Clinical Trial: Evaluation of Benefit for Treatment of Single Sided Deafness (SSD) Between Two Bone Conduction Prosthetic Devices; Osseointegrated Implant Versus Maxilla Anchored Removable Oral Appliance ("SoundBite")

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

Official Title: Evaluation of Benefit for Treatment of Single Sided Deafness (SSD) Between Two Bone Conduction Prosthetic Devices; Osseointegrated Implant Versus Maxilla Anchored Removabl

Brief Summary: The primary objective of this study is to compare the SoundBite™ Hearing System to surgically implanted BCD systems.

Detailed Summary:
Sponsor: Sonitus Medical Inc

Current Primary Outcome: APHAB Questionnaire [ Time Frame: 30 days ]

Comparison of the SoundBite™ System and surgically implanted bone conduction devices


Original Primary Outcome: Same as current

Current Secondary Outcome: Single Sided Deafness Questionnaire [ Time Frame: 30 days ]

Comparison of the SoundBite™ System and surgically implanted BCD systems.


Original Secondary Outcome: Same as current

Information By: Sonitus Medical Inc

Dates:
Date Received: August 28, 2013
Date Started: September 2013
Date Completion: February 2014
Last Updated: October 25, 2013
Last Verified: October 2013