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

Brief Title

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

Official Title

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

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.
    

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.
    

Study Type

Observational

Primary Outcome

Listening Effort

Condition

Severe Unilateral Sensorineural Hearing Loss

Intervention

Cochlear implant

Study Arms / Comparison Groups

 cochlear implant

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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Device

Estimated Enrollment

40

Start Date

March 2014

Completion Date

March 2018

Primary Completion Date

March 2018

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)
      

Gender

All

Ages

7 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Matthew L Carlson, MD, , 

Location Countries

United States

Location Countries

United States

NCT ID

NCT02105441

Organization ID

13-009050

Responsible Party

Principal Investigator

Study Sponsor

Mayo Clinic

Study Sponsor

Matthew L Carlson, MD, Principal Investigator, Mayo Clinic

Verification Date

April 2018