Cochlear Implant for Hearing Loss

Overseen By David M. Landsberger, Ph.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: NYU Langone Health

Disqualifiers: Under 18, Pregnancy, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to enhance cochlear implants for individuals with moderate to profound hearing loss. The aim is to improve speech understanding and sound quality by stimulating the entire cochlea without requiring a longer electrode. Participants are divided into two groups: one using the new technique (modified surgical approach) and the other using the standard approach. Suitable candidates for this trial include those already evaluated for a cochlear implant at NYU, who have chosen a Cochlear Limited device, and have moderate to profound sensorineural hearing loss. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could advance cochlear implant technology.

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

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this new technique is safe for cochlear implant patients?

Research has shown that cochlear implants, like the one being studied, are generally safe for most people. In a study of adults with these implants, only about 6.6% experienced major complications, which is quite low. These complications might require medical attention but are not very common.

In another study with children, about 26% experienced some side effects, but only a few were serious. This indicates that while minor issues can occur, serious problems are less frequent.

The new surgical method in this trial aims to improve hearing without increasing the risk of harm. Previous research indicates that cochlear implants are a safe option for those with severe hearing loss. By using a technique that covers the entire cochlea without enlarging the implant, the risk of complications might not increase significantly.

Overall, the safety data is encouraging, with most people handling the implant well. Serious issues are rare, making cochlear implants a dependable choice for many with hearing loss. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a modified surgical approach for cochlear implants, focusing on the placement of the ground electrode. Unlike the standard method, which uses a typical electrode position, this new approach places the electrode at the apical ground, potentially improving the implant's performance. By altering the electrode placement, researchers hope to enhance hearing outcomes and provide a more effective solution for individuals with hearing loss. This could lead to better sound quality and listening experiences for cochlear implant users.

What evidence suggests that this new technique for cochlear implants is effective for improving hearing loss?

Research has shown that cochlear implants can greatly improve hearing for many people. One study found that 82% of adults who lost their hearing after learning to speak understood speech better after receiving a cochlear implant. Another study found that 98% of patients had better sentence scores in the ear with the implant, with an average improvement of 65.3%. In this trial, participants will receive either the standard cochlear implant approach or a new technique designed to stimulate the whole cochlea. This new method, tested in one of the trial arms, could further enhance speech understanding and sound quality. Early signs suggest this new method could provide these benefits without increasing the risk of damage or incomplete insertions. ^{1 2 6 7 8}

Who Is on the Research Team?

David M. Landsberger, Ph.D.

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 implant surgery. The study aims to test a new surgical technique and implant device designed to stimulate the entire cochlea without using longer electrodes.

Inclusion Criteria

Participants must have already been evaluated at the NYU cochlear implant center as being eligible for a cochlear implant

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

I am getting a Cochlear implant for my moderate to profound hearing loss.

Exclusion Criteria

Participants are pregnant or plan to conceive within 6 months of consenting

I have not chosen a Cochlear Limited brand cochlear implant.

I do not have severe hearing loss in the ear that will be treated.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive cochlear implant intervention using the new technique or standard approach

12 months

Follow-up

Participants are monitored for speech understanding and auditory system encoding outcomes

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Cochlear Nucleus CI632 cochlear implant
• Modified surgical approach

Trial Overview

The trial investigates a modified surgical approach alongside the Cochlear Nucleus CI632 cochlear implant. It seeks to improve speech understanding and sound quality by stimulating all parts of the cochlea without increasing electrode length.

How Is the Trial Designed?

Group I: Apical ground electrode Experimental Treatment 2 Interventions

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.

Group II: Standard location ground electrode Active Control 1 Intervention

Participants in this group have received a cochlear implant with the typical ground electrode placement.

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

National Institute on Deafness and Other Communication Disorders (NIDCD)

Collaborator

Trials

377

Recruited

190,000+

Published Research Related to This Trial

In a study of 84 adults with severe to profound hearing loss, those who received multichannel cochlear implants showed a significant improvement in speech understanding and quality of life, with most benefits occurring within the first 6 months after implantation.

The cost-effectiveness of cochlear implants was favorable, with a marginal cost per quality-adjusted life-year (QALY) calculated at $14,670, indicating that the intervention provides good value for the health benefits it delivers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A prospective study of the cost-utility of the multichannel cochlear implant. Palmer, CS., Niparko, JK., Wyatt, JR., et al.[2022]

Cochlear implants, which send electrical impulses directly to the cochlear nerve, are a significant advancement for patients with severe hearing loss who cannot benefit from traditional hearing aids, and they are now being used in pediatric patients as well.

A multidisciplinary team approach is crucial for the successful implantation and follow-up care of cochlear implants, with 29 patients having received implants using a preferred multi-channel intracochlear system, demonstrating a positive impact on their quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Cochlear implants in children]. Garabedian, EN., Moatti, L., Roger, G., et al.[2006]

A review of 31,857 adverse events from cochlear implants revealed that implants from manufacturer C had a higher incidence of complications, including infection (0.97%), cerebrospinal fluid leak (0.07%), extrusion (0.44%), and facial nerve stimulation (0.11%).

Manufacturer B's implants were linked to a higher rate of meningitis (0.07%), highlighting the importance of considering both patient risk factors and the specific manufacturer when evaluating the safety of cochlear implants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complications of cochlear implants: a MAUDE database study. Jinka, S., Wase, S., Jeyakumar, A.[2023]

Cochlear implants are now approved for patients with severe to profound unilateral hearing loss, expanding candidacy beyond the previous requirement of bilateral profound loss, which enhances accessibility for more patients.

Advancements in surgical techniques, such as the use of short electrode arrays for shallow insertion, allow patients to retain low-frequency hearing while benefiting from cochlear implants for high frequencies, improving both safety and efficacy of the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New criteria of indication and selection of patients to cochlear implant. Sampaio, AL., Araújo, MF., Oliveira, CA.[2022]

In a study of 113 patients with Advanced Bionics Ultra cochlear implants, 17.7% experienced device failure, primarily in children, highlighting the need for ongoing monitoring of at-risk devices.

After revision surgeries, patients generally maintained stable auditory performance, indicating that revision procedures are effective and safe, with most patients opting to stay with the same manufacturer for their new devices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

HiRes ultra series cochlear implant field recall: failure rates and early outcomes. Winchester, A., Kay-Rivest, E., Friedmann, DR., et al.[2023]

A retrospective analysis of cochlear implant adverse events over a 10-year period revealed a significant increase in cases with multiple or unknown causes, particularly gradual idiopathic loss of performance, indicating a shift in the nature of reported issues.

Despite improvements in manufacturing and surgical techniques, the rise in complex adverse events suggests a need for further research to understand and address these idiopathic cases to enhance cochlear implant outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trends in cochlear implant complications: implications for improving long-term outcomes. Causon, A., Verschuur, C., Newman, TA.[2013]

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This report provides reliability data for the internal (cochlear implant) and external (sound processor) components of our Nucleus® Systems.

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Recent systematic reviews have reported an overall RCI rate of 5.5%–6.0% and a device failure rate of 2.2%–3.6% [8,10], findings that align with our own series.

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Slim Modiolar Electrode (CI632) Perimodiolar electrode designed to maximize placement and deliver improved hearing outcomes.

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Adult safety data are based on a total of 133 patients implanted with ... complete loss of residual hearing in the implanted ear. When selecting the ...