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

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

• Hearing Loss

Interventions

DEVICE

Vibrant Soundbridge

Mixed and conductive hearing loss using round window stimulation

Sponsors & Collaborators

• Med-El Corporation

  lead INDUSTRY

Principal Investigators

• David Foyt, MD · Capital Region Ear Institute

• Jose Fayad, MD · House Ear Institute

• Jennifer Maw, MD · Jennifer Maw, MD

• Robert Cullen, MD · Midwest Ear Institute

• Douglas Chen, MD · Pittsburgh Ear Associates

• Jack Wazen, MD · Silverstein Institute

• Hinrich Staecker, MD, PhD · University of Kansas Medical Center

• Fred Telischi, MD · University of Miami

• Craig Buchman, MD · University of North Carolina Hospital

• Peter Roland, MD · University of Texas Southwestern Medical Center

• Richard Wiet, MD · Ear Institute of Chicago

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2007-12-31

Primary Completion

2014-03-31

Completion

2014-03-31

Countries

• United States

Study Locations