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

NCT05365646 | Recruiting FDA Device

• 1 other identifier: 60900
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 1

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.

Conditions

Hearing Loss; Dizziness; Vertigo; Fall Related Injury Risk; Fall Prevention; Imbalance; Speech Intelligibility

Keywords

Fall risk; Hearing loss

Outcome Measures

Primary Outcomes (8)

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

  approximately 15 minutes to assess

• Timed Up and Go Test

  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.

  approximately 15 minutes to assess

• 30-Second Chair Stand Test

  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.

  approximately 15 minutes to assess

• 4-Stage Balance Test

  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.

  approximately 15 minutes to assess

• Consonant-Nucleus-Consonant (CNC)

  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.

  Approximately 10-15 minutes.

• Quick Speech-in-Noise (QuickSIN)

  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.

  Approximately 10-15 minutes.

• Words-in-Noise (WIN)

  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.

  Approximately 10-15 minutes.

• Nonsense Syllable Test (NST)

  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.

  Approximately 10-15 minutes.

Secondary Outcomes (10)

• Fall screening questionnaire using CDC's STEADI protocol

  Approximately 2 minutes.

• Listening Effort Questionnaire Scale Score

  Approximately 5 minutes.

• Auditory Lifestyle and Demand Scale Score

  Approximately 5 minutes.

• User Experience Questionnaire

  Approximately 2 minutes.

• Demographic and Health Questionnaires

  Approximately 15 minutes.

Study Arms (2)

Fall risk assessment

EXPERIMENTAL

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

Speech intelligibility

EXPERIMENTAL

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

Interventions

Hearing aids equipped with motion sensing abilities DEVICE

Participants will wear hearing aids that will assess their movement, and fall risk.

Fall risk assessment; Speech intelligibility

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stanford University: lead
• Starkey Laboratories, Inc: collaborator

Study Sites (1)

Stanford Ear Institute

Palo Alto, California, 94303, United States

RECRUITING

Related Publications (2)

• Rahme M, Folkeard P, Scollie S. Evaluating the Accuracy of Step Tracking and Fall Detection in the Starkey Livio Artificial Intelligence Hearing Aids: A Pilot Study. Am J Audiol. 2021 Mar 10;30(1):182-189. doi: 10.1044/2020_AJA-20-00105. Epub 2020 Dec 7.

  PMID: 33284647 BACKGROUND

• Burwinkel JR, Xu B, Crukley J. Preliminary Examination of the Accuracy of a Fall Detection Device Embedded into Hearing Instruments. J Am Acad Audiol. 2020 Jun;31(6):393-403. doi: 10.3766/jaaa.19056. Epub 2020 Aug 3.

  PMID: 31914373 BACKGROUND

MeSH Terms

Conditions

Hearing Loss; Dizziness; Vertigo; Speech Intelligibility

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Vestibular Diseases; Labyrinth Diseases; Speech; Verbal Behavior; Communication; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor in Otoneurology

Study Record Dates

• First Submitted: April 26, 2022
• First Posted: May 9, 2022
• Study Start: May 23, 2022
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)