Iowa Cochlear Implant Clinical Research Center Hybrid L24 and Standard Cochlear Implants in Profo… (NCT03156465) | Clinical Trial Compass
CompletedNot Applicable
Iowa Cochlear Implant Clinical Research Center Hybrid L24 and Standard Cochlear Implants in Profoundly Deaf Infants
United States11 participantsStarted 2011-09-15
Plain-language 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.
Who can participate
Age range12 Months – 24 Months
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Twelve to twenty-four months of age at the time of implantation.
✓. Audiometric thresholds for frequencies 250 to 8000 Hz in the profound hearing range bilaterally. The type of hearing loss must be categorized as sensorineural in nature.
✓. English spoken as a primary language (mono-lingual English speaking family, where English is the primary language).
✓. Willingness to comply with all study requirements.
✓. Minimum of three-month hearing aid trial with appropriately fit hearing aids.
✓. Patent cochlea and normal cochlear anatomy as shown by a CT scan. It is standard clinical practice to perform a CT scan on any patient pursuing cochlear implantation.
Exclusion criteria
✕. Medical or psychological conditions that contraindicate undergoing surgery.
✕. Ossification or any other cochlear anomaly that might prevent complete insertion of the electrode array.
✕
What they're measuring
1
The Infant-Toddler Meaningful Auditory Integration Scale (IT-MAIS)
Timeframe: Preoperative through 24 months
2
The Early Speech Perception Four Choice Spondee and Monosyllable
. Developmental disabilities or other conditions that would prevent or restrict participation in the audiological evaluations and clinical trial.
✕. Hearing loss of neural or central origin.
✕. Unrealistic expectations on the part of the candidate and/or candidate's family, regarding the possible benefits, risks, and limitations that are inherent to the surgical procedure(s) and prosthetic devices.
✕. Unwillingness or inability of the candidate to comply with all investigational requirements.