Hearing LossVSBRWNCT00748540
Safety and Efficacy of the Vibrant Soundbridge (VSB) for Mixed and Conductive Hearing Losses
A study testing Vibrant Soundbridge in people with Hearing Loss, run by Med-El Corporation at 11 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hearing Loss
- What is being tested?
- Vibrant Soundbridge
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 11 sitesUnited States
- Study dates
- Dec 2007to Mar 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
University of North Carolina Hospital
Chapel Hill, North Carolina, 27514
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
Ear Institute of Chicago
Hinsdale, Illinois, 60521
University of Kansas Medical Center
Kansas City, Kansas, 66160
Midwest Ear Institute
Kansas City, Missouri, 64111
House Ear Institute
Los Angeles, California, 90057
University of Miami Ear Institute
Miami, Florida, 33136
Pittsburgh Ear Associates
Pittsburgh, Pennsylvania, 15212
Jennifer Maw, MD
San Jose, California, 95124-3910
Silverstein Institute
Sarasota, Florida, 34239
Capitol Region Ear Institute
Slingerlands, New York, 12159
About this study
Official title: 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.
- Conditions
- Hearing Loss
- Being tested
- Vibrant Soundbridge
- Keywords
- sensorineural hearing loss, conductive hearing loss, mixed hearing loss
- Medical subject headings
- Hearing Loss, Hearing Loss, Sensorineural, Hearing Loss, Conductive, Hearing Loss, Mixed Conductive-Sensorineural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vibrant SoundbridgeDevice
Also called VSB, VSB RW, RW VSB, Round Window Stimulation
Mixed and conductive hearing loss using round window stimulation
| Study group | Role | What they receive |
|---|---|---|
| Implanted | Experimental | Implanted with Vibrant Soundbridge Receives: Device: Vibrant Soundbridge |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months post initial activation
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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
Measured: 10 months post initial activation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2008 (estimated)
- Study startDec 2007
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hearing LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Med-El Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Foyt, MD, Principal investigator, Capital Region Ear InstituteJose Fayad, MD, Principal investigator, House Ear InstituteJennifer Maw, MD, Principal investigator, Jennifer Maw, MDRobert Cullen, MD, Principal investigator, Midwest Ear InstituteDouglas Chen, MD, Principal investigator, Pittsburgh Ear AssociatesJack Wazen, MD, Principal investigator, Silverstein InstituteHinrich Staecker, MD, PhD, Principal investigator, University of Kansas Medical CenterFred Telischi, MD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00748540
- Sponsor's protocol ID
- G060227
- Acronym
- VSBRW
- Status last verified
- Sep 2019
- First submitted
- 5 Sep 2008
- Last updated
- 25 Sep 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
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.
PubMed 17062502Kiefer 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.
PubMed 17065833
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial of the Vibrant Soundbridge as a Treatment for Conductive and Mixed Hearing Losses, Using Direct Round Window Cochlear Stimulation.
- ClinicalTrials.gov ID
- NCT00748540
- Acronym / sponsor ID
- VSBRW / G060227
- Conditions
- Hearing Loss
- Keywords
- sensorineural hearing loss, conductive hearing loss, mixed hearing loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Med-El CorporationIndustry (pharma, biotech, devices)
- Study start
- Dec 2007
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 8 Sep 2008 (estimated)
- Results
- Posted 31 Jul 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Implanted | Experimental | Device: Vibrant SoundbridgeImplanted with Vibrant Soundbridge |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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).
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vibrant SoundbridgeAlso: VSB, VSB RW, RW VSB, Round Window StimulationMixed and conductive hearing loss using round window stimulation | Device | Implanted |
Primary outcome
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.
3 secondary outcomes
Functional Gain Compared to Preoperative Unaided Condition in Patients Implanted With Vibrant Soundbridge.
Time frame: 6 months post initial activation
Speech Perception in Noise (HINT Sentences) in Patients Implanted With Vibrant Soundbridge.
Time frame: 6 months post initial activation
Residual Hearing in Patients Implanted With Vibrant Soundbridge
Time frame: 10 months post initial activation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 17062502Colletti 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.
- Background: PubMed 17065833Kiefer 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Foyt, MD principal investigator
Capital Region Ear Institute
Jose Fayad, MD principal investigator
House Ear Institute
Jennifer Maw, MD principal investigator
Jennifer Maw, MD
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vibrant Soundbridge in people with Hearing Loss, run by Med-El Corporation at 11 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Jul 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Speech Perception in Quiet (Monosyllables) in Patients Implanted With Vibrant Soundbridge (time frame: 6 months post initial activation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00748540, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2019.