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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
Sponsor:
Information provided by (Responsible Party):
Matthew L. Carlson, M.D., Mayo Clinic

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

Condition or disease Intervention/treatment
Severe Unilateral Sensorineural Hearing Loss Device: Cochlear implant

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.


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Study Type : Observational
Actual Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
cochlear implant
How well patients with cochlear implants understand speech in noise with implant on, compared to implant off.
Device: Cochlear implant
Implantable hearing device




Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   7 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
This study includes adults and children over 7 years of age who have suffered single sided deafness. Word understanding on the impaired side must not exceed 50% correct in the best aided condition.
Criteria

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)

Information from the National Library of Medicine

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


Locations
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United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Matthew L Carlson, MD Mayo Clinic

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Responsible Party: Matthew L. Carlson, M.D., Associate Professor of Neurosurgery and Otolaryngology, Mayo Clinic
ClinicalTrials.gov Identifier: NCT02105441     History of Changes
Other Study ID Numbers: 13-009050
First Posted: April 7, 2014    Key Record Dates
Last Update Posted: April 5, 2018
Last Verified: April 2018
Keywords provided by Matthew L. Carlson, M.D., Mayo Clinic:
cochlear implant
Additional relevant MeSH terms:
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Hearing Loss
Deafness
Hearing Loss, Sensorineural
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms