Fall Risk Assessment and Speech Intelligibility Enhancement Using In-ear Device

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to develop and validate methods to use hearing aids equipped with embedded sensors and artificial intelligence to assist in the assessment of fall risk and in the implementation of interventions aimed at reducing the risk of falling, as well as to improve speech intelligibility in quiet and in background noise, track physical activity, and social engagement. The investigators hope is that the knowledge that is generated through this study will ultimately translate to the clinical setting and will help reduce the likelihood that individuals experience a fall, and improve the quality of hearing in individuals who wear hearing aids.

Official Title
-----------------
Fall Risk Assessment and Speech Intelligibility Enhancement Using In-ear Device

Conditions
-----------------
Hearing Loss, Dizziness, Vertigo

Intervention / Treatment
-----------------
* Device: Hearing aids equipped with motion sensing abilities


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 55 years or older Bilateral hearing aid user Able to consent in English Having access to a phone capable of running the mobile app required for the study Screen for fall risk (Yes to any question: Feels unsteady when standing or walking? Worries about falling? Has fallen in past year? If the participant has fallen: how many times? were they injured/hurt?) Ambulatory without need for a wheelchair Exclusion Criteria: People with mobility restrictions (e.g., wheelchair bound) that would prevent the performance of the functional assessments. People with severe movement (e.g., Advanced Parkinson's disease) or cognitive (e.g., advanced dementia) disorders that would prevent the individual from either performing the functional assessments, or would lead to restricted activities that would prevent motion data from being collected according to the goal of the study. Inability to understand, consent, and complete requirements including verbal instructions and non-ambulatory/wheelchair-dependent.

Ages Eligible for Study
-----------------
Minimum Age: 55 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Participants<br>Participants will wear study hearing aids that are equipped with embedded sensors and artificial intelligence. This will help track their movement and signal if the participant falls or is at fall risk. | Device: Hearing aids equipped with motion sensing abilities<br>* Participants will wear hearing aids that will assess their movement, and fall risk.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fall risk assessment using CDC's STEADI protocol | Participants will undergo the Centers for Disease Control and Prevention (CDC)'s STEADI (Stopping Elderly Accidents, Deaths & Injuries) fall risk assessment with the hearing aids on. The scoring for these tests will be done by the tester, 2 independent raters, and the hearing aids. A comparison of the fall risk assessments by the testers and the hearing aids is the primary outcome measure. | 2 years |