NCT06901674

Stimulating the Cochlear Apex Without Longer Electrodes

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: NYU Langone Health · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

The most common cochlear implant intervention provides an electrode array that stimulates less than half of the length of the cochlea, leaving the regions which represent lower frequencies in the normally functioning ear unstimulated. Providing stimulation over the entire cochlea has the potential to improve speech understanding, sound quality, as well as spectral and temporal representation. Increasing the length of the electrode array to cover a greater portion of the cochlea has many potential issues, including increased damage to the cochlea and probability of incomplete insertions. In this study, a new technique is being investigated that allows stimulation across the entire cochlear extent without increasing the length of the electrode array. The purpose of this study is to evaluate the benefit of the new technique on speech understanding outcomes. Additionally, the study will investigate the new configuration to explore how the auditory system encodes temporal and spectral information.

Conditions

• Deafness With a Cochlear Implant

Interventions

Type	Name	Description
PROCEDURE	Modified surgical approach	An electrode typically placed under the temporalis muscle will be placed into the cochlear helicotrema instead.
DEVICE	Cochlear Nucleus CI632 cochlear implant	Cochlear implant (CI) system where stimulation from one of the intracochear electrodes is grounded via one of two (or both) extra cochlear electrodes in the device.

Timeline

• Start date: 2022-08-01
• Primary completion: 2027-01-01
• Completion: 2027-01-01
• First posted: 2025-03-30
• Last updated: 2026-03-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study