40 Participants Needed

Electrocochleography Monitoring for Hearing Loss Preservation During Cochlear Implant Surgery

Recruiting at 6 trial locations
WJ
LK
BM
MH
Overseen ByMeghan Hiss, AuD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 2 JurisdictionsThis treatment is already approved in other countries

Trial Summary

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 data supports the effectiveness of the treatment Electrocochleography (ECochG) for hearing loss preservation during cochlear implant surgery?

Research suggests that using Electrocochleography (ECochG) during cochlear implant surgery can help monitor and potentially preserve hearing. Studies show that ECochG provides real-time feedback on cochlear function, which may help in maintaining hearing after surgery.12345

Is Electrocochleography (ECochG) safe for use in humans during cochlear implant surgery?

The research does not specifically address the safety of Electrocochleography (ECochG) in humans, but it is used as a monitoring tool during cochlear implant surgeries to help preserve hearing, suggesting it is considered safe enough for this purpose.13678

How is the treatment Electrocochleography (ECochG) different from other treatments for hearing loss during cochlear implant surgery?

Electrocochleography (ECochG) is unique because it involves monitoring the electrical activity of the inner ear during cochlear implant surgery to help preserve hearing. Unlike other treatments that may focus on post-surgery recovery, ECochG is used during the surgery itself to provide real-time feedback, potentially improving hearing outcomes by minimizing damage to the cochlea.123910

What is the purpose of this trial?

The current study is a randomized multi-center clinical trial that investigates the role an intraoperative hearing monitoring system (electrocochleography) has on helping to save residual hearing in patients undergoing cochlear implantation (CI).

Research Team

OA

Oliver Adunka, MD

Principal Investigator

Ohio State University

AO

Amanda Ortmann, PhD

Principal Investigator

Washington University School of Medicine

Eligibility Criteria

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.
See 13 more

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
I have a health condition that makes surgery unsafe for me.
See 6 more

Timeline

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

Treatment Details

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.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: ECochG monitoringExperimental Treatment1 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 GroupActive Control1 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:

๐Ÿ‡ช๐Ÿ‡บ
Approved in European Union as ECochG for:
  • Diagnosis and monitoring of Meniere's disease/endolymphatic hydrops
  • Intraoperative nerve monitoring
  • Assessment of auditory neuropathy
๐Ÿ‡บ๐Ÿ‡ธ
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

Find a Clinic Near You

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+

Findings from Research

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.
Can Electrocochleography Help Preserve Hearing After Cochlear Implantation With Full Electrode Insertion?Harris, MS., Koka, K., Riggs, WJ., et al.[2022]
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.
Relationship Between Intraoperative Electrocochleography and Hearing Preservation.Lenarz, T., Buechner, A., Gantz, B., et al.[2023]
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.
Preliminary results and technique for electrophysiological intra-operative monitoring of residual hearing during cochlear implantation.Harris, R., Cruise, A., Gibson, W., et al.[2012]

References

Can Electrocochleography Help Preserve Hearing After Cochlear Implantation With Full Electrode Insertion? [2022]
Relationship Between Intraoperative Electrocochleography and Hearing Preservation. [2023]
Preliminary results and technique for electrophysiological intra-operative monitoring of residual hearing during cochlear implantation. [2012]
Correlation of Electrophysiological Properties and Hearing Preservation in Cochlear Implant Patients. [2018]
Electrocochleography in Cochlear Implant Users with Residual Acoustic Hearing: A Systematic Review. [2020]
Toward a Better Understanding of Electrocochleography: Analysis of Real-Time Recordings. [2021]
Acute effects of cochleostomy and electrode-array insertion on compound action potentials in normal-hearing guinea pigs. [2023]
Intraoperative Observational Real-time Electrocochleography as a Predictor of Hearing Loss After Cochlear Implantation: 3 and 12 Month Outcomes. [2023]
Clinical Utility of Intraoperative Electrocochleography (ECochG) During Cochlear Implantation: A Systematic Review and Quantitative Analysis. [2021]
Extra- and Intracochlear Electrocochleography in Cochlear Implant Recipients. [2015]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of ServiceยทPrivacy PolicyยทCookiesยทSecurity