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Expanded Indications in the MED-EL Pediatric Cochlear Implant Population

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03900897
Recruitment Status : Enrolling by invitation
First Posted : April 3, 2019
Last Update Posted : March 29, 2022
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 Other: Cochlear Implant Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: Multicenter, open-label, non-randomized, repeated-measures design with two study arms as follows. Prospective: interventional study arm with prospective enrollment and treatment through one year of implant use. Retrospective: observational study arm with retrospective protocol for systematic chart review of patients with at least one year of implant use.
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


Arm Intervention/treatment
Experimental: Prospective
Detailed interventions and outcome measures refer to the prospective, experimental study arm. The prospective arm is active but not enrolling.
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

Retrospective
Study identification, sponsor/collaborators, oversight, purpose, indications, and primary endpoints for the retrospective, observational study arm align with the prospective study arm. The retrospective arm will be enrolling by invitation for chart review of subjects implanted with a MED-EL cochlear implant under 6 years of age between January 2005 and October 2020. The specific devices and outcome measures will vary slightly for retrospective subjects, based on what was clinically available and used at the time of implantation.
Other: Cochlear Implant
Chart review of subjects implanted with a MED-EL cochlear implant under 6 years of age between January 2005 and October 2020.




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


Locations
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United States, California
UCSF Benioff Children's Hospital Oakland
Oakland, California, United States, 94609
United States, Florida
University of Miami Health System
Miami, Florida, United States, 33136
United States, Illinois
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States, 60611
United States, Mississippi
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216
United States, North Carolina
University of North Carolina Hospitals
Chapel Hill, North Carolina, United States, 27514
United States, Oregon
Oregon Health and Sciences University
Portland, Oregon, United States, 97239-3098
United States, Texas
ENT for Children
Coppell, Texas, United States, 75019
United States, Wisconsin
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
Med-El Corporation
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Responsible Party: Med-El Corporation
ClinicalTrials.gov Identifier: NCT03900897    
Obsolete Identifiers: NCT04130113
Other Study ID Numbers: G180269
First Posted: April 3, 2019    Key Record Dates
Last Update Posted: March 29, 2022
Last Verified: March 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
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