Cochlear Implant UsersNCT07114744
Early Cochlear Implant Use
An observational study of Cochlear Implant Users, run by NYU Langone Health at 1 site in United States.
Trial summary
This observational study will examine newly activated cochlear implant users and determine whether their abilities to discern simple sounds change and relate to improved speech perception. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Cochlear Implant Users
- What is being tested?
- Take home tests
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jun 2025to 1 Jul 2027
- Phase
- Observational
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The population includes hearing impaired adults. Both genders will be recruited. All subjects will be recruited from the NYU Cochlear Implant Clinic.
Who may be able to join
- Postlingually deaf cochlear implant users
- severe or profound hearing loss
- who do not have other diagnoses communicative or cognitive disorders.
- Test population: no prior experience with cochlear implants (recruitment happens prior to cochlear implantation).
- Control population: subjects who have used the same stimulation strategy since initial stimulation, who note no continuing improvements or changes with their devices with respect to speech comprehension.
Who cannot join
- Diagnosed cognitive or communicative disorders (other than deafness)
- Below 18 years of age
- Above the age of 85 years old.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
NYU Langone Health
New York, New York, 10016
About this study
This observational study will examine newly activated cochlear implant users and determine whether their abilities to discern simple sounds change and relate to improved speech perception. Take-home computers and test-equipment will be sent home, and subjects will complete approximately 25 test sessions over the first 3 months of cochlea implant use. Then, subjects will be tested 3 more times in the laboratory until 1 year-post activation. The primary objective is to determine and quantify how sounds change and speech perception improves over the course of early cochlear implant use.
- Conditions
- Cochlear Implant Users
- Being tested
- Take home tests
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Take home testsOther
These tests will test the discriminability of sounds that vary systematically along the frequency and temporal dimensions of sound. Over the course of the 3 months post-activation, subjects will self-complete "take-home" tests at location of their choosing. Each test session will include the entire test-battery will be repeated frequency as often as every day and then reducing frequency of testing corresponding to the rate of speech perception improvement.
| Study group | Role | What they receive |
|---|---|---|
| Newly Implanted Users | Participants have no prior experience with cochlear implants (recruitment happens prior to cochlear implantation) will complete at home testing (~25 sessions) over ~3 months of implant use. Receives: Other: Take home tests | |
| Experienced Cochlear Implant Users | Participants who have used the same stimulation strategy since initial stimulation will complete at home testing (~25 sessions) over ~3 months of implant use. Receives: Other: Take home tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in percentage of correct responses during speech perception tests
Speech perception tests involves presentation of a speech stimulus (may be a word, sentence, nonsense words, or other speech sounds) and subjects will have to indicate what they heard. The total score is the percentage of speech stimulus correctly understood, ranging from 0-100%.
Measured: Baseline, 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2025
- Study start11 Jun 2025
- Primary completion1 May 2027 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cochlear Implant UsersStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Responsible party
- Sponsor
- Investigators
- Mario A. Svirsky, PhD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07114744
- Sponsor's protocol ID
- 24-01603
- Other IDs
- K99DC021727
- Status last verified
- Jun 2026
- First submitted
- 4 Aug 2025
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The de-identified participant data from the final research dataset will be shared upon reasonable request beginning 9 to 36 months after publication or as required by a condition of awards or supporting agreements, provided the requesting investigator executes a data use agreement with NYU Langone Health. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's Data Sharing Strategy Board (DSSB). Requests should be directed to:ariel.hight@nyulangone.org. The protocol and statistical analysis plan will be posted on Clinicaltrials.gov only as required by federal regulation or supporting awards and agreements.
