RecruitingNot ApplicableNCT04506853
Single-Sided Deafness and Asymmetric Hearing Loss
Single-Sided Deafness and Asymmetric Hearing Loss Post-Approval Study
Sponsor
Med-El Corporation
Enrollment
65 participants
Start Date
Feb 22, 2021
Study Type
INTERVENTIONAL
Conditions
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.
Eligibility
Min Age: 5 Years
Inclusion Criteria7
- 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 Criteria7
- 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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Interventions
DEVICEMED-EL Cochlear Implant System
Cochlear implant and audio processor
Locations(6)
View Full Details on ClinicalTrials.gov
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NCT04506853
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