Sensorineural Hearing LossNCT07039435
Perceptual Adaptation Following Cochlear Implantation (Aim 3a)
A study testing Alternative Frequency Mapping in people with Sensorineural Hearing Loss and Cochlear Implantation, run by NYU Langone Health at 1 site in United States.
Trial summary
The goal of this study is to study the adaptation process in newly implanted Single-Sided Deaf Cochlear Implant (SSD-CI) users. Subjects will use four frequency maps for the first month after CI activation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sensorineural Hearing Loss, Cochlear Implantation, Perceptual Adaptation
- What is being tested?
- Alternative Frequency Mapping
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Jan 2024to 31 Jul 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 or older
- No known anatomical abnormalities in either ear
- English speaking
- Intends to receive a cochlear implant in one ear (or has already received it but it has not been activated).
- Normal hearing (or minimal hearing loss) in the contralateral ear
Who cannot join
- Under age 18
- Documented anatomical abnormality of the implanted ear
- Non-English speaking
- Greater than minimal hearing loss in the contralateral ear.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
NYU Langone Health
New York, New York, 10016
About this study
Official title: Evaluation of Frequency Allocation Tables for Recently Implanted Single-Sided Deaf Cochlear Implant Users
The goal of this study is to study the adaptation process in newly implanted Single-Sided Deaf Cochlear Implant (SSD-CI) users. Subjects will use four frequency maps for the first month after CI activation. One of these maps will be standard of care and the other three will have higher low frequency edges than the standard of care default maps. These maps will alternate daily during the first month (with exceptions made for situations when the subject is allowed to use a preferred map rather than the map predetermined for use that day), and after that point each subject will make a selection at the beginning of the week to compare all four maps and decide which one to use at the beginning of the following week. The goal of this study is to investigate how reducing place-pitch mismatch in SSD CI users affects 1) sound quality, 2) device use, and 3) speech perception.
- Being tested
- Alternative Frequency Mapping
- Medical subject headings
- Hearing Loss, Sensorineural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alternative Frequency MappingOther
Patients will have their speech processors programmed with four maps, three of which use a higher low-frequency cutoff than the default map (313 Hz, 438 Hz, 563 Hz, compared to the default map that has a low-frequency cutoff of 188 Hz).
| Study group | Role | What they receive |
|---|---|---|
| Newly implanted Single-Sided Deaf Cochlear Implant (SSD-CI) Users | Experimental | Subjects will use four frequency maps for the first month after CI activation. One of these maps will be standard of care (i.e., 188-7938 Hz for Cochlear users) and the other three will have higher low frequency edges than the standard of care default maps (starting at 313, 438, and 563 Hz, respectively). These maps will alternate daily during the first month (with exceptions made for situations when the subject is allowed to use a preferred map rather than the map predetermined for use that day), and after that point each subject will make a selection at the beginning of the week to compare all four maps and decide which one to use at the beginning of the following week. Receives: Other: Alternative Frequency Mapping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bilateral speech perception as measured by Bamford-Kowal-Bench (BKB-SIN) speech-in-noise score while using standard 188 Hz Frequency-Allocation Table (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.
Measured: Baseline
Bilateral speech perception as measured by BKB-SIN speech-in-noise score while 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.
Measured: 1 month post activation of implant
Bilateral speech perception as measured by BKB-SIN speech-in-noise score while 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.
Measured: 3 months post activation of implant
Bilateral speech perception as measured by BKB-SIN speech-in-noise score while 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.
Measured: 6 months post activation of implant
Bilateral speech perception as measured by BKB-SIN speech-in-noise score while 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.
Measured: 12 months post activation of implant
Bilateral speech perception as measured by BKB-SIN speech-in-noise score while using experimental 313 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.
Measured: Baseline
Bilateral speech perception as measured by BKB-SIN speech-in-noise score while using experimental 313 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.
Measured: 1 month post activation of implant
Bilateral speech perception as measured by BKB-SIN speech-in-noise score while using experimental 313 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.
Measured: 3 months post activation of implant
Bilateral speech perception as measured by BKB-SIN speech-in-noise score while using experimental 313 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.
