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
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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%?
Clinical Study Identifier: NCT02689349
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Andy Anderson, PhD
Lahey Hospital and Medical Center Burlington, MA United States2.28miles
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