A new electrode for residual hearing preservation in cochlear implantation: first clinical results.
Wolfgang Gstoettner, Silke Helbig, Claudia Settevendemie...
https://pubmed.ncbi.nlm.nih.gov/19140036/Actively Recruiting
Led by Ohio State University · Updated on 2025-09-12
40
Participants Needed
5
Research Sites
52 weeks
Total Duration
Researchers are investigating the role of an intraoperative hearing monitoring system called electrocochleography ECochG in preserving residual hearing during cochlear implant CI surgery. This randomized multi-center clinical trial focuses on adults with bilateral sensorineural hearing loss who face the challenge of losing residual hearing as a result of CI surgery. The study aims to understand how ECochG monitoring might reduce hearing loss during implantation and to evaluate benefits of combined hearing from hearing aids and cochlear implants compared to electric-only stimulation. Participants are randomly assigned to one of two groups. In the experimental group, surgeons use ECochG monitoring during CI surgery by placing a device coil and sound applicator to provide live feedback, allowing adjustments during electrode insertion to minimize trauma and preserve hearing. The control group undergoes standard CI surgery without ECochG monitoring but with adherence to soft surgical principles to enhance hearing preservation. Full electrode insertion is performed in the control group as per usual care. During the study, participants undergo assessments at 3, 6, 12, and 24 months to measure hearing preservation advantages. Researchers will evaluate speech perception and quality of life related to hearing outcomes. Participants complete testing and study visits, and surgeons monitor intraoperative feedback in the experimental group. The total study duration includes these follow-up periods to understand long-term hearing preservation effects after CI surgery.
CONDITIONS
Clinical Utility of Residual Hearing in the Cochlear Implant Ear
B
Beth Miles-Markley
M
Meghan Hiss, AuD
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Ohio State University
Lead Sponsor
National Institute on Deafness and Other Communication Disorders (NIDCD)
Collaborating Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | Intraoperative ECochG Monitoring | Standard Surgery (No ECochG Monitoring) |
|---|---|---|
| What it is | Cochlear implant surgery in which intraoperative ECochG (electrocochleography) signals are recorded throughout electrode insertion to help inform surgical technique in real time. | Standard cochlear implant surgery is performed without the use of intraoperative ECochG monitoring; electrode insertion follows current practice without additional real-time electrophysiological feedback. |
| Role in the study | Assesses whether using ECochG feedback during surgery helps preserve residual hearing in adults with sensorineural hearing loss. | Provides a comparison group undergoing cochlear implant surgery with current practice, without ECochG guidance. |
| Main use or purpose | Aims to utilize real-time ECochG measurements to monitor cochlear function and potentially minimize trauma during electrode insertion, seeking improved preservation of residual hearing. | Provides cochlear implants using standard surgical technique, aiming to restore hearing without intraoperative electrophysiological feedback. |
| How it is given or performed | ECochG signals are recorded via the cochlear implant electrode while the device is being inserted. Signals from a 500 Hz tone burst are used to guide the surgeon in real time. Monitoring is performed throughout the electrode insertion during cochlear implant surgery. | Electrode insertion is carried out without ECochG signal recording or intraoperative monitoring. Standard surgical technique is followed as per current practice. |
| Published evidence status | Clinical studies show that intraoperative ECochG signals can be successfully recorded and may correlate with postoperative hearing preservation, but clear evidence for improved long-term hearing outcomes remains under investigation. | Standard cochlear implant surgery is well-established for improving speech recognition and quality of life in eligible adults, but residual hearing preservation varies based on surgical technique and patient anatomy. |
| Important limitations | Additional time and resources are required for intraoperative ECochG monitoring, and the method’s impact on long-term hearing outcomes has not yet been firmly established. Applicability is limited to cochlear implants compatible with ECochG measurement. | Without intraoperative objective feedback, the ability to protect residual hearing depends solely on surgical technique and anatomical factors. Residual hearing loss remains a recognized risk despite improvements in surgical approach. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
You may qualify if you...
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo cochlear implant surgery. Those in the experimental group receive electrocochleography (ECochG) monitoring during electrode insertion to help preserve residual hearing. The control group receives standard cochlear implant surgery without ECochG monitoring.
Surgery and immediate post-operative care visit
Duration - Up to 24 months
Participants are followed to assess hearing preservation and benefits of hearing aid/cochlear implant combined hearing over electric-only stimulation.
Visits at 3, 6, 12, and 24 months post-surgery
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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https://pubmed.ncbi.nlm.nih.gov/9093674/Ohio State University
Lead Sponsor
National Institute on Deafness and Other Communication Disorders (NIDCD)
Collaborating Sponsor