Clinical Trial: Bone Conduction Auditory Performance Via the Tooth for Single-Sided Deafness

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Bone Conduction Auditory Performance Via the Tooth for Single-Sided Deafness

Brief Summary: The purpose of this study is to determine the safety and efficacy of using bone conduction via the teeth to treat Single-Sided Deafness (SSD).

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:

  • 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.


Original Primary Outcome:

Current Secondary Outcome: 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)


Original Secondary Outcome:

Information By: Sonitus Medical Inc

Dates:
Date Received: September 14, 2009
Date Started: September 2009
Date Completion:
Last Updated: October 10, 2014
Last Verified: October 2014