Measured: 6 months post activation of implant
Bilateral speech perception as measured by BKB-SIN speech-in-noise score while using experimental 313 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.
Measured: 12 months post activation of implant
Bilateral speech perception as measured by BKB-SIN speech-in-noise score while 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.
Measured: Baseline
Bilateral speech perception as measured by BKB-SIN speech-in-noise score while 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.
Measured: 1 month post activation of implant
Bilateral speech perception as measured by BKB-SIN speech-in-noise score while 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.
Measured: 3 months post activation of implant
Bilateral speech perception as measured by BKB-SIN speech-in-noise score while 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.
Measured: 6 months post activation of implant
Bilateral speech perception as measured by BKB-SIN speech-in-noise score while 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.
Measured: 12 months post activation of implant
Bilateral speech perception as measured by BKB-SIN speech-in-noise score while using experimental 563 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.
Measured: Baseline
Bilateral speech perception as measured by BKB-SIN speech-in-noise score while using experimental 563 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.
Measured: 1 month post activation of implant
Bilateral speech perception as measured by BKB-SIN speech-in-noise score while using experimental 563 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.
Measured: 3 months post activation of implant
Bilateral speech perception as measured by BKB-SIN speech-in-noise score while using experimental 563 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.
Measured: 6 months post activation of implant
Bilateral speech perception as measured by BKB-SIN speech-in-noise score while using experimental 563 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.
Measured: 12 months post activation of implant
Cochlear Implant (CI)-only speech perception as measured by 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.
Measured: Baseline
CI-only speech perception as measured by the 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.
Measured: 1 month post activation of implant
CI-only speech perception as measured by the 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.
Measured: 3 months post activation of implant
CI-only speech perception as measured by the 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.
Measured: 6 months post activation of implant
CI-only speech perception as measured by the 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.
Measured: 12 months post activation of implant
CI-only speech perception as measured by the CNC word list score while using experimental 313 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.
Measured: Baseline
CI-only speech perception as measured by the CNC word list score while using experimental 313 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.
Measured: 1 month post activation of implant
CI-only speech perception as measured by the CNC word list score while using experimental 313 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.
Measured: 3 months post activation of implant
CI-only speech perception as measured by the CNC word list score while using experimental 313 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.
Measured: 6 months post activation of implant
CI-only speech perception as measured by the CNC word list score while using experimental 313 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.
Measured: 12 months post activation of implant
CI-only speech perception as measured by the 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.
Measured: Baseline
CI-only speech perception as measured by the 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.
Measured: 1 month post activation of implant
CI-only speech perception as measured by the 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.
Measured: 3 months post activation of implant
CI-only speech perception as measured by the 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.
Measured: 6 months post activation of implant
CI-only speech perception as measured by the 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.
Measured: 12 months post activation of implant
CI-only speech perception as measured by the CNC word list score while using experimental 563 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.
Measured: Baseline
CI-only speech perception as measured by the CNC word list score while using experimental 563 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.
Measured: 1 month post activation of implant
CI-only speech perception as measured by the CNC word list score while using experimental 563 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.
Measured: 3 months post activation of implant
CI-only speech perception as measured by the CNC word list score while using experimental 563 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.
Measured: 6 months post activation of implant
CI-only speech perception as measured by the CNC word list score while using experimental 563 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.
Measured: 12 months post activation of implant
Secondary outcomes (20)
Sound Quality Survey score while using standard 188 Hz FAT
The Sound Quality Survey records subjective thoughts regarding sound quality, listening effort and intelligibility with all four maps at various time points. The survey was created for this study and consists of 4 questions address speech understanding, listening effort, sound quality, and music when the CI is ON versus when the CI is off. Items are rated from 1 (worst) to 9 (best). Scores range from 4-36, higher scores indicate better overall sound quality when the CI is on. Participants will provide a separate answers for each of the 4 maps.
Measured: Baseline
Sound Quality Survey score while using standard 188 Hz FAT
The Sound Quality Survey records subjective thoughts regarding sound quality, listening effort and intelligibility with all four maps at various time points. The survey was created for this study and consists of 4 questions address speech understanding, listening effort, sound quality, and music when the CI is ON versus when the CI is off. Items are rated from 1 (worst) to 9 (best). Scores range from 4-36, higher scores indicate better overall sound quality when the CI is on. Participants will provide a separate answers for each of the 4 maps.
