NCT05527730

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Whisper.ai · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

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.

Conditions

• Hearing Loss

Interventions

Type	Name	Description
DEVICE	Comparison of PRO-FIT or SELF-FIT fitting	add

Timeline

• Start date: 2022-07-07
• Primary completion: 2022-12-10
• Completion: 2022-12-20
• First posted: 2022-09-02
• Last updated: 2022-12-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study