Single-Sided Deafness and Asymmetric Hearing Loss

Last updated: September 12, 2024
Sponsor: Med-El Corporation
Overall Status: Active - Recruiting

Phase

N/A

Condition

Hearing Impairment

Hearing Loss

Deafness

Treatment

MED-EL Cochlear Implant System

Clinical Study ID

NCT04506853
P000025/S113
  • Ages > 5
  • All Genders

Study Summary

The purpose of the study is to evaluate the long-term safety and effectiveness of cochlear implantation of the approved population in adults and children with single-sided deafness and asymmetric hearing loss.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Five years of age or older at the time of implantation

  • Unilateral profound hearing loss, as defined by a pure-tone average (500, 1000, 2000, and 4000 Hz) of 90 dB or greater in the ear to be implanted

  • Sensorineural hearing loss in the ear to be implanted, as defined by an air-bone gapless than or equal to 10 dB at two or more frequencies out of 500, 1000, 2000, and 4000 Hz and a diagnosed pathology of the outer or middle ear

  • Normal hearing or mild to moderate hearing loss in the non-implanted ear, as definedby a pure-tone average (500, 1000, 2000, and 4000 Hz) of 55 dB or less

  • Word recognition in the ear to be implanted of 5% or less on CNC word score in quiet

  • Previous experience with an appropriately-fit Contralateral Routing of Signal (CROS)hearing aid, BI-Contralateral Routing of Signal (CROS) hearing aid, bone conduction,or traditional hearing aid, as deemed appropriate by investigator

  • Fluent in English

Exclusion

Exclusion Criteria:

  • Duration of profound hearing loss of 10 years or more

  • Absence of cochlear development or non-functionality of cochlear nerve

  • Other retrocochlear hearing loss

  • Evidence of severe cochlear malformation (i.e., common cavity or ossification)

  • External or middle ear infection

  • Suspected developmental or cognitive concern

  • Other medical contraindication for surgery or anesthesia

Study Design

Total Participants: 65
Treatment Group(s): 1
Primary Treatment: MED-EL Cochlear Implant System
Phase:
Study Start date:
February 22, 2021
Estimated Completion Date:
September 30, 2026

Study Description

The study will be conducted as a single-subject, repeated measures, multi center study at 6 sites. Sixty-five subjects will be enrolled in this study. Six centers across the United States and Canada will recruit subjects into this study. Study subjects will be followed for a minimum of 3 years post-implantation of the device.

Connect with a study center

  • Sunnybrook Health Sciences Center

    Toronto, Ontario M4N 3M5
    Canada

    Active - Recruiting

  • Ann & Robert H. Lurie Children's Hospital of Chicago

    Chicago, Illinois 60611
    United States

    Site Not Available

  • University of Iowa

    Iowa City, Iowa 52242-1078
    United States

    Active - Recruiting

  • Massachusetts Eye and Ear

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • New York Eye and Ear Infirmary

    New York, New York 10003
    United States

    Active - Recruiting

  • University of North Carolina

    Chapel Hill, North Carolina 27517
    United States

    Site Not Available

  • Virginia Mason Medical Center

    Seattle, Washington 98101
    United States

    Active - Recruiting

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