Last updated on February 2018

Esteem New Subject Enrollment Post Approval Study

---

Brief description of 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.

Detailed Study Description

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%?