Status:
RECRUITING
Single-Sided Deafness and Asymmetric Hearing Loss
Lead Sponsor:
Med-El Corporation
Conditions:
Hearing Loss, Unilateral
Hearing Loss, Sensorineural
Eligibility:
All Genders
5+ years
Phase:
NA
Brief 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 hear...
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 w...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 22 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT04506853
Start Date
February 22 2021
End Date
December 1 2026
Last Update
September 24 2025
Active Locations (6)
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1
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States, 60611
2
University of Iowa
Iowa City, Iowa, United States, 52242-1078
3
New York Eye and Ear Infirmary
New York, New York, United States, 10003
4
University of North Carolina
Chapel Hill, North Carolina, United States, 27517