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NCT05527730

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

Status unknown NA Last updated 7 December 2022
What this trial tests

NA trial testing Comparison of PRO-FIT or SELF-FIT fitting in Hearing Loss in 80 participants. Status unknown.

Timeline
7 July 2022
Primary endpoint
10 December 2022
20 December 2022

Quick facts

Lead sponsorWhisper.ai
PhaseNA
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationrandomized
Designcrossover
Maskingsingle
Primary purposebasic science
Enrollment80
Start date7 July 2022
Primary completion10 December 2022
Estimated completion20 December 2022
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Whisper.ai

Who can join

Adults 18 to 80, any sex, with Hearing Loss. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other recruiting trials for Hearing Loss

Currently open trials in the same condition.

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Data sources for this page

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