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RecruitingNCT05365646Updated Oct 27, 2026

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

An interventional study of Hearing aids equipped with motion sensing abilities in Hearing Loss, Dizziness and Vertigo, sponsored by Stanford University. Recruiting at 1 site in United States. Open to participants aged 55 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-27.

Sponsored by Stanford University · Not applicable, Interventional, and Screening

From the registry’s dates

  • Started May 2022; still recruiting 4 years 5 months later.
Updated Oct 27, 2026Primary completion movedStudy completion movedGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
350
Allocation
Non-randomized
Ages
55 Years and older
Sex
All
01

Study 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.

02

Conditions studied

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

Keywords

  • Fall risk
  • Hearing loss
03

In context

Hearing Loss

796 studies on the registry are indexed under Hearing Loss; 193 are open to participants now.

This study's planned enrollment of 350 is above the median of 44 across 561 interventional studies indexed under Hearing Loss.

Browse Hearing Loss studies →

Lead sponsor

Stanford University is the lead sponsor of 2,168 studies on the registry; 431 are open to participants now.

Of its 267 completed or terminated interventional studies of FDA-regulated products, 207 (78%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
55 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
350 participants (estimated)

Study arms

  • Experimental
    Fall risk assessment

    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

  • Experimental
    Speech intelligibility

    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

  • DeviceHearing aids equipped with motion sensing abilities

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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: approximately 15 minutes to assess

  2. 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.

    Time frame: approximately 15 minutes to assess

  3. 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.

    Time frame: approximately 15 minutes to assess

  4. 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.

    Time frame: approximately 15 minutes to assess

  5. 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.

    Time frame: Approximately 10-15 minutes.

  6. 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.

    Time frame: Approximately 10-15 minutes.

  7. 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.

    Time frame: Approximately 10-15 minutes.

  8. 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.

    Time frame: Approximately 10-15 minutes.

Secondary outcomes

  1. Fall screening questionnaire using CDC's STEADI protocol

    Participants are screened using the CDC's "Three Key Questions" which are part of the STEADI Protocol.

    Time frame: Approximately 2 minutes.

  2. Listening Effort Questionnaire Scale Score

    Listening effort scale score measures the participant's perceived listening effort. This outcome is measured in Speech Intelligibility participants only.

    Time frame: Approximately 5 minutes.

  3. Auditory Lifestyle and Demand Scale Score

    Auditory Lifestyle and Demand scale score measures perceived demands of hearing on lifestyle. This outcome is measured in Speech Intelligibility participants only.

    Time frame: Approximately 5 minutes.

  4. User Experience Questionnaire

    Participants rate their experience with the hearing aid regarding the following aspects: perceived difficulty communicating and listening effort in different environments.

    Time frame: Approximately 2 minutes.

  5. Demographic and Health Questionnaires

    Data is gathered on age, sex, education level, hand-laterality, professional background, exercise habits, race, ethnicity, marital status, health literacy scores, medical conditions, and medications.

    Time frame: Approximately 15 minutes.

  6. Orthostatic Blood Pressure

    Blood pressure measurements in laying down, sitting, and standing positions.

    Time frame: Approximately 15 minutes.

  7. Pure-Tone Audiometry

    Hearing thresholds are measured from 250Hz through 8kHz in both ears, air and bone conduction.

    Time frame: Approximately 15 minutes.

  8. Activities-Specific Balance Confidence Questionnaire

    Participants rate their confidence level in various balance situations.

    Time frame: Approximately 10 minutes.

  9. Speech, Spatial Qualities of Hearing Scale (SSQ)

    Participants rate their difficulty level with understanding speech in various hearing situations.

    Time frame: Approximately 10 minutes.

  10. Hearing Aid Data

    Data is gathered from the participants' hearing aids on wear-time, streaming time, time spent in various sound classes and software updates. Data is also collected on the participants' required receiver length and coupling, as well as any specific fitting requirements they may have.

    Time frame: Approximately 5 minutes.

07

Study locations

1 of 1 sites recruiting
  • Stanford Ear Institute
    Palo Alto, California 94303, United States
    Recruiting
08

References and documents

Publications

  • 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. PubMed 33284647 ↗
  • 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. PubMed 31914373 ↗

Individual participant data

Plan to share: No

09

Updates

1 registry update since Sep 25, 2026
Primary completion
Oct 2026→Oct 2027
Oct 27, 2026
Study completion
Oct 2026→Oct 2027
Oct 27, 2026
Show all 1 update
  1. Oct 27, 2026
    Primary completion Oct 2026→Oct 2027
    Study completion Oct 2026→Oct 2027

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT05365646
Collaborators
Starkey Laboratories, Inc
Responsible party
Kristen K. Steenerson, MD (Clinical Associate Professor in Otoneurology, Stanford University) — Principal investigator
First posted
May 9, 2022
Start date
May 23, 2022
Primary completion
Oct 2027 (estimated)
Completion
Oct 2027 (estimated)
Last update
Oct 27, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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