Smart Hearing Aids for Fall Risk and Speech Clarity

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Stanford University

Disqualifiers: Mobility restrictions, Advanced Parkinson's, Dementia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 8

350 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests new hearing aids equipped with sensors and smart technology to reduce fall risk and improve hearing in various environments. The hearing aids detect movement and alert users to potential falls while enhancing speech clarity. The trial seeks participants aged 55 and older who use hearing aids, can walk without a wheelchair, and have concerns about falling or have fallen in the past year. Participants need a smartphone to use a special app for the study. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance safety and hearing for many.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on hearing aids and fall risk, so it's best to ask the trial organizers for more details.

What prior data suggests that these smart hearing aids are safe for assessing fall risk and improving speech clarity?

Research has shown that smart hearing aids with motion sensors are generally safe. These devices detect falls and improve speech clarity. Studies have not identified any major safety issues. Users have not reported serious problems. The sensors track movement and help manage risks, enhancing daily life. Overall, these smart hearing aids are well-tolerated and considered safe. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these smart hearing aids because they combine hearing enhancement with motion-sensing technology to address both fall risk and speech clarity. Unlike standard hearing aids, which primarily focus on amplifying sound, these innovative devices are equipped with sensors and artificial intelligence to track movement and detect potential falls. This dual functionality not only aims to improve speech intelligibility but also provides an added layer of safety for users by potentially preventing falls. This integration of technology into hearing aids represents a significant advancement in patient care, offering a comprehensive approach to hearing and mobility challenges.

What evidence suggests that these smart hearing aids are effective for fall risk and speech clarity?

This trial will evaluate smart hearing aids equipped with motion sensors for two purposes. In one arm, participants will use these hearing aids for fall risk assessment, as the devices track movements and signal if a participant falls or is at risk of falling. In the other arm, the focus will be on improving speech intelligibility, as these hearing aids enhance speech clarity, even in noisy environments. Research has shown that this technology not only helps prevent falls but also improves listening while walking, a challenge for many. Overall, AI and motion sensors in hearing aids offer promising support for those with hearing loss and balance issues. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I feel unsteady or have fallen in the past year.

Able to consent in English

Bilateral hearing aid user

Exclusion Criteria

I have mobility issues that stop me from doing certain physical tests.

I can understand and follow study instructions and am not wheelchair-bound.

I do not have severe movement or cognitive disorders that would prevent me from participating in assessments.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Fall Risk Assessment

Participants undergo fall risk assessment using hearing aids equipped with embedded sensors and artificial intelligence, following the CDC's STEADI protocol.

4 weeks

4 visits (in-person)

Speech Intelligibility Enhancement

Participants use hearing aids to improve speech intelligibility in various noise conditions, with assessments like Words-in-Noise and Quick Speech-in-Noise tests.

4 weeks

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the intervention, including assessments of physical activity and social engagement.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Hearing aids equipped with motion sensing abilities

Trial Overview 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.

How Is the Trial Designed?

Group I: Speech intelligibility Experimental Treatment 1 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 assessment Experimental Treatment 1 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.

Hearing aids equipped with motion sensing abilities is already approved in United States, European Union for the following indications:

Approved in United States as Hearing aids with fall detection for:

• Hearing loss
• Fall risk assessment

Approved in European Union as Smart hearing aids for:

• Hearing loss
• Fall risk assessment
• Physical activity tracking

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

Starkey Laboratories, Inc

Industry Sponsor

Trials

4

Recruited

420+

Published Research Related to This Trial

Air-conduction hearing aids are effective devices that help many people, especially older adults, improve their communication abilities by amplifying ambient sounds and delivering them directly to the ear canal.

The article emphasizes the importance of proper fitting and individual ear coupling for maximizing the effectiveness of hearing aids, as well as detailing their various designs and signal processing features.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[(Air-conduction) Hearing aids-indication, designs and applications : Signal processing and importance of individual fitting]. Husstedt, H., Schönweiler, R.[2022]

Active middle ear implants (AMEIs) can significantly improve hearing capacity and quality of life for patients who do not benefit adequately from traditional hearing aids, especially in cases of poor compliance or side effects from conventional devices.

While AMEIs offer advantages like increased hearing gain and better speech discrimination in noisy environments, their use is often debated in primary care due to potentially small functional gains compared to modern hearing aids.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Differential indication of active middle ear implants]. Braun, K., Zenner, HP., Friese, N., et al.[2018]

A study of 56 participants with mild sensorineural hearing loss showed that advanced digital technology (ADT) hearing aids significantly improved user satisfaction and outcomes, with users wearing them for an average of 10.5 hours per day.

Despite achieving good overall satisfaction and self-efficacy, users reported challenges with managing background noise and advanced device handling, highlighting the need for ongoing support from hearing health care providers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Benefits from, Satisfaction with, and Self-Efficacy for Advanced Digital Hearing Aids in Users with Mild Sensorineural Hearing Loss. Johnson, CE., Jilla, AM., Danhauer, JL., et al.[2020]

Recent advancements in the design and functionality of wearable hearing aids have significantly increased their effectiveness, allowing more people with hearing impairments to benefit from them.

