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

NCT ID: NCT00748540

Last Updated: 2019-09-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-12-31
• Study Completion Date: 2014-03-31

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Implanted

Implanted with Vibrant Soundbridge

Group Type: EXPERIMENTAL

Vibrant Soundbridge

Intervention Type: DEVICE

Mixed and conductive hearing loss using round window stimulation

Interventions

Vibrant Soundbridge

Mixed and conductive hearing loss using round window stimulation

Intervention Type: DEVICE

Other Intervention Names

VSB; VSB RW; RW VSB; Round Window Stimulation

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Med-El Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Foyt, MD

Role: PRINCIPAL_INVESTIGATOR

Capital Region Ear Institute

Jose Fayad, MD

Role: PRINCIPAL_INVESTIGATOR

House Ear Institute

Jennifer Maw, MD

Role: PRINCIPAL_INVESTIGATOR

Jennifer Maw, MD

Robert Cullen, MD

Role: PRINCIPAL_INVESTIGATOR

Midwest Ear Institute

Douglas Chen, MD

Role: PRINCIPAL_INVESTIGATOR

Pittsburgh Ear Associates

Jack Wazen, MD

Role: PRINCIPAL_INVESTIGATOR

Silverstein Institute

Hinrich Staecker, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Kansas Medical Center

Fred Telischi, MD

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Craig Buchman, MD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina Hospital

Peter Roland, MD

Role: PRINCIPAL_INVESTIGATOR

University of Texas Southwestern Medical Center

Richard Wiet, MD

Role: PRINCIPAL_INVESTIGATOR

Ear Institute of Chicago

Locations

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

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 17062502 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17065833 (View on PubMed)

Other Identifiers

G060227

Identifier Type: -

Identifier Source: org_study_id