Cochlear Implantation Among Adults and Older Children With Unilateral or Asymmetric Hearing Loss

Overview

Do adults and children over 7 years of age with unilateral or assymetric hearing loss benefit from cochlear implantation on the worst hearing side.

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: March 2018

Detailed Description

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.

Interventions

  • Device: Cochlear implant
    • Implantable hearing device

Arms, Groups and Cohorts

  • cochlear implant
    • How well patients with cochlear implants understand speech in noise with implant on, compared to implant off.

Clinical Trial Outcome Measures

Primary Measures

  • 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

Participating in This Clinical Trial

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)

Gender Eligibility: All

Minimum Age: 7 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Mayo Clinic
  • Provider of Information About this Clinical Study
    • Principal Investigator: Matthew L. Carlson, M.D., Associate Professor of Neurosurgery and Otolaryngology – Mayo Clinic
  • Overall Official(s)
    • Matthew L Carlson, MD, Principal Investigator, Mayo Clinic

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.