Clinical Trial Evaluating Outcomes of Self-Fit and Professionally Fit Hearing Aids

Whisper.ai

Status: Enrolling

Conditions: Hearing Loss

Treatments: Device: Comparison of PRO-FIT or SELF-FIT fitting

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05527730

DM0224

Details and patient eligibility

About

Approximately 48 million people in the United States have hearing loss or hearing difficulties in noisy environments. Whisper.ai Inc has previously brought to market a commercial hearing aid system that reduces background noise and amplifies voices and sounds of interest using its proprietary platform based on machine learning and artificial intelligence technologies.

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Adults age 18-80 years old
• 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

• History of neurological deficits (e.g. stroke, Alzheimer's disease, etc.)
• Inability to remain alert throughout initial testing appointment

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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80 participants in 2 patient groups

Screening, intake and first fit (either PRO-FIT or SELF-FIT fitting )

Active Comparator group

Description:

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.

Treatment:

Device: Comparison of PRO-FIT or SELF-FIT fitting

Second fit (either PRO-FIT or SELF-FIT fitting )

Sham Comparator group

Description:

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.

Treatment:

Device: Comparison of PRO-FIT or SELF-FIT fitting