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Expanded Indications in the MED-EL Pediatric Cochlear Implant Population

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ClinicalTrials.gov Identifier: NCT03900897
Recruitment Status : Recruiting
First Posted : April 3, 2019
Last Update Posted : July 9, 2019
Sponsor:
Information provided by (Responsible Party):
Med-El Corporation

Brief Summary:
The purpose of this investigation is to demonstrate the safety and effectiveness of MED‐EL cochlear implants in children 7 months to 5 years, 11 months of age who fall outside the current FDA‐approved candidacy criteria and, yet, continue to demonstrate insufficient functional access to sound with appropriately fit hearing aids and aural habilitation.

Condition or disease Intervention/treatment Phase
Hearing Loss, Sensorineural Device: MED-EL SYNCHRONY PIN Cochlear Implant Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Expanded Indications in the MED-EL Pediatric Cochlear Implant Population
Actual Study Start Date : June 17, 2019
Estimated Primary Completion Date : July 2022
Estimated Study Completion Date : July 2022

Resource links provided by the National Library of Medicine



Intervention Details:
  • Device: MED-EL SYNCHRONY PIN Cochlear Implant
    Subjects will be implanted with the MED-EL SYNCHRONY PIN Cochlear Implant System with +FLEX24, +FLEX28, +FLEXSOFT electrode arrays. Subjects will be fit with the SONNETEAS (ear-level) and/or RONDO 2 (single-unit) external audio processors.
    Other Names:
    • SYNCHRONY +FLEXSOFT
    • SYNCHRONY +FLEX28
    • SYNCHRONY +FLEX24


Primary Outcome Measures :
  1. Total Score on LittlEARS Auditory Questionnaire (LEAQ) [ Time Frame: Up to 12 Months Post-Activation ]
    Clinical success defined as a Total Score of 25 or more on the LittLEARS Auditory Questionnaire (LEAQ). Total Score ranges from zero to 35, with higher scores indicating development of increasingly complex listening skills.

  2. Percent correct on Multisyllabic Lexical Neighborhood Test (MLNT)/Lexical Neighborhood Test (LNT) [ Time Frame: Up to 12 Months Post-Activation ]
    Clinical success defined as an improvement of 10 percentage points or more on MLNT/LNT.

  3. Number and proportion of subjects experiencing device- and/or procedure-related adverse events. [ Time Frame: Up to 12 Months Post-Activation ]
    Adverse events will be collected and reported throughout the duration of the study.


Secondary Outcome Measures :
  1. Total Score on LittlEARS Auditory Questionnaire (LEAQ) [ Time Frame: Up to 12 Months Post-Activation ]
    Change from baseline in Total Score on the LittlEARS Auditory Questionnaire (LEAQ). Total Score ranges from zero to 35, with higher scores indicating development of increasingly complex listening skills. The LittlEARS Auditory Questionnaire is intended for young children with zero to 24 months of listening experience.

  2. Total Score on Auditory Skills Checklist (ASC) [ Time Frame: Up to 12 Months Post-Activation ]
    Change from baseline in Total Score on the Auditory Skills Checklist (ASC). Total Score ranges from zero to 70, with higher scores indicating development of increasingly complex listening skills. The Auditory Skills Checklist is intended for children from zero to 18 years of age.

  3. Speech recognition testing in the implanted ear(s) [ Time Frame: Up to 12 Month Post-Activation ]
    Percent change from baseline scores on speech recognition testing with words in quiet and sentences in quiet and noise.



Information from the National Library of Medicine

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Ages Eligible for Study:   7 Months to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Children 7 months to 5 years 11 months of age at the time of implantation
  • Bilateral, severe to profound sensorineural hearing loss (SNHL) in the high frequencies and

    • For subjects implanted under 12 months of age: bilateral, severe to profound SNHL in the low frequencies
    • For subjects implanted at 12 months to 5 years 11 months of age: bilateral, mild to profound sensorineural hearing loss in the low frequencies
  • Insufficient functional access to sound with appropriately fit amplification and aural habilitation
  • Objective measures consistent with repeatable unaided audiometric thresholds for subjects under 12 months of age
  • Radiologic evidence of potential for full insertion with one of the included electrode arrays
  • Ability to undergo general anesthesia
  • At least one parent/guardian who is fluent in one of the available languages of the LEAQ
  • Parental commitment to study parameters

Exclusion Criteria:

  • Magnetic Resonance Imaging (MRI) evidence of cochlear nerve deficiency
  • Active middle ear infection
  • Permanent conductive hearing loss
  • Treatable mixed hearing loss
  • Current or history of meningitis
  • Common cavity
  • Skin or scalp condition precluding use of external audio processor
  • Suspected cognitive impairment, organic brain dysfunction, or syndromic etiology that may affect performance
  • ASA (American Society of Anesthesiologists) Class 3 or higher in subjects under 12 months of age
  • History of prior use of a hearing implant
  • Unrealistic parental/patient expectations
  • Child is not able to complete speech perception testing in English

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03900897


Contacts
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Contact: MED-EL Corporation 1-888-633-3524 research.us@medel.com

Locations
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United States, North Carolina
University of North Carolina Hospitals Recruiting
Chapel Hill, North Carolina, United States, 27514
Contact: Lisa Park, AuD       Lisa_Park@med.unc.edu   
Principal Investigator: Lisa Park, AuD         
United States, Texas
ENT for Children Recruiting
Coppell, Texas, United States, 75019
Contact: Paul Bauer, M.D.       bauer@entforchildren.net   
Contact: Janée Gisclair, M.A.       gisclair@entforchildren.net   
Principal Investigator: Paul Bauer, M.D.         
Sub-Investigator: Janée Gisclair, M.A.         
Sponsors and Collaborators
Med-El Corporation

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Responsible Party: Med-El Corporation
ClinicalTrials.gov Identifier: NCT03900897     History of Changes
Other Study ID Numbers: G180269
First Posted: April 3, 2019    Key Record Dates
Last Update Posted: July 9, 2019
Last Verified: July 2019

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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

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