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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

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 hours for the testing, 4 weeks trial

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Hearing aid gain comparisons using Real Ear Measures Data Analysis Plan

Secondary outcome measures

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any open enrollments for this clinical experiment?

"Affirmative, clinicaltrials.gov confirms that this medical study is actively recruiting patients. It first appeared on July 7th 2022 and was last updated August 31st 202 - 80 participants need to be recruited from 1 location."

Answered by AI

Is there a possibility for me to become involved in this research undertaking?

"For this trial, 80 volunteers need to be recruited that possess mild-to-moderate hearing impairment in both ears (500 - 4000 Hz), have had at least one year of experience wearing a hearing aid device, are able to use laptops/desktops and surf the internet, complete web surveys with ease, converse verbally and write in English proficiently. Furthermore, all participants must fall between 18 and 80 years old."

Answered by AI

Is participation in this clinical trial restricted to particular age brackets?

"Adults aged between 18 and 80 are allowed to apply for this medical trial. There are additionally 49 trials that cater to minors, while 123 studies target seniors 65 years of age or older."

Answered by AI

How many people are enrolled in this experiment?

"Affirmative. Clinicaltrials.gov outlines that this clinical trial, established on July 7th 2022, is currently recruiting participants. There are 80 seats available across 1 medical centre."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Anusha Yellamsetty 2022. "Clinical Trial Evaluating Outcomes of Self-Fit and Professionally Fit Hearing Aids". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05527730.

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