Clinical Trial: SoundBite Hearing System 24 Month Multi Site Patient Use Study

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

Official Title: SoundBite Hearing System 24 Month Multi Site Patient Use Study

Brief 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.

Detailed Summary:
Sponsor: Sonitus Medical Inc

Current Primary Outcome: Abbreviated Profile of Hearing Aid Benefit (APHAB) Questionnaire [ Time Frame: 24 Months ]

Change in Abbreviated Profile of Hearing Aid Benefit (APHAB, Form A- New Formate, Hearing Aid Research Lab, University of Memphis, 1994) score at 24 months compared to baseline.


Original Primary Outcome: Same as current

Current Secondary Outcome: Aided Threshold Testing [ Time Frame: 24 Months ]

Aided Threshold testing of the impaired ear at 24 months as compared with baseline using the SoundBite Hearing System


Original Secondary Outcome: Same as current

Information By: Sonitus Medical Inc

Dates:
Date Received: March 6, 2013
Date Started: March 2013
Date Completion: August 2014
Last Updated: May 2, 2013
Last Verified: May 2013