Measured: 1 month post activation of implant
Sound Quality Survey score while using standard 188 Hz FAT
The Sound Quality Survey records subjective thoughts regarding sound quality, listening effort and intelligibility with all four maps at various time points. The survey was created for this study and consists of 4 questions address speech understanding, listening effort, sound quality, and music when the CI is ON versus when the CI is off. Items are rated from 1 (worst) to 9 (best). Scores range from 4-36, higher scores indicate better overall sound quality when the CI is on. Participants will provide a separate answers for each of the 4 maps.
Measured: 3 months post activation of implant
Sound Quality Survey score while using standard 188 Hz FAT
The Sound Quality Survey records subjective thoughts regarding sound quality, listening effort and intelligibility with all four maps at various time points. The survey was created for this study and consists of 4 questions address speech understanding, listening effort, sound quality, and music when the CI is ON versus when the CI is off. Items are rated from 1 (worst) to 9 (best). Scores range from 4-36, higher scores indicate better overall sound quality when the CI is on. Participants will provide a separate answers for each of the 4 maps.
Measured: 6 months post activation of implant
Sound Quality Survey score while using standard 188 Hz FAT
The Sound Quality Survey records subjective thoughts regarding sound quality, listening effort and intelligibility with all four maps at various time points. The survey was created for this study and consists of 4 questions address speech understanding, listening effort, sound quality, and music when the CI is ON versus when the CI is off. Items are rated from 1 (worst) to 9 (best). Scores range from 4-36, higher scores indicate better overall sound quality when the CI is on. Participants will provide a separate answers for each of the 4 maps.
Measured: 12 months post activation of implant
Sound Quality Survey score while using standard 313 Hz FAT
The Sound Quality Survey records subjective thoughts regarding sound quality, listening effort and intelligibility with all four maps at various time points. The survey was created for this study and consists of 4 questions address speech understanding, listening effort, sound quality, and music when the CI is ON versus when the CI is off. Items are rated from 1 (worst) to 9 (best). Scores range from 4-36, higher scores indicate better overall sound quality when the CI is on. Participants will provide a separate answers for each of the 4 maps.
Measured: Baseline
Sound Quality Survey score while using standard 313 Hz FAT
The Sound Quality Survey records subjective thoughts regarding sound quality, listening effort and intelligibility with all four maps at various time points. The survey was created for this study and consists of 4 questions address speech understanding, listening effort, sound quality, and music when the CI is ON versus when the CI is off. Items are rated from 1 (worst) to 9 (best). Scores range from 4-36, higher scores indicate better overall sound quality when the CI is on. Participants will provide a separate answers for each of the 4 maps.
Measured: 1 month post activation of implant
Sound Quality Survey score while using standard 313 Hz FAT
The Sound Quality Survey records subjective thoughts regarding sound quality, listening effort and intelligibility with all four maps at various time points. The survey was created for this study and consists of 4 questions address speech understanding, listening effort, sound quality, and music when the CI is ON versus when the CI is off. Items are rated from 1 (worst) to 9 (best). Scores range from 4-36, higher scores indicate better overall sound quality when the CI is on. Participants will provide a separate answers for each of the 4 maps.
Measured: 3 months post activation of implant
Sound Quality Survey score while using standard 313 Hz FAT
The Sound Quality Survey records subjective thoughts regarding sound quality, listening effort and intelligibility with all four maps at various time points. The survey was created for this study and consists of 4 questions address speech understanding, listening effort, sound quality, and music when the CI is ON versus when the CI is off. Items are rated from 1 (worst) to 9 (best). Scores range from 4-36, higher scores indicate better overall sound quality when the CI is on. Participants will provide a separate answers for each of the 4 maps.
Measured: 6 months post activation of implant
Sound Quality Survey score while using standard 313 Hz FAT
The Sound Quality Survey records subjective thoughts regarding sound quality, listening effort and intelligibility with all four maps at various time points. The survey was created for this study and consists of 4 questions address speech understanding, listening effort, sound quality, and music when the CI is ON versus when the CI is off. Items are rated from 1 (worst) to 9 (best). Scores range from 4-36, higher scores indicate better overall sound quality when the CI is on. Participants will provide a separate answers for each of the 4 maps.
