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Safety and Effectiveness of the MED-EL Electric-Acoustic System (EAS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Med-El Corporation
ClinicalTrials.gov Identifier:
NCT00747435
First received: September 4, 2008
Last updated: April 10, 2017
Last verified: April 2017
  Purpose
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.

Condition Intervention
Hearing Loss
Device: Electric Acoustic System

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: The MED-EL EAS (Electric-Acoustic System) Using the PULSARCI100 FLEXeas / SONATATI100 FLEXeas and the DUET Speech Processor

Resource links provided by NLM:


Further study details as provided by Med-El Corporation:

Primary Outcome Measures:
  • Improvement in Speech Perception in Noise With EAS When Compared to the Preoperative Hearing Aid Alone Condition. [ Time Frame: 12 months post initial activation ]
    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.


Secondary Outcome Measures:
  • Improvement in Speech Perception in Noise With EAS When Compared to the Cochlear Implant Alone Condition [ Time Frame: 12 months initial activation ]
    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.

  • Improvement on Speech Perception in the CI-only Condition as Compared to the Preoperative With Hearing Aid Condition. [ Time Frame: 12 months post initial activation ]
    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.

  • Increased Benefit With EAS as Compared to Their Preoperative Hearing Aid Condition as Measured by the APHAB Questionnaire. [ Time Frame: 12 months post initial activation ]
    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.

  • Increase in Satisfaction With EAS Compared to Preoperative Hearing Aid Condition as Measured by the HDSS. [ Time Frame: 12 months post initial activation ]
    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.


Enrollment: 73
Study Start Date: February 2007
Study Completion Date: February 2016
Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Original Audiological Criteria

Inclusion Criteria:

Pure-tone air-conduction threshold levels shall fall at or within the levels listed in the following chart.

Frequency (Hz): 250 500 750 1000 1500 2000 4000 8000 Lower Limit: 10 10 10 60 60 70 70 70 Upper Limit: 65 65 75 *110+ *110+*110+ *110+ *90+

Minimal benefit from optimally fit hearing aid/s, preferably bilateral, with monosyllabic word scores in quiet of ≤50% in the best-aided condition.

Device: Electric Acoustic System
Combination of a cochlear implant and a hearing aid
Other Names:
  • EAS
  • Electric Acoustic Systems
Experimental: Expanded Audiological Criteria

Pure-tone air-conduction threshold levels shall fall at or within the levels listed in the following chart.

Frequency (Hz): 250 500 750 1000 1500 2000 4000 8000 Lower Limit: 10 10 10 60 60 70 70 70 Upper Limit: 65 65 75 *110+ *110+*110+ *110+ *90+

Minimal benefit from optimally fit hearing aid/s, preferably bilateral, with monosyllabic word scores in quiet of ≤50% in the best-aided condition.

Study Arm 2 candidates are those who meet the inclusion criteria listed above with the exception that:

In the ear to be implanted, the pure-tone air conduction threshold(s) at 250, 500, and/or 750 Hz will be greater than or equal to 0 dB HL and less than 10 dB HL, and/or In the ear to be implanted, the pure-tone air conduction threshold(s) at 1000 and/or 1500 Hz will be greater than or equal to 0 dB HL and less than 60 dB HL and/or In their best-aided condition, they score 51-60% on monosyllabic word scores.

Device: Electric Acoustic System
Combination of a cochlear implant and a hearing aid
Other Names:
  • EAS
  • Electric Acoustic Systems

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Audiologic tests suggest a moderate sloping to severe/profound sensorineural hearing loss in the ear to be implanted. The non-implanted ear may fall outside of these criteria; however, threshold levels cannot be better than the indication criteria (for example, the non-implanted ear must be 60 dB or poorer at 1000 Hz, 70 dB or poorer at 2000-8000 Hz).
  • Pure-tone air-conduction threshold levels for the ear to be implanted shall fall at or within the following levels:

    250 Hz - 500 Hz hearing loss less than or equal to 65 dB HL 750 Hz hearing loss less than or equal to 75 dB HL 1000-1500 Hz hearing loss less than or equal to 60 dBHL (ie. 60-110+ dB HL) 2000 Hz - 8000 Hz hearing loss less than or equal to 70 dB HL

