Single-sided Deafness and Cochlear Implantation (NCT05052944) | Clinical Trial Compass
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 range18 Years
SexALL
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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
What they're measuring
1
Change in Speech recognition in quiet
Timeframe: Baseline and up to 1 year post-implantation
2
Change in Speech recognition in noise
Timeframe: Baseline and up to 1 year post-implantation