Clinical Trial: Safety and Efficacy of the Vibrant Soundbridge (VSB) for Mixed and Conductive Hearing Losses

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Clinical Trial of the Vibrant Soundbridge as a Treatment for Conductive and Mixed Hearing Losses, Using Direct Round Window Cochlear Stimulation.

Brief Summary: The purpose of this investigation is to collect feasibility data to assess the safety and efficacy of the Vibrant Soundbridge (VSB), a medical device designed to provide benefit in aided hearing thresholds, speech perception and sound quality to certain individuals with hearing loss with minimal changes in residual hearing. The VSB is currently indicated for adults with moderate-to-severe sensorineural hearing loss. Under the present investigation, adults with conductive and mixed hearing losses who are not successful users of traditional amplification will be assessed.

Detailed Summary:
Sponsor: Med-El Corporation

Current Primary Outcome: The use of the VSB provides subjects with significant benefit in speech perception in quiet (monosyllables) when compared with the unaided preoperative condition. [ Time Frame: 6 months post initial activation ]

Original Primary Outcome:

Current Secondary Outcome:

  • The use of the VSB provides subjects with significant measurable improvement in functional gain when compared to the preoperative unaided condition. [ Time Frame: 6 months post initial activation ]
  • The use of the VSB provides subjects with significant benefit in speech perception in noise (HINT sentences) when compared with the unaided preoperative condition. [ Time Frame: 6 months post initial activation ]
  • Surgical implantation of the VSB does not result in a significant decrease in residual hearing when compared to the preoperative unaided condition. [ Time Frame: 10 months post initial activation ]


Original Secondary Outcome:

Information By: Med-El Corporation

Dates:
Date Received: September 5, 2008
Date Started: December 2007
Date Completion:
Last Updated: March 9, 2016
Last Verified: March 2016