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

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: Completed
• Conditions: Hearing Loss
• Intervention / Treatment: Device: Vibrant Soundbridge

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Speech Perception in Quiet (Monosyllables) in Patients Implanted With Vibrant Soundbridge	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

Outcome Measure	Measure Description	Time Frame
Functional Gain Compared to Preoperative Unaided Condition in Patients Implanted With Vibrant Soundbridge.	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.	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	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

• Sponsor: 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: 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

General Publications

• Colletti V, Soli SD, Carner M, Colletti L. Treatment of mixed hearing losses via implantation of a vibratory transducer on the round window. Int J Audiol. 2006 Oct;45(10):600-8. doi: 10.1080/14992020600840903.
• Kiefer J, Arnold W, Staudenmaier R. Round window stimulation with an implantable hearing aid (Soundbridge) combined with autogenous reconstruction of the auricle - a new approach. ORL J Otorhinolaryngol Relat Spec. 2006;68(6):378-85. doi: 10.1159/000095282. Epub 2006 Oct 26.

Study record dates

Study Major Dates

• Study Start: December 1, 2007
• Primary Completion (ACTUAL): March 1, 2014
• Study Completion (ACTUAL): March 1, 2014

Study Registration Dates

• First Submitted: September 5, 2008
• First Submitted That Met QC Criteria: September 5, 2008
• First Posted (ESTIMATE): September 8, 2008

Study Record Updates

• Last Update Posted (ACTUAL): September 25, 2019
• Last Update Submitted That Met QC Criteria: September 10, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: sensorineural hearing loss; conductive hearing loss; mixed hearing loss
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Hearing Loss; Deafness
• Other Study ID Numbers: G060227