Electrocochleography Monitoring for Hearing Loss Preservation During Cochlear Implant Surgery

Recruiting at 7 trial locations

Overseen By Bruce Gantz, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Ohio State University

Disqualifiers: Previous cochlear implantation, Prelingual hearing loss, Abnormal inner ear anatomy, Auditory neuropathy, Retrocochlear pathology, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

Duration: 1 day

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether using a special monitoring system called Electrocochleography (ECochG) during cochlear implant surgery can protect any remaining hearing in patients. The study involves two groups: one group will undergo surgery with the additional hearing monitoring, while the other will have the usual surgery without it. This trial suits individuals who experienced hearing loss after learning to talk and found hearing aids ineffective. Participants must be fluent in English and willing to attend all study visits. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance hearing preservation techniques.

Will I have to stop taking my current medications?

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 electrocochleography is safe for hearing loss preservation during cochlear implant surgery?

Research has shown that using electrocochleography (ECochG) during cochlear implant surgery is generally safe. In past studies, ECochG helped surgeons protect patients' hearing during these operations. No major reports have indicated problems directly caused by ECochG. This suggests that ECochG is well-tolerated by patients and does not add extra risk beyond the usual risks of cochlear implant surgery. However, as with any surgery, discussing concerns with the medical team is important to understand the specific risks and benefits for each situation. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using electrocochleography (ECochG) monitoring during cochlear implant surgery because it offers a unique way to preserve hearing. Unlike the standard cochlear implantation process, which involves full electrode insertion without real-time feedback, ECochG provides surgeons with immediate insights into how the electrode insertion is impacting the cochlea. This feedback allows surgeons to adjust the insertion on-the-fly, potentially preventing damage and preserving more of the patient's natural hearing. This real-time monitoring could lead to better hearing outcomes compared to the current standard care, which relies on techniques like non-traumatic cochlear opening and slow electrode insertions but lacks this advanced feedback mechanism.

What evidence suggests that electrocochleography is effective for preserving hearing during cochlear implant surgery?

Research has shown that using electrocochleography (ECochG) during cochlear implant surgery can help monitor and possibly protect hearing. In this trial, participants in the ECochG monitoring arm will have their surgery guided by ECochG feedback, allowing surgeons to adjust the procedure to prevent further damage. Studies have found that patients who experience drops in ECochG signals during surgery often have more hearing loss afterward. This suggests that ECochG could help preserve as much of the original hearing as possible. Evidence supports that cochlear implants effectively restore hearing in people with severe loss, and ECochG might enhance these results by preserving existing hearing. Participants in the control group will undergo standard cochlear implant surgery without ECochG monitoring. ^{1 2 6 7 8}

Who Is on the Research Team?

Amanda Ortmann, PhD

Principal Investigator

Washington University School of Medicine

Oliver Adunka, MD

Principal Investigator

Ohio State University

Are You a Good Fit for This Trial?

This trial is for adults aged 18-79 with severe to profound sensorineural hearing loss who have had limited benefit from hearing aids. They must be proficient in English, willing to complete study visits, and not have prelingual deafness or inner ear abnormalities. Candidates should not have had a previous cochlear implant and must be getting an implant from Cochlear Limited or Advanced Bionics AG.

Inclusion Criteria

You have difficulty understanding certain words or sentences even with a hearing aid.

I have used hearing aids in both ears for at least 30 days, fitted and verified by a professional.

I am willing and able to attend all study visits and complete tests.

Exclusion Criteria

I am willing and able to follow all study requirements.

Additional medical, or social barriers that would prevent completion of all study requirements

The patient has chosen the Med El CI device for their treatment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo cochlear implantation surgery with or without ECochG monitoring

1 day

1 visit (in-person)

Follow-up

Participants are monitored for hearing preservation and quality of life improvements

24 months

Regular visits at 3, 6, 12, and 24 months

What Are the Treatments Tested in This Trial?

Interventions

• Electrocochleography

Trial Overview

The study tests if using electrocochleography during cochlear implant surgery can help preserve residual hearing. It's a randomized trial across multiple centers where participants are chosen by chance to receive this monitoring technique while being implanted.

