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NCT00748540 · ClinicalTrials.gov registry record · NA
Safety and Efficacy of the Vibrant Soundbridge (VSB) for Mixed and Conductive Hearing Losses
A NA study of Hearing Loss, sponsored by Med-El Corporation.
- Completed
- Registry status
- NA
- Development phase
- 50
- Enrollment target
- 11
- Study locations
NCT00748540: Completed NA study of Hearing Loss, sponsored by Med-El Corporation.
NCT00748540 is a NA study of Hearing Loss that has completed, run by Med-El Corporation. The registered enrollment target is 50 participants, below the 6,120-participant average among 58 other Hearing Loss trials with a reported enrollment target (99% lower). The trial reports 11 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00748540, a NA study of Hearing Loss, has completed, sponsored by Med-El Corporation.
- COMPLETED
- Registry status
- NA
- Development phase
- 50 participants
- Enrollment target
- 11
- Study locations
Study 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.
Primary Outcome
Percent correct on words in quiet at the preoperative interval compared to 6 month post operative interval.
Conditions Studied
Interventions
- DEVICE Vibrant Soundbridge
Study Locations (11)
California
- House Ear Institute - Los Angeles
- Jennifer Maw, MD - San Jose
Florida
- University of Miami Ear Institute - Miami
- Silverstein Institute - Sarasota
Illinois
- Ear Institute of Chicago - Hinsdale
Kansas
- University of Kansas Medical Center - Kansas City
Missouri
- Midwest Ear Institute - Kansas City
New York
- Capitol Region Ear Institute - Slingerlands
North Carolina
- University of North Carolina Hospital - Chapel Hill
Pennsylvania
- Pittsburgh Ear Associates - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2007-12 |
| Est. Completion | 2014-03 |
| Phase | NA |
What the finished NCT00748540 record still lists
NCT00748540 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 6,120-participant average among 58 other Hearing Loss trials with a reported enrollment target (99% lower).
The record links to 1 condition, with Hearing Loss appearing as the primary indexed condition, and to 1 intervention - of which Vibrant Soundbridge is the first listed.
NCT00748540 lists 11 locations in 9 states (California, Florida, Illinois).
Frequently Asked Questions
What is clinical trial NCT00748540 about?
NCT00748540 is a clinical study titled "Safety and Efficacy of the Vibrant Soundbridge (VSB) for Mixed and Conductive Hearing Losses". 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 cha...
What is the current status of trial NCT00748540?
This trial is currently completed. It is a NA study. The enrollment target is 50 participants. The study started on 2007-12. Estimated completion is 2014-03.
What conditions does trial NCT00748540 study?
This clinical trial studies the following conditions: Hearing Loss.
What interventions are being tested in trial NCT00748540?
The interventions under investigation include: Vibrant Soundbridge (DEVICE).
Who is sponsoring clinical trial NCT00748540?
This trial is sponsored by Med-El Corporation, which has 14 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00748540 being conducted?
This trial has 11 study locations across California, Florida, Illinois, Kansas, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Hearing Loss
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00748540's enrollment target sits among peer trials
50 38th of 58 higher than 19 of 58 other Hearing Loss trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hearing Loss trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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