Expanded Indications in the MED-EL Pediatric Cochlear Implant Population

NCT03900897 | Completed FDA Device

• 1 other identifier: G180269
• Study Type: interventional
• Target: 247
• Locations: 1 country
• Sites: 8

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.

Conditions

Hearing Loss, Sensorineural

Outcome Measures

Primary Outcomes (3)

• Total Score on LittlEARS Auditory Questionnaire (LEAQ)

  Clinical success defined as a Total Score of 25 or more on the LittLEARS Auditory Questionnaire (LEAQ). Total Score ranges from zero to 35, with higher scores indicating development of increasingly complex listening skills.

  Up to 12 Months Post-Activation

• Percent correct on Multisyllabic Lexical Neighborhood Test (MLNT)/Lexical Neighborhood Test (LNT)

  Clinical success defined as an improvement of 10 percentage points or more on MLNT/LNT.

  Up to 12 Months Post-Activation

• Number and proportion of subjects experiencing device- and/or procedure-related adverse events.

  Adverse events will be collected and reported throughout the duration of the study.

  Up to 12 Months Post-Activation

Secondary Outcomes (3)

• Total Score on LittlEARS Auditory Questionnaire (LEAQ)

  Up to 12 Months Post-Activation

• Total Score on Auditory Skills Checklist (ASC)

  Up to 12 Months Post-Activation

• Speech recognition testing in the implanted ear(s)

  Up to 12 Month Post-Activation

Study Arms (2)

Prospective

EXPERIMENTAL

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

Device: MED-EL SYNCHRONY PIN Cochlear Implant

Retrospective

OTHER

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.

Other: Cochlear Implant

Interventions

MED-EL SYNCHRONY PIN Cochlear Implant DEVICE

Subjects will be implanted with the MED-EL SYNCHRONY PIN Cochlear Implant System with +FLEX24, +FLEX28, +FLEXSOFT electrode arrays. Subjects will be fit with the SONNETEAS (ear-level) and/or RONDO 2 (single-unit) external audio processors.

Also known as: SYNCHRONY +FLEXSOFT, SYNCHRONY +FLEX28, SYNCHRONY +FLEX24

Prospective

Cochlear Implant OTHER

Chart review of subjects implanted with a MED-EL cochlear implant under 6 years of age between January 2005 and October 2020.

Retrospective

Eligibility Criteria

• Age: 7 Months - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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

Sponsors & Collaborators

• Med-El Corporation: lead

Study Sites (8)

UCSF Benioff Children's Hospital Oakland

Oakland, California, 94609, United States

Location

University of Miami Health System

Miami, Florida, 33136, United States

Location

Ann & Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois, 60611, United States

Location

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

Location

University of North Carolina Hospitals

Chapel Hill, North Carolina, 27514, United States

Location

Oregon Health and Sciences University

Portland, Oregon, 97239-3098, United States

Location

ENT for Children

Coppell, Texas, 75019, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Hearing Loss, Sensorineural

Interventions

Cochlear Implants

Condition Hierarchy (Ancestors)

Hearing Loss; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Neural Prostheses; Implantable Neurostimulators; Electrodes, Implanted; Electrodes; Electrical Equipment and Supplies; Equipment and Supplies; Prostheses and Implants; Hearing Aids; Sensory Aids

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 1, 2019
• First Posted: April 3, 2019
• Study Start: June 17, 2019
• Primary Completion: November 1, 2023
• Study Completion: November 1, 2023
• Last Updated: October 15, 2024

Record last verified: 2024-10

Locations

US (8)