Hearing LossNCT05365646
Fall Risk Assessment and Speech Intelligibility Enhancement Using In-ear Device
A study testing Hearing aids equipped with motion sensing abilities in people with Hearing Loss and Dizziness, run by Stanford University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 55 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hearing Loss, Dizziness, Vertigo
- What is being tested?
- Hearing aids equipped with motion sensing abilities
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 1 siteUnited States
- Study dates
- 23 May 2022to Oct 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Stanford Ear Institute
Palo Alto, California, 94303
Matthew Fitzgerald, PhD, (650) 724-6015, fitzmb@stanford.edu
Jwala P. Rejimon, AuD, jrejimon@stanford.edu
About this study
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
- Being tested
- Hearing aids equipped with motion sensing abilities
- Keywords
- Fall risk, Hearing loss
- Medical subject headings
- Hearing Loss, Dizziness, Vertigo, Speech Intelligibility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hearing aids equipped with motion sensing abilitiesDevice
Participants will wear hearing aids that will assess their movement, and fall risk.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Hearing aids equipped with motion sensing abilities |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Approximately 10-15 minutes.
Secondary outcomes (10)
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.
Measured: Approximately 2 minutes.
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.
Measured: Approximately 5 minutes.
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.
Measured: Approximately 5 minutes.
User Experience Questionnaire
Participants rate their experience with the hearing aid regarding the following aspects: perceived difficulty communicating and listening effort in different environments.
Measured: Approximately 2 minutes.
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.
Measured: Approximately 15 minutes.
Orthostatic Blood Pressure
Blood pressure measurements in laying down, sitting, and standing positions.
Measured: Approximately 15 minutes.
Pure-Tone Audiometry
Hearing thresholds are measured from 250Hz through 8kHz in both ears, air and bone conduction.
Measured: Approximately 15 minutes.
Activities-Specific Balance Confidence Questionnaire
Participants rate their confidence level in various balance situations.
Measured: Approximately 10 minutes.
Speech, Spatial Qualities of Hearing Scale (SSQ)
Participants rate their difficulty level with understanding speech in various hearing situations.
Measured: Approximately 10 minutes.
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.
Measured: Approximately 5 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2022
- Study start23 May 2022
- Primary completionOct 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hearing LossStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- Starkey Laboratories, Inc
- Responsible party
- Principal investigator, Kristen K. Steenerson, MD, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05365646
- Sponsor's protocol ID
- 60900
- Status last verified
- Apr 2026
- First submitted
- 26 Apr 2022
- Last updated
- 28 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
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 33284647Burwinkel 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