Single-Sided Deafness and Asymmetric Hearing Loss Post-Approval Study
Med-El Corporation
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.
Description
The study will be conducted as a single-subject, repeated measures, multi center study at 6 sites. Sixty-five subjects will be enrolled in this study. Six centers across the United States and Canada will recruit subjects into this study. Study subjects will be followed for a minimum of 3 years post-implantation of the device.
Eligibility
- Age range
- 5+ years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- DeviceMED-EL Cochlear Implant System
Cochlear implant and audio processor
Locations (6)
- Ann & Robert H. Lurie Children's Hospital of ChicagoChicago, Illinois
- University of IowaIowa City, Iowa
- New York Eye and Ear InfirmaryNew York, New York
- University of North CarolinaChapel Hill, North Carolina
- Virginia Mason Medical CenterSeattle, Washington
- Sunnybrook Health Sciences CenterToronto, Ontario