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COMPLETED NA

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

NCT00748540 · View on ClinicalTrials.gov ↗

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

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

5 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00748540

The ClinicalTrials.gov registry entry for NCT00748540 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Med-El Corporation, which has 5 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00748540 reports 11 study locations spanning 9 distinct geographic areas — top geographies include California, Florida, Illinois. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00748540?

The interventions under investigation include: Vibrant Soundbridge (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00748540?

This trial is sponsored by Med-El Corporation, which has 5 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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