Summary

Eligibility
for people ages 7 months to 6 years (full criteria)
Location
at UCSF
Dates
study started
estimated completion

Description

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.

Keywords

Hearing Loss, Sensorineural Hearing Loss MED-EL SYNCHRONY PIN Cochlear Implant Cochlear Implant Prospective Retrospective

Eligibility

You can join if…

Open to people ages 7 months to 6 years

  • 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

You CAN'T join if...

  • 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

Locations

  • UCSF Benioff Children's Hospital Oakland
    Oakland California 94609 United States
  • Oregon Health and Sciences University
    Portland Oregon 97239-3098 United States

Details

Status
accepting new patients by invitation only
Start Date
Completion Date
(estimated)
Sponsor
Med-El Corporation
ID
NCT03900897
Study Type
Interventional
Participants
Expecting 60 study participants
Last Updated