Clinical Evaluation of Frequency Allocation for Bimodal CI Users

This study will examine experienced, bimodal cochlear implant (CI) patients who receive an alternative frequency allocation table (FAT) to determine how it improves sound quality, device satisfaction, and speech perception abilities with respect to the standard default FAT. The goal of this study is to investigate how improving place-pitch mismatch in bimodal CI users affects 1) sound quality, 2) satisfaction, and 3) speech perception.

Study Overview

• Status: Recruiting
• Conditions: Hearing Impairment
• Intervention / Treatment: Other: Experimental frequency allocation table (FAT) - 438 Hz; Other: Standard FAT - 188 Hz

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mario Svirsky, PhD; Phone Number: 212-263-7217; Email: Mario.svirsky@nyulangone.org
• Study Contact Backup: Name: Megan Eitel; Phone Number: 212-263-5271; Email: Megan.eitel@nyulangone.org

Study Locations

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

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

1. Age 18 or older
2. Regular usage of a cochlear implant device with at least 18 active electrodes, and compliance with programming/appointments
3. Received a cochlear implant at least 6 months ago and use a hearing aid in the contralateral ear
4. Pure tone average (.5, 1, and 2kHz) between 30 and 70 dB (decibel) hearing level in the contralateral (hearing aid) ear
5. Standard FAT use for all programs prior to study participation
6. No known anatomical abnormalities in either ear
7. English speaking
8. No known cognitive impairments
9. At least 25% of subjects should use the Cochlear EA32 electrode

Exclusion Criteria:

1. Under age 18
2. Non-English speaking. Participants that are Non-English speaking are excluded from this study due to the use of speech testing materials that are validated in the English language. Additionally, study team members are not equipped to appropriately score speech testing materials validated in other languages.
3. Cognitively impaired
4. Non-consistent device usage
5. Greater than 70 dB hearing level pure tone average in the contralateral ear
6. Normal hearing or mild hearing loss in the contralateral ear
7. Non-standard FAT programs
8. Use of any frequency transposition programming in hearing aid.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Experienced Users; All subjects will be fit with a modified cochlear implant program ("experimental FAT") that changes which frequencies are presented to the cochlear implant. Subjects will complete a 1 month adaptation to the experimental FAT (438 Hz) and then a one month re-adaptation to the standard FAT (188 Hz). Speech perception tests and questionnaires will be collected before and after each FAT adaptation.