Current guidelines for recommending hearing aids are outdated; now, individuals with any level of permanent hearing loss should be considered for aural rehabilitation and the use of hearing aids, regardless of their previous prognosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The successful hearing aid user. Sanders, JW.[2000]

In a study involving 50 hearing-impaired subjects, the Widex SENSO hearing aid was evaluated for performance against several analog hearing aids after a one-week adjustment period.

The performance was assessed through various tests, including speech perception in noise and user preference questionnaires, indicating that the SENSO's effectiveness could be fine-tuned based on user feedback.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparing the performance of the Widex SENSO digital hearing aid with analog hearing aids. Valente, M., Fabry, DA., Potts, LG., et al.[2022]

The Starkey Livio Artificial Intelligence hearing aids effectively tracked step count, showing accuracy comparable to other devices like pedometers and Fitbits during real-world walking conditions.

The Livio hearing aids successfully detected most fall maneuvers, indicating their potential as a reliable safety feature for users, although further research with larger sample sizes is recommended.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating the Accuracy of Step Tracking and Fall Detection in the Starkey Livio Artificial Intelligence Hearing Aids: A Pilot Study. Rahme, M., Folkeard, P., Scollie, S.[2021]

Modern hearing aids are now incorporating motion sensors, specifically accelerometers, to enhance their ability to evaluate listening environments and optimize settings based on user activity, such as being stationary or in motion.

The integration of both acoustic and motion sensors allows hearing aids to better anticipate and meet the listening needs of users, improving overall hearing experiences in various environments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Motion Sensors in Automatic Steering of Hearing Aids. Branda, E., Wurzbacher, T.[2021]

A new fall detection system using accelerometers placed at head level showed high sensitivity and specificity in distinguishing between falls and normal daily activities, outperforming traditional hip- or wrist-worn detectors.

The system was tested on a young volunteer and an elderly woman, identifying three key thresholds for detecting falls, which enhances the potential for timely medical response in case of an incident.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a fall detector based on accelerometers: a pilot study. Lindemann, U., Hock, A., Stuber, M., et al.[2019]

In a study involving 12 adult users of bone anchored hearing systems (BAHS), it was found that maximum power output (MPO) levels did not significantly affect speech understanding in quiet environments.

However, for users with sensorineural hearing loss greater than 35 dB, higher MPO levels improved speech understanding in noisy conditions, with an average enhancement of +3.2 dB in signal-to-noise ratio.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Influence of maximum power output on speech understanding with bone anchored hearing systems. Gawliczek, T., Wimmer, W., Caversaccio, M., et al.[2020]

In a study involving 22 older adults with moderate-to-severe hearing loss, a motion-based beamformer adaptation in hearing aids significantly improved speech understanding and sound localization compared to conventional technology.

Participants preferred the motion-based adaptation for overall listening experience and sound quality, indicating that using motion sensors in hearing aids can enhance user satisfaction and effectiveness during activities like walking.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating the benefit of hearing aids with motion-based beamformer adaptation in a real-world setup. Voss, SC., Pichora-Fuller, MK., Ishida, I., et al.[2022]

Citations

1. withpower.com withpower.com/trial/phase-vertigo-4-2022-d8511

Smart Hearing Aids for Fall Risk and Speech Clarity Research on smart hearing aids with motion sensors, including those with fall detection features, suggests they are generally safe for human use. Studies have ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8463124/

Improving Speech Understanding and Monitoring Health ... This article details ways that machine learning and artificial intelligence technologies are being integrated in modern hearing aids to improve speech ...

3. nature.com nature.com/articles/s43856-025-00878-8

Self-reported hearing measures can predict risk of falling ... This study examined whether a self-reported hearing test (AIADH) could predict balance issues and fall risk.

4. starkey.com starkey.com/press/press-releases/2025/02/stanford-university-and-starkey-collaborate-on-groundbreaking-study

Stanford & Starkey Collaborate on Groundbreaking Study Starkey's Balance Assessment feature uses advanced motion sensors and artificial intelligence (AI) to measure factors related to fall risk.

5. tandfonline.com tandfonline.com/doi/full/10.1080/14992027.2021.1948120

Evaluating the benefit of hearing aids with motion-based ... The purpose of the current study was to evaluate hearing aids that use a motion sensor to address listening needs during walking.

6. starkey.com starkey.com/press/press-releases/2025/09/starkey-hearing-aids-take-a-stand-against-falls-with-built-In-balance-technology

Starkey Hearing Aids Take a Stand Against Falls with Built- ... It includes a 12-question screening and functional assessments of gait, strength, and balance, all administered through the hearing aid. This ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9554784/

Impact of hearing aid use on falls and falls-related injury The study found that hearing aid use does not appear to modify the association between self-reported hearing status and falls or falls-related injury.

8. ncoa.org ncoa.org/product-resources/hearing-aids/best-hearing-aids/

The Best Hearing Aids in 2025 We tested over 50 models to find the best hearing aids in 2025. See which brands we love—and which we don't recommend.