  • Pure-tone air-conduction threshold levels shall fall at or within the levels listed in the following chart Frequency (Hz): 250 500 750 1000 1500 2000 4000 8000 Lower Limit: 10 10 10 60 60 70 70 70 Upper Limit: 65 65 75 *110+ *110+ *110+ *110+ *90+
  • Pure-tone air-conduction thresholds for both ears are within 20 dB of each other at 250, 500 and 1000 Hz.
  • Air-bone gap at 500, 1000, 2000 and 4000 Hz should be <10 dB at two or more of these frequencies.
  • Minimal benefit from optimally fit hearing aid/s, preferably bilateral, with monosyllabic word scores in quiet of ≤50% in the best-aided condition.
  • Normal middle ear anatomy and function (based on clinical assessment of tympanometry and acoustic reflex results). No prior middle ear surgery or history of postadolescent, chronic middle ear infections or inner ear disorders (i.e. vertigo or Meniere's syndrome).
  • No evidence that hearing loss origin is retrocochlear.
  • Current user of bilateral acoustic hearing aids for at least 3 months. Note: If the subject has not been a successful hearing aid user (i.e. improper fit, feedback and/or discomfort from high frequency amplification), he/she must complete a hearing aid trial in the ear to be implanted for at least 1 month. If the ear to be implanted is poorer than the contralateral ear, then the subject must complete a hearing aid trial in both ears for at least 1 month to ensure that he/she is tested in the best-aided condition.
  • Adults 18-70 years of age at time of implantation.
  • Persons who currently exhibit sufficient understanding and communicative skills to comprehend general conversation in an "oral/aural mode" through normal conversation channels.
  • English as primary language.
  • Appropriate motivation and expectation levels.

Expanded Criteria:

Study Arm 2 candidates are those who meet the inclusion criteria listed above with the exception that:

In the ear to be implanted, the pure-tone air conduction threshold(s) at 250, 500, and/or 750 Hz will be greater than or equal to 0 dB HL and less than 10 dB HL, and/or In the ear to be implanted, the pure-tone air conduction threshold(s) at 1000 and/or 1500 Hz will be greater than or equal to 0 dB HL and less than 60 dB HL and/or In their best-aided condition, they score 51-60% on monosyllabic word scores.

Exclusion Criteria:

  • Conductive, retrocochlear or central auditory disorders.
  • 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 as demonstrated by serial audiograms. Note: In cases where 2-year documentation is missing, documentation of at least 18 months is necessary along with patient report of no fluctuation in the past 2 years. If 18-month data is unavailable, the patient must be monitored until 18-month data is available.
  • Any physical, psychological, or emotional disorder that would interfere with surgery or the ability to perform on test and rehabilitation procedures.
  • Developmental delays or organic brain dysfunction.
  • Physical or geographic limitations that may interfere with the completion of scheduled follow-up evaluations.
  • Skin or scalp conditions that could preclude magnetic attachment of the speech processor or use of the acoustic hearing aid.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00747435

Locations
United States, California
Stanford University Medical Center
Stanford, California, United States, 94035
United States, Florida
University of Miami
Miami, Florida, United States, 33136
United States, Indiana
Indiana University School of Medicine
Indianapolis, Indiana, United States, 46202
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48108
United States, Nebraska
Boys Town
Omaha, Nebraska, United States, 68131
United States, New York
New York Eye & Ear
New York, New York, United States, 10003
United States, North Carolina
University of North Carolina Hospital
Chapel Hill, North Carolina, United States, 27514
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Oregon
Oregon Health Sciences Center
Portland, Oregon, United States, 97239
United States, Pennsylvania
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, Texas
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
United States, Washington
Swedish Medical Center
Seattle, Washington, United States, 98122
United States, Wisconsin
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
Med-El Corporation
Investigators
Principal Investigator: Debra Tucci, MD Duke University
Principal Investigator: Christina Runge, PhD Medical College of Wisconsin
Principal Investigator: Michael Ruckenstein, MD University of Pennsylvania
Principal Investigator: Hinrich Staecker, MD University of Kansas Medical Center
Principal Investigator: Peter Roland, MD University of Texas Southwestern Medical Center
Principal Investigator: Oliver Adunka, MD University of North Carolina Hospital
Principal Investigator: Ronald Hoffman, MD New York Eye and Ear
Principal Investigator: Richard Miyamoto, MD Indiana University School of Medicine
Principal Investigator: Teresa Zwolan, PhD University of Michigan
Principal Investigator: Nikolas Blevins, MD Stanford University
Principal Investigator: Rodney Lusk, MD Boys Town
Principal Investigator: Fred Telischi, MD University of Miami
Principal Investigator: Douglas Backous, MD Swedish Medical Center
Principal Investigator: Frank Warren, MD Oregon Health Sciences Center
  More Information

Publications:

Responsible Party: Med-El Corporation
ClinicalTrials.gov Identifier: NCT00747435     History of Changes
Other Study ID Numbers: G040002
Study First Received: September 4, 2008
Results First Received: February 13, 2017
Last Updated: April 10, 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No

Keywords provided by Med-El Corporation:
sensorineural hearing loss
ski slope audiogram
electric acoustic stimulation

Additional relevant MeSH terms:
Hearing Loss
Deafness
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on May 24, 2017