Trials / Completed
CompletedNCT05052944
Single-sided Deafness and Cochlear Implantation
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 78 (actual)
- Sponsor
- Johns Hopkins University · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Cochlear implantation | Patients who receive cochlear implant for single-sided deafness |
Timeline
- Start date
- 2020-11-19
- Primary completion
- 2023-07-24
- Completion
- 2023-11-09
- First posted
- 2021-09-22
- Last updated
- 2023-11-13
Locations
5 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05052944. Inclusion in this directory is not an endorsement.