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

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Hearing Loss
Comparison of PRO-FIT or SELF-FIT fitting - Device
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial evaluates the Whisper.ai hearing system that uses a "self-fitting" capability to calibrate hearing aids to the needs of individual users. The study will compare results from the self-fitting algorithm to those of standardized fitting procedures conducted by hearing professionals.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 2 Secondary · Reporting Duration: 2 hours for the testing, 4 weeks trial

Week 4
Speech perception scores comparison
4 weeks
Hearing aid gain comparisons using Real Ear Measures Data Analysis Plan
Hearing

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Screening, intake and first fit (either PRO-FIT or SELF-FIT fitting )
1 of 2
Second fit (either PRO-FIT or SELF-FIT fitting )
1 of 2
Active Control
Non-Treatment Group

80 Total Participants · 2 Treatment Groups

Primary Treatment: Screening, intake and first fit (either PRO-FIT or SELF-FIT fitting ) · Has Placebo Group · N/A

Screening, intake and first fit (either PRO-FIT or SELF-FIT fitting )
Device
ActiveComparator Group · 1 Intervention: Comparison of PRO-FIT or SELF-FIT fitting · Intervention Types: Device
Second fit (either PRO-FIT or SELF-FIT fitting )
Device
ShamComparator Group · 1 Intervention: Comparison of PRO-FIT or SELF-FIT fitting · Intervention Types: Device

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 2 hours for the testing, 4 weeks trial

Who is running the clinical trial?

San Jose State UniversityLead Sponsor
7 Previous Clinical Trials
488 Total Patients Enrolled
Whisper.aiIndustry Sponsor

Eligibility Criteria

Age 18+ · All Participants · 6 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have mild-to-moderate hearing loss in both ears from 500 to 4000 Hz.
You have had one year of previous hearing aid experience in at least one ear.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 14th, 2021

Last Reviewed: October 23rd, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.