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

NCT02105441 | Completed

• 1 other identifier: 13-009050
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Severe Unilateral Sensorineural Hearing Loss

Keywords

cochlear implant

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

cochlear implant

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

Device: Cochlear implant

Interventions

Cochlear implant DEVICE

Implantable hearing device

cochlear implant

Eligibility Criteria

• Age: 7 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study includes adults and children over 7 years of age who have suffered single sided deafness. Word understanding on the impaired side must not exceed 50% correct in the best aided condition.

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)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Interventions

Cochlear Implants

Intervention Hierarchy (Ancestors)

Neural Prostheses; Implantable Neurostimulators; Electrodes, Implanted; Electrodes; Electrical Equipment and Supplies; Equipment and Supplies; Prostheses and Implants; Hearing Aids; Sensory Aids

Study Officials

• Matthew L Carlson, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Neurosurgery and Otolaryngology

Study Record Dates

• First Submitted: April 2, 2014
• First Posted: April 7, 2014
• Study Start: March 1, 2014
• Primary Completion: March 1, 2018
• Study Completion: March 1, 2018
• Last Updated: April 5, 2018

Record last verified: 2018-04

Locations

US (1)