ClinicalTrials.gg
Not yet recruitingNCT07935603Updated Nov 13, 2026

Aural Rehab for Adult CI Outcomes

An interventional study of Computer-Based Auditory Training and Clinician-Guided Auditory Training in Bilateral Hearing Loss, sponsored by NYU Langone Health. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-13.

Sponsored by NYU Langone Health · Not applicable, Interventional, and Other

Updated Nov 13, 2026Newly registeredGo to Updates ↓

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Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 30 studies in Hearing Loss, Bilateral with a site in United States — 12 open to participants now, 14 under way, 1 of them phase 3. Hearing Loss, Bilateral · United States.

Planned enrollment
7th of 25
50 · median 35
Started
2026
with 2 others
No phase
20 of 30
7 open now
Primary completion
2029-01
later than 10 of 13 live
Registered
30th of 30
by date

Among the 30 studies in Hearing Loss, Bilateral with a site in United States, this one is the 7th largest by planned enrollment of the 25 interventional ones that give a count, is one of 3 that started in 2026, is one of 20 with no phase, reaches primary completion later than 10 of the 13 other live ones, and was the 30th registered.

Hearing Loss, Bilateral

55 studies on the registry are indexed under Hearing Loss, Bilateral; 17 are open to participants now.

Browse Hearing Loss, Bilateral studies →

Open to participants now

12 of the 30 studies in Hearing Loss, Bilateral with a site in United States are open now. Recruiting first, the newest first:

6 more — sign in →

All 12 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 12 Hearing Loss, Bilateral studies recruiting now, 7 (58%) set no upper age limit and 3 (25%) stop at 75 or younger; 4 take children under 18; 2 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

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02

Study summary

This study will compare two different types of aural rehabilitation schedules (computer-based auditory training vs computer based auditory training and clinician guided training) for adult cochlear implant (CI) users to determine the effect of rehabilitation type on speech perception, hearing related-quality of life, and CI management skills.

03

Conditions studied

  • Bilateral Hearing Loss
04

Who can participate

Ages eligible
18 Years and older
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

  • Be at least 18 years of age at the time of cochlear implantation.
  • Receive pre- and post-CI care at the NYU Langone Health Cochlear Implant Center.
  • Have bilateral hearing loss, with at least moderate to profound hearing loss in both ears.
  • Be able to participate in follow-up visits, either in person or via synchronous telehealth, and to use an app-based training platform (ReDi).
  • Be English-speaking or have native-like English proficiency.

Exclusion criteria

Exclusion Criteria:

  • Has significant cognitive impairment or a medical disability that precludes or reliable participation or develops such impairment during the study period.
  • Has pre-lingual or long-term (>20 years) severe to profound hearing loss
  • Is undergoing cochlear implantation for single-sided deafness.
  • Is undergoing revision CI surgery.
  • Is younger than 18 years of age.
Terms in these criteria, in plain language(1)

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.

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.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • Active comparator
    Computer-Based Auditory Training

    CI users assigned to receive computer-based auditory training only.

    Behavioral: Computer-Based Auditory Training

  • Experimental
    Computer-Based Auditory Training + Clinician-Guided Training

    CI users assigned to receive computer-based auditory training and clinician-guided training.

    Behavioral: Computer-Based Auditory Training · Behavioral: Clinician-Guided Auditory Training

Interventions

  • BehavioralComputer-Based Auditory Training

    Aural rehabilitation program delivered through an auditory training app. Each participant will be assigned to complete training 5 days per week, with each session being 15 minutes for the first 6 months post-activation.

  • BehavioralClinician-Guided Auditory Training

    Aural rehabilitation program delivered by a speech-language pathologist.

06

What researchers measure

Primary outcomes

  1. Change in CNC Word Recognition Score

    Calculated as the percentage of words a person can hear, repeat back, and understand.

    Time frame: Baseline (pre-cochlear implant), Year 1 Post-Activation

  2. Change in CNC Phoneme Recognition Score

    Calculated as the percentage of individual phonemes (sounds) identified correctly out of 150 total phonemes.

    Time frame: Baseline (pre-cochlear implant), Year 1 Post-Activation

  3. Change in AzBio Sentence Recognition Score

    Standardized speech perception assessment used by audiologists to measure how well a person understands everyday conversational speech. Patients are evaluated on their ability to recognize words correctly in a sentence. Each sentence has a set number of key words assigned specific point values. The final score is calculated as a percentage of words correct out of the total possible words in the list.

    Time frame: Baseline (pre-cochlear implant), Year 1 Post-Activation

Secondary outcomes

  1. Change in CIQOL35 Profile Score

    Patient-reported outcome measure designed to evaluate real-world functional abilities and quality of life for adult cochlear implant (CI) users. Each item is rated on a Likert scale; the raw score is re-scaled into a total score from 0 (low quality of life/functional ability) to 100 (high quality of life/functional ability).

    Time frame: Week 6 Post-Activation, Year 1 Post-Activation

  2. Change in CIMS-Self

    10-item self-administered assessment of how effectively a patient or caregiver handles and maintains a cochlear implant processor. Each response is rated from 0 to 3; the raw score is the sum of responses and is transformed to a percentage (0 - 100%); a score below 100% indicates a need for targeted training or retraining in specific maintenance areas.

    Time frame: Week 6 Post-Activation, Year 1 Post-Activation

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No — No plan to make IPD available.

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar 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

Start is estimated for Dec 2026; primary completion for Jan 2029, 25 months later.

Of 27 interventional studies with no phase under Hearing Loss, Bilateral, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 60. This study's planned 25 months is above that.

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

Registered
Nov 9, 2026
First posted
Nov 13, 2026
StartEst.
Dec 1, 2026
Primary completionEst.
Jan 1, 2029
CompletionEst.
Jan 1, 2029
Last update
Nov 13, 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.
Registered
First appeared on the registry. No changes since
Nov 13, 2026
Show all 1 update
  1. Nov 13, 2026
    First appeared on the registry

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
NCT07935603
Lead sponsor
NYU Langone Health
Responsible party
Sponsor
First posted
Nov 13, 2026
Start date
Dec 1, 2026 (estimated)
Primary completion
Jan 1, 2029 (estimated)
Completion
Jan 1, 2029 (estimated)
Last update
Nov 13, 2026

Study contacts

J. Thomas Roland, Jr., MD
Contact
J.Thomas.RolandJr@nyulangone.org
212-263-5565
J. Thomas Roland, Jr., MD
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 ↗

Not currently enrolling

This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.

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