Expanded Indications in the MED-EL Pediatric Cochlear Implant Population

Study Overview
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Brief Summary
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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.

Official Title
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Expanded Indications in the MED-EL Pediatric Cochlear Implant Population

Conditions
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Hearing Loss, Sensorineural

Intervention / Treatment
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* Device: MED-EL SYNCHRONY PIN Cochlear Implant
* Other: Cochlear Implant


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 7 Months
Maximum Age: 6 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prospective<br>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<br>* 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.<br>* Other names: SYNCHRONY +FLEX24;|
| Other: Retrospective<br>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<br>* Chart review of subjects implanted with a MED-EL cochlear implant under 6 years of age between January 2005 and October 2020.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Score on LittlEARS Auditory Questionnaire (LEAQ) | 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. | Up to 12 Months Post-Activation | 
| Percent correct on Multisyllabic Lexical Neighborhood Test (MLNT)/Lexical Neighborhood Test (LNT) | Clinical success defined as an improvement of 10 percentage points or more on MLNT/LNT. | Up to 12 Months Post-Activation | 
| Number and proportion of subjects experiencing device- and/or procedure-related adverse events. | Adverse events will be collected and reported throughout the duration of the study. | Up to 12 Months Post-Activation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Score on LittlEARS Auditory Questionnaire (LEAQ) | 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. | Up to 12 Months Post-Activation | 
| Total Score on Auditory Skills Checklist (ASC) | 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. | Up to 12 Months Post-Activation | 
| Speech recognition testing in the implanted ear(s) | Percent change from baseline scores on speech recognition testing with words in quiet and sentences in quiet and noise. | Up to 12 Month Post-Activation |