Sensorineural Hearing Loss Clinical Trial
Official title:
Esteem Totally Implantable Hearing System New Subject Enrollment Post Approval Study
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.
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%? ;
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