Clinical Evaluation of Frequency Allocation for Bimodal CI Users

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age 18 or older

• Regular usage of a cochlear implant device with at least 18 active electrodes, and compliance with programming/appointments

• Received a cochlear implant at least 6 months ago and use a hearing aid in the contralateral ear

• Pure tone average (.5, 1, and 2kHz) between 30 and 70 dB (decibel) hearing level in the contralateral (hearing aid) ear

• Standard FAT use for all programs prior to study participation

• No known anatomical abnormalities in either ear

• English speaking

• No known cognitive impairments

• At least 25% of subjects should use the Cochlear EA32 electrode

Locations
United States
New York
NYU Langone Health
RECRUITING
New York
Contact Information
Primary
Mario Svirsky, PhD
Mario.svirsky@nyulangone.org
212-263-7217
Backup
Megan Eitel
Megan.eitel@nyulangone.org
212-263-5271
Time Frame
Start Date: 2024-10-06
Estimated Completion Date: 2027-10-06
Participants
Target number of participants: 24
Treatments
Experimental: Experienced Users
All subjects will be fit with a modified cochlear implant program (experimental FAT) that changes which frequencies are presented to the cochlear implant. Subjects will complete a 1 month adaptation to the experimental FAT (438 Hz) and then a one month re-adaptation to the standard FAT (188 Hz). Speech perception tests and questionnaires will be collected before and after each FAT adaptation.
Related Therapeutic Areas
Sponsors
Leads: NYU Langone Health
Collaborators: National Institute on Deafness and Other Communication Disorders (NIDCD)

This content was sourced from clinicaltrials.gov