Clinical trial NCT06663917: Clinical Evaluation of Frequency Allocation for Bimodal CI Users
Official title: Clinical Evaluation of Frequency Allocation for Bimodal CI Users
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hearing Impairment
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: National Institute on Deafness and Other Communication Disorders (NIDCD)
First posted: 2024-10-29
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 bimodal CI users affects 1) sound quality, 2) satisfaction, and 3) speech perception.


Eligibility criteria: 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

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.

Primary outcomes:
measure: Sound Quality Questionnaire Score while using standard 188 Hz FAT
timeFrame: Baseline
measure: Sound Quality Questionnaire Score while using experimental 438 Hz FAT
timeFrame: Behavioral Visit 2 (1 month post 438 Hz FAT adaptation)
measure: Sound Quality Questionnaire Score while using standard 188 Hz FAT
timeFrame: Behavioral Visit 3 (1 month post 188 Hz FAT re-adaptation)
measure: The consonant-nucleus-consonant (CNC) word list score while using standard 188 Hz FAT
timeFrame: Baseline
measure: CNC word list score while using standard 188 Hz FAT
timeFrame: Behavioral Visit 2 (1 month post 438 Hz FAT adaptation)
measure: CNC word list score while using standard 188 Hz FAT
timeFrame: Behavioral Visit 3 (1 month post 188 Hz FAT re-adaptation)
measure: CNC word list score while using experimental 438 Hz FAT
timeFrame: Baseline
measure: CNC word list score while using experimental 438 Hz FAT
timeFrame: Behavioral Visit 2 (1 month post 438 Hz FAT adaptation)
measure: CNC word list score while using experimental 438 Hz FAT
timeFrame: Behavioral Visit 3 (1 month post 188 Hz FAT re-adaptation)
measure: Bamford-Kowal-Bench (BKB-SIN) speech-in-noise score using standard 188 Hz FAT
timeFrame: Baseline
measure: Bamford-Kowal-Bench (BKB-SIN) speech-in-noise score using standard 188 Hz FAT
timeFrame: Behavioral Visit 2 (1 month post 438 Hz FAT adaptation)
measure: Bamford-Kowal-Bench (BKB-SIN) speech-in-noise score using standard 188 Hz FAT
timeFrame: Behavioral Visit 3 (1 month post 188 Hz FAT re-adaptation)
measure: Bamford-Kowal-Bench (BKB-SIN) speech-in-noise score using experimental 438 Hz FAT
timeFrame: Baseline
measure: Bamford-Kowal-Bench (BKB-SIN) speech-in-noise score using experimental 438 Hz FAT
timeFrame: Behavioral Visit 2 (1 month post 438 Hz FAT adaptation)
measure: Bamford-Kowal-Bench (BKB-SIN) speech-in-noise score using experimental 438 Hz FAT
timeFrame: Behavioral Visit 3 (1 month post 188 Hz FAT re-adaptation)
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Mario A. Svirsky, PhD
role: PRINCIPAL_INVESTIGATOR
References: