Clinical trialNCT00748540CompletedInterventional

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

SponsorMed-El CorporationEnrollment50Hearing Loss

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

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Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Craig Buchman, MD
University of North Carolina Hospital
Principal Investigator
clinicaltrials.gov ↗
David Foyt, MD
Capital Region Ear Institute
Principal Investigator
clinicaltrials.gov ↗
Douglas Chen, MD
Pittsburgh Ear Associates
Principal Investigator
clinicaltrials.gov ↗
Fred Telischi, MD
University of Miami
Principal Investigator
clinicaltrials.gov ↗
Hinrich Staecker, MD, PhD
University of Kansas Medical Center
Principal Investigator
clinicaltrials.gov ↗
Jack Wazen, MD
Silverstein Institute
Principal Investigator
clinicaltrials.gov ↗
Jennifer Maw, MD
Jennifer Maw, MD
Principal Investigator
clinicaltrials.gov ↗
Jose Fayad, MD
House Ear Institute
Principal Investigator
clinicaltrials.gov ↗
Peter Roland, MD
University of Texas Southwestern Medical Center
Principal Investigator
clinicaltrials.gov ↗
Richard Wiet, MD
Ear Institute of Chicago
Principal Investigator
clinicaltrials.gov ↗
Robert Cullen, MD
Midwest Ear Institute
Principal Investigator
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

11 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

House Ear Institute
Los Angeles, California, United States
Jennifer Maw, Md
San Jose, California, United States
University of Miami Ear Institute
Miami, Florida, United States
Silverstein Institute
Sarasota, Florida, United States
Ear Institute of Chicago
Hinsdale, Illinois, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
Midwest Ear Institute
Kansas City, Missouri, United States
Capitol Region Ear Institute
Slingerlands, New York, United States
University of North Carolina Hospital
Chapel Hill, North Carolina, United States
Pittsburgh Ear Associates
Pittsburgh, Pennsylvania, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

No drug or biological interventions are in our data for this study. It may test a procedure, device or behavioral intervention, or the intervention list isn't in our current snapshot. See the registry record ↗. Why? →

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 31 Dec 2007
Primary completion: 31 Mar 2014
Completion: 31 Mar 2014
Last update posted: 25 Sept 2019
Registered enrollment: 50
Registry id: NCT00748540

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.