Perceptual Adaptation Following Cochlear Implantation (Aim 3a)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Alternative Frequency Mapping.
- Who it may be relevant to
- Registry conditions: Sensorineural Hearing Loss, Cochlear Implantation, Perceptual Adaptation. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Evaluation of Frequency Allocation Tables for Recently Implanted Single-Sided Deaf Cochlear Implant Users
Overview
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.
Interventions
- Other 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 measures
- 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]
Secondary outcome measures (12)
- Sound Quality Survey score while using standard 188 Hz FAT [Time frame: Baseline]
- Sound Quality Survey score while using standard 188 Hz FAT [Time frame: 1 month post activation of implant]
- Sound Quality Survey score while using standard 188 Hz FAT [Time frame: 3 months post activation of implant]
- Sound Quality Survey score while using standard 188 Hz FAT [Time frame: 6 months post activation of implant]
- Sound Quality Survey score while using standard 188 Hz FAT [Time frame: 12 months post activation of implant]
- Sound Quality Survey score while using standard 313 Hz FAT [Time frame: Baseline]
- Sound Quality Survey score while using standard 313 Hz FAT [Time frame: 1 month post activation of implant]
- Sound Quality Survey score while using standard 313 Hz FAT [Time frame: 3 months post activation of implant]
- Sound Quality Survey score while using standard 313 Hz FAT [Time frame: 6 months post activation of implant]
- Sound Quality Survey score while using standard 313 Hz FAT [Time frame: 12 months post activation of implant]
- Sound Quality Survey score while using standard 438 Hz FAT [Time frame: Baseline]
- Sound Quality Survey score while using standard 438 Hz FAT [Time frame: 1 month post activation of implant]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- Under age 18
- Documented anatomical abnormality of the implanted ear
- Non-English speaking
- Greater than minimal hearing loss in the contralateral ear.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- NYU Langone Health — New York
Identifiers
NCT: NCT07039435 · 23-01046 · R01DC021980