Expanded Indications in the MED-EL Pediatric Cochlear Implant Population

  • STATUS
    Recruiting
  • End date
    Jul 9, 2022
  • participants needed
    60
  • sponsor
    Med-El Corporation
Updated on 9 March 2021
anesthesia
deafness
cochlear implant
AIDS
profound sensorineural hearing loss

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.

Details
Condition Sensorineural hearing loss
Treatment MED-EL SYNCHRONY PIN Cochlear Implant
Clinical Study IdentifierNCT03900897
SponsorMed-El Corporation
Last Modified on9 March 2021

Eligibility

Yes No Not Sure

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
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