Expanded Indications in the MED-EL Pediatric Cochlear Implant Population

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.

Study Overview

• Status: Completed
• Conditions: Hearing Loss, Sensorineural
• Intervention / Treatment: Device: MED-EL SYNCHRONY PIN Cochlear Implant; Other: Cochlear Implant

• Study Type: Interventional
• Enrollment (Actual): 247
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Oakland, California, United States, 94609
      • UCSF Benioff Children's Hospital Oakland
  • Florida
    • Miami, Florida, United States, 33136
      • University of Miami Health System
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Ann & Robert H. Lurie Children's Hospital of Chicago
  • Mississippi
    • Jackson, Mississippi, United States, 39216
      • University of Mississippi Medical Center
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27514
      • University of North Carolina Hospitals
  • Oregon
    • Portland, Oregon, United States, 97239-3098
      • Oregon Health and Sciences University
  • Texas
    • Coppell, Texas, United States, 75019
      • ENT for Children
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Medical College of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 months to 6 years (Child)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Prospective; 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; 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.; Other Names: SYNCHRONY +FLEXSOFT; SYNCHRONY +FLEX28; SYNCHRONY +FLEX24
Other: Retrospective; 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; Chart review of subjects implanted with a MED-EL cochlear implant under 6 years of age between January 2005 and October 2020.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Score on LittlEARS Auditory Questionnaire (LEAQ)	Change from baseline in Total Score on the LittlEARS Auditory Questionnaire (LEAQ). Total Score ranges from zero to 35, with higher scores indicating development of increasingly complex listening skills. The LittlEARS Auditory Questionnaire is intended for young children with zero to 24 months of listening experience.	Up to 12 Months Post-Activation
Total Score on Auditory Skills Checklist (ASC)	Change from baseline in Total Score on the Auditory Skills Checklist (ASC). Total Score ranges from zero to 70, with higher scores indicating development of increasingly complex listening skills. The Auditory Skills Checklist is intended for children from zero to 18 years of age.	Up to 12 Months Post-Activation
Speech recognition testing in the implanted ear(s)	Percent change from baseline scores on speech recognition testing with words in quiet and sentences in quiet and noise.	Up to 12 Month Post-Activation

Collaborators and Investigators

• Sponsor: Med-El Corporation

Study record dates

Study Major Dates

• Study Start (Actual): June 17, 2019
• Primary Completion (Actual): November 1, 2023
• Study Completion (Actual): November 1, 2023

Study Registration Dates

• First Submitted: April 1, 2019
• First Submitted That Met QC Criteria: April 1, 2019
• First Posted (Actual): April 3, 2019

Study Record Updates

• Last Update Posted (Actual): April 9, 2024
• Last Update Submitted That Met QC Criteria: April 8, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Hearing Loss; Hearing Loss, Sensorineural
• Other Study ID Numbers: G180269

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes