Perceptual Adaptation Following Cochlear Implantation (Aim 3a)

NYU Langone Health

Status: Enrolling

Conditions: Perceptual Adaptation; Cochlear Implantation; Sensorineural Hearing Loss

Treatments: Other: Alternative Frequency Mapping

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07039435

23-01046

R01DC021980 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 22 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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22 participants in 1 patient group

Newly implanted Single-Sided Deaf Cochlear Implant (SSD-CI) Users

Experimental group

Description:

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.

Treatment:

Other: Alternative Frequency Mapping