Recruiting

Self-Fit & Professionally Fit

Sponsor:

Whisper.ai

Code:

NCT05527730

Conditions

Hearing Loss

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Comparison of PRO-FIT or SELF-FIT fitting

Study Details

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

Study ID

NCT05527730

Start date

Jul 7, 2022

Status verified date

Dec, 2022

Completion date

Dec 20, 2022

Anticipated

Primary completion date

Dec 10, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

active comparator: 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.

sham comparator: 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.

Interventions

Comparison of PRO-FIT or SELF-FIT fitting

add

Primary outcome measure

  • Hearing aid gain comparisons using Real Ear Measures Data Analysis Plan [ Time Frame: 4 weeks ]

Central Contacts and Locations

Central contacts

Becky Lewis, PhD

8449364327becky@whisper.ai

Anusha Yellamsetty, PhD

4089248686anusha.yellamsetty@sjsu.edu

Locations

Whisper.ai

Recruiting

San Francisco, California, United States, 94103

More Information

Sponsor

Whisper.ai

Last update posted

Dec 7, 2022

Last verified

Dec, 2022

Keywords

  • Self-fitting hearing aids
  • conventional hearing aid fitting

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Whisper.ai on 2022-12-07.