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

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment Cochlear Nucleus CI632 cochlear implant, Modified surgical approach?

Research shows that cochlear implants, like the Cochlear Nucleus CI632, significantly improve speech perception in people with severe to profound hearing loss, especially when traditional hearing aids are not effective. Studies have demonstrated that these implants can greatly enhance the quality of life for both adults and children with severe hearing loss. ^{1 2 3 4 5}

Is the cochlear implant generally safe for humans?

Cochlear implants, like the Cochlear Nucleus CI632, have been studied for safety, and while complications can occur, they are generally rare. Common issues include skin flap problems and electrode positioning, but the overall complication rate is low, around 4.6%, and no technical failures were reported in some studies. ^{6 7 8 9 10}

How does the modified surgical approach for cochlear implants differ from other treatments for hearing loss?

The modified surgical approach for cochlear implants involves accessing the cochlea through the middle cranial fossa, which is different from the traditional method that uses mastoidectomy and posterior tympanotomy. This novel approach can potentially reduce complications and preserve residual hearing by minimizing the need for extensive drilling and avoiding damage to neural structures. ^{11 12 13 14 15}

Research Team

David M. Landsberger, Ph.D.

Principal Investigator

NYU Langone Health

Eligibility Criteria

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 am younger than 18 years old.

I have not chosen a Cochlear Limited brand cochlear implant.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

References

1. France pubmed.ncbi.nlm.nih.gov

[Cochlear implants in children]. [2006]

2. United States pubmed.ncbi.nlm.nih.gov

A prospective study of the cost-utility of the multichannel cochlear implant. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Scala tympani cochleostomy I: results of a survey. [2018]

4. England pubmed.ncbi.nlm.nih.gov

Variables affecting speech perception in postlingually deaf adults following cochlear implantation. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Cochlear Implant Outcomes in Patients With Severe Compared With Profound Hearing Loss. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Complications of cochlear implants: a MAUDE database study. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Medical, surgical, and technical complications with the COMBI-40. [2004]

8. England pubmed.ncbi.nlm.nih.gov

A UK experience of daycase cochlear implant surgery. [2018]

9. England pubmed.ncbi.nlm.nih.gov

HiRes ultra series cochlear implant field recall: failure rates and early outcomes. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

Trends in cochlear implant complications: implications for improving long-term outcomes. [2013]

11. Brazil pubmed.ncbi.nlm.nih.gov

Cochlear implantation through the middle cranial fossa: a novel approach to access the basal turn of the cochlea. [2022]

12. China pubmed.ncbi.nlm.nih.gov

[Advances in minimally invasive cochlear implantation]. [2018]

13. England pubmed.ncbi.nlm.nih.gov

Exploratory tympanotomy: an integral part of cochlear implantation. [2019]

14. United States pubmed.ncbi.nlm.nih.gov

Hearing rehabilitation in children with malformed ears: The endoscopic-assisted approach for cochlear implantation. [2023]

15. United States pubmed.ncbi.nlm.nih.gov

New criteria of indication and selection of patients to cochlear implant. [2022]