Smart Hearing Aids for Fall Risk and Speech Clarity
Palo Alto (17 mi)Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: N/A
Recruiting
Sponsor: Stanford University
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.
What safety data exists for smart hearing aids with motion sensing and fall detection?The safety data for smart hearing aids with motion sensing and fall detection includes studies showing the feasibility and accuracy of these devices. The Starkey Livio AI hearing aids have been found to accurately track steps and detect falls, demonstrating consistency and sensitivity in real-world conditions. Additionally, a pilot study on fall detectors integrated into hearing aids showed high sensitivity and specificity in distinguishing falls from daily activities, indicating reliable fall detection capabilities.13789
Are smart hearing aids with motion sensors a promising treatment for better hearing and fall prevention?Yes, smart hearing aids with motion sensors are promising because they can adjust to different listening environments by detecting movement, which helps improve hearing clarity and potentially prevent falls.468910
Do I have to stop taking my current medications for this trial?The trial protocol does not specify whether you need to stop taking your current medications.
What data supports the idea that Smart Hearing Aids for Fall Risk and Speech Clarity is an effective treatment?The available research shows that Smart Hearing Aids, like the Starkey Livio, are effective in detecting falls and tracking steps accurately. In a study, these hearing aids recorded steps more accurately than other devices and successfully detected most fall maneuvers. This suggests they are reliable for fall risk management. However, the research suggests more studies with larger groups are needed to confirm these findings.12457
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.Treatment Details
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.
2Treatment groups
Experimental Treatment
Group I: Speech intelligibilityExperimental Treatment1 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 assessmentExperimental Treatment1 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
Find a clinic near you
Research locations nearbySelect from list below to view details:
Stanford Ear InstitutePalo Alto, CA
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Who is running the clinical trial?
Stanford UniversityLead Sponsor
Starkey Laboratories, IncIndustry Sponsor
References
The successful hearing aid user. [2000]Improvements and modifications in design, construction, evaluation, and application procedures with the wearable hearing aid have brought the benefits of successful hearing aid use to an ever increasing proportion of the hearing impaired population. Many of today's successful hearing aid users would have been regarded at one time as extremely poor risks for hearing aid use. As a consequence, many of the prognostic principles developed as guidelines in advising for or against hearing aid trial are no longer true and should be discarded. Every person who experiences difficulties related to a permanent hearing impairment, no matter how slight or severe hearing loss, should have access to aural rehabilitation, including the use of wearable amplication.
Comparing the performance of the Widex SENSO digital hearing aid with analog hearing aids. [2022]Differences in performance were evaluated between the Widex SENSO and several analog hearing aids currently worn by 50 hearing-impaired subjects. Subjects were initially fit with the SENSO using the manufacturer's recommended procedure. After wearing the hearing aids for 1 week, the adjustable parameters were fine-tuned based on subjective comments. Differences in performance between the SENSO and the subjects' current hearing aids were assessed using the Speech Perception in Noise administered at overall levels of 50, 65, and 80 dB SPL; the Hearing in Noise Test in which the background noise was presented at 50, 65, and 80 dBA; the Abbreviated Profile of Hearing Aid Benefit; and two questionnaires relating to overall preference between the SENSO and the subjects' current hearing aids.
Evaluation of a fall detector based on accelerometers: a pilot study. [2019]As falls and fall-related injuries remain a major challenge in the public health domain, reliable and immediate detection of falls is important so that adequate medical support can be delivered. Available home alarm systems are placed on the hip, but have several shortcomings. A fall detector based on accelerometers and placed at head level was developed, as well as an algorithm able to distinguish between activities of daily living and simulated falls. Accelerometers were integrated into a hearing-aid housing, which was fixed behind the ear. The sensitivity of the fall detection was assessed by investigation into the acceleration patterns of the head of a young volunteer during intentional falls. The specificity was assessed by investigation into activities of daily living of the same volunteer. In addition, a healthy elderly woman (83 years) wore the sensor during the day. Three trigger thresholds were identified so that a fall could be recognised: the sum-vector of acceleration in the xy-plane higher than 2 g; the sum-vector of velocity of all spatial components right before the impact higher than 0.7 m s(-1); and the sum-vector of acceleration of all spatial components higher than 6 g. The algorithm was able to discriminate activities of daily living from intentional falls. Thus high sensitivity and specificity of the algorithm could be demonstrated that was better than in other fall detectors worn at the hip or wrist at the same stage of development.
[Differential indication of active middle ear implants]. [2018]Hearing aids (HA) provide adequate support for many patients with hearing loss, but not all. Around one third of 10.000 patients provided with hearing aids in the Abbreviated Profile of Hearing Aid Benefit felt no actual benefit when using the hearing aid, although they demonstrated the necessary hearing improvement on speech audiometry. Epidemiological data show bad compliance, especially in older people. Only one in three hearing aid owners wears their device regularly. For this subpopulation of patients active middle ear implants (AMEIs) have been used since 1998. In the present review, the current indications for AMEIs are presented.
