Expanded Indications in the MED-EL Pediatric Cochlear Implant Population

Not Applicable

Completed

Interventions: Other: Cochlear Implant
Device: MED-EL SYNCHRONY PIN Cochlear Implant

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Retrospective	Cochlear Implant	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.
Prospective	MED-EL SYNCHRONY PIN Cochlear Implant	Detailed interventions and outcome measures refer to the prospective, experimental study arm. The prospective arm is active but not enrolling.

Primary Outcome Measures

Name	Time	Method
Percent correct on Multisyllabic Lexical Neighborhood Test (MLNT)/Lexical Neighborhood Test (LNT)	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.	Up to 12 Months Post-Activation	Adverse events will be collected and reported throughout the duration of the study.
Total Score on LittlEARS Auditory Questionnaire (LEAQ)	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.

Secondary Outcome Measures

Name	Time	Method
Total Score on Auditory Skills Checklist (ASC)	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.
Total Score on LittlEARS Auditory Questionnaire (LEAQ)	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.
Speech recognition testing in the implanted ear(s)	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.

Locations (8): University of Miami Health System
🇺🇸
Miami, Florida, United States
Ann & Robert H. Lurie Children's Hospital of Chicago
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Chicago, Illinois, United States
Oregon Health and Sciences University
🇺🇸
Portland, Oregon, United States
ENT for Children
🇺🇸
Coppell, Texas, United States
University of North Carolina Hospitals
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Chapel Hill, North Carolina, United States
University of Mississippi Medical Center
🇺🇸
Jackson, Mississippi, United States
Medical College of Wisconsin
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Milwaukee, Wisconsin, United States
UCSF Benioff Children's Hospital Oakland
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Oakland, California, United States