How Is the Trial Designed?

Group I: ECochG monitoring Experimental Treatment 1 Intervention

For those randomized to the experimental group, the CI surgery will proceed in a standard fashion. However, the surgeon will utilize ECochG-guided monitoring by placing the external device coil and processor over the receiver/stimulator of the implanted components. Also, a sound applicator (i.e. speaker) will be placed in the external auditory canal by the surgeon. During electrode insertion the surgeon will utilize the ECochG feedback to adjust insertion if needed. That is, once the electrode has been inserted at least 75% (75% of the electrode contacts inside the cochlea), the surgeon may proceed to full insertion if indicated during ECochG feedback or may modify and/or cease electrode insertion if indicated by the ECochG feedback in attempts to preserve RH.

Group II: Control Group Active Control 1 Intervention

For those randomized to the control group, they will receive their CI per the standard of care. That is, all procedures that take place during a routine CI surgery will be the same for those in the control group. As such, no ECochG monitoring will be performed. However, all study surgeons will be asked to adhere to soft surgical principles (non-traumatic cochlear opening, slow electrode insertions) to enhance HP outcomes even in the absence of intraoperative ECochG monitoring. Further, the standard of care for cochlear implantation is to perform full electrode insertions with all electrode contacts inside of the cochlea. Thus, for subjects in the control group, surgeons will be asked to perform full electrode insertions.

Electrocochleography is already approved in European Union, United States for the following indications:

Approved in European Union as ECochG for:

• Diagnosis and monitoring of Meniere's disease/endolymphatic hydrops
• Intraoperative nerve monitoring
• Assessment of auditory neuropathy

Approved in United States as ECochG for:

• Diagnosis and monitoring of Meniere's disease/endolymphatic hydrops
• Intraoperative nerve monitoring
• Assessment of auditory neuropathy
• Identification of wave I of the auditory brainstem response in patients with profound hearing loss

Who Is Running the Clinical Trial?

Ohio State University

Lead Sponsor

Trials

891

Recruited

2,659,000+

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 68 cochlear implant recipients, larger drops in intraoperative electrocochleography (ECochG) amplitude during electrode insertion were associated with poorer hearing preservation outcomes, indicating that ECochG monitoring can provide valuable insights during surgery.

The study found significant differences in hearing loss outcomes between the two types of electrode arrays used (MidScala and SlimJ), suggesting that the choice of electrode may impact hearing preservation after cochlear implantation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Relationship Between Intraoperative Electrocochleography and Hearing Preservation. Lenarz, T., Buechner, A., Gantz, B., et al.[2023]

In a study of 109 patients undergoing cochlear implantation, those who experienced a significant drop in intracochlear electrocochleographic (ECochG) amplitude during surgery had poorer hearing preservation at both 3 and 12 months post-operation.

The findings suggest that monitoring ECochG in real-time during surgery could help surgeons make immediate adjustments to improve long-term hearing outcomes for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intraoperative Observational Real-time Electrocochleography as a Predictor of Hearing Loss After Cochlear Implantation: 3 and 12 Month Outcomes. O'Leary, S., Briggs, R., Gerard, JM., et al.[2023]

A study involving 85 adult patients undergoing cochlear implant surgery found that using intracochlear electrocochleography (ECochG) monitoring did not significantly improve hearing preservation compared to surgery without ECochG monitoring, with both groups showing similar changes in low-frequency pure-tone averages.

Despite the lack of significant difference in hearing outcomes, the study highlighted that ECochG monitoring has important prognostic value, as it can help identify potential issues like electrode translocation during surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can Electrocochleography Help Preserve Hearing After Cochlear Implantation With Full Electrode Insertion? Harris, MS., Koka, K., Riggs, WJ., et al.[2022]

Electrocochleography (ECoG) was successfully used to monitor cochlear function in 9 cochlear implant recipients, showing that significant changes in cochlear function are primarily observed within the first week after surgery, particularly due to middle ear effusion.

