Clinical Evaluation of Frequency Allocation for Bimodal CI Users

Not Applicable

Recruiting

• Conditions: Hearing Impairment

• Registration Number: NCT06663917
• Lead Sponsor: NYU Langone Health

Brief 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 bimoda...

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2024-10
• Study Start: 2024-10-06
• Study First Submitted: 2024-10-28
• Study First Submitted QC: 2024-10-28
• Last Update Submitted: 2024-10-28
• Study First Posted: 2024-10-29
• Last Update Posted: 2024-10-29
• Primary Completion: 2027-10-06
• Study Completion: 2027-10-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

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

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Exclusion Criteria

1. Under age 18
2. 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.
3. Cognitively impaired
4. Non-consistent device usage
5. Greater than 70 dB hearing level pure tone average in the contralateral ear
6. Normal hearing or mild hearing loss in the contralateral ear
7. Non-standard FAT programs
8. Use of any frequency transposition programming in hearing aid.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Sound Quality Questionnaire Score while using standard 188 Hz FAT	Behavioral Visit 3 (1 month post 188 Hz FAT re-adaptation)	A questionnaire will be given to the subjects to record their subjective thoughts regarding sound quality and satisfaction with both the experiment FAT and the standard FAT. Questionnaires will be administered double blind. Patients evaluate the 16-item questionnaire using a likert-scale (1-strongly disagree to 5-strongly agree). Lower scores indicate decrea...
Sound Quality Questionnaire Score while using experimental 438 Hz FAT	Behavioral Visit 2 (1 month post 438 Hz FAT adaptation)	A questionnaire will be given to the subjects to record their subjective thoughts regarding sound quality and satisfaction with both the experiment FAT and the standard FAT. Questionnaires will be administered double blind. Patients evaluate the 16-item questionnaire using a likert-scale (1-strongly disagree to 5-strongly agree). Lower scores indicate decrea...
The consonant-nucleus-consonant (CNC) word list score while using standard 188 Hz FAT	Baseline	CNC word lists are used to evaluate the speech perception abilities of people with hearing impairments and cochlear implant users. A CNC score above 50% postoperatively indicates that a patient can communicate without relying too much on lip reading, sign language, or written communication.
CNC word list score while using standard 188 Hz FAT	Behavioral Visit 3 (1 month post 188 Hz FAT re-adaptation)	CNC word lists are used to evaluate the speech perception abilities of people with hearing impairments and cochlear implant users. A CNC score above 50% postoperatively indicates that a patient can communicate without relying too much on lip reading, sign language, or written communication.
CNC word list score while using experimental 438 Hz FAT	Behavioral Visit 3 (1 month post 188 Hz FAT re-adaptation)	CNC word lists are used to evaluate the speech perception abilities of people with hearing impairments and cochlear implant users. A CNC score above 50% postoperatively indicates that a patient can communicate without relying too much on lip reading, sign language, or written communication.
Bamford-Kowal-Bench (BKB-SIN) speech-in-noise score using standard 188 Hz FAT	Behavioral Visit 3 (1 month post 188 Hz FAT re-adaptation)	The BKB-SIN speech-in-noise test measures speech perception in noise by assessing a listener's signal-to-noise ratio (SNR) loss. The test results are presented as the SNR loss, which is the amount the signal-to-noise ratio needs to be increased for the listener to correctly repeat 50% of the sentences. A higher SNR loss indicates more difficulty hearing.
Bamford-Kowal-Bench (BKB-SIN) speech-in-noise score using experimental 438 Hz FAT	Behavioral Visit 3 (1 month post 188 Hz FAT re-adaptation)	The BKB-SIN speech-in-noise test measures speech perception in noise by assessing a listener's signal-to-noise ratio (SNR) loss. The test results are presented as the SNR loss, which is the amount the signal-to-noise ratio needs to be increased for the listener to correctly repeat 50% of the sentences. A higher SNR loss indicates more difficulty hearing.

Trial Locations

Locations (1)

NYU Langone Health; 🇺🇸 New York, New York, United States