Expanded Indications in the MED-EL Pediatric Cochlear Implant Population

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.

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