The study found that there was no gross intracochlear trauma during implantation, and ECoG recordings indicated that any persistent reductions in cochlear function were not due to surgical damage but rather to temporary conditions affecting the middle ear.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Extra- and Intracochlear Electrocochleography in Cochlear Implant Recipients. Dalbert, A., Pfiffner, F., Röösli, C., et al.[2015]

In a study of 55 patients undergoing cochlear implantation, an amplitude drop of 61% in real-time electrocochleography (ECochG) during electrode insertion was identified as a significant predictor of a 25% loss in hearing one month post-surgery.

The findings suggest that clearly defined ECochG events, particularly those with a steep slope of 0.2 µV/sec, can help guide surgeons to preserve acoustic hearing during cochlear implantation, as larger amplitude drops were associated with worse hearing outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Toward a Better Understanding of Electrocochleography: Analysis of Real-Time Recordings. Weder, S., Bester, C., Collins, A., et al.[2021]

Intraoperative electrocochleography (ECochG) can be successfully recorded in over 90% of patients during cochlear implantation, with extracochlear recordings showing a slightly higher success rate (94.9%) compared to intracochlear recordings (91.8%).

However, the ability of ECochG to accurately predict postoperative hearing loss is limited, indicating a need for standardization in monitoring techniques and data interpretation to improve its predictive value.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Utility of Intraoperative Electrocochleography (ECochG) During Cochlear Implantation: A Systematic Review and Quantitative Analysis. Yin, LX., Barnes, JH., Saoji, AA., et al.[2021]

Electrocochleography (ECoG) is a reliable method for monitoring cochlear function during cochlear implantation, with 95% of subjects showing measurable responses, indicating its effectiveness in assessing cochlear health.

In the study of 19 cochlear implant subjects, 94% showed no significant changes in ECoG after electrode insertion, but one subject experienced trauma leading to complete hearing loss, suggesting that ECoG changes can predict potential hearing loss post-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Correlation of Electrophysiological Properties and Hearing Preservation in Cochlear Implant Patients. Dalbert, A., Sim, JH., Gerig, R., et al.[2018]

Electrocochleography (ECoG) is a useful tool for monitoring the peripheral auditory system during cochlear implant (CI) surgery, providing real-time feedback on electrode placement and response amplitudes.

Postoperatively, ECoG can help assess hearing preservation and detect changes in hearing thresholds in CI users with some residual hearing, indicating its potential clinical value in this growing patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electrocochleography in Cochlear Implant Users with Residual Acoustic Hearing: A Systematic Review. Kim, JS.[2020]

Intra-operative monitoring of residual hearing using electrocochleography (ECOG) during cochlear implantation is feasible, with satisfactory recordings obtained in 11 out of 21 patients, indicating that most patients can maintain their hearing during the procedure.

The study suggests that cochleostomy does not typically lead to loss of residual hearing, but risks increase during electrode insertion, particularly at the cochlea's basal turn, and suction of perilymph can cause immediate and potentially irreversible changes in hearing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preliminary results and technique for electrophysiological intra-operative monitoring of residual hearing during cochlear implantation. Harris, R., Cruise, A., Gibson, W., et al.[2012]

In a study involving 11 normal-hearing guinea pigs, electrocochleography (ECochG) was used to monitor cochlear trauma during cochlear implant surgery, revealing that trauma severity increased with the insertion of the electrode array, which negatively impacted hearing thresholds.

The findings suggest that minimizing trauma during cochleostomy and electrode insertion is crucial for preserving low-frequency residual hearing in cochlear implant recipients, as significant threshold shifts were observed following these procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute effects of cochleostomy and electrode-array insertion on compound action potentials in normal-hearing guinea pigs. Jwair, S., Ramekers, D., Thomeer, HGXM., et al.[2023]

Citations

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Hearing and Structure Preservation Via ECochG

Cochlear implantation is a highly effective method of rehabilitating hearing in individuals with severe to profound hearing loss.

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sciencedirect.com

sciencedirect.com/science/article/pii/S2095881120300536

Review Article Electrocochleography in cochlear implantation

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