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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
September 4, 2008
April 10, 2017
February 2007
February 2016   (Final data collection date for primary outcome measure)
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.
Not Provided
Complete list of historical versions of study NCT00747435 on ClinicalTrials.gov Archive Site
  • 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.
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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
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.
Not Provided
Interventional
Not Provided
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Hearing Loss
Device: Electric Acoustic System
Combination of a cochlear implant and a hearing aid
Other Names:
  • EAS
  • Electric Acoustic Systems
  • 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.

    Intervention: Device: Electric Acoustic System
  • 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.

    Intervention: Device: Electric Acoustic System

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
73
February 2016
February 2016   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00747435
G040002
No
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
Not Provided
Med-El Corporation
Med-El Corporation
Not Provided
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
Med-El Corporation
April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP