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

This study has suspended participant recruitment.
Sponsor:
Information provided by (Responsible Party):
Med-El Corporation
ClinicalTrials.gov Identifier:
NCT00784043
First received: October 30, 2008
Last updated: March 16, 2012
Last verified: March 2012
  Purpose

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 Intervention
Hearing Loss
Device: Cochlear Implant

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Longitudinal Efficacy in Young Children Implanted Bilaterally With MED-EL COMBI 40+ / PULSARCI100/SONATATI100 Cochlear Implant Systems.

Resource links provided by NLM:


Further study details as provided by Med-El Corporation:

Primary Outcome Measures:
  • The primary objective of this investigation is to evaluate and document longitudinal efficacy in young children implanted bilaterally with MED-EL COMBI 40+ / PULSARCI100/SONATATI100 cochlear implant systems. [ Time Frame: 60 months post initial stimulation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To measure post-operative speech perception ability, language acquisition, and speech production over time in bilaterally implanted children. [ Time Frame: 60 months post initial activation ] [ Designated as safety issue: No ]
  • To measure post-operative speech perception ability in noise of bilaterally implanted subjects in the binaural versus monaural conditions [ Time Frame: 60 months post initial activation ] [ Designated as safety issue: No ]
  • To compare post-operative speech perception ability in noise of bilaterally implanted subjects to unilaterally implanted subjects [ Time Frame: 60 months post initial activation ] [ Designated as safety issue: No ]
  • To measure the localization abilities of bilaterally implanted subjects in the binaural versus monaural conditions. [ Time Frame: 60 months post initial activation ] [ Designated as safety issue: No ]
  • To compare localization abilities of bilaterally implanted subjects to unilaterally implanted subjects. [ Time Frame: 60 months post initial activation ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: March 2004
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Cochlear Implant
    Bilateral Implantation in children
    Other Names:
    • MED-EL Cochlear Implant
    • Combi 40+
    • PulsarCI100
    • SonataTI100
  Eligibility

Ages Eligible for Study:   12 Months to 36 Months
Genders Eligible for Study:   Both
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 benefitfrom 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00784043

Locations
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
Callier Center
Dallas, Texas, United States, 75235
Dallas Otolaryngology Associates
Dallas, Texas, United States, 75230
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

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.
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.
Dunn, L, Dunn, L. (1997). Peabody Picture Vocabulary Test Third Edition. Circle Pines, Minnesota: American Guidance Service.
Reynell, J, Gruber, C. (1990). Reynell Developmental Language Scales. Los Angeles, California: Western Psychological Services.
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.
Mawman, D. J., Ramsden, R. T., O'Driscoll, M., Adams, T. & Saeed, S. R. (2000). Bilateral cochlear implantation - a case report. Advances Otorhinolaryngology, 57, 360 363.
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.
Green, J. D, Mills, D. M., Bell, B. A., Luxford, W. M., & Tonokawa, L. L. (1992). Binaural cochlear implants. American Journal of Otology, 6, 502-506.

Responsible Party: Med-El Corporation
ClinicalTrials.gov Identifier: NCT00784043     History of Changes
Other Study ID Numbers: MED-EL NA 013
Study First Received: October 30, 2008
Last Updated: March 16, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Med-El Corporation:
Cochlear implant
hearing loss

Additional relevant MeSH terms:
Hearing Loss
Deafness
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on September 22, 2014