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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Med-El Corporation
ClinicalTrials.gov Identifier:
NCT00748540
First received: September 5, 2008
Last updated: March 9, 2016
Last verified: March 2016
  Purpose
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.

Condition Intervention
Hearing Loss
Device: Vibrant Soundbridge

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Clinical Trial of the Vibrant Soundbridge as a Treatment for Conductive and Mixed Hearing Losses, Using Direct Round Window Cochlear Stimulation.

Resource links provided by NLM:


Further study details as provided by Med-El Corporation:

Primary Outcome Measures:
  • The use of the VSB provides subjects with significant benefit in speech perception in quiet (monosyllables) when compared with the unaided preoperative condition. [ Time Frame: 6 months post initial activation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The use of the VSB provides subjects with significant measurable improvement in functional gain when compared to the preoperative unaided condition. [ Time Frame: 6 months post initial activation ] [ Designated as safety issue: No ]
  • The use of the VSB provides subjects with significant benefit in speech perception in noise (HINT sentences) when compared with the unaided preoperative condition. [ Time Frame: 6 months post initial activation ] [ Designated as safety issue: No ]
  • Surgical implantation of the VSB does not result in a significant decrease in residual hearing when compared to the preoperative unaided condition. [ Time Frame: 10 months post initial activation ] [ Designated as safety issue: Yes ]

Enrollment: 50
Study Start Date: December 2007
Study Completion Date: March 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00748540

Locations
United States, California
House Ear Institute
Los Angeles, California, United States, 90057
Jennifer Maw, MD
San Jose, California, United States, 95124-3910
United States, Florida
University of Miami Ear Institute
Miami, Florida, United States, 33136
Silverstein Institute
Sarasota, Florida, United States, 34239
United States, Illinois
Ear Institute of Chicago
Hinsdale, Illinois, United States, 60521
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
United States, Missouri
Midwest Ear Institute
Kansas City, Missouri, United States, 64111
United States, New York
Capitol Region Ear Institute
Slingerlands, New York, United States, 12159
United States, North Carolina
University of North Carolina Hospital
Chapel Hill, North Carolina, United States, 27514
United States, Pennsylvania
Pittsburgh Ear Associates
Pittsburgh, Pennsylvania, United States, 15212
United States, Texas
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Sponsors and Collaborators
Med-El Corporation
Investigators
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: Jack Wazen, MD Silverstein Institute
Principal Investigator: Hinrich Staecker, MD, PhD University of Kansas Medical Center
Principal Investigator: Fred Telischi, MD University of Miami
Principal Investigator: Craig Buchman, MD University of North Carolina Hospital
Principal Investigator: Peter Roland, MD University of Texas Southwestern Medical Center
Principal Investigator: Richard Wiet, MD Ear Institute of Chicago
  More Information

Publications:
Responsible Party: Med-El Corporation
ClinicalTrials.gov Identifier: NCT00748540     History of Changes
Other Study ID Numbers: G060227 
Study First Received: September 5, 2008
Last Updated: March 9, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by Med-El Corporation:
sensorineural hearing loss
conductive hearing loss
mixed hearing loss

Additional relevant MeSH terms:
Hearing Loss
Deafness
Hearing Loss, Conductive
Hearing Loss, Mixed Conductive-Sensorineural
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on September 23, 2016