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Clinical Evaluation of Frequency Allocation for Bimodal CI Users

RecruitingNAAges 18 Years - anyAllNYU Langone Health
NCT06663917 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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.
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What it tests

  • Experimental frequency allocation table (FAT) - 438 Hz
  • Standard FAT - 188 Hz
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Where

1 site
NYU Langone Health
New York, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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