Single-Sided Deafness and Asymmetric Hearing Loss

Description

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.

Conditions

Hearing Loss, Unilateral, Hearing Loss, Sensorineural

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Study Overview

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Study Details

Study overview

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.

Single-Sided Deafness and Asymmetric Hearing Loss Post-Approval Study

Single-Sided Deafness and Asymmetric Hearing Loss

Condition
Hearing Loss, Unilateral
Intervention / Treatment

-

Contacts and Locations

Chicago

Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago, Illinois, United States, 60611

Iowa City

University of Iowa, Iowa City, Iowa, United States, 52242-1078

New York

New York Eye and Ear Infirmary, New York, New York, United States, 10003

Chapel Hill

University of North Carolina, Chapel Hill, North Carolina, United States, 27517

Seattle

Virginia Mason Medical Center, Seattle, Washington, United States, 98101

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

5 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Med-El Corporation,

Study Record Dates

2026-09