Single-Sided Deafness and Asymmetric Hearing Loss Post-Approval Study

This is a multicenter research study to evaluate the long-term safety and effectiveness of cochlear implantation in adults and children with single-sided deafness and asymmetric hearing loss. Approval for cochlear implantation for single-sided deafness and asymmetric hearing loss was recently obtained by MED-EL Corporation; the FDA requires a post-approval study examining the long-term effects of cochlear implantation in single-sided deafness and asymmetric hearing loss. Data from the University of North Carolina at Chapel Hill reporting on 37 clinical trial subjects with single-sided deafness and asymmetric hearing loss provided the bulk of the evidence used to support this approval. The present study design is a replication of that clinical trial protocol with only necessary modifications to construct a feasible post-approval study protocol. Data from this study has been published and demonstrate significant improvements in speech perception in noise, localization, and quality of life.