Long Term Safety of the Sonitus SoundBite System
|ClinicalTrials.gov Identifier: NCT01108406|
Recruitment Status : Completed
First Posted : April 22, 2010
Results First Posted : October 10, 2014
Last Update Posted : October 20, 2014
|Condition or disease||Intervention/treatment||Phase|
|Hearing Loss Unilateral Hearing Loss Total Unilateral Deafness||Device: Sonitus SoundBite System Device: SoundBite Hearing System||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||22 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Long Term Safety of the Sonitus SoundBite System|
|Study Start Date :||April 2010|
|Actual Primary Completion Date :||December 2010|
|Actual Study Completion Date :||December 2010|
Experimental: SoundBite Hearing System
The objective of this study was to assess the long-term safety and quality of life impact of the SoundBite™ Hearing System.
Safety was measured in terms of dental, audiological and medical adverse events related to device or procedure.
Quality of Life was measured in terms of changes in Abbreviated Profile of Hearing Aid Benefit (APHAB) and as reported in a quality of life survey (SSD Questionnaire).
The duration of the study was 6 months with measures taken at Day 1, 3 months and 6 months.
Device: Sonitus SoundBite System
Non Surgical Bone Conduction Device
Other Name: Sonitus Bone Conduction DeviceDevice: SoundBite Hearing System
- Long Term Safety [ Time Frame: 6 months ]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.
- Measurement of Device Benefit With the Abbreviated Profile of Hearing Aid Benefit (APHAB) [ Time Frame: 3 months and 6 months ]The 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).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01108406
|United States, California|
|Camino Ear Nose and Throat|
|San Jose, California, United States, 95123|
|Principal Investigator:||Michael Murray, MD||Camino ENT|