Perceptual Adaptation Following Cochlear Implantation (Aim 3a)

NCT ID: NCT07039435

Last Updated: 2025-06-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-04

Study Completion Date

2029-07-31

Brief Summary

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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

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Conditions

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Sensorineural Hearing Loss Cochlear Implantation Perceptual Adaptation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Alternative Frequency Mapping

Intervention Type OTHER

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).

Interventions

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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).

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Deafness and Other Communication Disorders (NIDCD)

NIH

Sponsor Role collaborator

NYU Langone Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mario A. Svirsky, PhD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

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NYU Langone Health

New York, New York, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Mario A. Svirsky, PhD

Role: CONTACT

646-284-2457

Nicole H. Capach, AuD

Role: CONTACT

646-501-6905

Other Identifiers

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R01DC021980

Identifier Type: NIH

Identifier Source: secondary_id

View Link

23-01046

Identifier Type: -

Identifier Source: org_study_id

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