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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-03-31

Study Completion Date

2018-03-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Severe Unilateral Sensorineural Hearing Loss

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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cochlear implant

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

Cochlear implant

Intervention Type DEVICE

Implantable hearing device

Interventions

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Cochlear implant

Implantable hearing device

Intervention Type DEVICE

Eligibility Criteria

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Inclusion 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)

Minimum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No