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Prosthesis
Cochlear Implant for Unilateral Hearing Loss Post-Surgery
N/A
Recruiting
Led By Oliver Adunka, MD
Research Sponsored by Ohio State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Have a diagnosis of a vestibular schwannoma confirmed by a physician with an MRI and/or CT scan; Or have a diagnosis of Meniere's disease by a physician
Be scheduled to undergo surgery to remove the vestibular schwannoma through translabyrinthine approach; Or be scheduled to undergo a labyrinthectomy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up measurements assessed 2 weeks, 1 month, 3 months, 6 months, 9 months, and 12 months post-implantation.
Awards & highlights
Study Summary
This trial is testing whether it is safe and effective to use a cochlear implant on people who are losing their hearing in one ear due to surgery. The implant is a devices that helps people with hearing loss hear. It is approved for use in people with hearing loss in both ears, but this study will test whether it is effective for people with hearing loss in just one ear.
Who is the study for?
This trial is for English-speaking adults under 70 with single-sided hearing loss due to a small vestibular schwannoma (VS) or Meniere's disease, where the auditory nerve can be preserved during surgery. It excludes those with large VS over 2 cm, bilateral conditions, middle ear disease, cochlear ossification/fibrosis, and refusal of pneumococcal vaccine.Check my eligibility
What is being tested?
The study tests if it's safe and effective to use a cochlear implant in patients who become deaf on one side after VS removal or labyrinthectomy. After surgery, an implant is inserted and later connected to an external processor. Hearing and quality of life are assessed over a year.See study design
What are the potential side effects?
Risks include device failure needing removal, irritation at surgical/processor sites, increased ringing in the ear (tinnitus), facial nerve stimulation, and altered sound perception through the implant.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with vestibular schwannoma or Meniere's disease by a doctor.
Select...
I am scheduled for surgery to remove a brain tumor via the ear or to have part of my inner ear removed.
Select...
My surgery will not damage the nerve related to hearing.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ measurements assessed 2 weeks, 1 month, 3 months, 6 months, 9 months, and 12 months post-implantation.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~measurements assessed 2 weeks, 1 month, 3 months, 6 months, 9 months, and 12 months post-implantation.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Sound Detection Testing
Change in Sound Localization Testing
Change in Speech Perception Testing
Secondary outcome measures
Change in Nijmegen Cochlear Implant Questionnaire (NCIQ) Scores
Change in Speech, Spatial and Qualities of Hearing Scale (SSQ) Scores
Change in Tinnitus Handicap Inventory (THI) Scores
Trial Design
1Treatment groups
Experimental Treatment
Group I: Meniere's Disease/Vestibular SchwannomaExperimental Treatment1 Intervention
Individuals diagnosed with Meniere's disease and undergoing labyrinthectomy or diagnosed with vestibular schwannoma and undergoing surgical excision via translabyrinthine approach for treatment will receive cochlear implant at the time of surgery.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cochlear Implant
2019
N/A
~310
Find a Location
Who is running the clinical trial?
Ohio State UniversityLead Sponsor
829 Previous Clinical Trials
505,620 Total Patients Enrolled
Advanced BionicsIndustry Sponsor
16 Previous Clinical Trials
475 Total Patients Enrolled
Oliver Adunka, MDPrincipal Investigator - Ohio State University
Nationwide Children's Hospital, Ohio State University Hospital - Wexner Medical Center, Richard M. Ross Heart Hospital
2 Previous Clinical Trials
113 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I cannot have surgery due to health reasons.You have a condition in your ear that makes it unsuitable for a cochlear implant.My vestibular schwannoma is larger than 2 cm.I have been diagnosed with vestibular schwannoma or Meniere's disease by a doctor.I am scheduled for surgery to remove a brain tumor via the ear or to have part of my inner ear removed.I have chosen not to receive the pneumococcal vaccine.I am over 70 years old.I have an ongoing ear infection.My surgery will not damage the nerve related to hearing.I speak English fluently.My hearing nerve cannot be saved during my brain tumor surgery.I have Meniere's disease or vestibular schwannomas in both ears.
Research Study Groups:
This trial has the following groups:- Group 1: Meniere's Disease/Vestibular Schwannoma
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is enrollment open to persons under the age of 80 for this research study?
"Adhering to the eligibility requirements of this trial, potential participants must be over 18 years old and under 70."
Answered by AI
Who is eligible for inclusion in this clinical research?
"This study is actively seeking 15 individuals, aged 18-70, suffering from vertigo and aural issues. Additionally, those interested must either have tumors removed via the preservation of their auditory cranial nerve; or be prepared for labyrinthectomy surgery."
Answered by AI
How many individuals are being monitored while partaking in this experiment?
"Affirmative. Information hosted on clinicaltrials.gov indicates that this medical trial is presently looking for participants, with the first posting occurring on January 14th 2019 and last update being April 25th 2022. The study requires 15 individuals from one medical site to participate in it."
Answered by AI
Is this research endeavor currently enlisting participants?
"Affirmative. Clinicaltrials.gov indicates that this medical investigation is recruiting participants, which began on January 14th 2019 and was most recently modified April 25th 2022. The trial requires 15 volunteers from 1 location to participate."
Answered by AI
Who else is applying?
What site did they apply to?
The Ohio State University
What portion of applicants met pre-screening criteria?
Did not meet criteria
Why did patients apply to this trial?
I've suffered with menieres since 2004. I have 5 percent usable hearing and severe tinnitus in my right ear.
PatientReceived 1 prior treatment
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