NCT06453343

Clinical Trial to Compare Two Surgical Approaches to the Cochlea

Multicenter Randomized Controlled Trial Comparing Surgical Approaches to the Cochlea for the Slim Modiolar Electrode: Assessing Intracochlear Trauma Using Intraoperative Electrocochleography Measurements and Preservation of Residual Hearing

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Radboud University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective multicenter multinational randomized control trial. The duration of the study for the individual patient will be approximately 1 year (pre-operative assessments, 1 week, 3 months and 12 months follow-up assessments). Participants will be randomized to one of two surgical approaches: eRW or CO, with a 1:1 allocation in a parallel design.

Detailed description

Rationale: Preserving residual hearing in cochlear implant (CI) surgery has gained significant attention. It not only signifies minimally invasive implantation but also supports natural sound perception and enables electrical-acoustic stimulation, enhancing sound localization, music appreciation, and speech recognition in noisy environments. Using the Cochlear™ Nucleus® CI with Slim Modiolar electrode (Cochlear Ltd., Sydney, Australia), potential sites of residual hearing loss in surgery include approaches to the cochlear lumen, potential damage during entry, and damage during electrode insertion. Studies comparing different surgical approaches (cochleostomy (CO) and extended round window (eRW)) show varied results. Electrocochleography (ECochG) can be used to indicate intracochlear damage during electrode insertion, however, the variability observed in ECochG responses during cochlear implantation remains significant. Moreover, ECochG has not yet been used to monitor cochlear functions throughout every phase of surgery, including the insertion of the sheath or stabilization of the electrode lead. Objective: The aim of this study is to investigate whether the type of surgical approach to the cochlea; CO or eRW using the CI632 affects the final residual hearing and secondarily, intracochlear trauma and electrode position, as determined by pure tone audiometry, EcochG and imaging. Study population: Adult CI candidates with post-lingual onset of severe to profound hearing loss, who are scheduled to receive a Nucleus CI632 with a slim modiolar electrode array and have a preoperative audiometric low-frequency average air conduction threshold of \<80 decibel (dB) hearing level at 500 Hz in the ear to be implanted.

Conditions

• Cochlear Implants
• Hearing Loss, Sensorineural

Interventions

Type	Name	Description
PROCEDURE	Surgical approach: cochleostomy or extended round window	Surgical placement of a cochlear implant electrode array

Timeline

• Start date: 2025-01-01
• Primary completion: 2026-12-31
• Completion: 2027-11-01
• First posted: 2024-06-11
• Last updated: 2025-02-25

Locations

1 site across 1 country: Netherlands