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Can a cochlear implant bring back hearing after tumor removal?

NCT ID NCT03795675

Disease control Sponsor: Ohio State University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether a cochlear implant can safely and effectively restore hearing in people who become deaf in one ear after surgery to remove a benign tumor (vestibular schwannoma) or to treat Meniere's disease. Fifteen participants will receive the implant during their surgery and be followed for a year with hearing tests and questionnaires. The goal is to see if the implant improves sound detection, speech understanding, and sound localization.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
cochlear implant device
What this could lead to
If successful, this could provide a way to restore hearing in one ear for people who become deaf after surgery for a benign tumor or Meniere's disease.
What could go wrong
This is a small, early-stage study with only 15 participants. Risks include device failure, facial nerve stimulation, or no improvement in hearing. Results may not apply to everyone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 15 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2019

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 * Be English-speaking due to objective speech perception tasks. Non-English speakers may show a reduced speech perception score due to language differences * For patients undergoing tumor removal, tumor removal must allow preservation of the auditory division of the VIIIth cranial nerve Exclusion Criteria: * Subjects with bilateral Meniere's disease or bilateral vestibular schwannomas * Inability to preserve the auditory division of the VIIIth cranial nerve during removal of vestibular schwannoma * Ossification or fibrosis of the cochlear found on preoperative imaging (CT or MRI) that precludes cochlear implantation * Active middle ear disease * Greater than 70 years of age * Vestibular schwannoma greater than 2 cm * Patient refusal of receiving pneumococcal vaccine * Any contra-indication(s) for undergoing surgery.

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Conditions

The condition(s) this trial relates to.

acoustic neuroma Meniere disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Meniere disease Vestibular schwannoma

Contacts and locations

Locations

  • The Ohio State University

    Columbus, Ohio, 43210, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.