RECRUITING

Clinical Evaluation of Frequency Allocation for Bimodal CI Users

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Clinical Evaluation of Frequency Allocation for Bimodal CI Users

Quick Facts

Study Start:2024-10-06
Study Completion:2027-10-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06663917

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Age 18 or older
  2. 2. Regular usage of a cochlear implant device with at least 18 active electrodes, and compliance with programming/appointments
  3. 3. Received a cochlear implant at least 6 months ago and use a hearing aid in the contralateral ear
  4. 4. Pure tone average (.5, 1, and 2kHz) between 30 and 70 dB (decibel) hearing level in the contralateral (hearing aid) ear
  5. 5. Standard FAT use for all programs prior to study participation
  6. 6. No known anatomical abnormalities in either ear
  7. 7. English speaking
  8. 8. No known cognitive impairments
  9. 9. At least 25% of subjects should use the Cochlear EA32 electrode
  1. 1. Under age 18
  2. 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. 3. Cognitively impaired
  4. 4. Non-consistent device usage
  5. 5. Greater than 70 dB hearing level pure tone average in the contralateral ear
  6. 6. Normal hearing or mild hearing loss in the contralateral ear
  7. 7. Non-standard FAT programs
  8. 8. Use of any frequency transposition programming in hearing aid.

Contacts and Locations

Study Contact

Mario Svirsky, PhD
CONTACT
212-263-7217
Mario.svirsky@nyulangone.org
Megan Eitel
CONTACT
212-263-5271
Megan.eitel@nyulangone.org

Principal Investigator

Mario A. Svirsky, PhD
PRINCIPAL_INVESTIGATOR
NYU Langone Health

Study Locations (Sites)

NYU Langone Health
New York, New York, 10016
United States

Collaborators and Investigators

Sponsor: NYU Langone Health

  • Mario A. Svirsky, PhD, PRINCIPAL_INVESTIGATOR, NYU Langone Health

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-10-06
Study Completion Date2027-10-06

Study Record Updates

Study Start Date2024-10-06
Study Completion Date2027-10-06

Terms related to this study

Additional Relevant MeSH Terms

  • Hearing Impairment