Benefits from, Satisfaction with, and Self-Efficacy for Advanced Digital Hearing Aids in Users with Mild Sensorineural Hearing Loss. [2020]Little evidence is available regarding outcomes of advanced digital technology (ADT) hearing aid wearers with mild sensorineural hearing loss (MSNHL). The purpose of this article is to report the characteristics of and outcomes for this population. A cross-sectional research design was employed with 56 participants from a private practice setting. The International Outcomes Inventory for Hearing Aids (IOI-HA), Satisfaction with Amplification in Daily Life (SADL), and the Measure of Audiologic Rehabilitation Self-Efficacy for Hearing Aids (MARS-HA) were completed, scored, and compared with normative data. Results revealed that ADT aids were worn 10.5 hours/day, were mostly advanced to premium (55%), had an average cost per aid of $2,138 (SD = $840), and provided significant benefit (IOI-HA overall score: mean = 4.1; SD = 0.6) and satisfaction (SADL global score: mean = 5.4; SD = 0.8) to users who had good overall self-efficacy (MARS-HA composite score: mean = 81.7; SD = 12.8). Patients were most dissatisfied with and had the least self-efficacy for managing background noise and advanced handling of their devices. ADT hearing aid users with MSNHL achieved excellent outcomes, but ongoing follow-up and counseling from hearing health care providers may be important for successful management of background noise and mastery of advanced handling skills.
Influence of maximum power output on speech understanding with bone anchored hearing systems. [2020]Background: Maximum power output (MPO) levels of bone anchored hearing systems (BAHS) vary between different devices, but are significantly lower than those of conventional hearing aids, potentially limiting speech understanding.Aims/objectives: To investigate, how MPO influences speech understanding in quiet and in noise in BAHS users.Materials and methods: 12 adult BAHS users with a bilateral conductive hearing loss and additional sensorineural hearing components between 4 and 45 dB (500-4000 Hz) participated in the study. Speech understanding was measured at 65 dB in quiet and in noise with 4 different MPO level settings, covering the approximate range of MPOs found in currently available BAHS devices.Results: Speech understanding in quiet and in noise decreased with increasing sensorineural hearing loss. MPOs levels did not influence speech understanding in quiet significantly. In contrast, speech understanding in noise was better with higher MPOs (average improvement in signal-to-noise ratio +3.2 dB, p < .001), but only if the sensorineural hearing loss component was above approximately 35 dB.Conclusions and significance: At normal conversational levels, higher MPOs have little or no influence on speech understanding in quiet with BAHS. However, they can improve speech understanding in noise for users with additional sensorineural hearing loss.
Evaluating the Accuracy of Step Tracking and Fall Detection in the Starkey Livio Artificial Intelligence Hearing Aids: A Pilot Study. [2021]Purpose The primary purpose of this study was to examine the efficacy and the effectiveness of Starkey Livio Artificial Intelligence hearing aids in tracking step count. A secondary purpose was to investigate the accuracy of the fall detection and alert system of Livio hearing aids in detecting fall maneuvers. Method A participant wore Binaural Starkey Livio receiver-in-the-canal style hearing aids, a Sportline pedometer, and a Fitbit Charge 3 concurrently during both real-world and treadmill walking conditions. The real-world condition was conducted over a 5-day period. Step count for the treadmill protocol was assessed at six different treadmill speeds (2 mph, 2.5 mph, 3 mph, 3.5 mph, 4 mph, 4.5 mph, and 5 mph). The fall detection and alert system were assessed through falling maneuvers of activities of daily living. Results In the real-world condition, Livio, Sportline, and Fitbit recorded steps within 1 SD of each other. In addition, Livio recorded the most accurate steps compared to actual physical steps taken. In the treadmill condition, Livio recorded the least number of steps across all walking paces compared to the rest of the devices. Also, Livio hearing aids detected majority of the engaged falling maneuvers. Conclusions The Livio was found to be feasible, consistent, and sensitive in detecting steps and falls. Further research of higher sample size and recruitment of individuals with hearing loss are suggested.
Evaluating the benefit of hearing aids with motion-based beamformer adaptation in a real-world setup. [2022]Conventional directional hearing aid microphone technology may obstruct listening intentions when the talker and listener walk side by side. The purpose of the current study was to evaluate hearing aids that use a motion sensor to address listening needs during walking.
Motion Sensors in Automatic Steering of Hearing Aids. [2021]A requirement for modern hearing aids is to evaluate a listening environment for the user and automatically apply appropriate gain and feature settings for optimal hearing in that listening environment. This has been predominantly achieved by the hearing aids' acoustic sensors, which measure acoustic characteristics such as the amplitude and modulation of the incoming sound sources. However, acoustic information alone is not always sufficient for providing a clear indication of the soundscape and user's listening needs. User activity such as being stationary or being in motion can drastically change these listening needs. Recently, hearing aids have begun utilizing integrated motion sensors to provide further information to the hearing aid's decision-making process when determining the listening environment. Specifically, accelerometer technology has proven to be an appropriate solution for motion sensor integration in hearing aids. Recent investigations have shown benefits with integrated motion sensors for both laboratory and real-world ecological momentary assessment measurements. The combination of acoustic and motion sensors provides the hearing aids with data to better optimize the hearing aid features in anticipation of the hearing aid user's listening needs.
[(Air-conduction) Hearing aids-indication, designs and applications : Signal processing and importance of individual fitting]. [2022]Many people in Germany and worldwide suffer from a reduced communication ability due to impaired hearing. Especially older people are affected. Hearing aids, which pick up ambient sounds, process them, and output airborne sound in the ear canal, can help in most cases. These so-called air-conduction hearing aids are commonly used to compensate for hearing loss and are described in more detail in this article. To this end, indications, differences to other hearing aids and implants, various designs, the importance of individual ear coupling, features of the signal processing, and the importance of the individual hearing aid fitting are explained in detail.