NCT01108406

Long Term Safety of the Sonitus SoundBite System

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Sonitus Medical Inc · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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 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

• Hearing Loss
• Unilateral Hearing Loss
• Total Unilateral Deafness

Interventions

Type	Name	Description
DEVICE	Sonitus SoundBite System	Non Surgical Bone Conduction Device
DEVICE	SoundBite Hearing System

Timeline

• Start date: 2010-04-01
• Primary completion: 2010-12-01
• Completion: 2010-12-01
• First posted: 2010-04-22
• Last updated: 2014-10-20
• Results posted: 2014-10-10

Locations

1 site across 1 country: United States