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Recruiting NCT06663917

Clinical Evaluation of Frequency Allocation for Bimodal CI Users

No phase Interventional Hearing Impairment

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Experimental frequency allocation table (FAT) - 438 Hz, Standard FAT - 188 Hz.
Who it may be relevant to
Registry conditions: Hearing Impairment. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Other Experimental frequency allocation table (FAT) - 438 Hz
    The 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.
  • Other Standard FAT - 188 Hz
    All subjects will retain one program with the standard 188 Hz FAT. Subjects will use the standard FAT for one month.

Primary outcome measures

  • Sound Quality Questionnaire Score while using standard 188 Hz FAT [Time frame: Baseline]
  • Sound Quality Questionnaire Score while using experimental 438 Hz FAT [Time frame: Behavioral Visit 2 (1 month post 438 Hz FAT adaptation)]
  • Sound Quality Questionnaire Score while using standard 188 Hz FAT [Time frame: Behavioral Visit 3 (1 month post 188 Hz FAT re-adaptation)]
  • The consonant-nucleus-consonant (CNC) word list score while using standard 188 Hz FAT [Time frame: Baseline]
  • CNC word list score while using standard 188 Hz FAT [Time frame: Behavioral Visit 2 (1 month post 438 Hz FAT adaptation)]
  • CNC word list score while using standard 188 Hz FAT [Time frame: Behavioral Visit 3 (1 month post 188 Hz FAT re-adaptation)]
  • CNC word list score while using experimental 438 Hz FAT [Time frame: Baseline]
  • CNC word list score while using experimental 438 Hz FAT [Time frame: Behavioral Visit 2 (1 month post 438 Hz FAT adaptation)]
  • CNC word list score while using experimental 438 Hz FAT [Time frame: Behavioral Visit 3 (1 month post 188 Hz FAT re-adaptation)]
  • Bamford-Kowal-Bench (BKB-SIN) speech-in-noise score using standard 188 Hz FAT [Time frame: Baseline]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • Greater than 70 dB hearing level pure tone average in the contralateral ear
  • Normal hearing or mild hearing loss in the contralateral ear
  • Non-standard FAT programs
  • Use of any frequency transposition programming in hearing aid.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • NYU Langone Health — New York

Identifiers

NCT: NCT06663917 · 24-00833 · R01DC021980-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