Perceptual Adaptation Following Cochlear Implantation (Aim 3a)

Not Applicable

Recruiting

• Conditions: Sensorineural Hearing Loss; Cochlear Implantation; Perceptual Adaptation

• Registration Number: NCT07039435
• Lead Sponsor: NYU Langone Health

Brief 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. 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-01-04
• Status Verified: 2025-06
• Study First Submitted: 2025-06-18
• Study First Submitted QC: 2025-06-18
• Last Update Submitted: 2025-06-18
• Study First Posted: 2025-06-26
• Last Update Posted: 2025-06-26
• Primary Completion: 2028-07-31
• Study Completion: 2029-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

1. Age 18 or older
2. No known anatomical abnormalities in either ear
3. English speaking
4. Intends to receive a cochlear implant in one ear (or has already received it but it has not been activated).
5. Normal hearing (or minimal hearing loss) in the contralateral ear

Exclusion Criteria

1. Under age 18
2. Documented anatomical abnormality of the implanted ear
3. Non-English speaking
4. Greater than minimal hearing loss in the contralateral ear.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Bilateral speech perception as measured by Bamford-Kowal-Bench (BKB-SIN) speech-in-noise score while using standard 188 Hz Frequency-Allocation Table (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.
Bilateral speech perception as measured by BKB-SIN speech-in-noise score while using standard 188 Hz FAT	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	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	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	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	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	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	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	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	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.

Secondary Outcome Measures

Name	Time	Method
Sound Quality Survey score while using standard 188 Hz FAT	12 months post activation of implant	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.
Sound Quality Survey score while using standard 313 Hz FAT	12 months post activation of implant	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.
Sound Quality Survey score while using standard 438 Hz FAT	12 months post activation of implant	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.
Sound Quality Survey score while using standard 563 Hz FAT	12 months post activation of implant	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.

Trial Locations

Locations (1)

NYU Langone Health; 🇺🇸 New York, New York, United States