Clinical Evaluation of Frequency Allocation for Bimodal CI Users
ConditionHearing Impairment
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNYU Langone Health
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Under age 18
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.
Cognitively impaired
Non-consistent device usage
Trial design
Design model
Single group
Treatments tested in this trial
Experimental frequency allocation table (FAT) - 438 Hz
Other interventionThe modified cochlear implant program ("experimental FAT") changes which frequencies are presented to the cochlear implant. The experimental FAT frequency of 438 Hz will be loaded onto the subjects processor via the CI Select Mobile App. Subjects will use the experimental FAT for one month.
Standard FAT - 188 Hz
Other interventionAll subjects will retain one program with the standard 188 Hz FAT. Subjects will use the standard FAT for one month.
Treatment groups
13 Participants
are divided into 1 treatment groupGroup A: Experienced UsersExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Sound Quality Questionnaire Score while using standard 188 Hz FAT
A questionnaire will be given to the subjects to record their subjective thoughts regarding sound quality and satisfaction with both the experiment FAT and the standard FAT. Questionnaires will be administered double blind. Patients evaluate the 16-item questionnaire using a likert-scale (1-strongly disagree to 5-strongly agree). Lower scores indicate decreased sound quality and satisfaction, while higher scores indicate increased sound quality and satisfaction.
Time frame
Baseline2
Sound Quality Questionnaire Score while using experimental 438 Hz FAT
A questionnaire will be given to the subjects to record their subjective thoughts regarding sound quality and satisfaction with both the experiment FAT and the standard FAT. Questionnaires will be administered double blind. Patients evaluate the 16-item questionnaire using a likert-scale (1-strongly disagree to 5-strongly agree). Lower scores indicate decreased sound quality and satisfaction, while higher scores indicate increased sound quality and satisfaction.
Time frame
Behavioral Visit 2 (1 month post 438 Hz FAT adaptation)3
Sound Quality Questionnaire Score while using standard 188 Hz FAT
A questionnaire will be given to the subjects to record their subjective thoughts regarding sound quality and satisfaction with both the experiment FAT and the standard FAT. Questionnaires will be administered double blind. Patients evaluate the 16-item questionnaire using a likert-scale (1-strongly disagree to 5-strongly agree). Lower scores indicate decreased sound quality and satisfaction, while higher scores indicate increased sound quality and satisfaction.
Time frame
Behavioral Visit 3 (1 month post 188 Hz FAT re-adaptation)4
The consonant-nucleus-consonant (CNC) word list score while using standard 188 Hz FAT
CNC word lists are used to evaluate the speech perception abilities of people with hearing impairments and cochlear implant users. A CNC score above 50% postoperatively indicates that a patient can communicate without relying too much on lip reading, sign language, or written communication.
Time frame
BaselineSponsors and contacts
Click on the lead sponsor to view all of their trials.
NYU Langone Health
Lead sponsor
National Institute on Deafness and Other Communication Disorders (NIDCD)
Collaborator
Source ClinicalTrials.gov