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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00784043
Recruitment Status : Terminated
First Posted : November 2, 2008
Results First Posted : May 25, 2018
Last Update Posted : May 25, 2018
Sponsor:
Information provided by (Responsible Party):
Med-El Corporation

Study Description
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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.

Condition or disease Intervention/treatment Phase
Hearing Loss Device: Cochlear Implant Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Longitudinal Efficacy in Young Children Implanted Bilaterally With MED-EL COMBI 40+ / PULSARCI100/SONATATI100 Cochlear Implant Systems.
Study Start Date : March 2004
Actual Primary Completion Date : September 2009
Actual Study Completion Date : February 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Language Acquisition Over Time in Bilaterally Implanted Children. [ Time Frame: 60 months post initial activation ]
    Scores over time on the MacArthur communicative development inventory.

  2. 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.


Eligibility Criteria
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Ages Eligible for Study:   12 Months to 36 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00784043


Locations
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United States, Florida
Nemours Children's Clinic
Jacksonville, Florida, United States, 32207
United States, Georgia
Children's Healthcare of Atlanta
Atlanta, Georgia, United States, 30324
United States, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44124
United States, Texas
Dallas Otolaryngology Associates
Dallas, Texas, United States, 75230
Callier Center
Dallas, Texas, United States, 75235
Texas Children's Hospital
Houston, Texas, United States, 77030
United States, Virginia
Eastern Virginia Medical School
Norfolk, Virginia, United States, 23507
United States, Wisconsin
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Canada, Ontario
London Health Sciences Centre
London, Ontario, Canada, N6A 5A5
Sponsors and Collaborators
Med-El Corporation
More Information
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Publications:
Caleffe-Schenck, N, Franz, D. (2004). Checklist of Auditory Communication Skills. Volta Review 104(3): 175-196.
Semel, E, Wiig, E, Secord, W. (2003). Clinical Evaluation of Language Fundamentals Fourth Edition. San Antonio, Texas: The Psychological Corporation
Stark, T, Müller, J, Vischer, M, Schön, F, Senn, P, Engel, A, Kompis, M, Hildmann, H, Helms, J. (2002). Multicenter study on bilateral cochlear implantation. In Kubo, T, Takahashi, Y, Iwaki, T, (eds.) Cochlear implants - an update. The Hague: Kugler.
Goldman, R, Fristoe, M. (2000). Goldman-Fristoe Test of Articulation Second Edition. Circle Pines, Minnesota: American Guidance Service.
In Kim, C, Chang, S, Lim, D, (eds). Updates in cochlear implantation. Adv. Otorhinolarygol, Basel: Karger.
Lawson, D, Wilson, B, Zerbi, M, Finley, C. (1999). Fourth quarterly progress report: Speech processors for auditory prostheses. NIH Contract N01-DC-8-2105.
Schön, F, Mueller, J, Helms, J. (1999). Results of bilateral cochlear implantation. European Archives of Oto-Rhino-Laryngology 156:106.
Lawson, D, Zerbi, M, Wilson, B. (1998). First quarterly progress report: Speech processors for auditory prostheses. NIH Contract N01-DC-8-2105.
Dunn, L, Dunn, L. (1997). Peabody Picture Vocabulary Test Third Edition. Circle Pines, Minnesota: American Guidance Service.
Williams, K. (1997). Expressive Vocabulary Test. Circle Pines, Minnesota: American Guidance Service.
Kaufman, N. (1995). Kaufman Speech Praxis Test for Children. Detroit, Michigan: Wayne State University Press.
Fenson, L, Dale, P, Resnick, J, Thal, D, Bates, E, Hartung, J, Pethick, S, Reilly, J. (1993). MacArthur Communicative Development Inventories: User's Guide and Technical Manual. Baltimore, Maryland: Paul H. Brokes Publishing Company.
Reynell, J, Gruber, C. (1990). Reynell Developmental Language Scales. Los Angeles, California: Western Psychological Services.
Jerger, S, Jerger, J. (1984). Pediatric Speech Intelligibility Test. St. Louis, Missouri: Auditec of St. Louis.
Erber, N. (1982). Auditory Training. Washington, DC: Alexander Graham Bell Association.
Haskins, H. (1949). A phonetically balanced test of speech discrimination for children. Master's Theis. Northwestern University, Evanston, Illinois.
Au, D., Hui, Y., Wei, W, & Wong, B. (2002). Speech recognition between bilaterally and unilaterally cochlear implanted and hearing aid fitted users. In Kubo, T., Takahashi Y., & Iwaki, T. (Ed.) Cochlear implants - an update. The Hague: Kugler.
Müller, J., Schoen, F., & Helms, J. (2000). Bilateral cochlear implant - new aspects for the future? In Kim, C. S., Chang, S. O. & Lim, D. (Ed.) Updates in cochlear implantation. Adv. Otorhinolarygol., Basel: Karger.
Lawson, D., Wilson, B., Zerbi, M., & Finley, C. (1999). Fourth Quarterly Progress Report. NIH Contract N01-DC-8-2105. Retrieved from http://npp.ninds.nih.gov/ProgressReports/Speech ProcessorsforAuditoryProstheses%20DC82105/SpeechProcessorsWilson4DC82105.pdf
van Hoesel, R. J. M., & Clark, G. M. (1999). Speech results with a bilateral multi-channel cochlear implant subject for spatially separated signal and noise. Australian Journal of Audiology, 21, 23-28.
Müller, J., Schön, F., & Helms J. (1998). Binaural cochlear implantation: a case report discussing preliminary results. European Archives of Oto-Rhino-Laryngology, 255, 38.
Lawson, D., Zerbi, M., & Wilson, B. (1998). First Quarterly Progress Report. NIH Contract N01-DC-8-2105. Retrieved from http://npp.ninds.nih.gov/ProgressReports/SpeechProcessorsfor AuditoryProstheses%20DC82105/qpr1/qpr1a.html
Lawson, D., Wilson, B., Zerbi, M., & Finley, C. (1996). Fifth Quarterly Progress Report. NIH Contract N01-DC-5-2103. Retrieved from http://npp.ninds.nih.gov/ProgressReports/Speech ProcessorsforAuditoryProstheses%20DC52103/qpr5/qpr5.html.

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Responsible Party: Med-El Corporation
ClinicalTrials.gov Identifier: NCT00784043    
Other Study ID Numbers: MED-EL NA 013
First Posted: November 2, 2008    Key Record Dates
Results First Posted: May 25, 2018
Last Update Posted: May 25, 2018
Last Verified: April 2018
Keywords provided by Med-El Corporation:
Cochlear implant
hearing loss
Additional relevant MeSH terms:
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Hearing Loss
Deafness
Hearing Disorders
Ear Diseases
 Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases