NCT06663917 Clinical Evaluation of Frequency Allocation for Bimodal CI Users
| NCT ID | NCT06663917 |
| Status | Recruiting |
| Phase | — |
| Sponsor | NYU Langone Health |
| Condition | Hearing Impairment |
| Study Type | INTERVENTIONAL |
| Enrollment | 13 participants |
| Start Date | 2024-10-06 |
| Primary Completion | 2027-10-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 13 participants in total. It began in 2024-10-06 with a primary completion date of 2027-10-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Contact & Investigator
Mario A. Svirsky, PhD
PRINCIPAL INVESTIGATOR
NYU Langone Health
Frequently Asked Questions
Who can join the NCT06663917 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Hearing Impairment. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06663917 currently recruiting?
Yes, NCT06663917 is actively recruiting participants. Contact the research team at Mario.svirsky@nyulangone.org for enrollment information.
Where is the NCT06663917 trial being conducted?
This trial is being conducted at New York, United States.
Who is sponsoring the NCT06663917 clinical trial?
NCT06663917 is sponsored by NYU Langone Health. The principal investigator is Mario A. Svirsky, PhD at NYU Langone Health. The trial plans to enroll 13 participants.