NCT01807559

SoundBite Hearing System 24 Month Multi Site Patient Use Study

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 75 (estimated)
• Sponsor: Sonitus Medical Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of this multi-site observational study is to further assess the long-term patient use of the Sonitus SoundBite Hearing System. Information can be gained by assessing benefit for the subjects that were enrolled in the SoundBite Hearing System Long Term Multi Site Study (Protocol CLN006) for an additional 12 months.

Conditions

• Single Sided Deafness
• Conductive Hearing Loss

Interventions

Type	Name	Description
DEVICE	SoundBite Hearing System	The Sonitus Medical SoundBite Hearing System prosthetic device is a bone conduction device that has been FDA cleared for the treatment of single-sided deafness (SSD) and conductive hearing loss (CHL). The Sonitus Medical SoundBite Hearing System consists of an In-the-Mouth (ITM) component, an external microphone component worn behind the ear (BTE), a calibration interface cable and PC-controlled software for subject calibration. A charger is also provided to charge the ITM and the BTE. The objective of this study is multi-site observational study is to asses the long-term patient use of the Sonitus Medical SoundBite Hearing System.

Timeline

• Start date: 2013-03-01
• Primary completion: 2014-08-01
• Completion: 2014-08-01
• First posted: 2013-03-08
• Last updated: 2013-05-03

Locations

7 sites across 1 country: United States