NCT04707885

Clinical Utility of Residual Hearing in the Cochlear Implant Ear

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Ohio State University · Academic / Other
• Sex: All
• Age: 18 Years – 79 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

The clinical importance of residual acoustic hearing in CI remains unclear. It is estimated that only five percent of adult candidates undergo CI. A major barrier is the loss of residual hearing associated with surgery, meaning most patients lose any or all residual hearing as a result of the CI surgery, especially since the majority of today's candidates do not suffer from complete deafness. Hence, many candidates are faced with the decision to relinquish their remaining acoustic hearing in exchange for electric hearing via the CI, as CI surgery often results in complete loss of any residual hearing. However, recent developments in hearing monitoring systems during CI surgery have shown promise for providing the surgeon with live feedback of how the cochlear implant insertion process is proceeding, allowing the surgeon to make intraoperative adjustments during the insertion, potentially minimizing any trauma caused by the insertion of the implant, ultimately helping preserve residual hearing. This ultimately could lead to improvements in the rates of hearing preservation. Therefore, the current study seeks to investigate: 1) the advantage of using a hearing monitoring system (electrocochleography) monitoring guided CI surgery on hearing preservation rates, 2) determine the benefit that hearing aid/cochlear implant combined hearing provides participants over non-hearing preservation CI (electric-only stimulation from the CI) on measures of speech perception and quality of life.

Conditions

• Hearing Loss, Sensorineural
• Hearing Loss
• Hearing Loss, Bilateral

Interventions

Type	Name	Description
DEVICE	Electrocochleography	The use of ECochG monitoring will be employed. This will be conducted intraoperatively during the entire portion of the CI electrode insertion component. For the purposes of this clinical trial, the stimulus will consist of a 500 Hz tone burst presented at \~105-110 dB SPL. This was chosen due to the time and resource limitations in the operating room. Hence, the surgical team can only utilize a very limited dataset for intraoperative decision making and previous studies have demonstrated that 500 Hz stimulation offers the most robust, reliable, and useful ECochG signal during electrode insertions.

Timeline

• Start date: 2021-11-10
• Primary completion: 2026-12-31
• Completion: 2027-12-31
• First posted: 2021-01-13
• Last updated: 2025-09-12

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated device study