Expanded Indications in the MED-EL Pediatric Cochlear Implant Population

Hearing Loss, Sensorineural Clinical Trial

Official title:

Expanded Indications in the MED-EL Pediatric Cochlear Implant Population

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03900897
• Other study ID #: G180269
• Status: Completed
• Phase: N/A
• Start date: June 17, 2019
• Est. completion date: November 1, 2023

Study information

• Verified date: April 2024
• Source: Med-El Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Other known NCT identifiers

• NCT04130113

Recruitment information / eligibility

• Status: Completed
• Enrollment: 247
• Est. completion date: November 1, 2023
• Est. primary completion date: November 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Months to 6 Years

Eligibility

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

Related Conditions & MeSH terms

• Hearing Loss
• Hearing Loss, Sensorineural

Intervention

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

Locations

Country	Name	City	State
United States	University of North Carolina Hospitals	Chapel Hill	North Carolina
United States	Ann & Robert H. Lurie Children's Hospital of Chicago	Chicago	Illinois
United States	ENT for Children	Coppell	Texas
United States	University of Mississippi Medical Center	Jackson	Mississippi
United States	University of Miami Health System	Miami	Florida
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	UCSF Benioff Children's Hospital Oakland	Oakland	California
United States	Oregon Health and Sciences University	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Med-El Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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