CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 50 enrolled
Drug / intervention
Vibrant Soundbridgedevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00748540
NCT00748540N/ACompleted
CompareCT.gov

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

Med-El Corporation·interventional·Posted Sep 8, 2008·Updated Sep 25, 2019

In Brief

A clinical study evaluating Vibrant Soundbridge for Hearing Loss. Completed, enrolled 50 participants across 11 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHearing Loss
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 8, 2008
Enrollment StartDec 1, 2007
Primary CompletionMar 1, 2014
TodayJul 2, 2026
Enrollment to primary: 6.3 yearsPosted 17.8 years ago

Interventions

Vibrant Soundbridgedevice

Mixed and conductive hearing loss using round window stimulation