NCT02310399|RecruitingDMCFDA Device
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Sponsor study identifier
interventional
20
1 country
1
Study Start
May 2014
Actual (reported)Primary Completion
May 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
May 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
This study is a feasibility study of the Nucleus 24 ABI in children without NF2. It will be conducted as a repeated-measures, single subject experiment in order to accommodate the known variability in cochlear implant clinical results. Data obtained in the course of this study will be compared with the existing published outcome data from children with normal hearing and with cochlear implants (CIs). These comparisons may provide additional useful information about the progress of ABI subjects' performance over time. Also, this may allow the results of the current study to be utilized to design future pivotal studies of the device in the pediatric population.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 2014
Actual (reported)November 28, 2014
Actual (reported)December 8, 2014
Actual (reported)May 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
May 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
ABI Device Complications
Study participants will be monitored on a case-by-case basis for ongoing or unanticipated medical complications. Adverse events will be tracked on a case-by-case basis and recorded at the time of occurrence and followed up at resolution. Any adverse events will be reported to the NYUSOM IRB. Should there be concern for the safety of the subjects because of their participation in the study by the investigators or the IRB, the study would be halted at least temporarily and a detailed discussion with the investigators and the IRB would be undertaken.
5 Years from date of surgery
Audiologic Performance with ABI (Hearing, Speech and Language Assessments)
36 months from date of surgery
Surgical implantation of the Nucleus ABI541 Auditory Brainstem Implant in prelingiustically deaf children ages 18 months - 5 years
Surgical implantation of the Nucleus ABI541 Auditory Brainstem Implant in postlinguistically deaf children \< 21 years of age
Surgical implantation of the Nucleus ABI541 Auditory Brainstem Implant device
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
NYU Cochlear Implant Center
New York, New York, 10016, United States
Colletti V, Shannon R, Carner M, Veronese S, Colletti L. Outcomes in nontumor adults fitted with the auditory brainstem implant: 10 years' experience. Otol Neurotol. 2009 Aug;30(5):614-8. doi: 10.1097/MAO.0b013e3181a864f2.
Colletti L, Zoccante L. Nonverbal cognitive abilities and auditory performance in children fitted with auditory brainstem implants: preliminary report. Laryngoscope. 2008 Aug;118(8):1443-8. doi: 10.1097/MLG.0b013e318173a011.
John T. Roland, Jr., MD
NYU Langone Health
First Submitted
November 28, 2014
First Posted
December 8, 2014
Study Start
May 2014
Actual (reported)Primary Completion
May 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Contact the study team to confirm eligibility.
Sennaroglu L, Ziyal I, Atas A, Sennaroglu G, Yucel E, Sevinc S, Ekin MC, Sarac S, Atay G, Ozgen B, Ozcan OE, Belgin E, Colletti V, Turan E. Preliminary results of auditory brainstem implantation in prelingually deaf children with inner ear malformations including severe stenosis of the cochlear aperture and aplasia of the cochlear nerve. Otol Neurotol. 2009 Sep;30(6):708-15. doi: 10.1097/MAO.0b013e3181b07d41.
Sennaroglu L, Ziyal I. Auditory brainstem implantation. Auris Nasus Larynx. 2012 Oct;39(5):439-50. doi: 10.1016/j.anl.2011.10.013. Epub 2011 Dec 22.
Colletti L, Shannon RV, Colletti V. The development of auditory perception in children after auditory brainstem implantation. Audiol Neurootol. 2014;19(6):386-94. doi: 10.1159/000363684. Epub 2014 Nov 4.
Colletti L, Wilkinson EP, Colletti V. Auditory brainstem implantation after unsuccessful cochlear implantation of children with clinical diagnosis of cochlear nerve deficiency. Ann Otol Rhinol Laryngol. 2013 Oct;122(10):605-12.
Study Completion
May 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
August 28, 2026
Record last verified: 2026-08
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Source: ClinicalTrials.gov.
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