Measured: 12 months post activation of implant
Sound Quality Survey score while using standard 438 Hz FAT
The Sound Quality Survey records subjective thoughts regarding sound quality, listening effort and intelligibility with all four maps at various time points. The survey was created for this study and consists of 4 questions address speech understanding, listening effort, sound quality, and music when the CI is ON versus when the CI is off. Items are rated from 1 (worst) to 9 (best). Scores range from 4-36, higher scores indicate better overall sound quality when the CI is on. Participants will provide a separate answers for each of the 4 maps.
Measured: Baseline
Sound Quality Survey score while using standard 438 Hz FAT
The Sound Quality Survey records subjective thoughts regarding sound quality, listening effort and intelligibility with all four maps at various time points. The survey was created for this study and consists of 4 questions address speech understanding, listening effort, sound quality, and music when the CI is ON versus when the CI is off. Items are rated from 1 (worst) to 9 (best). Scores range from 4-36, higher scores indicate better overall sound quality when the CI is on. Participants will provide a separate answers for each of the 4 maps.
Measured: 1 month post activation of implant
Sound Quality Survey score while using standard 438 Hz FAT
The Sound Quality Survey records subjective thoughts regarding sound quality, listening effort and intelligibility with all four maps at various time points. The survey was created for this study and consists of 4 questions address speech understanding, listening effort, sound quality, and music when the CI is ON versus when the CI is off. Items are rated from 1 (worst) to 9 (best). Scores range from 4-36, higher scores indicate better overall sound quality when the CI is on. Participants will provide a separate answers for each of the 4 maps.
Measured: 3 months post activation of implant
Sound Quality Survey score while using standard 438 Hz FAT
The Sound Quality Survey records subjective thoughts regarding sound quality, listening effort and intelligibility with all four maps at various time points. The survey was created for this study and consists of 4 questions address speech understanding, listening effort, sound quality, and music when the CI is ON versus when the CI is off. Items are rated from 1 (worst) to 9 (best). Scores range from 4-36, higher scores indicate better overall sound quality when the CI is on. Participants will provide a separate answers for each of the 4 maps.
Measured: 6 months post activation of implant
Sound Quality Survey score while using standard 438 Hz FAT
The Sound Quality Survey records subjective thoughts regarding sound quality, listening effort and intelligibility with all four maps at various time points. The survey was created for this study and consists of 4 questions address speech understanding, listening effort, sound quality, and music when the CI is ON versus when the CI is off. Items are rated from 1 (worst) to 9 (best). Scores range from 4-36, higher scores indicate better overall sound quality when the CI is on. Participants will provide a separate answers for each of the 4 maps.
Measured: 12 months post activation of implant
Sound Quality Survey score while using standard 563 Hz FAT
The Sound Quality Survey records subjective thoughts regarding sound quality, listening effort and intelligibility with all four maps at various time points. The survey was created for this study and consists of 4 questions address speech understanding, listening effort, sound quality, and music when the CI is ON versus when the CI is off. Items are rated from 1 (worst) to 9 (best). Scores range from 4-36, higher scores indicate better overall sound quality when the CI is on. Participants will provide a separate answers for each of the 4 maps.
Measured: Baseline
Sound Quality Survey score while using standard 563 Hz FAT
The Sound Quality Survey records subjective thoughts regarding sound quality, listening effort and intelligibility with all four maps at various time points. The survey was created for this study and consists of 4 questions address speech understanding, listening effort, sound quality, and music when the CI is ON versus when the CI is off. Items are rated from 1 (worst) to 9 (best). Scores range from 4-36, higher scores indicate better overall sound quality when the CI is on. Participants will provide a separate answers for each of the 4 maps.
