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

April 26, 2018 updated by: Med-El Corporation

Longitudinal Efficacy in Young Children Implanted Bilaterally With MED-EL COMBI 40+ / PULSARCI100/SONATATI100 Cochlear Implant Systems.

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

37

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • London, Ontario, Canada, N6A 5A5
        • London Health Sciences Centre
  • United States
    • Florida
      • Jacksonville, Florida, United States, 32207
        • Nemours Children's Clinic
    • Georgia
      • Atlanta, Georgia, United States, 30324
        • Children's Healthcare of Atlanta
    • Ohio
      • Cleveland, Ohio, United States, 44124
        • Cleveland Clinic Foundation
    • Texas
      • Dallas, Texas, United States, 75230
        • Dallas Otolaryngology Associates
      • Dallas, Texas, United States, 75235
        • Callier Center
      • Houston, Texas, United States, 77030
        • Texas Children's Hospital
    • Virginia
      • Norfolk, Virginia, United States, 23507
        • Eastern Virginia Medical School
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Medical College of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 3 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Bilateral
Bilaterally implanted simultaneously
Device: Cochlear Implant
Bilateral Implantation in children
Other Names:
  • MED-EL Cochlear Implant
  • Combi 40+
  • PulsarCI100
  • SonataTI100
Experimental: Unilateral
Unilaterally implanted
Device: Cochlear Implant
Bilateral Implantation in children
Other Names:
  • MED-EL Cochlear Implant
  • Combi 40+
  • PulsarCI100
  • SonataTI100

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Longitudinal Efficacy in Young Children Implanted Bilaterally With MED-EL COMBI 40+ / PULSARCI100/SONATATI100 Cochlear Implant Systems
Time Frame: 60 months post initial stimulation
Speech perception scores will be compared pre-operatively and postoperatively.
60 months post initial stimulation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Language Acquisition Over Time in Bilaterally Implanted Children.
Time Frame: 60 months post initial activation
Scores over time on the MacArthur communicative development inventory.
60 months post initial activation
Speech Production Over Time in Children Implanted Bilaterally With a MED-EL Cochlear Implant.
Time Frame: 5 years
Speech production scores over time on the Goldman-Fristoe test of articulation and the Kaufman speech praxis test for children.
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Med-El Corporation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2004

Primary Completion (Actual)

September 1, 2009

Study Completion (Actual)

February 1, 2017

Study Registration Dates

First Submitted

October 30, 2008

First Submitted That Met QC Criteria

October 31, 2008

First Posted (Estimate)

November 2, 2008

Study Record Updates

Last Update Posted (Actual)

May 25, 2018

Last Update Submitted That Met QC Criteria

April 26, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MED-EL NA 013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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