Single-sided Deafness and Cochlear Implantation

NCT ID: NCT05052944

Last Updated: 2023-11-13

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 78 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-11-19
• Study Completion Date: 2023-11-09

Brief Summary

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

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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Cochlear implant recipients

Patients with single-sided deafness undergoing cochlear implantation

Cochlear implantation

Intervention Type: DEVICE

Patients who receive cochlear implant for single-sided deafness

Interventions

Cochlear implantation

Patients who receive cochlear implant for single-sided deafness

Intervention Type: DEVICE

Other Intervention Names

Med El cochlear implant

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Daniel Sun, MD

Role: PRINCIPAL_INVESTIGATOR

JHU

Locations

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, United States

Countries

United States

Other Identifiers

IRB00230644

Identifier Type: -

Identifier Source: org_study_id