Completed

Single-sided Deafness and Cochlear Implantation

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What is being collected

Data Collection

Collected from today forward - Prospective
Who is being recruted

Hearing Loss, Sudden+12

+ Ear Diseases

+ Hearing Disorders

Over 18 Years
+7 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: November 2020
See protocol details

Summary

Principal SponsorJohns Hopkins University
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: November 19, 2020

Actual date on which the first participant was enrolled.

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 TitleSingle-sided Deafness and Cochlear Implantation
NCT05052944
Principal SponsorJohns Hopkins University
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

78 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Hearing Loss, SuddenEar DiseasesHearing DisordersHearing Loss, SensorineuralLabyrinth DiseasesLabyrinthitisNervous System DiseasesNeurologic ManifestationsOtitisOtorhinolaryngologic DiseasesSensation DisordersSigns and SymptomsPathological Conditions, Signs and SymptomsHearing LossHearing Loss, Unilateral

Criteria

3 inclusion criteria required to participate
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.

4 exclusion criteria prevent from participating
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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 5 locations

Suspended

Johns Hopkins Bayview

Baltimore, United StatesOpen Johns Hopkins Bayview in Google Maps
Suspended

Johns Hopkins Outpatient Center

Baltimore, United States
Suspended

Johns Hopkins Suburban

Bethesda, United States
Suspended

Johns Hopkins Greenspring Station

Lutherville-Timonium, United States
Completed5 Study Centers