Cochlear Implantation Among Adults and Older Children With Unilateral or Asymmetric Hearing Loss (CI and SSD)
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|ClinicalTrials.gov Identifier: NCT02105441|
Recruitment Status : Completed
First Posted : April 7, 2014
Last Update Posted : April 5, 2018
|Condition or disease||Intervention/treatment|
|Severe Unilateral Sensorineural Hearing Loss||Device: Cochlear implant|
Unilateral hearing loss is known to impair binaural hearing abilities. Specifically, localization, speech understanding in noise, and binaural squelch suffer due to lack of binaural timing and level cues. This study is designed to examine how binaural hearing is improved following cochlear implantation on the impaired side. The study endpoints are collected at 6 months and 12 months post activation of the implant.
This is not a funded study. All costs are billed through insurance for reimbursement. There is an insurance approval process that we move through after a participant has been evaluated at the Mayo Clinic and found to be a candidate for cochlear implantation.
|Study Type :||Observational|
|Actual Enrollment :||40 participants|
|Official Title:||Cochlear Implantation Among Adults and Older Children With Unilateral or Asymmetric Hearing Loss|
|Study Start Date :||March 2014|
|Actual Primary Completion Date :||March 2018|
|Actual Study Completion Date :||March 2018|
How well patients with cochlear implants understand speech in noise with implant on, compared to implant off.
Device: Cochlear implant
Implantable hearing device
- Listening Effort [ Time Frame: one year post operative test time ]A dual task performance paradigm will be used in which both the primary task and the secondary task will be performed simultaneously. The primary task will consist of speech recognition testing in varying levels of background noise and quiet, whereas the secondary task will consist of a motor reaction to a randomly presented light
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02105441
|United States, Minnesota|
|Mayo Clinic in Rochester|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Matthew L Carlson, MD||Mayo Clinic|