NCT02689349

Esteem New Subject Enrollment Post Approval Study

Esteem Totally Implantable Hearing System New Subject Enrollment Post Approval Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 117 (actual)
• Sponsor: Envoy Medical Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed 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%?

Conditions

• Sensorineural Hearing Loss

Interventions

Type	Name	Description
DEVICE	Implantation of Esteem	Subjects meeting indications are implanted with the Esteem Totally Implantable Hearing System

Timeline

• Start date: 2010-08-01
• Primary completion: 2021-09-01
• Completion: 2021-09-01
• First posted: 2016-02-23
• Last updated: 2022-06-27
• Results posted: 2022-06-01

Locations

6 sites across 1 country: United States