Clinical Trial: 0205 Esteem New Subject Enrollment Post Approval Study

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Esteem Totally Implantable Hearing System New Subject Enrollment Post Approval Study

Brief Summary: The New Enrollment Post-Approval Study is designed to evaluate the long-term safety and efficacy of the Esteem Totally Implantable Hearing System in subjects suffering from moderate to severe hearing loss.

Detailed Summary:

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 5 year follow-up?
• Is Esteem safe through 5 year follow-up?
• Is the incidence of facial paresis/paralysis at 1 month follow-up no greater than 7%?

Sponsor: Envoy Medical Corporation

Current Primary Outcome:

• Change in Speech Reception Threshold (SRT) [ Time Frame: Change in SRT from Baseline Aided to 10-month post-activation with Esteem ]
  Comparison of the speech reception threshold (SRT) using the Esteem System as compared to the pre-implant aided condition
• Change in Word Recognition Score (WRS) [ Time Frame: Change in WRS from Baseline Aided to 10-month post-activation with Esteem ]
  Comparison of the word recognition score using the Esteem compared to the pre-implant aided condition
• Incidence of SADEs, Device Failures, & Replacements [ Time Frame: Incidence at 10-month post-activation ]
  The analysis of the incidence of Serious Adverse Device Effects (SADEs) and device failures and replacements
• Incidence of Facial Pareses/Paralysis [ Time Frame: Incidence at one month post-op ]
  The analysis of the incidence of facial pareses/paralysis at one month follow-up
• Change in Bone Conduction Threshold (BCT) [ Time Frame: Change in BCT from Baseline to 10-month post-activation ]
  Comparison of bone conduction (BC) threshold post activation compared to the pre-implant BC threshold

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Change in Subjective Quality of Life as Measured with APHAB [ Time Frame: Change from Baseline Aided to 10-month post-activation with Esteem ]
  To show that the Esteem System improves Quality of Life when compared to the pre-implant aided condition, as shown by Abbreviated Profile of Hearing Aid Benefit (APHAB) results
• Esteem Questionnaire Results [ Time Frame: 10-month post-activation with Esteem ]
  To gather subject feedback and comments on the use of the Esteem System through subject ratings on questionnaire items specifically focusing on factors such as the clarity of sound, the user's ability to understand speech in background noise, naturalness of sound, benefits of the system, etc. -- relative to the pre-implant aided condition

Original Secondary Outcome: Same as current

Information By: Envoy Medical Corporation

Dates:
Date Received: February 8, 2016
Date Started: August 2010
Date Completion: July 2020
Last Updated: February 18, 2016
Last Verified: September 2015