Single-sided Deafness and Cochlear Implantation

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

Detailed Description
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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.

Official Title
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Single-sided Deafness and Cochlear Implantation

Conditions
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Hearing Loss, Hearing Loss, Sensorineural, Hearing Loss, Unilateral, Hearing Loss, Sudden, Hearing Loss, Cochlear, Hearing Loss in Left Ear, Hearing Loss in Right Ear, Labyrinthitis

Intervention / Treatment
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* Device: Cochlear implantation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cochlear implant recipients<br>Patients with single-sided deafness undergoing cochlear implantation | Device: Cochlear implantation<br>* Patients who receive cochlear implant for single-sided deafness<br>* Other names: Med El cochlear implant;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Speech recognition in quiet | 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 | 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 | 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 | 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 | 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 | Score on Health Utility Index. Range: 0-1.0. Lower score signifies lower health utility. | Baseline and up to 1 year post-implantation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cochlear implantation