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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05527730
Other study ID # DM0224
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date July 7, 2022
Est. completion date December 20, 2022

Study information

Verified date December 2022
Source Whisper.ai
Contact Becky Lewis, PhD
Phone 8449364327
Email becky@whisper.ai
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 80
Est. completion date December 20, 2022
Est. primary completion date December 10, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 80 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States Whisper.ai San Francisco California

Sponsors (2)

Lead Sponsor Collaborator
Whisper.ai San Jose State University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Speech perception scores comparison The Quick Speech In Noise (QuickSIN) will provide a behavioral measure that will be compared across fitting conditions.The outcome of a non-inferiority trial may be assessed by a two-sided t-test, using a 95% confidence interval. A two-sided t-test will be used to compare the two final Quick Speech in Noise scores across fitting groups.Minimum value: -4.5 SNR Loss Maximum value: 25.5 SNR Loss Lower score here is better performance/outcome (-4.5 is the best possible score). 2 hours for the testing, 4 weeks trial
Secondary Overall perception hearing Abbreviated Profile of Hearing Aid Benefit (APHAB) is a 24-item self-assessment inventory in which subjects report the amount of trouble they are having with communication or noises in various everyday situations. The APHAB produces scores for 4 subscales: Ease of Communication, Reverberation, Background Noise, and Aversiveness. These are combined to create a global score, which will be used to evaluate the overall benefit of amplification for each fitting strategy (SELF-FIT and PRO-FIT).
The outcome of a non-inferiority trial may be assessed by a two-sided t-test, using a 95% confidence interval. A two-sided t-test with 95% confidence intervals will be used to determine whether APHAB outcomes differ between the SELF-FIT and the PRO-FIT.
Minimum value: 0% of problems Maximum value: 100% of problems Lower score here is a lower percent of problems, or better performance/outcome.
4 weeks
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