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 Information
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
Administrative Informations
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