Recruiting

SSD-CI

Sponsor:

NYU Langone Health

Code:

NCT07039435

Conditions

Sensorineural Hearing Loss

Cochlear Implantation

Perceptual Adaptation

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Alternative Frequency Mapping

Study Details

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.

Conditions

Sensorineural Hearing Loss

Cochlear Implantation

Perceptual Adaptation

Study ID

NCT07039435

Start date

Jan 4, 2024

Status verified date

Jun, 2026

Completion date

Jul 31, 2029

Anticipated

Primary completion date

Jul 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

22 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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 (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

Alternative Frequency Mapping

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).

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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • Bilateral speech perception as measured by BKB-SIN speech-in-noise score while using experimental 313 Hz FAT [ Time Frame: Baseline ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • Bilateral speech perception as measured by BKB-SIN speech-in-noise score while using experimental 438 Hz FAT [ Time Frame: Baseline ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • Bilateral speech perception as measured by BKB-SIN speech-in-noise score while using experimental 563 Hz FAT [ Time Frame: Baseline ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • CI-only speech perception as measured by the CNC word list score while using experimental 313 Hz FAT [ Time Frame: Baseline ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • CI-only speech perception as measured by the CNC word list score while using experimental 438 Hz FAT [ Time Frame: Baseline ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • CI-only speech perception as measured by the CNC word list score while using experimental 563 Hz FAT [ Time Frame: Baseline ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]

Central Contacts and Locations

Central contacts

Mario A. Svirsky, PhD

646-284-2457Mario.svirsky@nyulangone.org

Nicole H. Capach, AuD

646-501-6905Nicole.capach@nyulangone.org

Locations

NYU Langone Health

Recruiting

New York, New York, United States, 10016

More Information

Sponsor

NYU Langone Health

Last update posted

Jul 7, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by NYU Langone Health on 2026-07-07.