RecruitingHearing Loss, UnilateralHearing Loss, Sensorineural
Single-Sided Deafness and Asymmetric Hearing Loss
Eligible age
5+ yrs
Accepts
All genders
Locations
5 states
Healthy volunteers
No
See if you qualify for this study
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About this study
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.
Sponsor: Med-El Corporation
You may qualify if…
- ✓ 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
You may not qualify if…
- ✕ 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
Where it's recruiting
Source: ClinicalTrials.gov · NCT04506853 · last updated 2025-09-24