Measured: 1 month post activation of implant
Sound Quality Survey score while using standard 563 Hz FAT
The Sound Quality Survey records subjective thoughts regarding sound quality, listening effort and intelligibility with all four maps at various time points. The survey was created for this study and consists of 4 questions address speech understanding, listening effort, sound quality, and music when the CI is ON versus when the CI is off. Items are rated from 1 (worst) to 9 (best). Scores range from 4-36, higher scores indicate better overall sound quality when the CI is on. Participants will provide a separate answers for each of the 4 maps.
Measured: 3 months post activation of implant
Sound Quality Survey score while using standard 563 Hz FAT
The Sound Quality Survey records subjective thoughts regarding sound quality, listening effort and intelligibility with all four maps at various time points. The survey was created for this study and consists of 4 questions address speech understanding, listening effort, sound quality, and music when the CI is ON versus when the CI is off. Items are rated from 1 (worst) to 9 (best). Scores range from 4-36, higher scores indicate better overall sound quality when the CI is on. Participants will provide a separate answers for each of the 4 maps.
Measured: 6 months post activation of implant
Sound Quality Survey score while using standard 563 Hz FAT
The Sound Quality Survey records subjective thoughts regarding sound quality, listening effort and intelligibility with all four maps at various time points. The survey was created for this study and consists of 4 questions address speech understanding, listening effort, sound quality, and music when the CI is ON versus when the CI is off. Items are rated from 1 (worst) to 9 (best). Scores range from 4-36, higher scores indicate better overall sound quality when the CI is on. Participants will provide a separate answers for each of the 4 maps.
Measured: 12 months post activation of implant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2025
- Study start4 Jan 2024
- Primary completion31 Jul 2028 (estimated)
- Study completion31 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sensorineural Hearing LossStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Responsible party
- Sponsor
- Investigators
- Mario A. Svirsky, PhD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07039435
- Sponsor's protocol ID
- 23-01046
- Other IDs
- R01DC021980
- Status last verified
- Jun 2026
- First submitted
- 18 Jun 2025
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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). Requests should be directed to: mario.svirsky@nyulangone.org. The protocol and statistical analysis plan will be posted on Clinicaltrials.gov only as required by federal regulation or supporting awards and agreements.
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Frequency Allocation Tables for Recently Implanted Single-Sided Deaf Cochlear Implant Users
- ClinicalTrials.gov ID
- NCT07039435
- Acronym / sponsor ID
- 23-01046
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Study start
- 4 Jan 2024 (actual)
- Primary completion
- 31 Jul 2028 (estimated)
- Study completion
- 31 Jul 2029 (estimated)
- First posted
- 26 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to study the adaptation process in newly implanted Single-Sided Deaf Cochlear Implant (SSD-CI) users. Subjects will use four frequency maps for the first month after CI activation. One of these maps will be standard of care and the other three will have higher low frequency edges than the standard of care default maps. These maps will alternate daily during the first month (with exceptions made for situations when the subject is allowed to use a preferred map rather than the map predetermined for use that day), and after that point each subject will make a selection at the beginning of the week to compare all four maps and decide which one to use at the beginning of the following week. The goal of this study is to investigate how reducing place-pitch mismatch in SSD CI users affects 1) sound quality, 2) device use, and 3) speech perception.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Newly implanted Single-Sided Deaf Cochlear Implant (SSD-CI) Users | Experimental | Other: Alternative Frequency MappingSubjects will use four frequency maps for the first month after CI activation. One of these maps will be standard of care (i.e., 188-7938 Hz for Cochlear users) and the other three will have higher low frequency edges than the standard of care default maps (starting at 313, 438, and 563 Hz, respectively). These maps will alternate daily during the first month (with exceptions made for situations when the subject is allowed to use a preferred map rather than the map predetermined for use that day), and after that point each subject will make a selection at the beginning of the week to compare all four maps and decide which one to use at the beginning of the following week. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18 or older
- No known anatomical abnormalities in either ear
- English speaking
- Intends to receive a cochlear implant in one ear (or has already received it but it has not been activated).
