Bilateral Cochlear Implantation in Children With the MED-EL Cochlear Implant

Inclusion Criteria:

- Between 12 and 36 months of age at time of implantation

- Profound bilateral sensorineural hearing loss

- English as the primary language in the home

- Realistic expectations of guardians

- Child must be enrolled in a post-operative rehabilitative/educational program that
supports the use of cochlear implants and the development of auditory-based skills

- Willing and available to comply with all scheduled procedures as defined in the
protocol

Audiological:

- Profound bilateral sensorineural hearing loss with average thresholds between ears of
90 dB HL or greater at 1000 Hz and above, and must demonstrate minimal functional
benefit from conventional amplification

- Behavioral test measures must include unaided threshold measures for the right and
left ears using insert earphones; left-alone and right-alone aided sound field
threshold measurements; and aided and unaided speech-awareness / detection thresholds
(for each ear individually)

- Children accepted into the study must be able to demonstrate a consistent response to
sound. If a child has no measurable hearing, he/she must be able to demonstrate a
consistent response to vibrotactile stimuli.

- All children must have completed an appropriate trial period with optimally fit
amplification prior to inclusion in the study.

Medical:

- Good general health status, as judged by Primary Investigator

- Patent cochleae bilaterally, as indicated by radiological evaluation

- No contraindications for surgery, in general, or cochlear implant surgery in
particular

Exclusion Criteria:

- Prior experience with any cochlear implant system

- Younger than 12 months or older than 36 months at time of implantation

- Audiological: Presence of otoacoustic emissions and/or cochlear microphonic,
indicating possible condition of auditory neuropathy

Medical:

- Evidence of ossification that would prevent full insertion of the standard C40+ /
PULSARCI100 /SONATATI100 electrode array in the cochlea(e) to be implanted, as
indicated by radiological evaluation

- Abnormal or malformed cochlea(e) to be implanted

- Severed or non-functional auditory nerve in the ear(s) to be implanted

- Central auditory lesion

- Cognitive and/or neurological dysfunction

- Auditory neuropathy