Hearing Impairment
Conditions
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.
Interventions
OTHERExperimental 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.
OTHERStandard FAT - 188 Hz
All subjects will retain one program with the standard 188 Hz FAT. Subjects will use the standard FAT for one month.
Sponsors
NYU Langone Health
National Institute on Deafness and Other Communication Disorders (NIDCD)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sound Quality Questionnaire Score while using standard 188 Hz FAT | Baseline | A questionnaire will be given to the subjects to record their subjective thoughts regarding sound quality and satisfaction with both the experiment FAT and the standard FAT. Questionnaires will be administered double blind. Patients evaluate the 16-item questionnaire using a likert-scale (1-strongly disagree to 5-strongly agree). Lower scores indicate decreased sound quality and satisfaction, while higher scores indicate increased sound quality and satisfaction. |
| Sound Quality Questionnaire Score while using experimental 438 Hz FAT | 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. |
| The consonant-nucleus-consonant (CNC) word list score while using standard 188 Hz FAT | Baseline | CNC word lists are used to evaluate the speech perception abilities of people with hearing impairments and cochlear implant users. A CNC score above 50% postoperatively indicates that a patient can communicate without relying too much on lip reading, sign language, or written communication. |
| CNC word list score while using standard 188 Hz FAT | Behavioral Visit 2 (1 month post 438 Hz FAT adaptation) | CNC word lists are used to evaluate the speech perception abilities of people with hearing impairments and cochlear implant users. A CNC score above 50% postoperatively indicates that a patient can communicate without relying too much on lip reading, sign language, or written communication. |
| CNC word list score while using experimental 438 Hz FAT | 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. |
| Bamford-Kowal-Bench (BKB-SIN) speech-in-noise score using standard 188 Hz FAT | Baseline | The BKB-SIN speech-in-noise test measures speech perception in noise by assessing a listener's signal-to-noise ratio (SNR) loss. The test results are presented as the SNR loss, which is the amount the signal-to-noise ratio needs to be increased for the listener to correctly repeat 50% of the sentences. A higher SNR loss indicates more difficulty hearing. |
| Bamford-Kowal-Bench (BKB-SIN) speech-in-noise score using experimental 438 Hz FAT | 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. |
Countries
United States
Contacts
CONTACTMario Svirsky, PhD
CONTACTMegan Eitel
PRINCIPAL_INVESTIGATORMario A. Svirsky, PhD
NYU Langone Health
Outcome results
None listed