NCT00747435

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

The MED-EL EAS (Electric-Acoustic System) Using the PULSARCI100 FLEXeas / SONATATI100 FLEXeas and the DUET Speech Processor

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 73 (actual)
• Sponsor: Med-El Corporation · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DEVICE	Electric Acoustic System	Combination of a cochlear implant and a hearing aid

Timeline

• Start date: 2007-02-01
• Primary completion: 2016-02-01
• Completion: 2016-02-01
• First posted: 2008-09-05
• Last updated: 2017-05-17
• Results posted: 2017-05-17

Locations

14 sites across 1 country: United States

Regulatory

• FDA-regulated device study