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Bilateral Cochlear Implantation in Children With the MED-EL Cochlear Implant

Primary Purpose

Hearing Loss

Status
Terminated
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
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 focused on measuring Cochlear implant, hearing loss

Eligibility Criteria

12 Months - 36 Months (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Between 12 and 36 months of age at time of implantation
  • Profound bilateral sensorineural hearing loss
  • English as the primary language in the home
  • Realistic expectations of guardians
  • Child must be enrolled in a post-operative rehabilitative/educational program that supports the use of cochlear implants and the development of auditory-based skills
  • Willing and available to comply with all scheduled procedures as defined in the protocol

Audiological:

  • Profound bilateral sensorineural hearing loss with average thresholds between ears of 90 dB HL or greater at 1000 Hz and above, and must demonstrate minimal functional benefit from conventional amplification
  • Behavioral test measures must include unaided threshold measures for the right and left ears using insert earphones; left-alone and right-alone aided sound field threshold measurements; and aided and unaided speech-awareness / detection thresholds (for each ear individually)
  • Children accepted into the study must be able to demonstrate a consistent response to sound. If a child has no measurable hearing, he/she must be able to demonstrate a consistent response to vibrotactile stimuli.
  • All children must have completed an appropriate trial period with optimally fit amplification prior to inclusion in the study.

Medical:

  • Good general health status, as judged by Primary Investigator
  • Patent cochleae bilaterally, as indicated by radiological evaluation
  • No contraindications for surgery, in general, or cochlear implant surgery in particular

Exclusion Criteria:

  • Prior experience with any cochlear implant system
  • Younger than 12 months or older than 36 months at time of implantation
  • Audiological: Presence of otoacoustic emissions and/or cochlear microphonic, indicating possible condition of auditory neuropathy

Medical:

  • Evidence of ossification that would prevent full insertion of the standard C40+ / PULSARCI100 /SONATATI100 electrode array in the cochlea(e) to be implanted, as indicated by radiological evaluation
  • Abnormal or malformed cochlea(e) to be implanted
  • Severed or non-functional auditory nerve in the ear(s) to be implanted
  • Central auditory lesion
  • Cognitive and/or neurological dysfunction
  • Auditory neuropathy

Sites / Locations

  • Nemours Children's Clinic
  • Children's Healthcare of Atlanta
  • Cleveland Clinic Foundation
  • Dallas Otolaryngology Associates
  • Callier Center
  • Texas Children's Hospital
  • Eastern Virginia Medical School
  • Medical College of Wisconsin
  • London Health Sciences Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Bilateral

Unilateral

Arm Description

Bilaterally implanted simultaneously

Unilaterally implanted

Outcomes

Primary Outcome Measures

Longitudinal Efficacy in Young Children Implanted Bilaterally With MED-EL COMBI 40+ / PULSARCI100/SONATATI100 Cochlear Implant Systems
Speech perception scores will be compared pre-operatively and postoperatively.

Secondary Outcome Measures

Language Acquisition Over Time in Bilaterally Implanted Children.
Scores over time on the MacArthur communicative development inventory.
Speech Production Over Time in Children Implanted Bilaterally With a MED-EL Cochlear Implant.
Speech production scores over time on the Goldman-Fristoe test of articulation and the Kaufman speech praxis test for children.

Full Information

First Posted
October 30, 2008
Last Updated
April 26, 2018
Sponsor
Med-El Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT00784043
Brief Title
Bilateral Cochlear Implantation in Children With the MED-EL Cochlear Implant
Official Title
Longitudinal Efficacy in Young Children Implanted Bilaterally With MED-EL COMBI 40+ / PULSARCI100/SONATATI100 Cochlear Implant Systems.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Terminated
Study Start Date
March 2004 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
February 2017 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to evaluate and document longitudinal efficacy in young children implanted bilaterally with MED-EL COMBI 40+ / PULSARCI100/SONATATI100 cochlear implant systems.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss
Keywords
Cochlear implant, hearing loss

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
37 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bilateral
Arm Type
Experimental
Arm Description
Bilaterally implanted simultaneously
Arm Title
Unilateral
Arm Type
Experimental
Arm Description
Unilaterally implanted
Intervention Type
Device
Intervention Name(s)
Cochlear Implant
Other Intervention Name(s)
MED-EL Cochlear Implant, Combi 40+, PulsarCI100, SonataTI100
Intervention Description
Bilateral Implantation in children
Primary Outcome Measure Information:
Title
Longitudinal Efficacy in Young Children Implanted Bilaterally With MED-EL COMBI 40+ / PULSARCI100/SONATATI100 Cochlear Implant Systems
Description
Speech perception scores will be compared pre-operatively and postoperatively.
Time Frame
60 months post initial stimulation
Secondary Outcome Measure Information:
Title
Language Acquisition Over Time in Bilaterally Implanted Children.
Description
Scores over time on the MacArthur communicative development inventory.
Time Frame
60 months post initial activation
Title
Speech Production Over Time in Children Implanted Bilaterally With a MED-EL Cochlear Implant.
Description
Speech production scores over time on the Goldman-Fristoe test of articulation and the Kaufman speech praxis test for children.
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Months
Maximum Age & Unit of Time
36 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Between 12 and 36 months of age at time of implantation Profound bilateral sensorineural hearing loss English as the primary language in the home Realistic expectations of guardians Child must be enrolled in a post-operative rehabilitative/educational program that supports the use of cochlear implants and the development of auditory-based skills Willing and available to comply with all scheduled procedures as defined in the protocol Audiological: Profound bilateral sensorineural hearing loss with average thresholds between ears of 90 dB HL or greater at 1000 Hz and above, and must demonstrate minimal functional benefit from conventional amplification Behavioral test measures must include unaided threshold measures for the right and left ears using insert earphones; left-alone and right-alone aided sound field threshold measurements; and aided and unaided speech-awareness / detection thresholds (for each ear individually) Children accepted into the study must be able to demonstrate a consistent response to sound. If a child has no measurable hearing, he/she must be able to demonstrate a consistent response to vibrotactile stimuli. All children must have completed an appropriate trial period with optimally fit amplification prior to inclusion in the study. Medical: Good general health status, as judged by Primary Investigator Patent cochleae bilaterally, as indicated by radiological evaluation No contraindications for surgery, in general, or cochlear implant surgery in particular Exclusion Criteria: Prior experience with any cochlear implant system Younger than 12 months or older than 36 months at time of implantation Audiological: Presence of otoacoustic emissions and/or cochlear microphonic, indicating possible condition of auditory neuropathy Medical: Evidence of ossification that would prevent full insertion of the standard C40+ / PULSARCI100 /SONATATI100 electrode array in the cochlea(e) to be implanted, as indicated by radiological evaluation Abnormal or malformed cochlea(e) to be implanted Severed or non-functional auditory nerve in the ear(s) to be implanted Central auditory lesion Cognitive and/or neurological dysfunction Auditory neuropathy
Facility Information:
Facility Name
Nemours Children's Clinic
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Facility Name
Children's Healthcare of Atlanta
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30324
Country
United States
Facility Name
Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44124
Country
United States
Facility Name
Dallas Otolaryngology Associates
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
Callier Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Facility Name
Texas Children's Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Eastern Virginia Medical School
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
London Health Sciences Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5A5
Country
Canada

12. IPD Sharing Statement

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Bilateral Cochlear Implantation in Children With the MED-EL Cochlear Implant

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