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Smart Hearing Aids for Fall Risk and Speech Clarity

N/A
Recruiting
Research Sponsored by Stanford University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 10-15 minutes.
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to create and test hearing aids with sensors and AI to help assess and reduce the risk of falls, improve speech clarity, track activity levels, and social interactions. The goal is to use

Who is the study for?
This trial is for people aged 55 or older who use hearing aids in both ears, can consent in English, have concerns about falling (feeling unsteady, worrying about falls, or having fallen before), and can walk without a wheelchair. They also need to have a phone that can run the study's mobile app.
What is being tested?
The study tests hearing aids with sensors and AI designed to assess fall risk and improve speech clarity in different environments. It aims to enhance safety by reducing falls and improving hearing quality through technology.
What are the potential side effects?
While not explicitly stated, potential side effects may include discomfort from wearing the device, skin irritation around the ear area where the device is worn, or possible auditory issues due to incorrect usage.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 10-15 minutes.
This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 10-15 minutes. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
30-Second Chair Stand Test
4-Stage Balance Test
Consonant-Nucleus-Consonant (CNC)
+5 more
Secondary study objectives
Activities-Specific Balance Confidence Questionnaire
Auditory Lifestyle and Demand Scale Score
Demographic and Health Questionnaires
+7 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Speech intelligibilityExperimental Treatment1 Intervention
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.
Group II: Fall risk assessmentExperimental Treatment1 Intervention
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.

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Who is running the clinical trial?

Starkey Laboratories, IncIndustry Sponsor
3 Previous Clinical Trials
74 Total Patients Enrolled
Stanford UniversityLead Sponsor
2,469 Previous Clinical Trials
17,501,397 Total Patients Enrolled
~148 spots leftby Oct 2026