Single-Sided Deafness and Asymmetric Hearing Loss

  • STATUS
    Recruiting
  • End date
    Sep 24, 2026
  • participants needed
    65
  • sponsor
    Med-El Corporation
Updated on 24 March 2022

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.

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.

Details
Condition Hearing Loss, Unilateral, Hearing Loss, Sensorineural
Treatment MED-EL Cochlear Implant System
Clinical Study IdentifierNCT04506853
SponsorMed-El Corporation
Last Modified on24 March 2022

Eligibility

Yes No Not Sure

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 gap less 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 defined by 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 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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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