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

NCT00748540 | Completed Results

• 1 other identifier: G060227
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 11

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

Keywords

sensorineural hearing loss; conductive hearing loss; mixed hearing loss

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Functional Gain Compared to Preoperative Unaided Condition in Patients Implanted With Vibrant Soundbridge.

  6 months post initial activation

• Speech Perception in Noise (HINT Sentences) in Patients Implanted With Vibrant Soundbridge.

  6 months post initial activation

• Residual Hearing in Patients Implanted With Vibrant Soundbridge

  10 months post initial activation

Study Arms (1)

Implanted

EXPERIMENTAL

Implanted with Vibrant Soundbridge

Device: Vibrant Soundbridge

Interventions

Vibrant Soundbridge DEVICE

Mixed and conductive hearing loss using round window stimulation

Also known as: VSB, VSB RW, RW VSB, Round Window Stimulation

Implanted

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Med-El Corporation: lead

Study Sites (11)

House Ear Institute

Los Angeles, California, 90057, United States

Location

Jennifer Maw, MD

San Jose, California, 95124-3910, United States

Location

University of Miami Ear Institute

Miami, Florida, 33136, United States

Location

Silverstein Institute

Sarasota, Florida, 34239, United States

Location

Ear Institute of Chicago

Hinsdale, Illinois, 60521, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Midwest Ear Institute

Kansas City, Missouri, 64111, United States

Location

Capitol Region Ear Institute

Slingerlands, New York, 12159, United States

Location

University of North Carolina Hospital

Chapel Hill, North Carolina, 27514, United States

Location

Pittsburgh Ear Associates

Pittsburgh, Pennsylvania, 15212, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Related Publications (2)

• 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.

  PMID: 17062502 BACKGROUND

• 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.

  PMID: 17065833 BACKGROUND

MeSH Terms

Conditions

Hearing Loss; Hearing Loss, Sensorineural; Hearing Loss, Conductive; Hearing Loss, Mixed Conductive-Sensorineural

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Allison Racey, AuD
• Organization: MED-EL Corporation

allison.racey@medel.com

888-633-3524

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2008
• First Posted: September 8, 2008
• Study Start: December 1, 2007
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: September 25, 2019
• Results First Posted: July 31, 2018

Record last verified: 2019-09

Locations

US (11)