Hearing Loss, Bilateral (Causes Other Than Tumors)NCT02310399
Auditory Brainstem Implant (ABI) in Children With No Cochleae or Auditory Nerves
A study testing Nucleus ABI541 Auditory Brainstem Implant in people with Hearing Loss, Bilateral (Causes Other Than Tumors), run by NYU Langone Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 months to 21 years
- Conditions the study is for
- Hearing Loss, Bilateral (Causes Other Than Tumors)
- What is being tested?
- Nucleus ABI541 Auditory Brainstem Implant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- May 2014to May 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 months to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Show all 28Show fewer
- 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
- Failed revision CI without benefit
- Previously developed open set speech perception and auditory-oral language skills
- No medical contraindications
- Willing to receive the appropriate meningitis vaccinations
- No or limited cognitive/developmental delays.
- Strong family support
- Reasonable expectations from parents/guardians including a thorough understanding:
- of potential benefits and limitations of ABI
- of parental role in rehabilitation
- that the child may not develop spoken language as a primary communication mode or even sufficient spoken language to make significant academic progress in an aural/oral environment
- Involvement in a rehabilitation program that emphasizes development of auditory skills with or without the use of supplementary visual communication.
- Able to comply with study requirements including travel to investigation sites.
- Informed consent for the procedure from the child's parents/legal guardian.
Who cannot join
- 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.
Show all 15Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ashley Feng contact
United States1 site, 1 recruiting
- Recruiting
NYU Cochlear Implant Center
New York, New York, 10016
Kristin Montella, 212-263-8182, km302@nyumc.org
John T. Roland, MD
About this study
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.
Read the detailed description
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.
- Being tested
- Nucleus ABI541 Auditory Brainstem Implant
- Keywords
- Auditory Brainstem Implant, Deafness, Hearing Loss, ABI
- Medical subject headings
- Hearing Loss, Deafness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nucleus ABI541 Auditory Brainstem ImplantDevice
Surgical implantation of the Nucleus ABI541 Auditory Brainstem Implant device
| Study group | Role | What they receive |
|---|---|---|
| Pre-lingual Deafness | Experimental | Surgical implantation of the Nucleus ABI541 Auditory Brainstem Implant in prelingiustically deaf children ages 18 months - 5 years Receives: Device: Nucleus ABI541 Auditory Brainstem Implant |
| Post-Lingual Deafness | Experimental | Surgical implantation of the Nucleus ABI541 Auditory Brainstem Implant in postlinguistically deaf children < 21 years of age Receives: Device: Nucleus ABI541 Auditory Brainstem Implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 Years from date of surgery
Secondary outcomes (1)
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
Measured: 36 months from date of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2014 (estimated)
- Study startMay 2014
- Primary completionMay 2030 (estimated)
- Study completionMay 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Hearing Loss, Bilateral (Causes Other Than Tumors)Studies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John T. Roland, Jr., MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02310399
- Sponsor's protocol ID
- S14-01010
- Status last verified
- Aug 2026
- First submitted
- 28 Nov 2014
- Last updated
- 28 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
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.
PubMed 19546832Colletti 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.
PubMed 18496153Sennaroglu 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.
PubMed 19704357Sennaroglu 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.
PubMed 22196501Colletti 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.
PubMed 25377987Colletti 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.
PubMed 24294682
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Auditory Brainstem Implant (ABI) in Children With No Cochleae or Auditory Nerves
- ClinicalTrials.gov ID
- NCT02310399
- Acronym / sponsor ID
- S14-01010
- Keywords
- Auditory Brainstem Implant, Deafness, Hearing Loss, ABI
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- May 2014 (actual)
- Primary completion
- May 2030 (estimated)
- Study completion
- May 2030 (estimated)
- First posted
- 8 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pre-lingual Deafness | Experimental | Device: Nucleus ABI541 Auditory Brainstem ImplantSurgical implantation of the Nucleus ABI541 Auditory Brainstem Implant in prelingiustically deaf children ages 18 months - 5 years |
| Post-Lingual Deafness | Experimental | Device: Nucleus ABI541 Auditory Brainstem ImplantSurgical implantation of the Nucleus ABI541 Auditory Brainstem Implant in postlinguistically deaf children < 21 years of age |
Who may qualify
- Ages
- 18 months to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (28 listed)
- 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:
- 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)
Key exclusion criteria (15 listed)
- 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:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nucleus ABI541 Auditory Brainstem ImplantSurgical implantation of the Nucleus ABI541 Auditory Brainstem Implant device | Device | Post-Lingual Deafness, Pre-lingual Deafness |
Primary outcome
ABI Device Complications
Time frame: 5 Years from date of surgery
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.
1 secondary outcome
Audiologic Performance with ABI (Hearing, Speech and Language Assessments)
Time frame: 36 months from date of surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2026.
- Background: PubMed 19546832Colletti 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.
- Background: PubMed 18496153Colletti 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.
- Background: PubMed 19704357Sennaroglu 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.
- Background: PubMed 22196501Sennaroglu 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.
- Background: PubMed 25377987Colletti 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.
- Background: PubMed 24294682Colletti 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ashley Feng contact
John T. Roland, Jr., MD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nucleus ABI541 Auditory Brainstem Implant in people with Hearing Loss, Bilateral (Causes Other Than Tumors), run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 28 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact William Shapiro (212-263-3311, William.Shapiro@nyulangone.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ABI Device Complications (time frame: 5 Years from date of surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02310399, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2026; AzTrials last refreshed its copy on 7 Nov 2026.