CClinicalTrials.gg
CompletedNCT02105441CI and SSDUpdated Apr 5, 2018

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

An observational study in Severe Unilateral Sensorineural Hearing Loss, sponsored by Mayo Clinic. Completed at 1 site in United States. Open to participants aged 7 Years and older. Per ClinicalTrials.gov, last updated 2018-04-05.

Sponsored by Mayo Clinic · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
40
Ages
7 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Severe Unilateral Sensorineural Hearing Loss

Keywords

  • cochlear implant
03

In context

Hearing Loss

1,092 studies on the registry are indexed under Hearing Loss; 235 are open to participants now.

This study's enrollment of 40 is below the median of 87 across 270 observational studies indexed under Hearing Loss.

Browse Hearing Loss studies →

Lead sponsor

Mayo Clinic is the lead sponsor of 3,218 studies on the registry; 670 are open to participants now.

Of its 445 completed or terminated interventional studies of FDA-regulated products, 313 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
7 Years and older
Sexes eligible
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.

Eligibility 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)
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
40 participants (actual)
Patient registry
No

Groups and cohorts

  • cochlear implant

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

    Device: Cochlear implant

Interventions

  • DeviceCochlear implant

    Implantable hearing device

06

What researchers measure

Primary outcomes

  1. Listening Effort

    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

    Time frame: one year post operative test time

07

Study locations

1 site
  • Mayo Clinic in Rochester
    Rochester, Minnesota 55905, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 5, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02105441
Lead sponsor
Mayo Clinic
Responsible party
Matthew L. Carlson, M.D. (Associate Professor of Neurosurgery and Otolaryngology, Mayo Clinic) — Principal investigator
First posted
Apr 7, 2014
Start date
Mar 2014
Primary completion
Mar 2018
Completion
Mar 2018
Last update
Apr 5, 2018

Study contacts

Matthew L Carlson, MD
principal investigator · Mayo Clinic

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.

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