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Completed

NCT Number: NCT05052944

Single-sided Deafness and Cochlear Implantation

This observational study evaluates the effects of cochlear implantation in patients with deafness in one ear.

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Key information

Conditions

Hearing Loss Ear Diseases Hearing Disorders Hearing Loss in Left Ear Hearing Loss in Right Ear Hearing Loss, Cochlear Hearing Loss, Sensorineural Hearing Loss, Sudden Hearing Loss, Unilateral Labyrinth Diseases Labyrinthitis Nervous System Diseases Neurologic Manifestations Otitis Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Johns Hopkins Bayview, Baltimore, Maryland, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cochlear implantation

Device

Patients who receive cochlear implant for single-sided deafness

Other names: Med El cochlear implant

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Registry information

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Sep 22, 2021
Registry last updated
Nov 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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