Electric-Acoustic Stimulation Extended Follow-up Post Approval Study

Completed · Not applicable

Conditions studied: Hearing Loss, Sensorineural

In brief

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.

Key facts

Study ID

NCT03031678

Run by

Med-El Corporation

People needed

50

Starts

2016-12-01

Expected to finish

2019-12-01

Last updated by the study team

2020-09-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Conductive, retrocochlear, or central auditory disorder
• Hearing loss in the ear to be implanted that has demonstrated a recent fluctuation at two or more frequencies of 15 dB in either direction in the last 2 years
• Any physical, psychological, or emotional disorder that interferes with surgery or the ability to perform on test and rehabilitation procedures
• Developmental delays or organic brain dysfunction
• Unrealistic expectations on the part of the subject, regarding the possible benefits, risks, and limitations
• Unwillingness or inability of the candidate to comply with all investigational requirements

Where it is running

• Stanford Unversity — Palo Alto, California, United States
• University of Miami — Miami, Florida, United States
• University of Kansas University Medical Center — Kansas City, Kansas, United States
• University of North Carolina — Chapel Hill, North Carolina, United States
• The Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States
• University of Texas Southwestern Medical Center — Dallas, Texas, United States
• Medical College of Wisconsin — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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