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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 : March 1, 2021
Sponsor:
Information provided by (Responsible Party):
Med-El Corporation

Tracking Information
First Submitted Date  ICMJE April 1, 2019
First Posted Date  ICMJE April 3, 2019
Last Update Posted Date March 1, 2021
Actual Study Start Date  ICMJE June 17, 2019
Estimated Primary Completion Date July 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 3, 2019)
  • 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.
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: April 1, 2019)
  • 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 LEAQ
  • 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
  • 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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 3, 2019)
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 1, 2019)
  • Total score on LittlEARS Auditory Questionnaire (LEAQ) and Auditory Skills Checklist (ASC) [ Time Frame: Up to 12 Months Post-Activation ]
    Change from baseline score and total score on LEAQ and ASC
  • 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 on words in quiet and sentences in quiet and noise.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Expanded Indications in the MED-EL Pediatric Cochlear Implant Population
Official Title  ICMJE Expanded Indications in the MED-EL Pediatric Cochlear Implant Population
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hearing Loss, Sensorineural
Intervention  ICMJE 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
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 1, 2019)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2022
Estimated Primary Completion Date July 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 7 Months to 6 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03900897
Other Study ID Numbers  ICMJE G180269
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Med-El Corporation
Study Sponsor  ICMJE Med-El Corporation
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Med-El Corporation
Verification Date February 2021

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