Other: Experimental frequency allocation table (FAT) - 438 Hz; The modified cochlear implant program ("experimental FAT") changes which frequencies are presented to the cochlear implant. The experimental FAT frequency of 438 Hz will be loaded onto the subjects processor via the CI Select Mobile App. Subjects will use the experimental FAT for one month.; Other: Standard FAT - 188 Hz; All subjects will retain one program with the standard 188 Hz FAT. Subjects will use the standard FAT for one month.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sound Quality Questionnaire Score while using standard 188 Hz FAT	A questionnaire will be given to the subjects to record their subjective thoughts regarding sound quality and satisfaction with both the experiment FAT and the standard FAT. Questionnaires will be administered double blind. Patients evaluate the 16-item questionnaire using a likert-scale (1-strongly disagree to 5-strongly agree). Lower scores indicate decreased sound quality and satisfaction, while higher scores indicate increased sound quality and satisfaction.	Baseline
Sound Quality Questionnaire Score while using experimental 438 Hz FAT	A questionnaire will be given to the subjects to record their subjective thoughts regarding sound quality and satisfaction with both the experiment FAT and the standard FAT. Questionnaires will be administered double blind. Patients evaluate the 16-item questionnaire using a likert-scale (1-strongly disagree to 5-strongly agree). Lower scores indicate decreased sound quality and satisfaction, while higher scores indicate increased sound quality and satisfaction.	Behavioral Visit 2 (1 month post 438 Hz FAT adaptation)
Sound Quality Questionnaire Score while using standard 188 Hz FAT	A questionnaire will be given to the subjects to record their subjective thoughts regarding sound quality and satisfaction with both the experiment FAT and the standard FAT. Questionnaires will be administered double blind. Patients evaluate the 16-item questionnaire using a likert-scale (1-strongly disagree to 5-strongly agree). Lower scores indicate decreased sound quality and satisfaction, while higher scores indicate increased sound quality and satisfaction.	Behavioral Visit 3 (1 month post 188 Hz FAT re-adaptation)
The consonant-nucleus-consonant (CNC) word list score while using standard 188 Hz FAT	CNC word lists are used to evaluate the speech perception abilities of people with hearing impairments and cochlear implant users. A CNC score above 50% postoperatively indicates that a patient can communicate without relying too much on lip reading, sign language, or written communication.	Baseline
CNC word list score while using standard 188 Hz FAT	CNC word lists are used to evaluate the speech perception abilities of people with hearing impairments and cochlear implant users. A CNC score above 50% postoperatively indicates that a patient can communicate without relying too much on lip reading, sign language, or written communication.	Behavioral Visit 2 (1 month post 438 Hz FAT adaptation)
CNC word list score while using standard 188 Hz FAT	CNC word lists are used to evaluate the speech perception abilities of people with hearing impairments and cochlear implant users. A CNC score above 50% postoperatively indicates that a patient can communicate without relying too much on lip reading, sign language, or written communication.	Behavioral Visit 3 (1 month post 188 Hz FAT re-adaptation)
CNC word list score while using experimental 438 Hz FAT	CNC word lists are used to evaluate the speech perception abilities of people with hearing impairments and cochlear implant users. A CNC score above 50% postoperatively indicates that a patient can communicate without relying too much on lip reading, sign language, or written communication.	Baseline
CNC word list score while using experimental 438 Hz FAT	CNC word lists are used to evaluate the speech perception abilities of people with hearing impairments and cochlear implant users. A CNC score above 50% postoperatively indicates that a patient can communicate without relying too much on lip reading, sign language, or written communication.	Behavioral Visit 2 (1 month post 438 Hz FAT adaptation)
CNC word list score while using experimental 438 Hz FAT	CNC word lists are used to evaluate the speech perception abilities of people with hearing impairments and cochlear implant users. A CNC score above 50% postoperatively indicates that a patient can communicate without relying too much on lip reading, sign language, or written communication.	Behavioral Visit 3 (1 month post 188 Hz FAT re-adaptation)
Bamford-Kowal-Bench (BKB-SIN) speech-in-noise score using standard 188 Hz FAT	The BKB-SIN speech-in-noise test measures speech perception in noise by assessing a listener's signal-to-noise ratio (SNR) loss. The test results are presented as the SNR loss, which is the amount the signal-to-noise ratio needs to be increased for the listener to correctly repeat 50% of the sentences. A higher SNR loss indicates more difficulty hearing.	Baseline
Bamford-Kowal-Bench (BKB-SIN) speech-in-noise score using standard 188 Hz FAT	The BKB-SIN speech-in-noise test measures speech perception in noise by assessing a listener's signal-to-noise ratio (SNR) loss. The test results are presented as the SNR loss, which is the amount the signal-to-noise ratio needs to be increased for the listener to correctly repeat 50% of the sentences. A higher SNR loss indicates more difficulty hearing.	Behavioral Visit 2 (1 month post 438 Hz FAT adaptation)
Bamford-Kowal-Bench (BKB-SIN) speech-in-noise score using standard 188 Hz FAT	The BKB-SIN speech-in-noise test measures speech perception in noise by assessing a listener's signal-to-noise ratio (SNR) loss. The test results are presented as the SNR loss, which is the amount the signal-to-noise ratio needs to be increased for the listener to correctly repeat 50% of the sentences. A higher SNR loss indicates more difficulty hearing.	Behavioral Visit 3 (1 month post 188 Hz FAT re-adaptation)
Bamford-Kowal-Bench (BKB-SIN) speech-in-noise score using experimental 438 Hz FAT	The BKB-SIN speech-in-noise test measures speech perception in noise by assessing a listener's signal-to-noise ratio (SNR) loss. The test results are presented as the SNR loss, which is the amount the signal-to-noise ratio needs to be increased for the listener to correctly repeat 50% of the sentences. A higher SNR loss indicates more difficulty hearing.	Baseline
Bamford-Kowal-Bench (BKB-SIN) speech-in-noise score using experimental 438 Hz FAT	The BKB-SIN speech-in-noise test measures speech perception in noise by assessing a listener's signal-to-noise ratio (SNR) loss. The test results are presented as the SNR loss, which is the amount the signal-to-noise ratio needs to be increased for the listener to correctly repeat 50% of the sentences. A higher SNR loss indicates more difficulty hearing.	Behavioral Visit 2 (1 month post 438 Hz FAT adaptation)
Bamford-Kowal-Bench (BKB-SIN) speech-in-noise score using experimental 438 Hz FAT	The BKB-SIN speech-in-noise test measures speech perception in noise by assessing a listener's signal-to-noise ratio (SNR) loss. The test results are presented as the SNR loss, which is the amount the signal-to-noise ratio needs to be increased for the listener to correctly repeat 50% of the sentences. A higher SNR loss indicates more difficulty hearing.	Behavioral Visit 3 (1 month post 188 Hz FAT re-adaptation)

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Collaborators: National Institute on Deafness and Other Communication Disorders (NIDCD)
• Investigators: Principal Investigator: Mario A. Svirsky, PhD, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Actual): October 6, 2024
• Primary Completion (Estimated): October 6, 2027
• Study Completion (Estimated): October 6, 2027

Study Registration Dates

• First Submitted: October 28, 2024
• First Submitted That Met QC Criteria: October 28, 2024
• First Posted (Actual): October 29, 2024

Study Record Updates

• Last Update Posted (Estimated): September 2, 2025
• Last Update Submitted That Met QC Criteria: August 29, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Ear Diseases; Hearing Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Hearing Loss
• Other Study ID Numbers: 24-00833; R01DC021980-01 (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). Data are available indefinitely in Databrary database (Link to be included when database is created). 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: The investigator who proposed to use the data will be provided access upon reasonable request. Data are available indefinitely in Databrary database (Link to be included when database is created). To gain access, data requestors will need to sign a data access agreement.
• 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: No