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

NCT05527730 | Unknown DMC FDA Device

• 1 other identifier: DM0224
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hearing Loss

Keywords

Self-fitting hearing aids; conventional hearing aid fitting

Outcome Measures

Primary Outcomes (1)

• Hearing aid gain comparisons using Real Ear Measures Data Analysis Plan

  To evaluate, fine-tune, and compare the gains produced by the Whisper Hearing System using both PRO-FIT and SELF-FIT, general standard-of-care real-ear measurements (REM) will be used. Real Ear Measures (REMs) provide an objective measure of sound pressure level in an individual's ear canal. Frequencies critical to speech understanding (500 through 4000 Hz) will be averaged to yield a single value similar to a pure tone average. A mean absolute difference will be used to evaluate whether the SELF-FIT is non-inferior to the PRO-FIT; a mean absolute difference less than 5 dB will be considered as a non-significant difference when comparing REMs between the SELF-FIT and PRO-FIT groups.

  4 weeks

Secondary Outcomes (2)

• Speech perception scores comparison

  2 hours for the testing, 4 weeks trial

• Overall perception hearing

  4 weeks

Study Arms (2)

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

ACTIVE COMPARATOR

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.

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

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

SHAM COMPARATOR

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.

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

Interventions

Comparison of PRO-FIT or SELF-FIT fitting DEVICE

add

Also known as: SELF-FIT fitting, PRO-FIT fitting

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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Whisper.ai: lead
• San Jose State University: collaborator

Study Sites (1)

Whisper.ai

San Francisco, California, 94103, United States

RECRUITING

MeSH Terms

Conditions

Hearing Loss

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Becky Lewis, PhD

CONTACT

8449364327; becky@whisper.ai

Anusha Yellamsetty, PhD

CONTACT

4089248686; anusha.yellamsetty@sjsu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The participant were be blind folded for the type of fitting for the study.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 21, 2022
• First Posted: September 2, 2022
• Study Start: July 7, 2022
• Primary Completion: December 10, 2022
• Study Completion: December 20, 2022
• Last Updated: December 7, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)