Clinical trial NCT00748540: Safety and Efficacy of the Vibrant Soundbridge (VSB) for Mixed and Conductive Hearing Losses
Official title: Clinical Trial of the Vibrant Soundbridge as a Treatment for Conductive and Mixed Hearing Losses, Using Direct Round Window Cochlear Stimulation.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hearing Loss
Keywords: sensorineural hearing loss
conductive hearing loss
mixed hearing loss
Lead sponsor: Med-El Corporation
Sponsor class: INDUSTRY
First posted: 2008-09-08
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Speech Perception in Quiet (Monosyllables) in Patients Implanted With Vibrant Soundbridge
timeFrame: 6 months post initial activation
Secondary outcomes:
measure: Functional Gain Compared to Preoperative Unaided Condition in Patients Implanted With Vibrant Soundbridge.
timeFrame: 6 months post initial activation
measure: Speech Perception in Noise (HINT Sentences) in Patients Implanted With Vibrant Soundbridge.
timeFrame: 6 months post initial activation
measure: Residual Hearing in Patients Implanted With Vibrant Soundbridge
timeFrame: 10 months post initial activation
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: House Ear Institute
state: California
city: San Jose
country: United States
facility: Jennifer Maw, MD
state: California
city: Miami
country: United States
facility: University of Miami Ear Institute
state: Florida
city: Sarasota
country: United States
facility: Silverstein Institute
state: Florida
city: Hinsdale
country: United States
facility: Ear Institute of Chicago
state: Illinois
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Kansas City
country: United States
facility: Midwest Ear Institute
state: Missouri
city: Slingerlands
country: United States
facility: Capitol Region Ear Institute
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina Hospital
state: North Carolina
city: Pittsburgh
country: United States
facility: Pittsburgh Ear Associates
state: Pennsylvania
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
Study officials:
affiliation: Capital Region Ear Institute
name: David Foyt, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: House Ear Institute
name: Jose Fayad, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Jennifer Maw, MD
name: Jennifer Maw, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Midwest Ear Institute
name: Robert Cullen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Pittsburgh Ear Associates
name: Douglas Chen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Silverstein Institute
name: Jack Wazen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Kansas Medical Center
name: Hinrich Staecker, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Miami
name: Fred Telischi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of North Carolina Hospital
name: Craig Buchman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Texas Southwestern Medical Center
name: Peter Roland, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ear Institute of Chicago
name: Richard Wiet, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.