Clinical trial NCT03900897: Expanded Indications in the MED-EL Pediatric Cochlear Implant Population
Official title: Expanded Indications in the MED-EL Pediatric Cochlear Implant Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hearing Loss, Sensorineural
Lead sponsor: Med-El Corporation
Sponsor class: INDUSTRY
First posted: 2019-04-03
Enrollment: 247
Sex: ALL
Minimum age (years): 7
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Multicenter, open-label, non-randomized, repeated-measures design with two study arms as follows. Prospective: interventional study arm with prospective enrollment and treatment through one year of implant use. Retrospective: observational study arm with retrospective protocol for systematic chart review of patients with at least one year of implant use.
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Total Score on LittlEARS Auditory Questionnaire (LEAQ)
timeFrame: Up to 12 Months Post-Activation
measure: Percent correct on Multisyllabic Lexical Neighborhood Test (MLNT)/Lexical Neighborhood Test (LNT)
timeFrame: Up to 12 Months Post-Activation
measure: Number and proportion of subjects experiencing device- and/or procedure-related adverse events.
timeFrame: Up to 12 Months Post-Activation
Secondary outcomes:
measure: Total Score on LittlEARS Auditory Questionnaire (LEAQ)
timeFrame: Up to 12 Months Post-Activation
measure: Total Score on Auditory Skills Checklist (ASC)
timeFrame: Up to 12 Months Post-Activation
measure: Speech recognition testing in the implanted ear(s)
timeFrame: Up to 12 Month Post-Activation
Other outcomes:
Locations:
city: Oakland
country: United States
facility: UCSF Benioff Children's Hospital Oakland
state: California
city: Miami
country: United States
facility: University of Miami Health System
state: Florida
city: Chicago
country: United States
facility: Ann & Robert H. Lurie Children's Hospital of Chicago
state: Illinois
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Mississippi
city: Chapel Hill
country: United States
facility: University of North Carolina Hospitals
state: North Carolina
city: Portland
country: United States
facility: Oregon Health and Sciences University
state: Oregon
city: Coppell
country: United States
facility: ENT for Children
state: Texas
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
Study officials:
References: