RecruitingNot ApplicableNCT06663917

Clinical Evaluation of Frequency Allocation for Bimodal CI Users

Sponsor

NYU Langone Health

Enrollment

24 participants

Start Date

Oct 6, 2024

Study Type

INTERVENTIONAL

Conditions

Hearing impairment

Summary

This study will examine experienced, bimodal cochlear implant (CI) patients who receive an alternative frequency allocation table (FAT) to determine how it improves sound quality, device satisfaction, and speech perception abilities with respect to the standard default FAT. The goal of this study is to investigate how improving place-pitch mismatch in bimodal CI users affects 1) sound quality, 2) satisfaction, and 3) speech perception.

Eligibility

Min Age: 18 Years

Inclusion Criteria9

Age 18 or older
Regular usage of a cochlear implant device with at least 18 active electrodes, and compliance with programming/appointments
Received a cochlear implant at least 6 months ago and use a hearing aid in the contralateral ear
Pure tone average (.5, 1, and 2kHz) between 30 and 70 dB (decibel) hearing level in the contralateral (hearing aid) ear
Standard FAT use for all programs prior to study participation
No known anatomical abnormalities in either ear
English speaking
No known cognitive impairments
At least 25% of subjects should use the Cochlear EA32 electrode

Exclusion Criteria8

Under age 18
Non-English speaking. Participants that are Non-English speaking are excluded from this study due to the use of speech testing materials that are validated in the English language. Additionally, study team members are not equipped to appropriately score speech testing materials validated in other languages.
Cognitively impaired
Non-consistent device usage
Greater than 70 dB hearing level pure tone average in the contralateral ear
Normal hearing or mild hearing loss in the contralateral ear
Non-standard FAT programs
Use of any frequency transposition programming in hearing aid.

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Interventions

OTHERExperimental frequency allocation table (FAT) - 438 Hz

The modified cochlear implant program ("experimental FAT") changes which frequencies are presented to the cochlear implant. The experimental FAT frequency of 438 Hz will be loaded onto the subjects processor via the CI Select Mobile App. Subjects will use the experimental FAT for one month.

OTHERStandard FAT - 188 Hz

All subjects will retain one program with the standard 188 Hz FAT. Subjects will use the standard FAT for one month.