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

Med-El Corporation11 sites in 1 country50 target enrollmentDecember 2007

ConditionsHearing Loss

Overview

Phase: N/A
Intervention: Not specified
Conditions: Hearing Loss
Sponsor: Med-El Corporation
Enrollment: 50
Locations: 11
Primary Endpoint: Speech Perception in Quiet (Monosyllables) in Patients Implanted With Vibrant Soundbridge
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

December 2007

End Date

March 2014

Last Updated

6 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Med-El Corporation

Responsible Party

Sponsor

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.

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

Outcomes

Primary Outcomes

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.

Secondary Outcomes

Speech Perception in Noise (HINT Sentences) in Patients Implanted With Vibrant Soundbridge.(6 months post initial activation)
Functional Gain Compared to Preoperative Unaided Condition in Patients Implanted With Vibrant Soundbridge.(6 months post initial activation)
Residual Hearing in Patients Implanted With Vibrant Soundbridge(10 months post initial activation)