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Pediatric Expanded Cochlear Implant Indications (PECII)

University of North Carolina at Chapel Hill


Description

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 FDA-approved candidacy criteria, but are not making enough progress with hearing aids and auditory therapy.


Keywords:

Ears, Hearing, Pediatrics


Category:

Device

Qualifications

 


Age
0 - 5 years


Gender
Any


Study Population

Infants under 12 months of age with severe-to-profound hearing loss in both ears. Children 12 months of age or older with bilateral moderate to profound hearing loss.


Investigator

Lisa Park
Research Assistant Professor
Otolaryngology (ENT)

For questions, contact:

Lisa Park
Lisa_Park@med.unc.edu
(919) 419-1449
Visit Website

Recruitment Period End

March 31, 2022

Location

Primary Location
The Children's Cochlear Implant Center at UNC
5501 Fortunes Ridge Dr A, Durham, NC 27713, USA
Secondary Location
UNC Hospitals
101 Manning Drive N.C, Children's Hospital, Chapel Hill, NC 27514, USA

Study Qualifications

Gender Any

Age Range 0 - 5 years

Participant qualification(s) 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 under 12 months of age and those wanting implants in both ears: Severe to profound hearing loss in both ears For subjects implanted aged 12 months to 5 years, 11 months of age: bilateral, mild to profound hearing loss in the low frequencies. MRI that shows the cochlea is able to be implanted with a full electrode array. Healthy enough for anesthesia At least one parent/guardian who is fluent in English. Parental commitment to study parameters, as determined by the implant team

Not eligible if: MRI that shows a missing or incomplete cochlear nerve Active middle ear infection Permanent conductive hearing loss Treatable mixed hearing loss A history of meningitis A cochlea that is shaped as a common cavity Suspected cognitive impairment History of prior use of a hearing implant Unrealistic parental/patient expectations Child is not able to complete developmentally-appropriate speech perception testing in English

Number of Visits

    » 12 In person visit(s)

    1 Screening (audiology and medical), 1 Surgery, 1 Switch on, 9 audiology visits

    » 0 Remote visit(s)

Participation Period

1.25 years

Compensation

By clicking I am interested, your contact information will be sent to the researcher/study coordinator for this study. The coordinator will respond by email with additional information on how to proceed.