The Esteem® Hearing Implant Post Approval Study

Hearing Loss Clinical Trial

Official title: To Evaluate the Long-term Safety and Efficacy of the Esteem® Hearing Implant in Subjects Suffering From Moderate to Severe Hearing Loss

Status Completed

Clinical Trial Summary

The purpose of this study is to evaluate the long-term safety and efficacy of the Esteem® Hearing Implant in subjects suffering from moderate to severe hearing loss.

Clinical Trial Description

The Post Approval Study is an extension of the pivotal clinical trial, which was designed as a prospective, multi-center, non-randomized, clinical trial to evaluate the safety and efficacy of the Esteem® System. For this trial the subject acts as his or her own control.

This trial has been designed to meet the United States' regulatory requirements.

The subjects included in this study include the 57 subjects implanted under the original IDE study and the five (5) subjects implanted under the continued access expansion approved by the FDA. Of these 62 subjects, all but one (explant) are available for continued follow-up. These subjects will be re-consented for the 5 year Post Approval Study. No new subjects will be enrolled and implanted in this study. The goal will be to monitor the 61 remaining subjects through their five (5) year follow-up.

The following questions are to be answered:

• Is the Esteem effective through 5 year follow-up?

• Is the Esteem safe through 5 year follow-up? ;

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Deafness
• Hearing Loss

• NCT number: NCT02666222
• Study type: Observational
• Source: Envoy Medical Corporation
• Status: Completed
• Phase: Phase 4
• Start date: March 2011
• Completion date: January 2016