Single-sided Deafness and Cochlear Implantation

Johns Hopkins University

Status

Completed

Conditions

Hearing Loss in Left Ear

Hearing Loss, Sudden

Hearing Loss

Hearing Loss in Right Ear

Labyrinthitis

Hearing Loss, Cochlear

Hearing Loss, Unilateral

Hearing Loss, Sensorineural

Treatments

Device: Cochlear implantation

Study type

Observational

Funder types

Other

Identifiers

NCT05052944

IRB00230644

Details and patient eligibility

About

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

Full 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.

Enrollment

78 patients

Sex

All

Ages

18+ years old

Volunteers

No 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