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Cochlear Implantation After Labyrinthectomy or a Translabyrinthine Surgical Approach

NCT02309099 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2019-01-07

Study results available
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Summary

The goal of this project is to determine whether subjects who have undergone labyrinthectomy or a translabyrinthine surgical approach as the treatment for vestibular schwannoma or Meniere's disease benefit from cochlear implantation on speech perception and localization tasks.

If the auditory nerve is able to transmit this signal effectively, then these two populations may be able to utilize the combination of electric (in the affected ear) and acoustic (in the non-affected ear) information for improved speech perception in noise and localization as reportedly experienced in other unilateral sensorineural hearing loss populations.

Conditions

  • Unilateral Acoustic Neuroma
  • Meniere's Disease

Interventions

DEVICE

Cochlear Implant

Cochlear implantation used a treatment for single-sided deafness resultant of labyrinthectomy or a translabyrinthine surgical approach

Sponsors & Collaborators

  • Med-El Corporation

    collaborator INDUSTRY

  • University of North Carolina, Chapel Hill

    lead OTHER

Principal Investigators

  • Kevin Brown, MD, PhD · University of North Carolina, Chapel Hill

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-11-30
Primary Completion
2017-11-08
Completion
2017-11-08

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02309099 on ClinicalTrials.gov