Office of Device Evaluation Lead-MED-EL EAS Extended f/u Study
Status: Completed
Location: See all (7) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 18 years of age or older at the time of implantation
• Severe to profound sensorineural hearing loss for frequencies greater than 1500 Hz (i.e., threshold no better than 70 dB HL at 2000-8000 Hz)
• Low-frequency thresholds up to and including 500 Hz no poorer than 65 dB HL
• CNC word recognition score less than or equal to 60% in the ear to be implanted
• CNC word recognition score less than or equal to 60% in the contralateral ear
• English spoken as the primary language
Locations
United States
California
Stanford Unversity
Palo Alto
Florida
University of Miami
Miami
Kansas
University of Kansas University Medical Center
Kansas City
North Carolina
University of North Carolina
Chapel Hill
Pennsylvania
The Hospital of the University of Pennsylvania
Philadelphia
Texas
University of Texas Southwestern Medical Center
Dallas
Wisconsin
Medical College of Wisconsin
Milwaukee
Time Frame
Start Date: 2016-12
Completion Date: 2019-12
Participants
Target number of participants: 50
Treatments
Other: Study procedures
Authors
Margaret Dillon, Michael Ruckenstein
Related Therapeutic Areas
Sponsors
Leads: Med-El Corporation