Clinical Trial: Iowa Cochlear Implant Clinical Research Center Hybrid L24 and Standard Cochlear Implants in Profoundly Deaf Infants

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Iowa Cochlear Implant Clinical Research Center Hybrid L24 and Standard Cochlear Implants in Profoundly Deaf Infants

Brief Summary: The purpose of this feasibility study is to evaluate whether implantation of one Nucleus L24 electrode array and one FDA approved standard-length device in the contralateral ear can provide useful binaural hearing in pediatric subjects who have bilateral severe to profound hearing loss, meeting the criteria for cochlear implantation. Unlike a conventional cochlear implant, the Nucleus L24 is expected to preserve the regions of the cochlear partition that are apical to the electrode, thus leaving them available for possible future advances in the field of otolaryngology and hearing devices, such as mammalian hair cell regeneration techniques or improved implantable hearing devices. Whether or not this group of children will be able to take advantage of future hair cell regeneration strategies is yet to be determined and will have to wait for future development. At this time there are no accurate imaging strategies available to identify preservation of the scala media. Ultra thin micro CT scanning is in development, however the level of radiation delivery to the subject is too great to be considered for clinical use. When imaging strategies become available to determine cellular structure of the inner ear, they will be applied to this group of subjects. The Nucleus L24 array stimulates the basal turn of the cochlea, in an attempt to preserve the middle and apical regions of the scala media.

Detailed Summary:

The purpose of this feasibility study is to evaluate whether a Nucleus L24 and a FDA approved standard-length device in the contralateral ear can provide useful binaural hearing in pediatric subjects who have bilateral profound hearing loss, meeting the criteria for cochlear implantation. Unlike a conventional cochlear implant, the Nucleus L24 is designed to preserve the regions of the cochlear partition that are apical to the electrode, thus leaving them available for possible future advances in the field of otolaryngology and hearing devices, such as mammalian hair cell regeneration techniques or improved implantable hearing devices. The Nucleus L24 (16 mm) array stimulates the basal turn of the cochlea, in an attempt to preserve the middle and apical regions of the scala media.

The study will be conducted as a repeated-measure, single-subject experiment. A single-subject research design (in which each participant serves as his or her own control) is appropriate because it accommodates the heterogeneity that characterizes hearing-impaired populations. Blinding or masking procedures are not included in the design, as it is not possible to conceal the presence or absence of a cochlear implant from device recipients and/or clinical investigators.

Preoperatively, candidates will be assessed with their current amplification to evaluate their appropriateness for entrance into the study. The candidates' audiometric configuration must meet the above inclusion criteria. That is, the candidate must have a profound sensorineural hearing loss from 250 to 8000 Hz. Prior to testing, the appropriateness of the hearing aid fitting will be assessed and adjustments made if necessary. In cases where amplification has not been used for more than one year, new hearing aids will be fit, worn for a minimum three-month trial and the participant
Sponsor: Bruce J Gantz

Current Primary Outcome:

  • The Infant-Toddler Meaningful Auditory Integration Scale (IT-MAIS) [ Time Frame: PreOperative ]
    Parent questionnaire that consists of ten questions regarding a young infant or toddler's auditory behavior, e.g. "Does the child spontaneously respond to his/her name in quiet with auditory cues?" Each question is scored on a five point scale: 0=never, 1=rarely, 2=occasionally, 3=frequently, and 4=always. The aim of this tool is to assess the benefit of the child's personal amplification device(s). This questionnaire is generally used during the cochlear implant work-up to assess hearing aid benefit. It is also used post-cochlear implantation to chart the progress the child is making with his/her cochlear implant when other formalized speech perception tests are not appropriate.
  • The Infant-Toddler Meaningful Auditory Integration Scale (IT-MAIS) [ Time Frame: Post-operative through 2 years ]
    Parent questionnaire that consists of ten questions regarding a young infant or toddler's auditory behavior, e.g. "Does the child spontaneously respond to his/her name in quiet with auditory cues?" Each question is scored on a five point scale: 0=never, 1=rarely, 2=occasionally, 3=frequently, and 4=always. The aim of this tool is to assess the benefit of the child's personal amplification device(s). This questionnaire is generally used during the cochlear implant work-up to assess hearing aid benefit. It is also used post-cochlear implantation to chart the progress the child is making with his/her cochlear implant when other formalized speech perception tests are not appropriate.
  • The Glendonald Auditory Screening Procedure Word Test (GASP) [ Time Frame: 

    Original Primary Outcome: Same as current

    Current Secondary Outcome:

    • The Preschool Language Scale-3 (PLS-3) [ Time Frame: Pre-Operative ]
      A standardized language test that is used to measure the language development of children with normal hearing aged 0 months to 83 months. The test evaluates "Expressive Communication" and "Auditory Comprehension" and is designed to evaluate skills in a variety of areas: vocal development, social communication, attention, semantics (content), structure (form), and integrative thinking skills.
    • The Preschool Language Scale-3 (PLS-3) [ Time Frame: Post-operatively through study completion at which time the child is 5 years of age. ]
      A standardized language test that is used to measure the language development of children with normal hearing aged 0 months to 83 months. The test evaluates "Expressive Communication" and "Auditory Comprehension" and is designed to evaluate skills in a variety of areas: vocal development, social communication, attention, semantics (content), structure (form), and integrative thinking skills.
    • Peabody Picture Vocabulary Development Scale (PPVT). [ Time Frame: Post-operatively through study completion at which time the child is 5 years of age. ]
      The PPVT (Dunn & Dunn, 1997) is a standardized, norm-referenced measure of receptive vocabulary skills. The test is a multiple-choice measure consisting of sets of four black and white line drawings. The examiner names one of the pictures and the test recipient is expected to indicate which picture has been labeled, either verbally or through pointing.
    • Goldman-Fristoe Test of Articulation-2 [ Time Frame: Post-operatively through study completion at which time the child is 5 years of age. ]
      The GFTA-2 is a standardized, norm-based articulation measure that samples spontaneous sound production. Children are asked to respond to picture plates and verbal cues from the examiner with single words that test consonant accuracy in initial, medial, and final positions. This measure has norms based on the performance of normal-hearing children from age 2 years to 21 years.


    Original Secondary Outcome: Same as current

    Information By: University of Iowa

    Dates:
    Date Received: April 14, 2017
    Date Started: September 15, 2011
    Date Completion: September 2020
    Last Updated: May 15, 2017
    Last Verified: May 2017