Single-sided Deafness and Cochlear Implantation

November 10, 2023 updated by: Johns Hopkins University
This observational study evaluates the effects of cochlear implantation in patients with deafness in one ear.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Cochlear implant (CI) technology has been widely used for individuals with bilateral sensorineural hearing loss to improve the ability to perceive sound by bypassing the damaged portion of the inner ear. Recently in the U.S., Cochlear implantation has also been approved by the FDA for treatment of single-sided deafness. By restoring binaural hearing, cochlear implantation in unilateral hearing loss may improve hearing in noise and sound localization, however its audiologic outcomes and quality of life impact for patients remain incompletely understood.

This study aims to establish a prospective database to track and quantify the change in general health status, tinnitus severity, spatial hearing ability, and difficulty with communication in noise after unilateral cochlear implantation in patients with SSD undergoing routine medical and audiologic evaluation at the Johns Hopkins Cochlear Implant Center. Study participants will complete survey questionnaires and undergo standard-of-care audiological evaluation before and after cochlear implantation. Data collected in this study will be invaluable in gaining an in-depth understanding of the effects of cochlear implantation in patients with SSD in the context of current FDA guidelines, and lead to better counseling and patient selection for this treatment modality.

Study Type

Observational

Enrollment (Actual)

78

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21224
        • Johns Hopkins Bayview
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins Outpatient Center
      • Bethesda, Maryland, United States, 20814
        • Johns Hopkins Suburban
      • Lutherville-Timonium, Maryland, United States, 21093
        • Johns Hopkins Greenspring Station
      • Nottingham, Maryland, United States, 21236
        • Johns Hopkins White Marsh

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study population comprises individuals with single-sided deafness or asymmetric hearing loss resulting in poor hearing in one ear.

Description

Inclusion Criteria:

  • For individuals ages 18 years-old and above, limited benefit from unilateral amplification is defined by test scores of 5% correct or less on monosyllabic consonant-nucleus-consonant (CNC) words in quiet when tested in the ear to be implanted alone.
  • Before implantation with a cochlear implant, individuals with SSD or AHL must have at least 1-month experience wearing a Contra Lateral Routing of Signal (CROS) hearing aid or other relevant device and not show any subjective benefit.
  • Medical and surgical clearance for cochlear implantation.

Exclusion Criteria:

  • Not meeting FDA candidacy criteria for cochlear implantation in SSD
  • Inability to perform audiologic tasks (e.g. non-English speaking)
  • Medical or surgical contraindication to general anesthesia or cochlear implant surgery
  • Does not wish to participate

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cochlear implant recipients
Patients with single-sided deafness undergoing cochlear implantation
Device: Cochlear implantation
Patients who receive cochlear implant for single-sided deafness
Other Names:
  • Med El cochlear implant

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Speech recognition in quiet
Time Frame: Baseline and up to 1 year post-implantation
Change in Speech recognition in quiet will be assessed using the percent correct on Consonant-Noun-Consonant words and phonemes.
Baseline and up to 1 year post-implantation
Change in Speech recognition in noise
Time Frame: Baseline and up to 1 year post-implantation
Change in Speech recognition in noise will be assessed using the percent correct on AzBio with multitalker babble at 8dB signal-to-noise ratio.
Baseline and up to 1 year post-implantation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Spatial hearing as assessed by the Spatial Hearing Questionnaire
Time Frame: Baseline and up to 1 year post-implantation
Score on Spatial Hearing Questionnaire. Range: 0-100. Higher score signifies less handicap related to sound localization.
Baseline and up to 1 year post-implantation
Change in Tinnitus handicap as assessed by the Tinnitus Handicap Inventory
Time Frame: Baseline and up to 1 year post-implantation
Score on Tinnitus Handicap Inventory. Range: 0-100. Higher score signifies more handicap due to tinnitus.
Baseline and up to 1 year post-implantation
Change in Hearing aid benefit as assessed by the Abbreviated Profile of Hearing Aid Benefit
Time Frame: Baseline and up to 1 year post-implantation
Score on Abbreviated Profile of Hearing Aid Benefit. Range: 0-100. Higher score signifies more frequent problems with hearing.
Baseline and up to 1 year post-implantation
Change in Health utility as assessed by the Health Utility Index
Time Frame: Baseline and up to 1 year post-implantation
Score on Health Utility Index. Range: 0-1.0. Lower score signifies lower health utility.
Baseline and up to 1 year post-implantation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins University

Investigators

  • Principal Investigator: Daniel Sun, MD, JHU

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 19, 2020

Primary Completion (Actual)

July 24, 2023

Study Completion (Actual)

November 9, 2023

Study Registration Dates

First Submitted

September 14, 2021

First Submitted That Met QC Criteria

September 14, 2021

First Posted (Actual)

September 22, 2021

Study Record Updates

Last Update Posted (Actual)

November 13, 2023

Last Update Submitted That Met QC Criteria

November 10, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00230644

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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