Smart Hearing Aids for Fall Risk and Speech Clarity

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Stanford University

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

No Placebo Group

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment Smart Hearing Aids for Fall Risk and Speech Clarity?

The Starkey Livio hearing aids, which are similar to the smart hearing aids in the trial, were found to accurately track steps and detect falls, suggesting they could help reduce fall risk. Additionally, advanced digital hearing aids have been shown to provide significant benefits and satisfaction for users with hearing loss, indicating potential improvements in speech clarity. ^{1 2 3 4 5}

Are smart hearing aids with motion sensors safe for human use?

Research on smart hearing aids with motion sensors, including those with fall detection features, suggests they are generally safe for human use. Studies have shown these devices to be feasible and effective in detecting steps and falls, with no reported safety concerns. ^{1 2 6 7 8}

How do smart hearing aids with motion sensing differ from other treatments for fall risk and speech clarity?

Smart hearing aids with motion sensing are unique because they combine acoustic sensors with motion sensors to better adapt to the user's environment, improving both speech clarity and fall detection. This dual-sensor approach allows the hearing aids to adjust settings based on whether the user is stationary or moving, which is not a feature of conventional hearing aids. ^{3 6 7 9 10}

Research Team

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

• Hearing aids equipped with motion sensing abilities (Other)

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.

Participant Groups

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.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Stanford Ear Institute Palo Alto, CA

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2527

Patients Recruited

17,430,000+

Starkey Laboratories, Inc

Industry Sponsor

Trials

4

Patients Recruited

420+

Findings from Research

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]

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]

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]

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]

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]

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]

References

1. United States 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. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

The successful hearing aid user. [2000]

3. Germany pubmed.ncbi.nlm.nih.gov

[Differential indication of active middle ear implants]. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Benefits from, Satisfaction with, and Self-Efficacy for Advanced Digital Hearing Aids in Users with Mild Sensorineural Hearing Loss. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

Comparing the performance of the Widex SENSO digital hearing aid with analog hearing aids. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Motion Sensors in Automatic Steering of Hearing Aids. [2021]

7. England pubmed.ncbi.nlm.nih.gov

Evaluating the benefit of hearing aids with motion-based beamformer adaptation in a real-world setup. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Evaluation of a fall detector based on accelerometers: a pilot study. [2019]

9. Germany pubmed.ncbi.nlm.nih.gov

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

10. England pubmed.ncbi.nlm.nih.gov

Influence of maximum power output on speech understanding with bone anchored hearing systems. [2020]