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NCT04506853NARecruiting

Single-Sided Deafness and Asymmetric Hearing Loss

Med-El Corporation

Start Date

2/22/2021

Completion Date

12/1/2026

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.

Detailed 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.

Eligibility Criteria

Age Range: 5 years to No maximum

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

Interventions

DEVICE

MED-EL Cochlear Implant System

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Conditions

Hearing Loss, UnilateralHearing Loss, Sensorineural

Locations

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

Chicago, Illinois 60611

United States

University of Iowa

Iowa City, Iowa 52242-1078

United States

New York Eye and Ear Infirmary

New York, New York 10003

United States

University of North Carolina

Chapel Hill, North Carolina 27517

United States

Virginia Mason Medical Center

Seattle, Washington 98101

United States

Sunnybrook Health Sciences Center

Toronto, Ontario M4N 3M5

Canada