse events were reported from the time of implantation through 12-months post-op.
|
|
Congenital, familial and genetic disorders
Congenital Defect/Deformity
|
2.0%
1/49 • 12 months
Adverse events were reported from the time of implantation through 12-months post-op.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
2.0%
1/49 • 12 months
Adverse events were reported from the time of implantation through 12-months post-op.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
2.0%
1/49 • 12 months
Adverse events were reported from the time of implantation through 12-months post-op.
|
|
Skin and subcutaneous tissue disorders
Skin Inflammation/Irritation
|
2.0%
1/49 • 12 months
Adverse events were reported from the time of implantation through 12-months post-op.
|
|
Vascular disorders
Hematoma
|
2.0%
1/49 • 12 months
Adverse events were reported from the time of implantation through 12-months post-op.
|
Other adverse events
| Measure |
Implanted With the Osia 2 System
n=49 participants at risk
Osia 2 System in a pediatric population aged 5 - 11 years.
|
|---|---|
|
Injury, poisoning and procedural complications
Implant Pain
|
12.2%
6/49 • 12 months
Adverse events were reported from the time of implantation through 12-months post-op.
|
|
Ear and labyrinth disorders
Ear Infection
|
12.2%
6/49 • 12 months
Adverse events were reported from the time of implantation through 12-months post-op.
|
|
Infections and infestations
Viral Infection
|
12.2%
6/49 • 12 months
Adverse events were reported from the time of implantation through 12-months post-op.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngitis
|
10.2%
5/49 • 12 months
Adverse events were reported from the time of implantation through 12-months post-op.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Tract Infection
|
16.3%
8/49 • 12 months
Adverse events were reported from the time of implantation through 12-months post-op.
|
|
Nervous system disorders
Headache
|
10.2%
5/49 • 12 months
Adverse events were reported from the time of implantation through 12-months post-op.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor has first rights to publish the multi-site data. During the study and the 12-months following the conclusion of the study, the PI may not publish or present on its own data obtained under the study. The PI may publish on their own study data (without permission from the Sponsor) or the consolidated data (with written consent from the Sponsor) by providing notice and a copy of the publication to the Sponsor at least 30 days prior to submission and allowing the Sponsor 30 days to review.
- Publication restrictions are in place
Restriction type: OTHER