- Normal hearing (or minimal hearing loss) in the contralateral ear
Key exclusion criteria (4 listed)
- Under age 18
- Documented anatomical abnormality of the implanted ear
- Non-English speaking
- Greater than minimal hearing loss in the contralateral ear.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alternative Frequency MappingPatients will have their speech processors programmed with four maps, three of which use a higher low-frequency cutoff than the default map (313 Hz, 438 Hz, 563 Hz, compared to the default map that has a low-frequency cutoff of 188 Hz). | Other | Newly implanted Single-Sided Deaf Cochlear Implant (SSD-CI) Users |
Primary outcome
Bilateral speech perception as measured by Bamford-Kowal-Bench (BKB-SIN) speech-in-noise score while using standard 188 Hz Frequency-Allocation Table (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.
Bilateral speech perception as measured by BKB-SIN speech-in-noise score while using standard 188 Hz FAT
Time frame: 1 month post activation of implant
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.
Bilateral speech perception as measured by BKB-SIN speech-in-noise score while using standard 188 Hz FAT
Time frame: 3 months post activation of implant
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.
Bilateral speech perception as measured by BKB-SIN speech-in-noise score while using standard 188 Hz FAT
Time frame: 6 months post activation of implant
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.
Bilateral speech perception as measured by BKB-SIN speech-in-noise score while using standard 188 Hz FAT
Time frame: 12 months post activation of implant
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.
Bilateral speech perception as measured by BKB-SIN speech-in-noise score while using experimental 313 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.
Bilateral speech perception as measured by BKB-SIN speech-in-noise score while using experimental 313 Hz FAT
Time frame: 1 month post activation of implant
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.
Bilateral speech perception as measured by BKB-SIN speech-in-noise score while using experimental 313 Hz FAT
Time frame: 3 months post activation of implant
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.
Bilateral speech perception as measured by BKB-SIN speech-in-noise score while using experimental 313 Hz FAT
Time frame: 6 months post activation of implant
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.
Bilateral speech perception as measured by BKB-SIN speech-in-noise score while using experimental 313 Hz FAT
Time frame: 12 months post activation of implant
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.
Bilateral speech perception as measured by BKB-SIN speech-in-noise score while 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.
Bilateral speech perception as measured by BKB-SIN speech-in-noise score while using experimental 438 Hz FAT
Time frame: 1 month post activation of implant
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.
Bilateral speech perception as measured by BKB-SIN speech-in-noise score while using experimental 438 Hz FAT
Time frame: 3 months post activation of implant
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.
Bilateral speech perception as measured by BKB-SIN speech-in-noise score while using experimental 438 Hz FAT
Time frame: 6 months post activation of implant
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.
Bilateral speech perception as measured by BKB-SIN speech-in-noise score while using experimental 438 Hz FAT
Time frame: 12 months post activation of implant
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.
Bilateral speech perception as measured by BKB-SIN speech-in-noise score while using experimental 563 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.
Bilateral speech perception as measured by BKB-SIN speech-in-noise score while using experimental 563 Hz FAT
Time frame: 1 month post activation of implant
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.
Bilateral speech perception as measured by BKB-SIN speech-in-noise score while using experimental 563 Hz FAT
Time frame: 3 months post activation of implant
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.
Bilateral speech perception as measured by BKB-SIN speech-in-noise score while using experimental 563 Hz FAT
Time frame: 6 months post activation of implant
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.
Bilateral speech perception as measured by BKB-SIN speech-in-noise score while using experimental 563 Hz FAT
Time frame: 12 months post activation of implant
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.
Cochlear Implant (CI)-only speech perception as measured by 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.
CI-only speech perception as measured by the CNC word list score while using standard 188 Hz FAT
Time frame: 1 month post activation of implant
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.
CI-only speech perception as measured by the CNC word list score while using standard 188 Hz FAT
Time frame: 3 months post activation of implant
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.
CI-only speech perception as measured by the CNC word list score while using standard 188 Hz FAT
Time frame: 6 months post activation of implant
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.
CI-only speech perception as measured by the CNC word list score while using standard 188 Hz FAT
Time frame: 12 months post activation of implant
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.
CI-only speech perception as measured by the CNC word list score while using experimental 313 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.
CI-only speech perception as measured by the CNC word list score while using experimental 313 Hz FAT
Time frame: 1 month post activation of implant
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.
CI-only speech perception as measured by the CNC word list score while using experimental 313 Hz FAT
Time frame: 3 months post activation of implant
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.
