fbpx
  • Home
  • Study Details
Open

Pediatric Expanded Cochlear Implant Indications (PECII)

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.

Age & Gender

  • 0 years ~ 5.9 years
  • Male, Female, Gender Inclusive

Visit Availability

  • Standard business hours (M-F, 8-5)
  • Visits can be combined with regular clinical appointments

Location

North Carolina (Statewide)

What will be asked of you

At each visit, we will assess your child's listening abilities and reprogram their speech processor(s). Children will be expected to wear the devices all waking hours. This study will involve surgical placement of the internal device.

In-person visits : 12
Total length of participation : 1.25 years

Looking for Specific Volunteers

Able to participate:

  • Children who will be 7 months to 5 years, 11 months old at the time of implantation
  • Bilateral severe to profound sensorineural hearing loss in the high frequencies
  • Insufficient functional access to sound with appropriately fit hearing aids
  • Healthy enough to undergo surgery
  • At least one parent/guardian who is fluent in one of several languages in which questionnaires are available.

Not eligible if:

  • Evidence of an insufficient cochlear nerve
  • Permanent conductive hearing loss or treatable mixed loss
  • History of meningitis or common cavity
  • Suspected cognitive impairment.
  • Inability to complete speech perception testing in English

Contact the Team

Visit Location

100% Remote (online, phone, text)

Additional Study Information

Principal Investigator

Lisa Park
Otolaryngology (ENT)

Study Type

Clinical or Medical

Study Topics

Child and Teen Health
Healthy Volunteer or General Population

IRB Number

19-0461

ClinicalTrials.gov

NCT03900897

logo for the North Carolina Translational and Clinical Sciences Institute
logo for UNC Health
logo for UNC School of Medicine
logo for UNC Research
Research for Me logo

Copyright © 2013-2020 The NC TraCS Institute, the integrated home of the NIH Clinical and Translational Science Awards (CTSA) Program at UNC-CH.  This website is made possible by CTSA Grant UL1TR002489 and the National Center for Advancing Translational Sciences.

Questions?

  • This email address is being protected from spambots. You need JavaScript enabled to view it.