SoundBite Hearing System Long Term Multi Site Patient Use Study

Status:	Archived
Conditions:	Other Indications
Therapuetic Areas:	Other
Healthy:	No
Age Range:	Any
Updated:	7/1/2011
Start Date:	September 2011
End Date:	June 2013
Contact:	Linda Galow, M.S.
Email:	linda@sonitusmedical.com
Phone:	1-866-816-2076

This study is designed to collect data about the SoundBite™ Hearing System to answer
specific questions. The hearing system has been cleared for commercial distribution by the
Food and Drug Administration (FDA). Sonitus hopes to learn from a larger group of users what
features and settings of this device provide the best hearing ability for people diagnosed
with Single Sided Deafness (SSD) or Conductive Hearing Loss (CHL).

The Sonitus SoundBite Hearing System prosthetic device is a bone conduction device that has
been FDA cleared for treatment of single-sided deafness (SSD) and conductive hearing loss
(CHL). The Sonitus 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 calibration software for subject calibration. A charger is also provided to
charge the ITM and the BTE. The objective of this multi-sites observational study is to
assess the long-term patient use of the Sonitus SoundBite Hearing System.

We found this trial at

sites

The George Washington University- Department of Otolaryngology

Washington, District of Columbia 20006

from

Washington,