Clinical Evaluation of Frequency Allocation for Bimodal CI Users

NCT06663917 | Recruiting

• 2 other identifiers: 24-00833R01DC021980-01
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hearing Impairment

Outcome Measures

Primary Outcomes (15)

• 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)

Study Arms (1)

Experienced Users

EXPERIMENTAL

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; Other: Standard FAT - 188 Hz

Interventions

Experimental frequency allocation table (FAT) - 438 Hz OTHER

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.

Experienced Users

Standard FAT - 188 Hz OTHER

All subjects will retain one program with the standard 188 Hz FAT. Subjects will use the standard FAT for one month.

Experienced Users

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Under age 18
• 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.
• Cognitively impaired
• Non-consistent device usage
• Greater than 70 dB hearing level pure tone average in the contralateral ear
• Normal hearing or mild hearing loss in the contralateral ear
• Non-standard FAT programs
• Use of any frequency transposition programming in hearing aid.

Sponsors & Collaborators

• NYU Langone Health: lead
• National Institute on Deafness and Other Communication Disorders (NIDCD): collaborator

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

RECRUITING

MeSH Terms

Conditions

Hearing Loss

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Mario A. Svirsky, PhD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mario Svirsky, PhD

CONTACT

212-263-7217; Mario.svirsky@nyulangone.org

Megan Eitel

CONTACT

212-263-5271; Megan.eitel@nyulangone.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2024
• First Posted: October 29, 2024
• Study Start: October 6, 2024
• Primary Completion (Estimated): October 6, 2027
• Study Completion (Estimated): October 6, 2027
• Last Updated: September 2, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• 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.
• 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.

Locations

US (1)