Single-Sided Deafness and Asymmetric Hearing Loss

Launched by MED-EL CORPORATION · Aug 6, 2020

Keywords

ClinConnect Summary

This clinical trial is looking at the long-term safety and effectiveness of cochlear implants for people with single-sided deafness and asymmetric hearing loss. Essentially, this means they are studying how well cochlear implants work for individuals who can hear well in one ear but have significant hearing loss in the other ear. The trial is open to both adults and children aged 5 years and older who have a specific type of hearing loss that meets certain criteria, such as very poor hearing in one ear and normal or mild hearing loss in the other.

Participants in this trial can expect to undergo a cochlear implant procedure, which is a surgical treatment designed to help them hear better. To be eligible, they need to have a certain level of hearing loss in the affected ear and have tried other hearing aids before. It’s important to note that people with very long-term hearing loss, certain ear conditions, or specific medical issues may not qualify. Overall, this study aims to provide more information about how effective cochlear implants can be for improving hearing in individuals with these specific hearing challenges.

Gender

ALL

Eligibility criteria

• 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 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 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