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

September 10, 2019 updated by: Med-El Corporation

Clinical Trial of the Vibrant Soundbridge as a Treatment for Conductive and Mixed Hearing Losses, Using Direct Round Window Cochlear Stimulation.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90057
        • House Ear Institute
      • San Jose, California, United States, 95124-3910
        • Jennifer Maw, MD
    • Florida
      • Miami, Florida, United States, 33136
        • University of Miami Ear Institute
      • Sarasota, Florida, United States, 34239
        • Silverstein Institute
    • Illinois
      • Hinsdale, Illinois, United States, 60521
        • Ear Institute of Chicago
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Medical Center
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • Midwest Ear Institute
    • New York
      • Slingerlands, New York, United States, 12159
        • Capitol Region Ear Institute
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27514
        • University of North Carolina Hospital
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15212
        • Pittsburgh Ear Associates
    • Texas
      • Dallas, Texas, United States, 75390
        • University of Texas Southwestern Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adults, 18 years of age or older at time of implantation
  • English as the primary language
  • Appropriate motivation and expectation levels
  • Geographically and physically able to return to the investigational center for scheduled evaluations and follow-up appointments.
  • At least a 28-day unsuccessful hearing aid trial (within the past 24 months prior to enrolment).
  • Persons who after being informed that a different hearing aid than the one they currently have may provide improved hearing, still request an implant.
  • Ability to undergo general anesthesia
  • Audiological tests suggest either a conductive or mixed hearing loss. The non-implanted ear may fall outside these criteria; however, threshold levels may not be worse than severe sloping to profound.
  • Conductive Hearing Loss
  • Pure-tone bone-conduction threshold levels in the ear to be implanted shall fall at or within the levels stated below. There should be an air-bone gap of 15 dB HL or more at three or more of the frequencies 500, 1000, 1500, 2000, 3000, and 4000 Hz. Pure-tone air-conduction levels should indicate the presence of at least a moderate hearing loss of at least 41 dB HL. Air conduction levels are not limited on the upper end.
  • Upper Limits of Bone Conduction Thresholds for Conductive Hearing Loss Frequency (kHz) 0.5 1.0 1.5 2.0 3.0 4.0 Bone Conduction upper limit (dBHL) <25 <25 <25 <25 <25 <25
  • Mixed Hearing Loss
  • Pure-tone bone conduction threshold levels in the ear to be implanted shall fall at or within the levels stated below. There should be an air-bone gap of 15 dB HL or more at three or more of the frequencies 500, 1000, 1500, 2000, 3000, and 4000 Hz. Bone conduction thresholds at least three of the frequencies should be 26 dB or greater. Pure-tone air-conduction thresholds should be, on average, at least moderately impaired of 41 dB or greater. Air-conduction levels are not limited on the upper end.
  • Lower and Upper Limits of Bone Conduction Thresholds for Mixed Hearing Loss Frequency (kHz) 0.5 1.0 1.5 2.0 3.0 4.0 Bone Conduction lower limit (dBHL) 0 0 0 0 0 0 Bone Conduction upper limit (dBHL) 45 50 55 65 65 65
  • Good potential for aided speech recognition as indicated by a pre-operative monosyllabic word score of > 30% in the ear to be implanted as measured under headphones at 40 dB SL or at MCL
  • Hearing aid trial with appropriately fitted hearing aids of at least 28 days duration within the past 24 months, unless the subject is unable to wear hearing aids for medical reasons
  • Most recent audiometric data, if available, judged to be of good test-retest reliability.

Exclusion Criteria:

  • Hearing loss of purely sensorineural origin
  • Retrocochlear or central auditory disorders
  • Active middle ear infection
  • Tympanic membrane perforation, ears with previously reconstructed tympanic membranes may be included
  • Bone-conduction thresholds in the ear to be implanted that have demonstrated a recent fluctuation at two or more frequencies of 15 dB in either direction in the last 6 months, as demonstrated by serial audiograms.
  • History of post-adolescent, inner-ear disorders, such as vertigo or labyrinthitis
  • Chronic or non-revisable vestibular or balance disorders
  • Middle ear infections not responsive to medical treatment
  • Skin or scalp conditions that may preclude attachment of the Audio Processor or that may interfere with the use of the Audio Processor
  • Chronic pain in or around the head
  • Current or previous use of an active hearing implant in either ear.
  • Any known physical, psychological, or emotional disorder that may interfere with the completion of scheduled follow-up evaluations
  • Developmental delays or organic brain dysfunction

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Implanted
Implanted with Vibrant Soundbridge
Device: Vibrant Soundbridge
Mixed and conductive hearing loss using round window stimulation
Other Names:
  • VSB
  • VSB RW
  • RW VSB
  • Round Window Stimulation

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Speech Perception in Quiet (Monosyllables) in Patients Implanted With Vibrant Soundbridge
Time Frame: 6 months post initial activation
Percent correct on words in quiet at the preoperative interval compared to 6 month post operative interval.
6 months post initial activation

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Functional Gain Compared to Preoperative Unaided Condition in Patients Implanted With Vibrant Soundbridge.
Time Frame: 6 months post initial activation
Auditory thresholds in the soundfield at the preoperative interval compared to the 6 month postoperative interval.
6 months post initial activation
Speech Perception in Noise (HINT Sentences) in Patients Implanted With Vibrant Soundbridge.
Time Frame: 6 months post initial activation
Signal to Noise Ratio for sentences at the preoperative interval compared to the 6 month interval.
6 months post initial activation
Residual Hearing in Patients Implanted With Vibrant Soundbridge
Time Frame: 10 months post initial activation
Unaided hearing thresholds measured at the 10 month interval compared to the preoperative interval in order to assess any changes
10 months post initial activation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Med-El Corporation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: David Foyt, MD, Capital Region Ear Institute
  • Principal Investigator: Jose Fayad, MD, House Ear Institute
  • Principal Investigator: Jennifer Maw, MD, Jennifer Maw, MD
  • Principal Investigator: Robert Cullen, MD, Midwest Ear Institute
  • Principal Investigator: Douglas Chen, MD, Pittsburgh Ear Associates
  • Principal Investigator: Hinrich Staecker, MD, PhD, University of Kansas Medical Center
  • Principal Investigator: Craig Buchman, MD, University of North Carolina Hospital
  • Principal Investigator: Richard Wiet, MD, Ear Institute of Chicago

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2007

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2014

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 5, 2008

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 5, 2008

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 8, 2008

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 25, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 10, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • G060227

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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