Clinical Trial: SoundBite Hearing System Long Term Multi Site Patient Use Study

Study Status: Completed
Recruit Status: Unknown status
Study Type: Observational

Official Title: SoundBite Hearing System Long Term Multi Site Patient Use Study

Brief Summary: 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).

Detailed Summary: 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.
Sponsor: Sonitus Medical Inc

Current Primary Outcome:

  • Aided Threshold Testing [ Time Frame: 12 months ]
    Aided threshold testing of the impaired ear at 12 months as compared with baseline using the SoundBite Hearing System
  • Abbreviated Profile of Hearing Aid Benefit (APHAB) Questionnaire [ Time Frame: 12 months ]
    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
  • Single Sided Deafness Questionnaire [ Time Frame: 12 months ]
    This questionnaire assesses qualitative outcomes.


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Sonitus Medical Inc

Dates:
Date Received: September 28, 2011
Date Started: September 2011
Date Completion: September 2013
Last Updated: August 1, 2013
Last Verified: August 2013