Bone Conduction Auditory Performance Via the Tooth for Single-Sided Deafness
|ClinicalTrials.gov Identifier: NCT00977314|
Recruitment Status : Completed
First Posted : September 15, 2009
Results First Posted : October 17, 2014
Last Update Posted : October 17, 2014
|Condition or disease||Intervention/treatment||Phase|
|Unilateral Hearing Loss||Device: The Sonitus Bone Conduction Hearing System Device: SoundBite Device: SoundBite Hearing System||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||35 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Bone Conduction Auditory Performance Via the Tooth for Single-Sided Deafness|
|Study Start Date :||September 2009|
|Actual Primary Completion Date :||February 2010|
|Actual Study Completion Date :||February 2010|
Experimental: SoundBite Hearing System
The objective of this study was to assess the safety and effectiveness of the SoundBite hearing system by Sonitus Medical and to support its intended use for the treatment of unilateral hearing loss. The SoundBite hearing system is a Bone Conduction Device (BCD) and is occasionally referred to as such in the protocol and within this report.
Device: The Sonitus Bone Conduction Hearing System
Comparison of HINT scores (Speech front with noise at better ear) at 30 days tested with the device in place verses with the device removed.
Device: SoundBite Hearing System
- Incidence of Device- and Procedure-related Adverse Events at 30 Days [ Time Frame: 30 days ]
The safety parameters for the trial were monitored throughout the Evaluation Phase (30 days). The safety checks included:
Comprehensive Medical evaluation at Enrollment and at Termination Comprehensive Dental evaluation at Enrollment and at Termination, with interim dental checks at each visit in between, if needed Comprehensive Audiological evaluation at Enrollment and Termination.
- Efficacy: Ability to Understand Speech in Noise [ Time Frame: Day 1, Day 30 ]The primary efficacy outcome was a measure of the ability to understand speech in noise while wearing the device compared with not wearing the device. The Hearing in Noise Test (HINT) was utilized for this measure as it is the most widely used test for SSD devices. An improvement in HINT score is indicated as a negative (-) dB value change. A more negative (-dB) value indicates an improvement in understanding speech in noise. An improvement in a HINT score of -1 dB is equivalent to a 10% improvement in the ability to understand speech in noise and is likely of clinical benefit. The scores are calculated as HINT Advantage (aided compared with unaided) which depict the differences of using a device as compared to not wearing a device.
- Measure of Benefit of SoundBite Using Abbreviated Profile of Hearing Aid Benefit (APHAB). [ Time Frame: 30 days ]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. A software program is utilized to score the APHAB and results are compared a different time points. The APHAB is well characterized and broadly used as a quantifiable measurement of device benefit. 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): NCT00977314
|United States, California|
|Hearing Resource Center|
|Redwood City, California, United States, 94063|
|Camino Ear Nose and Throat|
|San Jose, California, United States, 95123|
|Principal Investigator:||Michael Murray, MD|