Cochlear Implantation Among Adults and Older Children With Unilateral or Asymmetric Hearing Loss (CI and SSD)

Mayo Clinic

Status: Completed

Conditions: Severe Unilateral Sensorineural Hearing Loss

Treatments: Device: Cochlear implant

Study type: Observational

Funder types: Other

Identifiers

NCT02105441

13-009050

Details and patient eligibility

About

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

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 7+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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)

Trial design

40 participants in 1 patient group

cochlear implant

Description:

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

Treatment:

Device: Cochlear implant