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Cochlear Implant Use
- ClinicalTrials.gov ID
- NCT07114744
- Acronym / sponsor ID
- 24-01603
- Conditions
- Cochlear Implant Users
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Study start
- 11 Jun 2025 (actual)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 11 Aug 2025 (actual)
- 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 observational study will examine newly activated cochlear implant users and determine whether their abilities to discern simple sounds change and relate to improved speech perception. Take-home computers and test-equipment will be sent home, and subjects will complete approximately 25 test sessions over the first 3 months of cochlea implant use. Then, subjects will be tested 3 more times in the laboratory until 1 year-post activation. The primary objective is to determine and quantify how sounds change and speech perception improves over the course of early cochlear implant use.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Newly Implanted Users | – | Other: Take home testsParticipants have no prior experience with cochlear implants (recruitment happens prior to cochlear implantation) will complete at home testing (~25 sessions) over ~3 months of implant use. |
| Experienced Cochlear Implant Users | – | Other: Take home testsParticipants who have used the same stimulation strategy since initial stimulation will complete at home testing (~25 sessions) over ~3 months of implant use. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The population includes hearing impaired adults. Both genders will be recruited. All subjects will be recruited from the NYU Cochlear Implant Clinic.
Key inclusion criteria (5 listed)
- Postlingually deaf cochlear implant users
- severe or profound hearing loss
- who do not have other diagnoses communicative or cognitive disorders.
- Test population: no prior experience with cochlear implants (recruitment happens prior to cochlear implantation).
- Control population: subjects who have used the same stimulation strategy since initial stimulation, who note no continuing improvements or changes with their devices with respect to speech comprehension.
Key exclusion criteria (3 listed)
- Diagnosed cognitive or communicative disorders (other than deafness)
- Below 18 years of age
- Above the age of 85 years old.
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 |
|---|---|---|
| Take home testsThese tests will test the discriminability of sounds that vary systematically along the frequency and temporal dimensions of sound. Over the course of the 3 months post-activation, subjects will self-complete "take-home" tests at location of their choosing. Each test session will include the entire test-battery will be repeated frequency as often as every day and then reducing frequency of testing corresponding to the rate of speech perception improvement. | Other | Experienced Cochlear Implant Users, Newly Implanted Users |
Primary outcome
Change in percentage of correct responses during speech perception tests
Time frame: Baseline, 1 year
Speech perception tests involves presentation of a speech stimulus (may be a word, sentence, nonsense words, or other speech sounds) and subjects will have to indicate what they heard. The total score is the percentage of speech stimulus correctly understood, ranging from 0-100%.
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 1 Jul 2026.
- Individual participant dataSharing planned: Yes. The de-identified participant data from the final research dataset will be shared upon reasonable request beginning 9 to 36 months after publication or as required by a condition of awards or supporting agreements, provided the requesting investigator executes a data use agreement with NYU Langone Health. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's Data Sharing Strategy Board (DSSB). Requests should be directed to:ariel.hight@nyulangone.org. The protocol and statistical analysis plan will be posted on Clinicaltrials.gov only as required by federal regulation or supporting awards and agreements.
Related trials for Cochlear Implant Users
Not yet recruiting
Patient-Oriented Research to Optimize Cochlear Implant Outcomes
Cochlear Implant, Cochlear Implant Users
Recruiting
Assessment of a Method to Improve Cochlear Implant Users' Speech Perception in Noisy Environments While Maintaining Their Ability to Determine Where a Sound Originates From
Cochlear Implant Users
Recruiting
Investigating the Acceptance and Performance of Low Energy Audio Streaming in Nucleus 8 and Kanso 3 Sound Processors by Experienced Cochlear Implant Users
Cochlear Implant Users
Recruiting
Listening Effort in Cochlear Implant Users
Auditory Perception; Abnormal, Hearing Loss, Sensorineural
Recruiting
The Effect of Anatomy-based Fitting on the Perception of Speech in Noise and Music in Single-sided Deaf Cochlear Implant Users
Cochlear Implant, Sensorineural Hearing Loss
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.
Mario A. Svirsky, PhD 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?
An observational study of Cochlear Implant Users, 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 5 inclusion and 3 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 1 Jul 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 Ariel E. Hight, PhD (212-263-7217, Ariel.hight@nyulangone.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in percentage of correct responses during speech perception tests (time frame: Baseline, 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Jul 2026.