Perceptual Adaptation Following Cochlear Implantation (Aim 3a)
Evaluation of Frequency Allocation Tables for Recently Implanted Single-Sided Deaf Cochlear Implant Users
2 other identifiers
interventional
22
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2024
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 3, 2024
CompletedFirst Submitted
Initial submission to the registry
June 18, 2025
CompletedFirst Posted
Study publicly available on registry
June 26, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 31, 2029
May 1, 2026
April 1, 2026
4.3 years
June 18, 2025
April 27, 2026
Conditions
Outcome Measures
Primary Outcomes (40)
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
12 months post activation of implant
Secondary Outcomes (20)
Sound Quality Survey score while using standard 188 Hz FAT
Baseline
Sound Quality Survey score while using standard 188 Hz FAT
1 month post activation of implant
Sound Quality Survey score while using standard 188 Hz FAT
3 months post activation of implant
Sound Quality Survey score while using standard 188 Hz FAT
6 months post activation of implant
Sound Quality Survey score while using standard 188 Hz FAT
12 months post activation of implant
- +15 more secondary outcomes
Study Arms (1)
Newly implanted Single-Sided Deaf Cochlear Implant (SSD-CI) Users
EXPERIMENTALSubjects 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.
Interventions
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).
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Under age 18
- Documented anatomical abnormality of the implanted ear
- Non-English speaking
- Greater than minimal hearing loss in the contralateral ear.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
NYU Langone Health
New York, New York, 10016, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mario A. Svirsky, PhD
NYU Langone Health
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 18, 2025
First Posted
June 26, 2025
Study Start
April 3, 2024
Primary Completion (Estimated)
July 31, 2028
Study Completion (Estimated)
July 31, 2029
Last Updated
May 1, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
- Access Criteria
- The investigator who proposed to use the data will be granted access upon reasonable request. Requests should be directed to mario.svirsky@nyulangone.org. To gain access, data requestors will need to sign a data access agreement. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's DSSB.
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.