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| ID | Type | Description | Link |
|---|---|---|---|
| R01DC021980-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Deafness and Other Communication Disorders (NIDCD) | NIH |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experienced Users | Experimental | All subjects will be fit with a modified cochlear implant program ("experimental FAT") that changes which frequencies are presented to the cochlear implant. Subjects will complete a 1 month adaptation to the experimental FAT (438 Hz) and then a one month re-adaptation to the standard FAT (188 Hz). Speech perception tests and questionnaires will be collected before and after each FAT adaptation. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Sound Quality Questionnaire Score while using standard 188 Hz FAT | A questionnaire will be given to the subjects to record their subjective thoughts regarding sound quality and satisfaction with both the experiment FAT and the standard FAT. Questionnaires will be administered double blind. Patients evaluate the 16-item questionnaire using a likert-scale (1-strongly disagree to 5-strongly agree). Lower scores indicate decreased sound quality and satisfaction, while higher scores indicate increased sound quality and satisfaction. | Baseline |
| Sound Quality Questionnaire Score while using experimental 438 Hz FAT | A questionnaire will be given to the subjects to record their subjective thoughts regarding sound quality and satisfaction with both the experiment FAT and the standard FAT. Questionnaires will be administered double blind. Patients evaluate the 16-item questionnaire using a likert-scale (1-strongly disagree to 5-strongly agree). Lower scores indicate decreased sound quality and satisfaction, while higher scores indicate increased sound quality and satisfaction. | Behavioral Visit 2 (1 month post 438 Hz FAT adaptation) |
| Sound Quality Questionnaire Score while using standard 188 Hz FAT | A questionnaire will be given to the subjects to record their subjective thoughts regarding sound quality and satisfaction with both the experiment FAT and the standard FAT. Questionnaires will be administered double blind. Patients evaluate the 16-item questionnaire using a likert-scale (1-strongly disagree to 5-strongly agree). Lower scores indicate decreased sound quality and satisfaction, while higher scores indicate increased sound quality and satisfaction. | Behavioral Visit 3 (1 month post 188 Hz FAT re-adaptation) |
| The consonant-nucleus-consonant (CNC) word list score while using standard 188 Hz FAT | CNC word lists are used to evaluate the speech perception abilities of people with hearing impairments and cochlear implant users. A CNC score above 50% postoperatively indicates that a patient can communicate without relying too much on lip reading, sign language, or written communication. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mario Svirsky, PhD | Contact | 212-263-7217 | Mario.svirsky@nyulangone.org | |
| Megan Eitel | Contact | 212-263-5271 | Megan.eitel@nyulangone.org |
| Name | Affiliation | Role |
|---|---|---|
| Mario A. Svirsky, PhD | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Langone Health | Recruiting | New York | New York | 10016 | United States |
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). Data are available indefinitely in Databrary database (Link to be included when database is created). The protocol and statistical analysis plan will be posted on Clinicaltrials.gov only as required by federal regulation or supporting awards and agreements.
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
The investigator who proposed to use the data will be provided access upon reasonable request. Data are available indefinitely in Databrary database (Link to be included when database is created). To gain access, data requestors will need to sign a data access agreement.
