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Search / Trial NCT06663917

Clinical Evaluation of Frequency Allocation for Bimodal CI Users

Launched by NYU LANGONE HEALTH · Oct 28, 2024

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is looking at how a new way of organizing sound frequencies can improve the experience for people who use both a cochlear implant (CI) and a hearing aid, known as bimodal CI users. The researchers want to see if this alternative frequency allocation can make sounds clearer, increase satisfaction with the devices, and help in understanding speech better compared to the usual method. If you are at least 18 years old, have been using a cochlear implant for more than six months, and also use a hearing aid in the other ear, you might be eligible to participate.

Participants in this study will be asked to use a different setup for their devices and share their experiences regarding sound quality and speech understanding. It’s important to note that only English speakers with no significant cognitive impairments can join, and the study requires regular use of the devices. This trial aims to help improve the technology and support for individuals with hearing impairments, potentially leading to better communication and overall quality of life.

Gender

ALL

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.

About Nyu Langone Health

NYU Langone Health is a premier academic medical center located in New York City, renowned for its commitment to advancing healthcare through innovative research and clinical excellence. As a leading sponsor of clinical trials, NYU Langone Health integrates cutting-edge scientific inquiry with patient-centered care, striving to develop new therapies and improve health outcomes across a wide range of medical conditions. The institution is dedicated to fostering collaboration among researchers, clinicians, and patients, ensuring rigorous adherence to ethical standards and regulatory guidelines in all clinical research initiatives. By leveraging its extensive resources and expertise, NYU Langone Health aims to contribute significantly to the advancement of medical knowledge and the enhancement of patient care.

Locations

New York, New York, United States

Patients applied

0 patients applied

Trial Officials

Mario A. Svirsky, PhD

Principal Investigator

NYU Langone Health

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported