Fall Risk Assessment and Speech Enhancement Using In-ear Devices

This study is testing hearing aids equipped with motion sensors to see if they can help assess your risk of falling and improve your ability to understand speech in different environments. Researchers hope these special hearing aids, which use artificial intelligence, can eventually help reduce falls and improve hearing for people who use hearing aids. To join, you must be 55 or older, use hearing aids in both ears, speak English, have a smartphone, and answer "Yes" to questions about feeling unsteady, worrying about falling, or having fallen in the past year. The study will measure fall risk using standard tests like the CDC's STEADI protocol, Timed Up and Go Test, and 30-Second Chair Stand Test. The current recruitment status is unclear.

Study design
This interventional study plans to enroll 350 participants. It is testing hearing aids equipped with motion sensing abilities.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Fall risk assessments will be measured at approximately 15 minutes.

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NCT05365646

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

Recruiting
NAAges 55+InterventionalScreening
Stanford University
~350 participants
Updated 2026-04-28 on ClinicalTrials.gov
What's tested:Hearing aids equipped with motion sensing abilities

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Fall risk assessment using CDC's STEADI protocol
Measured over approximately 15 minutes to assess
+7 more outcomes measured
Hearing Loss
Dizziness
Vertigo
Fall Related Injury Risk
Fall Prevention
Imbalance
Speech Intelligibility
1 sites across 1 states
California1

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Eligibility criteria

Inclusion

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

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.
  • Fall risk assessment using CDC's STEADI protocolapproximately 15 minutes to assess

    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. This outcome is assessed in Fall Risk Assessment participants only.

  • Timed Up and Go Testapproximately 15 minutes to assess

    Duration of time to stand, walk to a line on the floor (3 meters/10 feet away), turn around, return to chair and sit. Participants wear their regular footwear and can use a walking aid if needed. This outcome is assessed in Fall Risk Assessment participants only.

  • 30-Second Chair Stand Testapproximately 15 minutes to assess

    Number of times participants can stand without using their arms during the test. Participants wear their regular footwear and can use a walking aid if needed. This outcome is assessed in Fall Risk Assessment participants only.

  • 4-Stage Balance Testapproximately 15 minutes to assess

    Participants who are able to keep their balance for 10 second in each of four positions (feet together, feet staggered, feet in tandem, and single foot stand). They can hold their arms out, or move their body to help keep your balance, but not move their feet. This outcome is assessed in Fall Risk Assessment participants only.

  • Consonant-Nucleus-Consonant (CNC)Approximately 10-15 minutes.

    The number and percentage of words and phonemes accurately repeated are measured in aided (using hearing aids) and unaided conditions. This outcome is measured in Speech Intelligibility participants only.

  • Quick Speech-in-Noise (QuickSIN)Approximately 10-15 minutes.

    The number and percentage of words and phonemes accurately repeated are measured in ambient noise conditions in aided and unaided conditions. This outcome is measured in Speech Intelligibility participants only.

  • Words-in-Noise (WIN)Approximately 10-15 minutes.

    The number and percentage of words and phonemes accurately repeated are measured in muli-talker babble noise conditions in aided and unaided conditions. This outcome is measured in Speech Intelligibility participants only.

  • Nonsense Syllable Test (NST)Approximately 10-15 minutes.

    The number and percentage of words and phonemes accurately repeated are measured in continuous noise conditions in aided and unaided conditions. This outcome is measured in Speech Intelligibility participants only.