Adults 12 Months to 24 Months, any sex, with Implants, Cochlear or Child. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
The Infant-Toddler Meaningful Auditory Integration Scale (IT-MAIS)Primary· Preoperative through 24 months
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
Preoperative
Group
Value
95% CI
Hybrid L24 and Standard CI
0
± 0
3 months postoperative
Group
Value
95% CI
Hybrid L24 and Standard CI
53
± .07
6 months postoperative
Group
Value
95% CI
Hybrid L24 and Standard CI
64
± .07
12 months postoperative
Group
Value
95% CI
Hybrid L24 and Standard CI
75
± .03
24 months postoperative
Group
Value
95% CI
Hybrid L24 and Standard CI
83
± .05
The Early Speech Perception Four Choice Spondee and MonosyllablePrimary· 48 months
Speech perception test that requires the identification of a spondee or monosyllable from a set of four spondees (i.e., French fry, airplane, hotdog, popcorn) or monosyllables (i.e., ball, book, bird, boat), respectively presented in quiet. The CID test will be scored as total number of words correct. It will be administered in both the unilateral and bilateral listening conditions at 70 dB C. This test is given post-operatively until the child scores a ceiling effect which is considered 90% or better in all test conditions.
The PB-K test has multiple 50-word lists. The test will be scored as total number of words correct as well as phonemically. It will be administered in both the unilateral and bilateral listening conditions at 70 dB C. Test is administered age-appropriately through study completion.
Right Ear
Group
Value
95% CI
Hybrid L24 and Standard CI
80
± 3.5
Left Ear
Group
Value
95% CI
Hybrid L24 and Standard CI
78
± 4.5
Bilateral
Group
Value
95% CI
Hybrid L24 and Standard CI
81
± 5.6
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Sponsor: as reported to ClinicalTrials.gov by University of Iowa
Last refreshed: 8 January 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03156465.