Modified Cochlear Implant for Hearing Loss

Overseen By J. Thomas Roland, Jr., MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: NYU Langone Health

Disqualifiers: Prior ear surgery, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method for placing a small part of a cochlear implant, a device that can improve hearing. The study will determine if placing an electrode near a nerve behind the ear (Arnold's nerve) is as effective as the usual placement under a muscle. This method is called Extra-cochlear Electrode Placement at the Post-auricular Vagus Nerve. Individuals planning to receive a cochlear implant and who have not undergone ear surgery before may be suitable candidates for this trial.

As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance hearing solutions for future patients.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this modified cochlear implant technique is safe?

Research has shown that placing an electrode near the vagus nerve behind the ear, known as Arnold's nerve, is under study as part of a modified cochlear implant. While specific safety data for this exact placement is limited, cochlear implants are generally considered safe for treating hearing loss.

Previous studies on cochlear implants indicate they are usually well-tolerated, with most side effects being mild and manageable. Common issues include minor surgical risks, but serious complications are rare. Since this study involves a modification of a standard procedure, the safety profile is expected to be similar.

This trial is labeled as "Not Applicable" for phase, likely indicating a focus on improving techniques rather than testing new drugs. This often suggests that significant safety concerns are not expected based on existing knowledge. However, participants should always discuss any potential risks with the research team before joining. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike standard cochlear implants that focus solely on enhancing auditory nerve stimulation through the cochlea, this modified cochlear implant introduces a unique twist by placing an extra-cochlear electrode near Arnold's nerve at the vagus nerve post-auricular location. This innovative placement aims to potentially enhance the auditory experience by tapping into different neural pathways, potentially offering improved hearing outcomes. Researchers are excited about this approach because it could lead to a more holistic hearing improvement, offering benefits beyond what traditional implants currently provide.

What evidence suggests that this extra-cochlear electrode placement is effective for hearing loss?

Research has shown that cochlear implants can improve hearing by directly stimulating the nerve responsible for hearing. In this trial, participants will undergo a modified cochlear implantation procedure where the electrode is placed near a nerve located behind the ear, specifically at the approximate location of Arnold's nerve. This placement could reduce scarring and help preserve more natural hearing. Previous patients with similar electrode placements experienced better hearing. This new approach aims to maintain these benefits while possibly making the implant more comfortable and effective. ^{1 2 6 7 8}

Who Is on the Research Team?

J. Thomas Roland, Jr., MD

Principal Investigator

NYU Langone Health

Are You a Good Fit for This Trial?

This trial is for individuals with hearing loss who are candidates for cochlear implantation. Specific eligibility criteria have not been provided, but typically participants must meet certain health standards and have a type of hearing loss that is expected to benefit from the procedure.

Inclusion Criteria

I am willing to participate in the study.

I am scheduled for cochlear implant surgery with a device from Cochlear Americas.

Exclusion Criteria

Pregnant, planning to become pregnant, or breastfeeding patients cannot undergo the standard-of-care implantation procedures required for participation in the study.

I have had ear surgery, was born with an ear malformation, or have a cochlear implant in the ear that will be implanted.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery and Initial Treatment

Participants undergo cochlear implantation with placement of the ECE1 ground electrode near the post-auricular vagus nerve

1 week

Post-operative Follow-up

Participants are monitored for initial recovery and implant activation

4 weeks

Long-term Follow-up

Participants are monitored for hearing outcomes and safety, including AzBio Sentence Recognition Test

Up to 1 year post cochlear implant activation

What Are the Treatments Tested in This Trial?

Interventions

• Extra-cochlear Electrode Placement at the Post-auricular Vagus Nerve

Trial Overview The study is testing the effectiveness of a modified cochlear implant procedure where the ground electrode (ECE1) is placed near the post-auricular vagus nerve instead of under the temporalis muscle, to see if it's just as good.

How Is the Trial Designed?

Group I: Patients scheduled for Cochlear Implantation Experimental Treatment 2 Interventions

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.

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07011927?term=cochlear%20implant&aggFilters=status:&viewType=Table&rank=3

Extra-cochlear Electrode Placement at the Post-auricular ... This study will evaluate hearing outcomes after cochlear implantation with placement of the ECE1 ground electrode near the post-auricular vagus nerve (Arnold's ...

2. withpower.com withpower.com/trial/phase-hearing-loss-5-2025-9c225

Modified Cochlear Implant for Hearing Loss This study will evaluate hearing outcomes after cochlear implantation with placement of the ECE1 ground electrode near the post-auricular vagus nerve ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6937184/

Extra-Cochlear Insertion in Cochlear Implantation Insertion of the electrode in any place other than scala tympani is rare; it is observed in approximately 0.2%–5.8% of all cochlear implantation ...

4. frontiersin.org frontiersin.org/journals/neuroscience/articles/10.3389/fnins.2024.1425226/full

Decreasing the physical gap in the neural-electrode ... Zwitterionic polymer/Polydopamine coating of electrode arrays reduces fibrosis and residual hearing loss after Cochlear implantation. Adv ...

5. ovid.com ovid.com/journals/jocn/pdf/10.1002/cne.24802~electrical-stimulation-induces-synaptic-changes-in-the

Electrical stimulation induces synaptic changes in the peripheral ... A new electrode for residual hearing preservation in cochlear implantation: First clinical results. Acta Oto-Laryngologica, 129(4), 372–379. https://doi.org ...

6. go.drugbank.com go.drugbank.com/conditions/DBCOND0094276

hearing loss or impairment (DBCOND0094276) Extra-cochlear Electrode Placement at the Post-auricular Vagus Nerve in Cochlear Implantation ... Cochlear Implants in Post-lingually Children: Results ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7115972/

Detection of Extracochlear Electrodes in Cochlear Implants ... The presence of extracochlear electrodes frequently goes unnoticed and could result in them being assigned stimulation frequencies that are either not delivered ...

8. withpower.com withpower.com/clinical-trials/for-hearing-loss?page=4

Top Hearing Loss Clinical Trials | Power 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 ...