Mayo Clinic in Rochester
Rochester, Minnesota, 55905, United States
Completed
NCT Number: NCT02105441
Cochlear Implantation Among Adults and Older Children With Unilateral or Asymmetric Hearing Loss
Do adults and children over 7 years of age with unilateral or assymetric hearing loss benefit from cochlear implantation on the worst hearing side.
Completed
Looking for future studies?
Notify MeKey information
Conditions
Age range
7 year and older
Sex eligibility
All sexes
Study type
Observational
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Adults
- 18 years of age or older,
- Hearing loss in the ear to be implanted must such that speech understanding is not possible with a well fitted hearing aid. Specifically, less than 40% monosyllabic word understanding when that ear is tested in the best-aided condition and the other ear is sufficiently occluded or masked.
- Onset of hearing loss in the adult group must be post-lingual (after three years of age)
Children
- Children 7 years of age and older
- Hearing loss in the ear to be implanted configured such that word understanding is less 40% in the best aided condition
- Onset of hearing loss in the pediatric group must be post-lingual (after three years of age)
Treatment and study plan
Cochlear Implant
DeviceImplantable hearing device
Primary outcomes
-
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
Sponsors and collaborators
Lead sponsor
Mayo Clinic
Other
Registry information
Acronym: CI and SSD
Important dates
- Study start
- 2014
- Primary completion
- 2018
- Study completion
- 2018
- First posted
- Apr 7, 2014
- Registry last updated
- Apr 5, 2018
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.