NCT06663917 · NYU Langone Health
Clinical Evaluation of Frequency Allocation for Bimodal CI Users
What this study is about
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.
View original scientific description
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.
Interventions
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.
Primary outcome measures
Sound Quality Questionnaire Score while using standard 188 Hz FAT
Time frame: Baseline
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.
Sound Quality Questionnaire Score while using experimental 438 Hz FAT
Time frame: Behavioral Visit 2 (1 month post 438 Hz FAT adaptation)
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.
Sound Quality Questionnaire Score while using standard 188 Hz FAT
Time frame: Behavioral Visit 3 (1 month post 188 Hz FAT re-adaptation)
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.
The consonant-nucleus-consonant (CNC) word list score while using standard 188 Hz FAT
Time frame: Baseline
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.
CNC word list score while using standard 188 Hz FAT
Time frame: Behavioral Visit 2 (1 month post 438 Hz FAT adaptation)
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.
CNC word list score while using standard 188 Hz FAT
Time frame: Behavioral Visit 3 (1 month post 188 Hz FAT re-adaptation)
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.
CNC word list score while using experimental 438 Hz FAT
Time frame: Baseline
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.
CNC word list score while using experimental 438 Hz FAT
Time frame: Behavioral Visit 2 (1 month post 438 Hz FAT adaptation)
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.
CNC word list score while using experimental 438 Hz FAT
Time frame: Behavioral Visit 3 (1 month post 188 Hz FAT re-adaptation)
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.
Bamford-Kowal-Bench (BKB-SIN) speech-in-noise score using standard 188 Hz FAT
Time frame: Baseline
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.
Bamford-Kowal-Bench (BKB-SIN) speech-in-noise score using standard 188 Hz FAT
Time frame: Behavioral Visit 2 (1 month post 438 Hz FAT adaptation)
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.
Bamford-Kowal-Bench (BKB-SIN) speech-in-noise score using standard 188 Hz FAT
Time frame: Behavioral Visit 3 (1 month post 188 Hz FAT re-adaptation)
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.
Bamford-Kowal-Bench (BKB-SIN) speech-in-noise score using experimental 438 Hz FAT
Time frame: Baseline
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.
Bamford-Kowal-Bench (BKB-SIN) speech-in-noise score using experimental 438 Hz FAT
Time frame: Behavioral Visit 2 (1 month post 438 Hz FAT adaptation)
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.
Bamford-Kowal-Bench (BKB-SIN) speech-in-noise score using experimental 438 Hz FAT
Time frame: Behavioral Visit 3 (1 month post 188 Hz FAT re-adaptation)
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
Exclusion criteria
- 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.
Where
- New York, New York
Collaborators
National Institute on Deafness and Other Communication Disorders (NIDCD)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
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Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
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Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 26, 2026 · Source of record for eligibility and locations