Trials / Completed
CompletedNCT00748540
Safety and Efficacy of the Vibrant Soundbridge (VSB) for Mixed and Conductive Hearing Losses
Clinical Trial of the Vibrant Soundbridge as a Treatment for Conductive and Mixed Hearing Losses, Using Direct Round Window Cochlear Stimulation.
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 50 (actual)
- Sponsor
- Med-El Corporation · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Vibrant Soundbridge | Mixed and conductive hearing loss using round window stimulation |
Timeline
- Start date
- 2007-12-01
- Primary completion
- 2014-03-01
- Completion
- 2014-03-01
- First posted
- 2008-09-08
- Last updated
- 2019-09-25
- Results posted
- 2018-07-31
Locations
11 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00748540. Inclusion in this directory is not an endorsement.