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Stimulating the Cochlear Apex Without Longer Electrodes

NCT06901674 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-03-06

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • National Institute on Deafness and Other Communication Disorders (NIDCD)

    collaborator NIH

  • NYU Langone Health

    lead OTHER

Principal Investigators

  • David M. Landsberger, Ph.D. · NYU Langone Health

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-01
Primary Completion
2027-01-01
Completion
2027-01-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06901674 on ClinicalTrials.gov