Clinical Trial Evaluating Outcomes of Self-Fit and Professionally Fit Hearing Aids
NCT ID: NCT05527730
Last Updated: 2022-12-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
80 participants
INTERVENTIONAL
2022-07-07
2022-12-20
Brief Summary
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Whisper.ai Inc now seeks to bring to market a new hearing system that will incorporate a "self-fitting" capability. Self-fitting hearing aids have emerged in recent years as a potentially viable option to calibrate hearing aids to the needs of individual users without clinician intervention. The purpose of this project is to evaluate the efficiency and reliability of the fitting procedure and algorithms developed by Whisper.ai Inc. The study will be carried out using a randomized crossover design in two phases: in phase 1, subjects will be tested and a hearing aid will be fitted using conventional audiological standard procedures , and in phase 2, the subject will be tested and a hearing aid will be fitted using the results of the self-fitting algorithm.
Objective, subjective, and behavioral responses will be gathered from a variety of hearing-related surveys and tests, and will be analyzed quantitatively to evaluate the efficiency and reliability of the self-fitting algorithm. The investigators expect the fitting results of the Whisper.ai self-fitting algorithm to be similar to those of standardized fitting procedures conducted by hearing professionals.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
SINGLE
Study Groups
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Screening, intake and first fit (either PRO-FIT or SELF-FIT fitting )
This multi-center, prospective, randomized cross-over clinical trial compares two methods of fitting individuals with hearing loss with a therapeutic amplification device (i.e., hearing aids). Subjects will wear the Whisper Hearing System for the PRO-FIT and SELF-FIT for two weeks each, totalling to approximately 1 month of wear throughout the trial. At the first visit, all individuals will go through intake procedures and a basic audiologic evaluation. After this is completed, individuals are randomized into one of two arms of the study Individuals in the first visit of the study will receive the conventional PRO-FIT method for the first two weeks, then will switch to the experimental SELF-FIT method for the last half of the study.
Comparison of PRO-FIT or SELF-FIT fitting
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Second fit (either PRO-FIT or SELF-FIT fitting )
Conversely, individuals in the second visit of the study will receive the experimental SELF-FIT method for the first two weeks, then will switch to the conventional PRO-FIT method for the last two weeks. The two fitting methods (PRO-FIT and SELF-FIT) will be compared to evaluate the efficiency and reliability of the Whisper hearing system self-fitting algorithm.
Comparison of PRO-FIT or SELF-FIT fitting
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Interventions
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Comparison of PRO-FIT or SELF-FIT fitting
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Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Mild-to-moderate hearing loss in both ears from 500 to 4000 Hz
* Reported one year of previous hearing aid experience in at least one ear
* Ability to use a laptop/desktop computer to browse the internet
* Ability to complete online surveys in a web browser
* Communicates verbally and in writing in English
Exclusion Criteria
* Inability to remain alert throughout initial testing appointment
18 Years
80 Years
ALL
Yes
Sponsors
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San Jose State University
OTHER
Whisper.ai
INDUSTRY
Responsible Party
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Locations
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Whisper.ai
San Francisco, California, United States
Countries
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Central Contacts
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Other Identifiers
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DM0224
Identifier Type: -
Identifier Source: org_study_id
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