NCT02666222

The Esteem® Hearing Implant Post Approval Study

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 51 (actual)
• Sponsor: Envoy Medical Corporation · Industry
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Accepted

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.

Detailed 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 Investigational Device Exemption (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) were available for continued follow-up. These subjects were re-consented for the 5 year Post Approval Study. No new subjects were enrolled and implanted in this study. The goal was to monitor a minimum of 45 subjects through their five (5) year follow-up. Ultimately, 51 subjects completed the study. 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?

Conditions

• Hearing Loss

Interventions

Type	Name	Description
DEVICE	The Esteem Hearing Implant	The Esteem® Hearing Implant is designed to improve hearing in subjects suffering from moderate to severe hearing loss that is sensorineural in origin. The Esteem® has been approved by FDA for the US market under Pre-Market Approval P090018 and this study fulfills the requirement for one of the Post Approval Studies.

Timeline

• Start date: 2010-08-01
• Primary completion: 2014-08-01
• Completion: 2015-03-01
• First posted: 2016-01-28
• Last updated: 2016-05-04
• Results posted: 2016-05-04

Locations

5 sites across 1 country: United States