Expanded Indications in the MED-EL Pediatric Cochlear Implant Population

Completed · Not applicable

Conditions studied: Hearing Loss, Sensorineural

In brief

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.

Key facts

Study ID

NCT03900897

Run by

Med-El Corporation

People needed

247

Starts

2019-06-17

Expected to finish

2023-11-01

Last updated by the study team

2024-10-15

Who can join

Age: 1 and older, up to 5. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 may not qualify 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

Where it is running

• UCSF Benioff Children's Hospital Oakland — Oakland, California, United States
• University of Miami Health System — Miami, Florida, United States
• Ann & Robert H. Lurie Children's Hospital of Chicago — Chicago, Illinois, United States
• University of Mississippi Medical Center — Jackson, Mississippi, United States
• University of North Carolina Hospitals — Chapel Hill, North Carolina, United States
• Oregon Health and Sciences University — Portland, Oregon, United States
• ENT for Children — Coppell, Texas, United States
• Medical College of Wisconsin — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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