Stimulating the Cochlear Apex Without Longer Electrodes

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Deafness With a Cochlear Implant
• Intervention / Treatment: Procedure: Modified surgical approach; Device: Cochlear Nucleus CI632 cochlear implant

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • NYU Langone Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Participants in this study must have already been evaluated at the NYU cochlear implant center as being eligible for a cochlear implant.
• They must have decided to receive a cochlear implant manufactured by Cochlear Limited and have been diagnosed with a moderate to profound sensorineural hearing loss in the ear to be implanted.
• Individuals who have already been implanted with a cochlear implant manufactured by Cochlear Limited with or without this new approach may also participate in this study.

Exclusion Criteria:

• They are under the age of 18
• They have not been diagnosed with a moderate to profound sensorineural hearing loss in the ear to be implanted
• Have >15 years of profound deafness
• Have not chosen to receive a cochlear implant manufactured by Cochlear Limited
• Are pregnant or plan to conceive within 6 months of consenting

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Apical ground electrode; Participants in this group will have already received a cochlear implant using the new approach or be receiving a cochlear implant with the new approach.	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.
Active Comparator: Standard location ground electrode; Participants in this group have received a cochlear implant with the typical ground electrode placement.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Upper Limit of Rate Pitch Perception for Cochlear Implant Stimuli	The upper limit of rate pitch perception will be evaluated for Apex-monopolar (MP), 22-Apex, 22-MP, and 11-MP cochlear implant stimuli using a 3-up 1-down 2-interval forced-choice adaptive task. The task measures the highest modulation frequency perceived as a lower pitch compared to a rate 5 semitones higher. A series of 750-ms, 5000-pps pulse trains with 100% amplitude modulation will be presented at a loudness-balanced most-comfortable level. The upper limit will be estimated from the average modulation frequency of the last 6 reversals across 10 trials per stimulation site.	Month 12
Mean pitch rank	Pitch-ranking will be done using a 2-interval forced-choice protocol in which the pitch of a newly selected stimulus is ranked relative to the stimulus in the middle of a pitch-rank order list. Depending on the ranked pitch direction, this stimulus is repositioned in the pitch-rank order list and ranked against a neighboring stimulus until the correct position in the list is determined. This process repeated until all stimuli are successfully pitch ranked. A complete set of pitch ranks are measured 10 times allowing for the calculation of a mean rank and 95% confidence interval for the rank of each interval.	Month 12
Percentage of Consonant-Nucleus-Consonant (CNC) words correctly repeated	Speech perception will be assessed using CNC word lists, a common method for evaluating monosyllabic word recognition. The CNC Monosyllabic Word Test includes 10 lists of 50 words. The word test score range typically used is between 10% and 60% correct in the ear to be implanted, and equal to or better than that ear in the contralateral ear, but not better than 80% correct.	Month 12

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Collaborators: National Institute on Deafness and Other Communication Disorders (NIDCD)
• Investigators: Principal Investigator: David M. Landsberger, Ph.D., NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2022
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: March 24, 2025
• First Submitted That Met QC Criteria: March 24, 2025
• First Posted (Actual): March 30, 2025

Study Record Updates

• Last Update Posted (Actual): March 6, 2026
• Last Update Submitted That Met QC Criteria: March 4, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Ear Diseases; Hearing Loss; Hearing Disorders; Deafness
• Other Study ID Numbers: 20-01964; 5R21DC019743-02 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The de-identified participant data from the final research dataset will be shared upon reasonable request beginning 9 to 36 months after publication or as required by a condition of awards or supporting agreements, provided the requesting investigator executes a data use agreement with NYU Langone Health. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's Data Sharing Strategy Board (DSSB). Requests should be directed to:David.landsberger@nyulangone.org. The protocol and statistical analysis plan will be posted on Clinicaltrials.gov only as required by federal regulation or supporting awards and agreements.
• IPD Sharing Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
• IPD Sharing Access Criteria: Requests should be directed to David.landsberger@nyulangone.org. To gain access, data requestors will need to sign a data access agreement. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's DSSB.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes