NCT00977314

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Sonitus Medical Inc · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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 description

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.

Conditions

• Unilateral Hearing Loss

Interventions

Type	Name	Description
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
DEVICE	SoundBite Hearing System

Timeline

• Start date: 2009-09-01
• Primary completion: 2010-02-01
• Completion: 2010-02-01
• First posted: 2009-09-15
• Last updated: 2014-10-17
• Results posted: 2014-10-17

Locations

2 sites across 1 country: United States