Safety and Effectiveness of the MED-EL Electric-Acoustic System

Summary

The purpose of this investigation is to demonstrate the safety and effectiveness of the MED-EL Electric-Acoustic System (EAS), a medical device that combines the use of a cochlear implant with an external electric-acoustic processor designed to provide benefit in speech perception and sound quality to individuals with a sensorineural hearing loss with minimal changes in residual hearing. The acoustic component of the processor will aid residual acoustic hearing in low frequency ranges, while the cochlear implant and electric component of the processor will be used to electrically stimulate the auditory nerve across a wide range of frequencies necessary for speech perception.

Conditions

• Hearing Loss

Interventions

DEVICE

Electric Acoustic System

Combination of a cochlear implant and a hearing aid

Sponsors & Collaborators

• Med-El Corporation

  lead INDUSTRY

Principal Investigators

• Debra Tucci, MD · Duke University

• Christina Runge, PhD · Medical College of Wisconsin

• Michael Ruckenstein, MD · University of Pennsylvania

• Hinrich Staecker, MD · University of Kansas Medical Center

• Peter Roland, MD · University of Texas Southwestern Medical Center

• Oliver Adunka, MD · University of North Carolina Hospital

• Ronald Hoffman, MD · New York Eye and Ear

• Richard Miyamoto, MD · Indiana University School of Medicine

• Teresa Zwolan, PhD · University of Michigan

• Nikolas Blevins, MD · Stanford University

• Rodney Lusk, MD · Boys Town

• Fred Telischi, MD · University of Miami

• Douglas Backous, MD · Swedish Medical Center

• Frank Warren, MD · Oregon Health Sciences Center

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2007-02-28

Primary Completion

2016-02-29

Completion

2016-02-29

FDA Device

Yes

Countries

• United States

Study Locations