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NCT Number: NCT06663917

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NYU Langone Health

New York, 10016, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Mario Svirsky, PhD

CONTACT

[email protected]

212-263-7217

Megan Eitel

CONTACT

[email protected]

212-263-5271

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Collaborators

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

Registry information

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Oct 29, 2024
Registry last updated
Jun 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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