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

April 10, 2017 updated by: Med-El Corporation

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

73

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Stanford, California, United States, 94035
        • Stanford University Medical Center
    • Florida
      • Miami, Florida, United States, 33136
        • University of Miami
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University School of Medicine
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Medical Center
    • Michigan
      • Ann Arbor, Michigan, United States, 48108
        • University of Michigan
    • Nebraska
      • Omaha, Nebraska, United States, 68131
        • Boys Town
    • New York
      • New York, New York, United States, 10003
        • New York Eye & Ear
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27514
        • University of North Carolina Hospital
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health Sciences Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Hospital of the University of Pennsylvania
    • Texas
      • Dallas, Texas, United States, 75390
        • University of Texas Southwestern Medical Center
    • Washington
      • Seattle, Washington, United States, 98122
        • Swedish Medical Center
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Medical College of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months post initial activation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months initial activation
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.
12 months post initial activation
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.
12 months post initial activation
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.
12 months post initial activation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Med-El Corporation

Investigators

  • Principal Investigator: Teresa Zwolan, PhD, University of Michigan
  • Principal Investigator: Hinrich Staecker, MD, University of Kansas Medical Center
  • 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: 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: Nikolas Blevins, MD, Stanford University
  • Principal Investigator: Rodney Lusk, MD, Boys Town
  • Principal Investigator: Douglas Backous, MD, Swedish Medical Center
  • Principal Investigator: Frank Warren, MD, Oregon Health Sciences Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2007

Primary Completion (Actual)

February 1, 2016

Study Completion (Actual)

February 1, 2016

Study Registration Dates

First Submitted

September 4, 2008

First Submitted That Met QC Criteria

September 4, 2008

First Posted (Estimate)

September 5, 2008

Study Record Updates

Last Update Posted (Actual)

May 17, 2017

Last Update Submitted That Met QC Criteria

April 10, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • G040002

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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