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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

Must not have

Any contra-indication(s) for undergoing surgery

Vestibular schwannoma greater than 2 cm

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

No Placebo-Only Group

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.

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.

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 below

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I have been diagnosed with vestibular schwannoma or Meniere's disease by a doctor.

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I am scheduled for surgery to remove a brain tumor via the ear or to have part of my inner ear removed.

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My surgery will not damage the nerve related to hearing.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I cannot have surgery due to health reasons.

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My vestibular schwannoma is larger than 2 cm.

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I have chosen not to receive the pneumococcal vaccine.

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I am over 70 years old.

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I have an ongoing ear infection.

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My hearing nerve cannot be saved during my brain tumor surgery.

Select...

I have Meniere's disease or vestibular schwannomas in both ears.

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.

This trial's timeline: 3 weeks for screening, Varies for treatment, and measurements assessed 2 weeks, 1 month, 3 months, 6 months, 9 months, and 12 months post-implantation. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Sound Detection Testing

Change in Sound Localization Testing

Change in Speech Perception Testing

Secondary study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 10Eligibility criteria met