Clinical Evaluation of Frequency Allocation for Bimodal CI Users

Part of paid clinical trials in New York, New York.

Sponsor
NYU Langone Health
Study ID
NCT06663917
Status
Recruiting
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Conditions

  • Hearing Impairment

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Oct 6, 2024
Status verified
Aug 2025
Primary completion
Oct 6, 2027
Completion
Oct 6, 2027

Study Design

Enrollment
24 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Bamford-Kowal-Bench (BKB-SIN) speech-in-noise score using standard 188 Hz FAT [ Time Frame: Baseline ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
NYU Langone HealthNew YorkNew York10016-

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