Clinical trial NCT05527730: Clinical Trial Evaluating Outcomes of Self-Fit and Professionally Fit Hearing Aids
Official title: Clinical Trial Evaluating Outcomes of Self-Fit and Professionally Fit Hearing Aids
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hearing Loss
Keywords: Self-fitting hearing aids
conventional hearing aid fitting
Lead sponsor: Whisper.ai
Sponsor class: INDUSTRY
Collaborators: name: San Jose State University
First posted: 2022-09-02
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 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.
Primary purpose: BASIC_SCIENCE

Brief 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.


Eligibility criteria: Inclusion Criteria:

* Adults age 18-80 years old
* Mild-to-moderate hearing loss in both ears from 500 to 4000 Hz
* Reported one year of previous hearing aid experience in at least one ear
* Ability to use a laptop/desktop computer to browse the internet
* Ability to complete online surveys in a web browser
* Communicates verbally and in writing in English

Exclusion Criteria:

* History of neurological deficits (e.g. stroke, Alzheimer's disease, etc.)
* Inability to remain alert throughout initial testing appointment

Primary outcomes:
measure: Hearing aid gain comparisons using Real Ear Measures Data Analysis Plan
timeFrame: 4 weeks
Secondary outcomes:
measure: Speech perception scores comparison
timeFrame: 2 hours for the testing, 4 weeks trial
measure: Overall perception hearing
timeFrame: 4 weeks
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Whisper.ai
state: California
Study officials:
References: