CompletedNot Applicable

Single-sided Deafness and Cochlear Implantation

United States78 participantsStarted 2020-11-19

Plain-language summary

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

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Speech recognition in quiet

Timeframe: Baseline and up to 1 year post-implantation

Change in Speech recognition in noise

Timeframe: Baseline and up to 1 year post-implantation

Trial details

NCT IDNCT05052944

SponsorJohns Hopkins University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2023-07-24

View on ClinicalTrials.gov More Hearing Loss trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.