Clinical Trial: Long Term Safety of the Sonitus SoundBite System
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Long Term Safety of the Sonitus SoundBite System
Brief Summary: The objective of this study is to assess the long-term safety and quality of life improvement of the Sonitus SoundBite Hearing System.
Detailed Summary: 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.
Sponsor: Sonitus Medical Inc
Current Primary Outcome: Long Term Safety [ Time Frame: 6 months ]
Original Primary Outcome:
Current Secondary Outcome: Measurement of Device Benefit With the Abbreviated Profile of Hearing Aid Benefit (APHAB) [ Time Frame: 3 months and 6 months ]
Original Secondary Outcome:
Information By: Sonitus Medical Inc
Dates:
Date Received: April 15, 2010
Date Started: April 2010
Date Completion:
Last Updated: October 10, 2014
Last Verified: October 2014