CI-only speech perception as measured by the CNC word list score while using experimental 313 Hz FAT
Time frame: 6 months post activation of implant
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.
CI-only speech perception as measured by the CNC word list score while using experimental 313 Hz FAT
Time frame: 12 months post activation of implant
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.
CI-only speech perception as measured by the 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.
CI-only speech perception as measured by the CNC word list score while using experimental 438 Hz FAT
Time frame: 1 month post activation of implant
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.
CI-only speech perception as measured by the CNC word list score while using experimental 438 Hz FAT
Time frame: 3 months post activation of implant
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.
CI-only speech perception as measured by the CNC word list score while using experimental 438 Hz FAT
Time frame: 6 months post activation of implant
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.
CI-only speech perception as measured by the CNC word list score while using experimental 438 Hz FAT
Time frame: 12 months post activation of implant
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.
CI-only speech perception as measured by the CNC word list score while using experimental 563 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.
CI-only speech perception as measured by the CNC word list score while using experimental 563 Hz FAT
Time frame: 1 month post activation of implant
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.
CI-only speech perception as measured by the CNC word list score while using experimental 563 Hz FAT
Time frame: 3 months post activation of implant
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.
CI-only speech perception as measured by the CNC word list score while using experimental 563 Hz FAT
Time frame: 6 months post activation of implant
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.
CI-only speech perception as measured by the CNC word list score while using experimental 563 Hz FAT
Time frame: 12 months post activation of implant
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.
20 secondary outcomes
Sound Quality Survey score while using standard 188 Hz FAT
Time frame: Baseline
Sound Quality Survey score while using standard 188 Hz FAT
Time frame: 1 month post activation of implant
Sound Quality Survey score while using standard 188 Hz FAT
Time frame: 3 months post activation of implant
Sound Quality Survey score while using standard 188 Hz FAT
Time frame: 6 months post activation of implant
Sound Quality Survey score while using standard 188 Hz FAT
Time frame: 12 months post activation of implant
Sound Quality Survey score while using standard 313 Hz FAT
Time frame: Baseline
Sound Quality Survey score while using standard 313 Hz FAT
Time frame: 1 month post activation of implant
Sound Quality Survey score while using standard 313 Hz FAT
Time frame: 3 months post activation of implant
Sound Quality Survey score while using standard 313 Hz FAT
Time frame: 6 months post activation of implant
Sound Quality Survey score while using standard 313 Hz FAT
Time frame: 12 months post activation of implant
Sound Quality Survey score while using standard 438 Hz FAT
Time frame: Baseline
Sound Quality Survey score while using standard 438 Hz FAT
Time frame: 1 month post activation of implant
Sound Quality Survey score while using standard 438 Hz FAT
Time frame: 3 months post activation of implant
Sound Quality Survey score while using standard 438 Hz FAT
Time frame: 6 months post activation of implant
Sound Quality Survey score while using standard 438 Hz FAT
Time frame: 12 months post activation of implant
Sound Quality Survey score while using standard 563 Hz FAT
Time frame: Baseline
Sound Quality Survey score while using standard 563 Hz FAT
Time frame: 1 month post activation of implant
Sound Quality Survey score while using standard 563 Hz FAT
Time frame: 3 months post activation of implant
Sound Quality Survey score while using standard 563 Hz FAT
Time frame: 6 months post activation of implant
Sound Quality Survey score while using standard 563 Hz FAT
Time frame: 12 months post activation of implant
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
- Individual participant dataSharing planned: Yes. 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). Requests should be directed to: mario.svirsky@nyulangone.org. The protocol and statistical analysis plan will be posted on Clinicaltrials.gov only as required by federal regulation or supporting awards and agreements.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mario A. Svirsky, PhD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alternative Frequency Mapping in people with Sensorineural Hearing Loss and Cochlear Implantation, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mario A. Svirsky, PhD (646-284-2457, Mario.svirsky@nyulangone.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bilateral speech perception as measured by Bamford-Kowal-Bench (BKB-SIN) speech-in-noise score while using standard 188 Hz Frequency-Allocation Table (FAT) (time frame: Baseline). The study lists 40 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026.