Single-sided Deafness and Cochlear Implantation

Hearing Loss Clinical Trial

Official title:

Single-sided Deafness and Cochlear Implantation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05052944
• Other study ID #: IRB00230644
• Status: Completed
• Start date: November 19, 2020
• Est. completion date: November 9, 2023

Study information

• Verified date: November 2023
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: November 9, 2023
• Est. primary completion date: July 24, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Deafness
• Hearing Loss
• Hearing Loss, Cochlear
• Hearing Loss, Sensorineural
• Hearing Loss, Sudden
• Hearing Loss, Unilateral
• Labyrinthitis

Intervention

Device:
• Cochlear implantation
Patients who receive cochlear implant for single-sided deafness

Locations

Country	Name	City	State
United States	Johns Hopkins Bayview	Baltimore	Maryland
United States	Johns Hopkins Outpatient Center	Baltimore	Maryland
United States	Johns Hopkins Suburban	Bethesda	Maryland
United States	Johns Hopkins Greenspring Station	Lutherville-Timonium	Maryland
United States	Johns Hopkins White Marsh	Nottingham	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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