A System and Process to Improve the Satisfaction With Hearing Health Products

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-31

Study Completion Date

2024-09-30

Brief Summary

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Innovative Design Labs Inc. (IDL) and its collaborators, proposes to create a cloud-based system which integrates advances and techniques from Health and Wellness Coaching (HWC) into the Hearing Aid (HA) fitting and trial process.

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Detailed Description

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As of 2015, 28.8 million U.S. adults could benefit from using hearing aids and the prevalence of hearing loss in the United States is predicted to rise significantly due to an aging population and the growing use of personal listening devices. However, only 28.5% of individuals who could benefit from a HA actually wears one. The non-use of hearing aids by people with hearing loss has many far-reaching implications for their physical health, mental health, and their social life. As the market moves towards a, direct-to-consumer distribution model following the 2017 FDA directive, more patients will be receiving therapy for hearing loss. While in traditional practice, an audiologist assists the patient with support adjusting to their new therapy, there is no person fulfilling that role in the direct-to-consumer model. Hypothesis: The investigators hypothesize that the integration of Health and Wellness Coaching, aided by cloud-based tools, into this process will increase patients' satisfaction and usage of hearing health products. Specific Aims: 1) Create patient/coach interaction protocol and training; 2) Develop a cloud-based Health Coaching Interface; 3) Evaluate system effectiveness through a clinical trial.

Conditions

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Hearing Loss

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Standard Mobile App

This group will be supplied with Novidan DTC hearing aids and documentation following standard of care as a control. They will be provided with the mobile application allowing for the monitoring of data for study analysis and personal control of their hearing aids, but not Health and Wellness Coaching features.

Group Type NO_INTERVENTION

No interventions assigned to this group

Enhanced Mobile App with Health Coaching

This group will also be supplied with the Novidan DTC hearings aids and documentation, same as the control group, but will be supplied the enhanced mobile application that allows for participation in health coaching features. They will be assigned to a health coach and will have coaching sessions scheduled.

Group Type EXPERIMENTAL

Health and Wellness Coaching

Intervention Type BEHAVIORAL

An enhanced mobile application that allows for participation in health coaching features. Participants will be assigned to a health coach and will have coaching sessions scheduled.

Interventions

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Health and Wellness Coaching

An enhanced mobile application that allows for participation in health coaching features. Participants will be assigned to a health coach and will have coaching sessions scheduled.

Intervention Type BEHAVIORAL