Expanded Indications in the MED-EL Pediatric Cochlear Implant Population

Launched by MED-EL CORPORATION · Apr 1, 2019

Keywords

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Gender

ALL

Eligibility criteria

• 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