Cochlear implantation for single-sided deafness and asymmetric hearing loss
Single-Sided Deafness and Asymmetric Hearing Loss Post-Approval Study
This study is testing if cochlear implants can help adults and children with single-sided deafness and uneven hearing improve their hearing and quality of life over three years.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 65 (estimated) |
| Ages | 5 Years and up |
| Sex | All |
| Sponsor | Med-El Corporation Industry-sponsored |
| Locations | 6 sites (Chicago, Illinois and 5 other locations) |
| Trial ID | NCT04506853 on ClinicalTrials.gov |
What this trial studies
This study evaluates the long-term safety and effectiveness of cochlear implantation in adults and children suffering from single-sided deafness and asymmetric hearing loss. Conducted as a multi-center study across six sites in the United States and Canada, it aims to enroll 65 subjects who will be followed for a minimum of three years post-implantation. The study utilizes the MED-EL Cochlear Implant System to assess improvements in hearing outcomes and overall quality of life for participants.
Who should consider this trial
Good fit: Ideal candidates include individuals aged five years or older with unilateral profound sensorineural hearing loss and normal or mild to moderate hearing in the non-implanted ear.
Not a fit: Patients with bilateral profound hearing loss or those who do not meet the specific audiological criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly improve hearing capabilities and quality of life for patients with single-sided deafness and asymmetric hearing loss.
How similar studies have performed: Previous studies have shown promising results with cochlear implantation in similar populations, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Chicago, Illinois and 5 other locations
- Ann & Robert H. Lurie Children's Hospital of Chicago — Chicago, Illinois, United States (Withdrawn)
- University of Iowa — Iowa City, Iowa, United States (Recruiting)
- New York Eye and Ear Infirmary — New York, New York, United States (Recruiting)
- University of North Carolina — Chapel Hill, North Carolina, United States (Active_not_recruiting)
- Virginia Mason Medical Center — Seattle, Washington, United States (Recruiting)
- Sunnybrook Health Sciences Center — Toronto, Ontario, Canada (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.