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RecruitingNCT05810220Updated Oct 29, 2026

Investigating Auditory Processing in the Users of Auditory Brainstem and Cochlear Implants

An interventional study of Electrode-Neural Interface in Deafness, sponsored by NYU Langone Health. Recruiting at 1 site in United States. Open to participants aged 2 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-10-29.

Sponsored by NYU Langone Health · Not applicable, Interventional, and Basic science

From the registry’s dates

  • Registered 4 years 3 months after the study started (first participant enrolled Dec 2018, registered Mar 2023).
  • Started Dec 2018; still recruiting 7 years 11 months later.
Updated Oct 29, 2026Primary completion movedStudy completion movedGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Non-randomized
Ages
2 Years to 90 Years
Sex
All
01

Study summary

This is a basic investigational research study conducted with hearing impaired adults and children who use cochlear implant or auditory brainstem implant (ABI) devices. The study will evaluate different aspects of hearing and auditory processing in the users of implantable auditory devices.

02

Conditions studied

  • Deafness

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03

In context

Deafness

160 studies on the registry are indexed under Deafness; 46 are open to participants now.

This study's planned enrollment of 200 is above the median of 43 across 106 interventional studies indexed under Deafness.

Browse Deafness studies →

Lead sponsor

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.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Hearing impaired adult and or child (above 2 years old) who uses ABIs or cochlear implants.
  • No diagnosis of any other communicative or cognitive disorder other than hearing impairment. The individual must be able to visit the lab in order to participate in behavioral and electrophysiological experiments.
  • Patients' implant device must have useable electrodes that do not result in uncomfortable or unpleasant non-auditory sensation.

Exclusion criteria

Exclusion Criteria:

  • Diagnosed cognitive or communicative disorders (other than hearing impairment)
  • Severe neurological disorders
  • No useable electrodes in their implants
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
200 participants (estimated)

Study arms

  • Experimental
    Hearing-Impaired Individuals who use Cochlear Implants or Auditory Brainstem Implant (ABI) Devices

    Two types of measurements will be obtained: 1. Perceptual: one or more sounds are presented and a behavioral response is collected (e.g., judgements of loudness, pitch or other differences between the sounds, or identifying the word or sentence that was said). 2. Physiological: noninvasive electrophysiological recordings of nervous system activity.

    Device: Electrode-Neural Interface

Interventions

  • DeviceElectrode-Neural Interface

    Measurements taken from the electrode-neural interface will be used to guide elimination of poorly functioning ABI electrodes and improve speech perception outcomes.

06

What researchers measure

Primary outcomes

  1. Percent of Correctly-Identified Speech Materials

    Participants will listen to speech sounds and indicate what sentence or word they heard. The outcome is the percent of speech sounds that are correctly identified.

    Time frame: Day 1 (Visit 1 - Average visit length is about 3 hours)

  2. Percent of Correctly-Identified Stimuli Characteristics when Two or More Stimuli are Presented

    Two or more stimuli will be presented to participants, who will indicate which one is louder, which is higher pitched, or which one is different. The outcome is the percent of stimuli characteristics that are correctly identified.

    Time frame: Day 1 (Visit 1 - Average visit length is about 3 hours)

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Yes — The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: [Mahan.Azadpour@nyulangone.org]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

Supporting information: Study protocol, Statistical analysis plan

Time frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research

Access criteria: The investigator who proposed to use the data will be granted access upon reasonable request. Requests should be directed to Mahan.Azadpour@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Dec 2018 (actual). Primary completion is estimated for Dec 2027, 108 months after the start.

Of 50 non-industry interventional studies with no phase under Deafness, half reached primary completion within 46 months of starting (the median), counting those still running; a quarter within 20. This study's planned 108 months is above that.

Counting every sponsor, half of 58 studies reached it within 31 months; a quarter within 17.

Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 29, 2026: primary completion Dec 2026 → Dec 2027 and completion Dec 2026 → Dec 2027.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Mar 20, 2023
First posted
Apr 12, 2023
StartActual
Dec 2, 2018
Primary completionEst.
Dec 2027was Dec 2026
CompletionEst.
Dec 2027was Dec 2026
Last update
Oct 29, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Primary completion
Dec 2026→Dec 2027
Oct 29, 2026
Study completion
Dec 2026→Dec 2027
Oct 29, 2026
Show all 1 update
  1. Oct 29, 2026
    Primary completion Dec 2026→Dec 2027
    Study completion Dec 2026→Dec 2027
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT05810220
Lead sponsor
NYU Langone Health
Collaborators
Cochlear Americas
Responsible party
Sponsor
First posted
Apr 12, 2023
Start date
Dec 2, 2018
Primary completion
Dec 2027 (estimated)
Completion
Dec 2027 (estimated)
Last update
Oct 29, 2026

Study contacts

Mahan Azadpour
Contact
Mahan.Azadpour@nyulangone.org
2122637785
Mahan Azadpour
principal investigator · NYU Langone Health

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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