Single-Sided Deafness and Asymmetric Hearing Loss
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age5+
SponsorMed-El Corporation
About this trial
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 criteria
Qualifiers
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
Disqualifiers
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)
Trial design
Treatments tested in this trial
- MED-EL Cochlear Implant System
Treatment groups
65 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov