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Behavioural Intervention

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

N/A
Recruiting
Research Sponsored by Whisper.ai
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 hours for the testing, 4 weeks trial
Awards & highlights

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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 hours for the testing, 4 weeks trial
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 hours for the testing, 4 weeks trial for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Hearing aid gain comparisons using Real Ear Measures Data Analysis Plan
Secondary study objectives
Hearing
Speech perception scores comparison

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Screening, intake and first fit (either PRO-FIT or SELF-FIT fitting )Active Control1 Intervention
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.
Group II: Second fit (either PRO-FIT or SELF-FIT fitting )Placebo Group1 Intervention
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.

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Who is running the clinical trial?

Whisper.aiLead Sponsor
San Jose State UniversityOTHER
10 Previous Clinical Trials
1,861 Total Patients Enrolled
1 Trials studying Hearing Loss
21 Patients Enrolled for Hearing Loss
~25 spots leftby Sep 2025
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