Recruiting

Bimodal CI

Sponsor:

NYU Langone Health

Code:

NCT06663917

Conditions

Hearing Impairment

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Experimental frequency allocation table (FAT) - 438 Hz

Standard FAT - 188 Hz

Study Details

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

Study ID

NCT06663917

Start date

Oct 6, 2024

Status verified date

Jun, 2026

Completion date

Oct 6, 2027

Anticipated

Primary completion date

Oct 6, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

13 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

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.

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 measure

  • Sound Quality Questionnaire Score while using standard 188 Hz FAT [ Time Frame: Baseline ]
  • Sound Quality Questionnaire Score while using experimental 438 Hz FAT [ Time Frame: Behavioral Visit 2 (1 month post 438 Hz FAT adaptation) ]
  • Sound Quality Questionnaire Score while using standard 188 Hz FAT [ Time Frame: 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 [ Time Frame: Baseline ]
  • CNC word list score while using standard 188 Hz FAT [ Time Frame: Behavioral Visit 2 (1 month post 438 Hz FAT adaptation) ]
  • 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 list score while using experimental 438 Hz FAT [ Time Frame: Baseline ]
  • CNC word list score while using experimental 438 Hz FAT [ Time Frame: Behavioral Visit 2 (1 month post 438 Hz FAT adaptation) ]
  • CNC word list score while using experimental 438 Hz FAT [ Time Frame: 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 [ Time Frame: Baseline ]
  • 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) ]
  • 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) ]
  • Bamford-Kowal-Bench (BKB-SIN) speech-in-noise score using experimental 438 Hz FAT [ Time Frame: Baseline ]
  • 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) ]
  • 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) ]

Central Contacts and Locations

Central contacts

Mario Svirsky, PhD

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

Megan Eitel

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

Locations

NYU Langone Health

Recruiting

New York, New York, United States, 10016

More Information

Sponsor

NYU Langone Health

Last update posted

Jun 26, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by NYU Langone Health on 2026-06-26.