Expanded Indications in the MED-EL Pediatric Cochlear Implant Population

MED-EL

Status: Completed

Conditions: Hearing Loss, Sensorineural

Treatments: Other: Cochlear Implant; Device: MED-EL SYNCHRONY PIN Cochlear Implant

Study type: Interventional

Funder types: Industry

Identifiers

NCT03900897

G180269

Details and patient eligibility

About

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.

Enrollment: 247 patients

Sex: All

Ages: 7 months to 5 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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247 participants in 2 patient groups

Prospective

Experimental group

Description:

Detailed interventions and outcome measures refer to the prospective, experimental study arm. The prospective arm is active but not enrolling.

Treatment:

Device: MED-EL SYNCHRONY PIN Cochlear Implant

Retrospective

Other group

Description:

Study identification, sponsor/collaborators, oversight, purpose, indications, and primary endpoints for the retrospective, observational study arm align with the prospective study arm. The retrospective arm will be enrolling by invitation for chart review of subjects implanted with a MED-EL cochlear implant under 6 years of age between January 2005 and October 2020. The specific devices and outcome measures will vary slightly for retrospective subjects, based on what was clinically available and used at the time of implantation.

Treatment:

Other: Cochlear Implant