Expanded Indications in the MED-EL Pediatric Cochlear Implant Population

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: July 2022

Interventions

  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • 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.

Secondary Measures

  • 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 7 Months

Maximum Age: 6 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Med-El Corporation
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • MED-EL Corporation, 1-888-633-3524, research.us@medel.com

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