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Completed

NCT Number: NCT03900897

Expanded Indications in the MED-EL Pediatric Cochlear Implant Population

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.

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Key information

Conditions

Hearing Loss, Sensorineural Ear Diseases Hearing Disorders Hearing Loss Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms

Age range

7 month–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UCSF Benioff Children's Hospital Oakland, Oakland, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MED-EL SYNCHRONY PIN Cochlear Implant

Device

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

Cochlear Implant

Other

Chart review of subjects implanted with a MED-EL cochlear implant under 6 years of age between January 2005 and October 2020.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Med-El Corporation

Industry

Registry information

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Apr 3, 2019
Registry last updated
Oct 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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