Hearing LossNCT07011927
Extra-cochlear Electrode Placement at the Post-auricular Vagus Nerve in Cochlear Implantation
A study testing Cochlear Implant and Modified Implant Procedure in people with Hearing Loss, run by NYU Langone Health at 1 site in United States.
Trial summary
This study will evaluate hearing outcomes after cochlear implantation with placement of the ECE1 ground electrode near the post-auricular vagus nerve (Arnold's nerve) to assess non-inferiority with respect to placement under the temporalis muscle. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hearing Loss
- What is being tested?
- Cochlear Implant and Modified Implant Procedure
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Oct 2025to 1 Jul 2028
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- will be undergoing surgery for a cochlear implant from Cochlear Americas
- is willing to participate in the study
Who cannot join
- has history of prior ear surgery, congenital ear malformation, or prior cochlear implantation in the ear to be implanted
- pregnant, planning to become pregnant, or breastfeeding patients cannot undergo the standard-of-care implantation procedures required for participation in the study.
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
Official title: Single-center Non-inferiority Study of Extra-cochlear Electrode Placement at the Post-auricular Vagus Nerve in Cochlear Implantation
This study will evaluate hearing outcomes after cochlear implantation with placement of the ECE1 ground electrode near the post-auricular vagus nerve (Arnold's nerve) to assess non-inferiority with respect to placement under the temporalis muscle.
- Conditions
- Hearing Loss
- Being tested
- Cochlear Implant, Modified Implant Procedure
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cochlear ImplantDevice
Eligible Cochlear Americas devices eligible for inclusion in this study include any Cochlear Americas device that has two ground electrodes.
Modified Implant ProcedureDevice
Implant procedure will be modified to place ground electrode (ECE1) near Arnold's nerve.
| Study group | Role | What they receive |
|---|---|---|
| Patients scheduled for Cochlear Implantation | Experimental | The experimental arm will enroll patients over the age of 18 undergoing cochlear implantation involving the placement of ECE1 at the approximate location of Arnold's nerve within the ear canal. In the proposed study, a modification to the surgical approach will be done to place ECE1 near Arnold's nerve, while still using a standard electrode array. Receives: Device: Cochlear Implant; Device: Modified Implant Procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
AzBio Sentence Recognition Test Score
The AzBio Sentence Recognition Test is a clinical tool used to evaluate a person's ability to understand speech in noisy environments. The total score is the percentage of words correctly understood, ranging from 0-100%.
Measured: Up to Year 1 post cochlear implant activation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2025
- Study start17 Oct 2025
- Primary completion1 Jul 2028 (estimated)
- Study completion1 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing LossStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- J. Thomas Roland, Jr., MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07011927
- Sponsor's protocol ID
- 24-01768
- Status last verified
- Apr 2026
- First submitted
- 2 Jun 2025
- Last updated
- 1 May 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: mario.svirsky@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 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-center Non-inferiority Study of Extra-cochlear Electrode Placement at the Post-auricular Vagus Nerve in Cochlear Implantation
- ClinicalTrials.gov ID
- NCT07011927
- Acronym / sponsor ID
- 24-01768
- Conditions
- Hearing Loss
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 17 Oct 2025 (actual)
- Primary completion
- 1 Jul 2028 (estimated)
- Study completion
- 1 Jul 2028 (estimated)
- First posted
- 10 Jun 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 study will evaluate hearing outcomes after cochlear implantation with placement of the ECE1 ground electrode near the post-auricular vagus nerve (Arnold's nerve) to assess non-inferiority with respect to placement under the temporalis muscle.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients scheduled for Cochlear Implantation | Experimental | Device: Cochlear Implant, Device: Modified Implant ProcedureThe experimental arm will enroll patients over the age of 18 undergoing cochlear implantation involving the placement of ECE1 at the approximate location of Arnold's nerve within the ear canal. In the proposed study, a modification to the surgical approach will be done to place ECE1 near Arnold's nerve, while still using a standard electrode array. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- will be undergoing surgery for a cochlear implant from Cochlear Americas
- is willing to participate in the study
Key exclusion criteria (2 listed)
- has history of prior ear surgery, congenital ear malformation, or prior cochlear implantation in the ear to be implanted
- pregnant, planning to become pregnant, or breastfeeding patients cannot undergo the standard-of-care implantation procedures required for participation in the study.
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 |
|---|---|---|
| Cochlear ImplantEligible Cochlear Americas devices eligible for inclusion in this study include any Cochlear Americas device that has two ground electrodes. | Device | Patients scheduled for Cochlear Implantation |
| Modified Implant ProcedureImplant procedure will be modified to place ground electrode (ECE1) near Arnold's nerve. | Device | Patients scheduled for Cochlear Implantation |
Primary outcome
AzBio Sentence Recognition Test Score
Time frame: Up to Year 1 post cochlear implant activation
The AzBio Sentence Recognition Test is a clinical tool used to evaluate a person's ability to understand speech in noisy environments. The total score is the percentage of words 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 May 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: mario.svirsky@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.
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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.
J. Thomas 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 Cochlear Implant and Modified Implant Procedure in people with Hearing Loss, 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 2 inclusion and 2 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 May 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 Nicole Capach (646-501-6905, nicole.capach@nyulangone.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AzBio Sentence Recognition Test Score (time frame: Up to Year 1 post cochlear implant activation). 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 May 2026.