Trial Outcomes & Findings for Long Term Safety of the Sonitus SoundBite System (NCT NCT01108406)
NCT ID: NCT01108406
Last Updated: 2014-10-20
Results Overview
The safety outcomes were defined as no changes in medical, auditory, or dental status and no device or procedure related adverse events during the study period. Safety was evaluated by conducting a Comprehensive Medical evaluation at Enrollment and at study termination; Comprehensive Dental evaluation at Enrollment and at 3 and 6 months, with interim dental checks in between if necessary and Comprehensive Audiological evaluation at Enrollment and at 6 months.
COMPLETED
NA
22 participants
6 months
2014-10-20
Participant Flow
Recruitment occurred in April 2010. Subjects were informed about the potential for participation via IRB approved flyers or by indicating interest on consent forms from other studies.
Participant milestones
| Measure |
Sonitus SoundBite System
Long Term Safety was measured in terms of dental, audiological and medical adverse events related to device or procedure.
|
|---|---|
|
Overall Study
STARTED
|
22
|
|
Overall Study
COMPLETED
|
22
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Long Term Safety of the Sonitus SoundBite System
Baseline characteristics by cohort
| Measure |
Long Term Safety
n=22 Participants
Safety was measured in terms of dental, audiological and medical adverse events related to device or procedure.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
21 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=99 Participants
|
|
Age, Continuous
|
44.41 years
STANDARD_DEVIATION 11.54 • n=99 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
22 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 6 monthsThe safety outcomes were defined as no changes in medical, auditory, or dental status and no device or procedure related adverse events during the study period. Safety was evaluated by conducting a Comprehensive Medical evaluation at Enrollment and at study termination; Comprehensive Dental evaluation at Enrollment and at 3 and 6 months, with interim dental checks in between if necessary and Comprehensive Audiological evaluation at Enrollment and at 6 months.
Outcome measures
| Measure |
Number of Participants Experiencing no Adverse Events
n=22 Participants
Safety was measured in terms of dental, audiological and medical adverse events related to device or procedure. Dental measurements included periodontal measurements (bone loss, oral health, bleeding index, calculus, peridontal probing) at baseline compared to 6 months. Audiological included hearing evaluation and aided thresholds baseline compared to 6 months and medical compared medical and ear health baseline compared to 6 months.
|
Global Benefit APHAB Score Aided 6 Months
The Global Benefit APHAB at 6 months endpoint is the change in APHAB scores between the unaided score at the start of the study and the APHAB score after 6 months of therapy.The APHAB Questionnaire produces an overall Global score (GBL). The larger the APHAB benefit score the greater the benefit. A negative APHAB benefit score represents therapy resulting in a worse outcome than no therapy.
|
|---|---|---|
|
Long Term Safety
|
22 participants
|
—
|
SECONDARY outcome
Timeframe: 3 months and 6 monthsThe measure of the benefit of the device was assessed using the Abbreviated Profile of Hearing Aid Benefit (APHAB) , a 24-item self-assessment inventory in which the amount of difficulty in everyday situations is reported with larger numbers indicating more difficulty. Device benefit is calculated by subtracting the score obtained after using a device from the score obtained before using the device. Software is used to score the APHAB and results are compared from the different timepoints. The APHAB is well characterized and broadly used as a quantifiable measurement. The APHAB benefit scores can range from -99 (treatment worse than no treatment) to +99 (treatment better than no treatment).
Outcome measures
| Measure |
Number of Participants Experiencing no Adverse Events
n=22 Participants
Safety was measured in terms of dental, audiological and medical adverse events related to device or procedure. Dental measurements included periodontal measurements (bone loss, oral health, bleeding index, calculus, peridontal probing) at baseline compared to 6 months. Audiological included hearing evaluation and aided thresholds baseline compared to 6 months and medical compared medical and ear health baseline compared to 6 months.
|
Global Benefit APHAB Score Aided 6 Months
n=22 Participants
The Global Benefit APHAB at 6 months endpoint is the change in APHAB scores between the unaided score at the start of the study and the APHAB score after 6 months of therapy.The APHAB Questionnaire produces an overall Global score (GBL). The larger the APHAB benefit score the greater the benefit. A negative APHAB benefit score represents therapy resulting in a worse outcome than no therapy.
|
|---|---|---|
|
Measurement of Device Benefit With the Abbreviated Profile of Hearing Aid Benefit (APHAB)
|
21.3 Global Benefit Score
Standard Deviation 16.9
|
23.1 Global Benefit Score
Standard Deviation 16.0
|
Adverse Events
Long Term Safety
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60