Expanded Indications in the MED-EL Pediatric Cochlear Implant Population

• ClinicalTrials.gov Identifier: NCT03900897
• Recruitment Status: Recruiting
• First Posted: April 3, 2019
• Last Update Posted: February 27, 2020
• Sponsor: Med-El Corporation
• Information provided by (Responsible Party): Med-El Corporation

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Hearing Loss, Sensorineural	Device: MED-EL SYNCHRONY PIN Cochlear Implant	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 60 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Expanded Indications in the MED-EL Pediatric Cochlear Implant Population
• Actual Study Start Date: June 17, 2019
• Estimated Primary Completion Date: July 2022
• Estimated Study Completion Date: July 2022

Arms and Interventions

Intervention Details:

• 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

Outcome Measures

Primary Outcome Measures :

1. Total Score on LittlEARS Auditory Questionnaire (LEAQ) [ Time Frame: Up to 12 Months Post-Activation ]
   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.
2. Percent correct on Multisyllabic Lexical Neighborhood Test (MLNT)/Lexical Neighborhood Test (LNT) [ Time Frame: Up to 12 Months Post-Activation ]
   Clinical success defined as an improvement of 10 percentage points or more on MLNT/LNT.
3. Number and proportion of subjects experiencing device- and/or procedure-related adverse events. [ Time Frame: Up to 12 Months Post-Activation ]
   Adverse events will be collected and reported throughout the duration of the study.

Secondary Outcome Measures :

1. Total Score on LittlEARS Auditory Questionnaire (LEAQ) [ Time Frame: Up to 12 Months Post-Activation ]
   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.
2. Total Score on Auditory Skills Checklist (ASC) [ Time Frame: Up to 12 Months Post-Activation ]
   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.
3. Speech recognition testing in the implanted ear(s) [ Time Frame: Up to 12 Month Post-Activation ]
   Percent change from baseline scores on speech recognition testing with words in quiet and sentences in quiet and noise.

Eligibility Criteria

• Ages Eligible for Study: 7 Months to 6 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, Florida

University of Miami Health System; Recruiting

Miami, Florida, United States, 33136

Contact: Ivette Cejas, PhD 305-243-9199 ICejas@med.miami.edu

Contact: Christina Sarangoulis 305-243-8397 cmd247@med.miami.edu

Principal Investigator: Ivette Cejas, PhD

United States, Illinois

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

Chicago, Illinois, United States, 60611

Contact: Nancy Young, MD 312-227-3075 NYoung@luriechildrens.org

Contact: Denise Thomas, AuD 312-227-3075 dthomas@luriechildrens.org

Principal Investigator: Nancy Young, MD

Sub-Investigator: Denise Thomas, Au.D,CCC-A

United States, Mississippi

University of Mississippi Medical Center; Recruiting

Jackson, Mississippi, United States, 39216

Contact: Jeffrey Carron, MD 601-984-5162 jcarron@umc.edu

Contact: Victoria Gonzalez, AuD, PhD 601-984-5162 vgonzalez@umc.edu

Principal Investigator: Jeffery Carron, MD

Sub-Investigator: Victoria Gonzalez, AuD,PhD

United States, North Carolina

University of North Carolina Hospitals; Recruiting

Chapel Hill, North Carolina, United States, 27514

Contact: Lisa Park, AuD 919-966-8926 Lisa_Park@med.unc.edu

Principal Investigator: Lisa Park, AuD

United States, Texas

ENT for Children; Recruiting

Coppell, Texas, United States, 75019

Contact: Paul Bauer, M.D. 972-745-8400 bauer@entforchildren.net

Contact: Janée Gisclair, M.A. 972-745-8400 gisclair@entforchildren.net

Principal Investigator: Paul Bauer, M.D.

Sub-Investigator: Janée Gisclair, M.A.

Sponsors and Collaborators

Med-El Corporation

More Information

• Responsible Party: Med-El Corporation
• ClinicalTrials.gov Identifier: NCT03900897
• Obsolete Identifiers: NCT04130113
• Other Study ID Numbers: G180269
• First Posted: April 3, 2019
• Last Update Posted: February 27, 2020
• Last Verified: February 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes

Additional relevant MeSH terms:

Hearing Loss; Hearing Loss, Sensorineural; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases