Clinical Trial: Electric-Acoustic Stimulation Extended Follow-up Post Approval Study

Study Status: Enrolling by invitation
Recruit Status: Enrolling by invitation
Study Type: Interventional

Official Title: Office of Device Evaluation Lead-MED-EL EAS Extended f/u Study

Brief Summary: The MED-EL EAS Extended Follow-up Study is an extended follow-up of the subjects who were enrolled in the pivotal study to assess long-term safety and device performance.

Detailed Summary: The study will be conducted as a prospective, non-controlled, non-randomized, multicenter study at the 14 sites. Up to 68 available subjects who were enrolled in the pivotal study will be invited to participate in the extended follow-up. Study subjects will be followed for a minimum of 5 years post-implantation of the device.
Sponsor: Med-El Corporation

Current Primary Outcome: Long-term effectiveness of the Electric-Acoustic System will be assessed by speech perception testing completed through five years post-implantation. [ Time Frame: Five years (60 months) post-implantation ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Long-term safety will be assessed by monitoring the type and frequency of reported adverse events. Adverse events will be reported by the number and proportion of subjects experiencing device-related adverse events. [ Time Frame: Through study completion assessed for a total of at least 5 years post-implantation ]

Original Secondary Outcome: Same as current

Information By: Med-El Corporation

Dates:
Date Received: January 13, 2017
Date Started: December 2016
Date Completion: December 2019
Last Updated: May 4, 2017
Last Verified: May 2017