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.
Study Type
OBSERVATIONAL
Enrollment
150
Arizona Ear Center
Phoenix, Arizona, United States
California Hearing and Balance Center
La Jolla, California, United States
Shohet Ear Associates Medical Group
Aided Threshold Testing
Aided threshold testing of the impaired ear at 12 months as compared with baseline using the SoundBite Hearing System
Time frame: 12 months
Abbreviated Profile of Hearing Aid Benefit (APHAB) Questionnaire
Change in Abbreviated Profile of Hearing Aid Benefit (APHAB, Form A - New Format, Hearing Aid Research Lab, University of Memphis, 1994) score at 12 months compared to baseline
Time frame: 12 months
Single Sided Deafness Questionnaire
This questionnaire assesses qualitative outcomes.
Time frame: 12 months
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Newport Beach, California, United States
Camino Ear, Nose and Throat Clinic
San Jose, California, United States
Hearing Resource Center
San Mateo, California, United States
The George Washington University- Department of Otolaryngology
Washington D.C., District of Columbia, United States
University of Miami, Miller School of Medicine
Miami, Florida, United States
Physicians Choice Hearing and Dizziness Center
Tampa, Florida, United States
Henry Ford Health System- Department of Otolayrngology and Audiology
Detroit, Michigan, United States
New York Otology
New York, New York, United States
...and 3 more locations