Long Term Safety of the Sonitus SoundBite System
The objective of this study is to assess the long-term safety and quality of life improvement of the Sonitus SoundBite Hearing System.
Unilateral Hearing Loss
Total Unilateral Deafness
Device: Sonitus SoundBite System
Device: SoundBite Hearing System
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Long Term Safety of the Sonitus SoundBite System|
- Long Term Safety [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: No ]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).
|Study Start Date:||April 2010|
|Study Completion Date:||December 2010|
|Primary Completion Date:||December 2010 (Final data collection date for primary outcome measure)|
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
The Sonitus Bone Conduction Device (BCD) is a bone conduction device for single-sided deafness (SSD). The Sonitus BCD consists of an Oral Appliance (OA), an external microphone component, worn behind the ear (BTE), a calibration interface cable and a PC-controlled calibration software for subject calibration. The Sonitus BCD picks up sounds from a microphone located within the ear canal of the deaf ear, capitalizing on the acoustics of the natural pinna and ear canal. The signal picked up by the microphone is then transmitted wirelessly to a removeable bone conduction oral appliance located on the upper molars. The oral appliance receives the acoustic signal from the BTE and applies an equivalent vibratory signal to the teeth that reaches the skull via bone conduction and routed transcranially to the contralateral cochlea.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01108406
|United States, California|
|Camino Ear Nose and Throat|
|San Jose, California, United States, 95123|
|Principal Investigator:||Michael Murray, MD||Camino ENT|