Phase
Condition
Hearing Impairment
Hearing Loss
Deafness
Treatment
MED-EL Cochlear Implant System
Clinical Study ID
Ages > 5 All Genders
Study Summary
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
Study Description
Connect with a study center
Sunnybrook Health Sciences Center
Toronto, Ontario M4N 3M5
CanadaActive - Recruiting
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois 60611
United StatesSite Not Available
University of Iowa
Iowa City, Iowa 52242-1078
United StatesActive - Recruiting
Massachusetts Eye and Ear
Boston, Massachusetts 02114
United StatesSite Not Available
New York Eye and Ear Infirmary
New York, New York 10003
United StatesActive - Recruiting
University of North Carolina
Chapel Hill, North Carolina 27517
United StatesSite Not Available
Virginia Mason Medical Center
Seattle, Washington 98101
United StatesActive - Recruiting
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