An interventional study of Nucleus ABI541 Auditory Brainstem Implant in Hearing Loss, Bilateral (Causes Other Than Tumors), sponsored by NYU Langone Health. Recruiting at 1 site in United States. Open to participants aged 18 Months to 21 Years. Per ClinicalTrials.gov, last updated 2026-08-28.
Sponsored by NYU Langone Health · Not applicable, Interventional, and Treatment
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.
The purpose of this study is to evaluate the clinical safety and efficacy of the Nucleus™ 24 Auditory Brainstem Implant (ABI) in pediatric patients who do not have Neurofibromatosis Type 2 (NF2); specifically, children with total hearing loss due to severe cochlear anomalies, cochlear nerve disorders or failed cochlear implantation. These conditions can include: developmental or acquired cochlear nerve deficiency (CND), cochlear aplasia, post-meningitis cochlear ossification, or cochlear malformation. This study proposes to implant up to 10 pre-linguistic young children (18 mos to 5 yrs. of age) and up to 10 post-linguistic children (\<21 yrs of age) with the Nucleus 24 Multichannel ABI in an attempt to demonstrate safety of the surgical procedure and device stimulation and the potential for auditory benefit beyond that experienced with a CI. These children would not qualify for the Nucleus ABI device, as their etiology is not an approved indication such as neurofibromatosis Type 2(NF2). Further, these children do not benefit from conventional hearing aids or cochlear implants.
Two groups of children will be included: Group 1 will include prelingiustic deaf children ages 18 months - 5 years and Group 2 will include postlinguistic deaf children \< 21 years of age. Post-operative evaluations will be conducted at the initial activation and at 1, 3, 6, 12, 18, 24, 30, and 36-month intervals post-activation in order to demonstrate the emergence of open-set speech perception abilities prior to study cessation. Experience in the CI literature has shown that a minimum of 2 years of device usage is required for children with pre-lingual hearing impairment to develop some open-set speech perception abilities. While Group 2 is post-linguistic and some may have had significant hearing prior to becoming deaf, the same time intervals will be used for consistency. Blinding or masking procedures are not included in the design, as the presence/absence of a brainstem implant cannot be easily concealed from the device recipients and/or clinical investigators.
796 studies on the registry are indexed under Hearing Loss; 193 are open to participants now.
This study's planned enrollment of 20 is below the median of 44 across 561 interventional studies indexed under Hearing Loss.
Browse Hearing Loss studies →NYU Langone Health is the lead sponsor of 1,430 studies on the registry; 258 are open to participants now.
Of its 235 completed or terminated interventional studies of FDA-regulated products, 197 (84%) have results posted.
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Group 1: Prelinguistic hearing loss (birth-5 years; age at implantation of ABI 18 months-5 years)
MRI +/- CT evidence of one of the following:
When a cochlea is present or patent, lack of significant benefit from CI despite consistent use (>6 mo.)
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:
Reasonable expectations from parents/guardians including a thorough understanding:
Exclusion Criteria:
For both Groups 1 and 2:
MRI evidence of one of the following:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Surgical implantation of the Nucleus ABI541 Auditory Brainstem Implant in prelingiustically deaf children ages 18 months - 5 years
Device: Nucleus ABI541 Auditory Brainstem Implant
Surgical implantation of the Nucleus ABI541 Auditory Brainstem Implant in postlinguistically deaf children \< 21 years of age
Device: Nucleus ABI541 Auditory Brainstem Implant
Surgical implantation of the Nucleus ABI541 Auditory Brainstem Implant device
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.
Time frame: 5 Years from date of surgery
Audiologic Performance with ABI (Hearing, Speech and Language Assessments)
The following audiometry and speech perception tests will be administered as age-appropriate: * Detection audiogram, aided and unaided individual ears * IT-MAIS or MAIS * LING 6 sound test * ESP Low Verbal or Standard- MLV @ 50dB HL * PB-k words and phonemes- MLV @ 50dB HL * MLNT- recorded @ 60dB SPL * LNT- recorded @ 60dB SPL * HINT-C- 2 lists of 10 @ 60dB SPL * CNC- 50 words @ 60dB SPL Each child will receive speech/language intervention using the Comprehensive Assessment of Spoken Language (CASL, Elizabeth Carrow-Woolfolk, 1999) The following tests will be administered when appropriate: * The Oral and Written Language Scales (OWLS) * Goldman-Fristoe Test of Articulation * The Peabody Picture Vocabulary Test (PPVT) * The Rossetti Infant-Toddler Language Scale * Pre-School Language Scale, (PLS-5) * The Expressive Vocabulary Test, 2nd Ed * The Peabody Picture Vocabulary Test, 4th Ed
Time frame: 36 months from date of surgery
Plan to share: Undecided
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