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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
73
Combination of a cochlear implant and a hearing aid
Stanford University Medical Center
Stanford, California, United States
University of Miami
Miami, Florida, United States
Indiana University School of Medicine
Indianapolis, Indiana, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
University of Michigan
Ann Arbor, Michigan, United States
Boys Town
Omaha, Nebraska, United States
New York Eye & Ear
New York, New York, United States
University of North Carolina Hospital
Chapel Hill, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
Oregon Health Sciences Center
Portland, Oregon, United States
...and 4 more locations
Improvement in Speech Perception in Noise With EAS When Compared to the Preoperative Hearing Aid Alone Condition.
CUNY sentences in noise are scored as the percent correct of words in each sentence. The total percent correct for preoperative hearing aid use was subtracted from the total percent correct for EAS at 12 months giving a percentage point improvement in speech perception with EAS.
Time frame: 12 months post initial activation
Improvement in Speech Perception in Noise With EAS When Compared to the Cochlear Implant Alone Condition
CUNY sentences in noise are scored as the percent correct of words in each sentence. The total percent correct for the CI Alone condition was subtracted from the total percent correct for the EAS condition at 12 months giving an improvement in speech perception with EAS compared to CI Alone.
Time frame: 12 months initial activation
Improvement on Speech Perception in the CI-only Condition as Compared to the Preoperative With Hearing Aid Condition.
CNC words are scored as the percent correct out of 50 words. The percent correct for preoperative hearing aid use was subtracted from the percent correct for CI Alone at 12 months giving an improvement on speech perception for CI Alone compared to preoperative hearing aids.
Time frame: 12 months post initial activation
Increased Benefit With EAS as Compared to Their Preoperative Hearing Aid Condition as Measured by the APHAB Questionnaire.
A lower score on the APHAB indicates a better performance. The global score for preoperative hearing aid use was subtracted from the global score for EAS at 12 months giving an improvement on the APHAB with EAS.
Time frame: 12 months post initial activation
Increase in Satisfaction With EAS Compared to Preoperative Hearing Aid Condition as Measured by the HDSS.
Satisfaction is ranked from 1-5, with 1 being very dissatisfied and 5 being very satisfied. Data reported is the percentage of subjects who experienced an increase in satisfaction when using EAS compared to preoperative hearing aids.
Time frame: 12 months post initial activation
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