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Expanded Indications in the MED-EL Pediatric Cochlear Implant Population

Primary Purpose

Hearing Loss, Sensorineural

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MED-EL SYNCHRONY PIN Cochlear Implant
Cochlear Implant
Sponsored by
Med-El Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hearing Loss, Sensorineural

Eligibility Criteria

7 Months - 6 Years (Child)All SexesDoes not accept 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

Sites / Locations

  • UCSF Benioff Children's Hospital Oakland
  • University of Miami Health System
  • Ann & Robert H. Lurie Children's Hospital of Chicago
  • University of Mississippi Medical Center
  • University of North Carolina Hospitals
  • Oregon Health and Sciences University
  • ENT for Children
  • Medical College of Wisconsin

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Prospective

Retrospective

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
April 1, 2019
Last Updated
August 2, 2023
Sponsor
Med-El Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT03900897
Brief Title
Expanded Indications in the MED-EL Pediatric Cochlear Implant Population
Official Title
Expanded Indications in the MED-EL Pediatric Cochlear Implant Population
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
June 17, 2019 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
October 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Med-El Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss, Sensorineural

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Prospective
Arm Type
Experimental
Arm Description
Detailed interventions and outcome measures refer to the prospective, experimental study arm. The prospective arm is active but not enrolling.
Arm Title
Retrospective
Arm Type
Other
Arm 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.
Intervention Type
Device
Intervention Name(s)
MED-EL SYNCHRONY PIN Cochlear Implant
Other Intervention Name(s)
SYNCHRONY +FLEXSOFT, SYNCHRONY +FLEX28, SYNCHRONY +FLEX24
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Cochlear Implant
Intervention Description
Chart review of subjects implanted with a MED-EL cochlear implant under 6 years of age between January 2005 and October 2020.
Primary Outcome Measure Information:
Title
Total Score on LittlEARS Auditory Questionnaire (LEAQ)
Description
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.
Time Frame
Up to 12 Months Post-Activation
Title
Percent correct on Multisyllabic Lexical Neighborhood Test (MLNT)/Lexical Neighborhood Test (LNT)
Description
Clinical success defined as an improvement of 10 percentage points or more on MLNT/LNT.
Time Frame
Up to 12 Months Post-Activation
Title
Number and proportion of subjects experiencing device- and/or procedure-related adverse events.
Description
Adverse events will be collected and reported throughout the duration of the study.
Time Frame
Up to 12 Months Post-Activation
Secondary Outcome Measure Information:
Title
Total Score on LittlEARS Auditory Questionnaire (LEAQ)
Description
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.
Time Frame
Up to 12 Months Post-Activation
Title
Total Score on Auditory Skills Checklist (ASC)
Description
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.
Time Frame
Up to 12 Months Post-Activation
Title
Speech recognition testing in the implanted ear(s)
Description
Percent change from baseline scores on speech recognition testing with words in quiet and sentences in quiet and noise.
Time Frame
Up to 12 Month Post-Activation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Months
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
UCSF Benioff Children's Hospital Oakland
City
Oakland
State/Province
California
ZIP/Postal Code
94609
Country
United States
Facility Name
University of Miami Health System
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Ann & Robert H. Lurie Children's Hospital of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
University of Mississippi Medical Center
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Facility Name
University of North Carolina Hospitals
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27514
Country
United States
Facility Name
Oregon Health and Sciences University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239-3098
Country
United States
Facility Name
ENT for Children
City
Coppell
State/Province
Texas
ZIP/Postal Code
75019
Country
United States
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Expanded Indications in the MED-EL Pediatric Cochlear Implant Population

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