Evaluating a new frequency allocation for cochlear implant users
Clinical Evaluation of Frequency Allocation for Bimodal CI Users
This study is testing whether a new sound setting for cochlear implant users can improve their hearing experience and satisfaction compared to the standard setting.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | NYU Langone Health Academic / other |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT06663917 on ClinicalTrials.gov |
What this trial studies
This study examines experienced bimodal cochlear implant patients to assess the effects of an alternative frequency allocation table (FAT) on sound quality, device satisfaction, and speech perception. Participants will be provided with a new FAT set at 438 Hz compared to the standard FAT set at 188 Hz. The aim is to determine if this adjustment improves the auditory experience for users by reducing place-pitch mismatch. The study will involve regular assessments of participants' responses to the different frequency allocations.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who regularly use a cochlear implant and a hearing aid in the opposite ear.
Not a fit: Patients under 18, non-English speakers, or those with cognitive impairments may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the auditory experience and communication abilities of cochlear implant users.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in improving auditory outcomes for cochlear implant users.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
New York, New York
- NYU Langone Health — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Mario A. Svirsky, PhD — NYU Langone Health
- Study coordinator: Mario Svirsky, PhD
- Email: Mario.svirsky@nyulangone.org
- Phone: 212-263-7217
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.