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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 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.

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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.

Conditions Studied

Hearing Loss

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

FieldValue
Enrollment Target 50 participants
Start Date 2007-12
Est. Completion 2014-03
Phase NA

Sponsor

Med-El Corporation

14 total trials

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What the Registry Record Tells You About NCT00748540

The ClinicalTrials.gov registry entry for NCT00748540 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 6,120-participant average among 58 other Hearing Loss trials with a reported enrollment target (99% lower). The listed sponsor is Med-El Corporation, which has 14 total studies on file at ClinicalTrials.gov.

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 reports 11 study locations spanning 9 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.