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| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| ID | Term |
|---|---|
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
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| 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. |
|
| Baseline |
| CNC word list score while using standard 188 Hz FAT | CNC word lists are used to evaluate the speech perception abilities of people with hearing impairments and cochlear implant users. A CNC score above 50% postoperatively indicates that a patient can communicate without relying too much on lip reading, sign language, or written communication. | Behavioral Visit 2 (1 month post 438 Hz FAT adaptation) |
| CNC word list score while using standard 188 Hz FAT | CNC word lists are used to evaluate the speech perception abilities of people with hearing impairments and cochlear implant users. A CNC score above 50% postoperatively indicates that a patient can communicate without relying too much on lip reading, sign language, or written communication. | Behavioral Visit 3 (1 month post 188 Hz FAT re-adaptation) |
| CNC word list score while using experimental 438 Hz FAT | CNC word lists are used to evaluate the speech perception abilities of people with hearing impairments and cochlear implant users. A CNC score above 50% postoperatively indicates that a patient can communicate without relying too much on lip reading, sign language, or written communication. | Baseline |
| CNC word list score while using experimental 438 Hz FAT | CNC word lists are used to evaluate the speech perception abilities of people with hearing impairments and cochlear implant users. A CNC score above 50% postoperatively indicates that a patient can communicate without relying too much on lip reading, sign language, or written communication. | Behavioral Visit 2 (1 month post 438 Hz FAT adaptation) |
| CNC word list score while using experimental 438 Hz FAT | CNC word lists are used to evaluate the speech perception abilities of people with hearing impairments and cochlear implant users. A CNC score above 50% postoperatively indicates that a patient can communicate without relying too much on lip reading, sign language, or written communication. | Behavioral Visit 3 (1 month post 188 Hz FAT re-adaptation) |
| Bamford-Kowal-Bench (BKB-SIN) speech-in-noise score using standard 188 Hz FAT | The BKB-SIN speech-in-noise test measures speech perception in noise by assessing a listener's signal-to-noise ratio (SNR) loss. The test results are presented as the SNR loss, which is the amount the signal-to-noise ratio needs to be increased for the listener to correctly repeat 50% of the sentences. A higher SNR loss indicates more difficulty hearing. | Baseline |
| Bamford-Kowal-Bench (BKB-SIN) speech-in-noise score using standard 188 Hz FAT | The BKB-SIN speech-in-noise test measures speech perception in noise by assessing a listener's signal-to-noise ratio (SNR) loss. The test results are presented as the SNR loss, which is the amount the signal-to-noise ratio needs to be increased for the listener to correctly repeat 50% of the sentences. A higher SNR loss indicates more difficulty hearing. | Behavioral Visit 2 (1 month post 438 Hz FAT adaptation) |
| Bamford-Kowal-Bench (BKB-SIN) speech-in-noise score using standard 188 Hz FAT | The BKB-SIN speech-in-noise test measures speech perception in noise by assessing a listener's signal-to-noise ratio (SNR) loss. The test results are presented as the SNR loss, which is the amount the signal-to-noise ratio needs to be increased for the listener to correctly repeat 50% of the sentences. A higher SNR loss indicates more difficulty hearing. | Behavioral Visit 3 (1 month post 188 Hz FAT re-adaptation) |
| Bamford-Kowal-Bench (BKB-SIN) speech-in-noise score using experimental 438 Hz FAT | The BKB-SIN speech-in-noise test measures speech perception in noise by assessing a listener's signal-to-noise ratio (SNR) loss. The test results are presented as the SNR loss, which is the amount the signal-to-noise ratio needs to be increased for the listener to correctly repeat 50% of the sentences. A higher SNR loss indicates more difficulty hearing. | Baseline |
| Bamford-Kowal-Bench (BKB-SIN) speech-in-noise score using experimental 438 Hz FAT | The BKB-SIN speech-in-noise test measures speech perception in noise by assessing a listener's signal-to-noise ratio (SNR) loss. The test results are presented as the SNR loss, which is the amount the signal-to-noise ratio needs to be increased for the listener to correctly repeat 50% of the sentences. A higher SNR loss indicates more difficulty hearing. | Behavioral Visit 2 (1 month post 438 Hz FAT adaptation) |
| Bamford-Kowal-Bench (BKB-SIN) speech-in-noise score using experimental 438 Hz FAT | The BKB-SIN speech-in-noise test measures speech perception in noise by assessing a listener's signal-to-noise ratio (SNR) loss. The test results are presented as the SNR loss, which is the amount the signal-to-noise ratio needs to be increased for the listener to correctly repeat 50% of the sentences. A higher SNR loss indicates more difficulty hearing. | Behavioral Visit 3 (1 month post 188 Hz FAT re-adaptation) |
| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |