Purpose:~To evaluate the long-term safety and efficacy of the Esteem Totally Implantable Hearing System (hereafter called Esteem) in subjects suffering from moderate to severe hearing loss.~Questions:~The following questions are to be answered:~Is Esteem effective through 1 year follow-up?~Is Esteem safe through 1 year follow-up?~Is the incidence of facial paresis/paralysis at 1 month follow-up no greater than 7%?
The New Enrollment Post-Approval Study is designed to evaluate the safety and efficacy of the Esteem Totally Implantable Hearing System in subjects suffering from moderate to severe hearing loss.