Deafness With a Cochlear ImplantNCT06901674
Stimulating the Cochlear Apex Without Longer Electrodes
A study testing Modified surgical approach and Cochlear Nucleus CI632 cochlear implant in people with Deafness With a Cochlear Implant, run by NYU Langone Health at 1 site in United States.
Trial summary
The most common cochlear implant intervention provides an electrode array that stimulates less than half of the length of the cochlea, leaving the regions which represent lower frequencies in the normally functioning ear unstimulated. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Deafness With a Cochlear Implant
- What is being tested?
- Modified surgical approach and Cochlear Nucleus CI632 cochlear implant
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2022to 1 Jan 2027
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants in this study must have already been evaluated at the NYU cochlear implant center as being eligible for a cochlear implant.
- They must have decided to receive a cochlear implant manufactured by Cochlear Limited and have been diagnosed with a moderate to profound sensorineural hearing loss in the ear to be implanted.
- Individuals who have already been implanted with a cochlear implant manufactured by Cochlear Limited with or without this new approach may also participate in this study.
Who cannot join
- They are under the age of 18
- They have not been diagnosed with a moderate to profound sensorineural hearing loss in the ear to be implanted
- Have >15 years of profound deafness
- Have not chosen to receive a cochlear implant manufactured by Cochlear Limited
- Are pregnant or plan to conceive within 6 months of consenting
Trial locations and contacts
1 site in 1 country.
About this study
The most common cochlear implant intervention provides an electrode array that stimulates less than half of the length of the cochlea, leaving the regions which represent lower frequencies in the normally functioning ear unstimulated. Providing stimulation over the entire cochlea has the potential to improve speech understanding, sound quality, as well as spectral and temporal representation. Increasing the length of the electrode array to cover a greater portion of the cochlea has many potential issues, including increased damage to the cochlea and probability of incomplete insertions. In this study, a new technique is being investigated that allows stimulation across the entire cochlear extent without increasing the length of the electrode array. The purpose of this study is to evaluate the benefit of the new technique on speech understanding outcomes. Additionally, the study will investigate the new configuration to explore how the auditory system encodes temporal and spectral information.
- Conditions
- Deafness With a Cochlear Implant
- Being tested
- Modified surgical approach, Cochlear Nucleus CI632 cochlear implant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified surgical approachProcedure or surgery
An electrode typically placed under the temporalis muscle will be placed into the cochlear helicotrema instead.
Cochlear Nucleus CI632 cochlear implantDevice
Cochlear implant (CI) system where stimulation from one of the intracochear electrodes is grounded via one of two (or both) extra cochlear electrodes in the device.
| Study group | Role | What they receive |
|---|---|---|
| Apical ground electrode | Experimental | Participants in this group will have already received a cochlear implant using the new approach or be receiving a cochlear implant with the new approach. Receives: Procedure: Modified surgical approach; Device: Cochlear Nucleus CI632 cochlear implant |
| Standard location ground electrode | Active comparator | Participants in this group have received a cochlear implant with the typical ground electrode placement. Receives: Device: Cochlear Nucleus CI632 cochlear implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Upper Limit of Rate Pitch Perception for Cochlear Implant Stimuli
The upper limit of rate pitch perception will be evaluated for Apex-monopolar (MP), 22-Apex, 22-MP, and 11-MP cochlear implant stimuli using a 3-up 1-down 2-interval forced-choice adaptive task. The task measures the highest modulation frequency perceived as a lower pitch compared to a rate 5 semitones higher. A series of 750-ms, 5000-pps pulse trains with 100% amplitude modulation will be presented at a loudness-balanced most-comfortable level. The upper limit will be estimated from the average modulation frequency of the last 6 reversals across 10 trials per stimulation site.
Measured: Month 12
Mean pitch rank
Pitch-ranking will be done using a 2-interval forced-choice protocol in which the pitch of a newly selected stimulus is ranked relative to the stimulus in the middle of a pitch-rank order list. Depending on the ranked pitch direction, this stimulus is repositioned in the pitch-rank order list and ranked against a neighboring stimulus until the correct position in the list is determined. This process repeated until all stimuli are successfully pitch ranked. A complete set of pitch ranks are measured 10 times allowing for the calculation of a mean rank and 95% confidence interval for the rank of each interval.
Measured: Month 12
Percentage of Consonant-Nucleus-Consonant (CNC) words correctly repeated
Speech perception will be assessed using CNC word lists, a common method for evaluating monosyllabic word recognition. The CNC Monosyllabic Word Test includes 10 lists of 50 words. The word test score range typically used is between 10% and 60% correct in the ear to be implanted, and equal to or better than that ear in the contralateral ear, but not better than 80% correct.
