Auditory Brainstem Implant (ABI) in Children With No Cochleae or Auditory Nerves
1 other identifier
interventional
20
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2014
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2014
CompletedFirst Submitted
Initial submission to the registry
November 28, 2014
CompletedFirst Posted
Study publicly available on registry
December 8, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 1, 2030
October 30, 2025
October 1, 2025
16 years
November 28, 2014
October 29, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
Audiologic Performance with ABI (Hearing, Speech and Language Assessments)
36 months from date of surgery
Study Arms (2)
Pre-lingual Deafness
EXPERIMENTALSurgical implantation of the Nucleus ABI541 Auditory Brainstem Implant in prelingiustically deaf children ages 18 months - 5 years
Post-Lingual Deafness
EXPERIMENTALSurgical implantation of the Nucleus ABI541 Auditory Brainstem Implant in postlinguistically deaf children \< 21 years of age
Interventions
Surgical implantation of the Nucleus ABI541 Auditory Brainstem Implant device
Eligibility Criteria
You may qualify if:
- Group 1: Prelinguistic hearing loss (birth-5 years; age at implantation of ABI 18 months-5 years)
- Pre-linguistic hearing loss (birth-5 yrs.; age at ABI 18 months-5yrs) with both:
- MRI +/- CT evidence of one of the following:
- Cochlear nerve deficiency
- Cochlear aplasia or severe hypoplasia
- Severe inner ear malformation
- Post-meningitis ossification
- When a cochlea is present or patent, lack of significant benefit from CI despite consistent use (\>6 mo.)
- No or limited speech perception ability (limited to pattern perception on closed set testing materials using the CI)
- Lack of progress in auditory skills development
- Group 2: Post-linguistic hearing loss (\<21 yrs. of age)
- Post-linguistic hearing loss (\<21 yrs. of age) with:
- Loss or lack of benefit from appropriate CI without the possibility for revision or contralateral implantation. Examples might include:
- Post-meningitis ossification
- Bilateral temporal bone fractures with cochlear nerve avulsion
- +13 more criteria
You may not qualify if:
- For both Groups 1 and 2:
- Pre- or post-linguistic child currently making significant progress with CI Even for the very young children (18 months of age with 6 months of use), nearly all children with a good auditory signal from their CI will show evidence of improvement in these metrics over time.
- MRI evidence of one of the following:
- normal cochlea and cochlear nerves or NF2
- brainstem or cortical anomaly that makes implantation unfeasible
- Clear surgical reason for poor CI performance that can be remediated with revision CI or contralateral surgery rather than ABI.
- Intractable seizures or progressive, deteriorating neurological disorder
- Patients with evidence of Chiari malformation, hydrocephalus, spina bifid a
- Patients with any foreseeable need for a future MRI scan
- Unable to participate in behavioral testing and mapping with their CI. If this appears to be an age effect, ABI will be delayed until we can be assured that the child will be able to participate, as reliable objective measures of mapping are currently not available for mapping these devices.
- Unable to tolerate general anesthesia (cardiac, pulmonary, bleeding diathesis, etc.).
- Need for brainstem irradiation
- Unrealistic expectations on the part of the subject/family regarding the possible benefits, risks and limitations inherent to the procedure and ABI device.
- Unwilling to sign the informed consent.
- Unwilling to make necessary follow-up appointments.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
NYU Cochlear Implant Center
New York, New York, 10016, United States
Related Publications (6)
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.
PMID: 19546832BACKGROUNDColletti 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.
PMID: 18496153BACKGROUNDSennaroglu 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.
PMID: 19704357BACKGROUNDSennaroglu 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.
PMID: 22196501BACKGROUNDColletti 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.
PMID: 25377987BACKGROUNDColletti 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.
PMID: 24294682BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
John T. Roland, Jr., MD
NYU Langone Health
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 28, 2014
First Posted
December 8, 2014
Study Start
May 1, 2014
Primary Completion (Estimated)
May 1, 2030
Study Completion (Estimated)
May 1, 2030
Last Updated
October 30, 2025
Record last verified: 2025-10