Expanded Indications in the MED-EL Pediatric Cochlear Implant Population

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 highfrequencies and

• For subjects implanted under 12 months of age: bilateral, severe to profoundSNHL 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 andaural habilitation

• Objective measures consistent with repeatable unaided audiometric thresholds forsubjects under 12 months of age

• Radiologic evidence of potential for full insertion with one of the includedelectrode arrays

• Ability to undergo general anesthesia

• At least one parent/guardian who is fluent in one of the available languages of theLEAQ

• 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 etiologythat may affect performance

• ASA (American Society of Anesthesiologists) Class 3 or higher in subjects under 12months 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