Esteem New Subject Enrollment Post Approval Study

Status Completed

Clinical Trial Summary

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.

Clinical Trial 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%? ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02689349
Study type	Interventional
Source	Envoy Medical Corporation
Contact
Status	Completed
Phase	N/A
Start date	August 2010
Completion date	September 2021

View Details

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