Measured: Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2025
- Study start1 Aug 2022
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deafness With a Cochlear ImplantStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
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
- David M. Landsberger, Ph.D., Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06901674
- Sponsor's protocol ID
- 20-01964
- Other IDs
- 5R21DC019743-02
- Status last verified
- Mar 2026
- First submitted
- 24 Mar 2025
- Last updated
- 6 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- 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:David.landsberger@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 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stimulating the Cochlear Apex Without Longer Electrodes
- ClinicalTrials.gov ID
- NCT06901674
- Acronym / sponsor ID
- 20-01964
- Conditions
- Deafness With a Cochlear Implant
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 30 Mar 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.
The most common cochlear implant intervention provides an electrode array that stimulates less than half of the length of the cochlea, leaving the regions which represent lower frequencies in the normally functioning ear unstimulated. Providing stimulation over the entire cochlea has the potential to improve speech understanding, sound quality, as well as spectral and temporal representation. Increasing the length of the electrode array to cover a greater portion of the cochlea has many potential issues, including increased damage to the cochlea and probability of incomplete insertions. In this study, a new technique is being investigated that allows stimulation across the entire cochlear extent without increasing the length of the electrode array. The purpose of this study is to evaluate the benefit of the new technique on speech understanding outcomes. Additionally, the study will investigate the new configuration to explore how the auditory system encodes temporal and spectral information.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Apical ground electrode | Experimental | Procedure: Modified surgical approach, Device: Cochlear Nucleus CI632 cochlear implantParticipants in this group will have already received a cochlear implant using the new approach or be receiving a cochlear implant with the new approach. |
| Standard location ground electrode | Active comparator | Device: Cochlear Nucleus CI632 cochlear implantParticipants in this group have received a cochlear implant with the typical ground electrode placement. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participants in this study must have already been evaluated at the NYU cochlear implant center as being eligible for a cochlear implant.
- They must have decided to receive a cochlear implant manufactured by Cochlear Limited and have been diagnosed with a moderate to profound sensorineural hearing loss in the ear to be implanted.
- Individuals who have already been implanted with a cochlear implant manufactured by Cochlear Limited with or without this new approach may also participate in this study.
Key exclusion criteria (5 listed)
- They are under the age of 18
- They have not been diagnosed with a moderate to profound sensorineural hearing loss in the ear to be implanted
- Have >15 years of profound deafness
- Have not chosen to receive a cochlear implant manufactured by Cochlear Limited
- Are pregnant or plan to conceive within 6 months of consenting
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 |
|---|---|---|
| Modified surgical approachAn electrode typically placed under the temporalis muscle will be placed into the cochlear helicotrema instead. | Procedure or surgery | Apical ground electrode |
| Cochlear Nucleus CI632 cochlear implantCochlear implant (CI) system where stimulation from one of the intracochear electrodes is grounded via one of two (or both) extra cochlear electrodes in the device. | Device | Apical ground electrode, Standard location ground electrode |
Primary outcome
Upper Limit of Rate Pitch Perception for Cochlear Implant Stimuli
Time frame: Month 12
The upper limit of rate pitch perception will be evaluated for Apex-monopolar (MP), 22-Apex, 22-MP, and 11-MP cochlear implant stimuli using a 3-up 1-down 2-interval forced-choice adaptive task. The task measures the highest modulation frequency perceived as a lower pitch compared to a rate 5 semitones higher. A series of 750-ms, 5000-pps pulse trains with 100% amplitude modulation will be presented at a loudness-balanced most-comfortable level. The upper limit will be estimated from the average modulation frequency of the last 6 reversals across 10 trials per stimulation site.
Mean pitch rank
Time frame: Month 12
Pitch-ranking will be done using a 2-interval forced-choice protocol in which the pitch of a newly selected stimulus is ranked relative to the stimulus in the middle of a pitch-rank order list. Depending on the ranked pitch direction, this stimulus is repositioned in the pitch-rank order list and ranked against a neighboring stimulus until the correct position in the list is determined. This process repeated until all stimuli are successfully pitch ranked. A complete set of pitch ranks are measured 10 times allowing for the calculation of a mean rank and 95% confidence interval for the rank of each interval.
Percentage of Consonant-Nucleus-Consonant (CNC) words correctly repeated
Time frame: Month 12
Speech perception will be assessed using CNC word lists, a common method for evaluating monosyllabic word recognition. The CNC Monosyllabic Word Test includes 10 lists of 50 words. The word test score range typically used is between 10% and 60% correct in the ear to be implanted, and equal to or better than that ear in the contralateral ear, but not better than 80% correct.
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 6 Mar 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:David.landsberger@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 Deafness With a Cochlear Implant
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A Pivotal Study to Evaluate the Clinical Benefit, Performance and Safety of a Totally Implantable Cochlear Implant (TICI) System in Adults
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First In Human Randomised Trial of Rincell-1 in Adults With a Cochlear Implant
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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. This study is not recruiting at the moment.
David M. Landsberger, Ph.D. 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 Modified surgical approach and Cochlear Nucleus CI632 cochlear implant in people with Deafness With a Cochlear Implant, 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 3 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 6 Mar 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Upper Limit of Rate Pitch Perception for Cochlear Implant Stimuli (time frame: Month 12). The study lists 3 primary outcomes in all. 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 6 Mar 2026.