Single-sided Deafness and Cochlear Implantation

Sponsor

Johns Hopkins University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05052944

Collaborator

(none)

100

Enrollment

Locations

34.1

Anticipated Duration (Months)

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
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	Device: Cochlear implantation

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 Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

100 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Single-sided Deafness and Cochlear Implantation

Actual Study Start Date :

Nov 19, 2020

Anticipated Primary Completion Date :

Sep 24, 2023

Anticipated Study Completion Date :

Sep 24, 2023

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

Change in Speech recognition in quiet [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.
Change in Speech recognition in noise [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 Outcome Measures

Change in Spatial hearing as assessed by the Spatial Hearing Questionnaire [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.
Change in Tinnitus handicap as assessed by the Tinnitus Handicap Inventory [Baseline and up to 1 year post-implantation]
Score on Tinnitus Handicap Inventory. Range: 0-100. Higher score signifies more handicap due to tinnitus.
Change in Hearing aid benefit as assessed by the Abbreviated Profile of Hearing Aid Benefit [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.
Change in Health utility as assessed by the Health Utility Index [Baseline and up to 1 year post-implantation]
Score on Health Utility Index. Range: 0-1.0. Lower score signifies lower health utility.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Johns Hopkins Bayview	Baltimore	Maryland	United States	21224
2	Johns Hopkins Outpatient Center	Baltimore	Maryland	United States	21287
3	Johns Hopkins Suburban	Bethesda	Maryland	United States	20814
4	Johns Hopkins Greenspring Station	Lutherville-Timonium	Maryland	United States	21093
5	Johns Hopkins White Marsh	Nottingham	Maryland	United States	21236