Principal Investigator
Enrollment Status
Clinical Trial ID
Clinical Trial 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.
Phase
N/A
Funding Agency/Sponsor
Industry
Disease
Other
Enrollment Eligibility
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