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

Severe Unilateral Sensorineural Hearing Loss Clinical Trial

— CI and SSD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02105441
• Other study ID #: 13-009050
• Status: Completed
• First received: April 2, 2014
• Last updated: April 4, 2018
• Start date: March 2014
• Est. completion date: March 2018

Study information

• Verified date: April 2018
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Deafness
• Hearing Loss
• Hearing Loss, Sensorineural
• Severe Unilateral Sensorineural Hearing Loss

Intervention

Device:
• Cochlear implant
Implantable hearing device

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	one year post operative test time