Sound Exposure Monitoring for Hearing Loss
(AHS Trial)
Recruiting in Palo Alto (17 mi)
Overseen byRichard Neitzel, PhD, MS, CIH
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Apple Inc.
Disqualifiers: Shared iCloud, Shared iPhone, others
No Placebo Group
Trial Summary
What is the purpose of this trial?The Apple Hearing Study is a partnership between the University of Michigan and Apple to study sound exposure and its impact on hearing health. This groundbreaking study will advance the understanding of how hearing could be impacted over time by exposure to sound at certain levels. The investigators will measure headphone and environmental sound exposures over time among participants, and determine how these exposures impact hearing and stress levels. US residents who own an iPhone, download the Apple Research app and consent to participate will be randomly assigned to two groups, one with a "Basic" user interface in the Research app, and one with an "Advanced" user interface. Users in the "Advanced" group will receive additional information about their exposures and be given additional surveys and hearing tests based on their music and environmental sound exposures. The study will provide investigators with a better understanding of listening behavior and its overall impact on hearing health. This information will in turn help guide public health policy and prevention programs designed to protect and promote hearing health in the US and globally.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications.
What data supports the effectiveness of the treatment Apple Hearing Study for hearing loss?
The Apple Hearing Study collects extensive data on sound exposure and hearing assessments, which helps understand the impact of environmental and headphone sound levels on hearing health. This approach demonstrates the feasibility of gathering clinically relevant data outside traditional settings, potentially aiding in the development of effective hearing loss interventions.
12345Is sound exposure monitoring safe for humans?
The Apple Hearing Study, which monitors sound exposure using the Apple Watch and other devices, has collected extensive data on sound levels and hearing health, suggesting that the method is safe for participants. The study focuses on understanding sound exposure and its health impacts, indicating that the monitoring process itself does not pose safety concerns.
16789How does the Sound Exposure Monitoring treatment for hearing loss differ from other treatments?
The Sound Exposure Monitoring treatment is unique because it focuses on understanding and managing nonoccupational sound exposures using smart devices like the Apple Watch to measure environmental sound levels. This approach is different from traditional treatments that often focus on occupational noise exposure or use hearing aids, as it aims to prevent hearing loss by monitoring and adjusting everyday sound exposure.
17101112Eligibility Criteria
The Apple Hearing Study is open to US residents who are at least 18 years old (with some state-specific age variations), own an iPhone with iOS 13.2 or later, and can communicate in English. Participants should also have the option of owning an Apple Watch Series 4 or newer for additional data collection.Inclusion Criteria
I am at least 18 years old, or meet the age requirement for my location.
Possession of iPhone with iOS version 13.2 or later used to complete screening eligibility
Optional: Possession of Apple Watch paired with iPhone; Apple Watch Series 4 or later required to share environmental sound levels
+2 more
Exclusion Criteria
No additional exclusion criteria
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Baseline Assessment
Participants complete baseline surveys and initial hearing assessments, including Pure Tone Audiometry and Speech in Noise tests
4 weeks
1 visit (virtual)
Monitoring
Participants' headphone and environmental sound exposures are monitored over time using the Apple Research app, with periodic surveys and hearing tests
10 years
Continuous monitoring with periodic virtual assessments
Follow-up
Participants are monitored for changes in hearing health and related health conditions, with final assessments conducted
4 weeks
1 visit (virtual)
Participant Groups
Participants will use a special Research app on their iPhones to track sound exposure from headphones and the environment. They'll be split into two groups: one using a 'Basic' interface, and another using an 'Advanced' interface that provides more detailed feedback and requires extra surveys and hearing tests.
2Treatment groups
Active Control
Group I: BasicActive Control1 Intervention
Participants in the first ("Basic") group will have the iOS version 13.2 or later shipping user interface (UI) that provides ability to review exposure level data for headphone audio levels and environmental sound levels in the Health app.
Group II: AdvancedActive Control1 Intervention
Participants in the second ("Advanced") group will have a UI that includes notifications prompting personal data pattern review in the Health app and then prompting to do an abbreviated Pure Tone Audiometry module completed 0-24 hours after loud headphone audio level exposure (equivalent continuous average noise level, or LEQ, to \>97 A-weighted decibels, or dBA for \>30 minutes) to evaluate for a temporary threshold shift from baseline.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of Michigan School of Public HealthAnn Arbor, MI
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Who Is Running the Clinical Trial?
Apple Inc.Lead Sponsor
World Health OrganizationCollaborator
References
Toward a better understanding of nonoccupational sound exposures and associated health impacts: Methods of the Apple Hearing Study. [2022]Globally, noise exposure from occupational and nonoccupational sources is common, and, as a result, noise-induced hearing loss affects tens of millions of people. Occupational noise exposures have been studied and regulated for decades, but nonoccupational sound exposures are not well understood. The nationwide Apple Hearing Study, launched using the Apple research app in November 2019 (Apple Inc., Cupertino, CA), is characterizing the levels at which participants listen to headphone audio content, as well as their listening habits. This paper describes the methods of the study, which collects data from several types of hearing tests and uses the Apple Watch noise app to measure environmental sound levels and cardiovascular metrics. Participants, all of whom have consented to participate and share their data, have already contributed nearly 300 × 106 h of sound measurements and 200 000 hearing assessments. The preliminary results indicate that environmental sound levels have been higher, on average, than headphone audio, about 10% of the participants have a diagnosed hearing loss, and nearly 20% of the participants have hearing difficulty. The study's analyses will promote understanding of the overall exposures to sound and associated impacts on hearing and cardiovascular health. This study also demonstrates the feasibility of collecting clinically relevant exposure and health data outside of traditional research settings.
Unperceived hearing loss among Canadians aged 40 to 79. [2020]People with audiometrically measured hearing loss do not always self-report a hearing impairment.
Validation of a tablet-based assessment of auditory sensitivity for researchers. [2023]Quantifying hearing acuity is increasingly important across a wide range of research areas in the behavioral and neurosciences. Scientists have relied on either self-reported hearing status or the availability of diagnostic hearing assessment in past studies. There remains a need for a valid and reliable assessment of auditory sensitivity that can provide estimates of the magnitude of hearing loss, if present, without requirements for professional audiologists, facilities, and equipment that are needed to conduct a diagnostic hearing assessment. The goal of this experiment was to validate the NIH Toolbox® Hearing Threshold Test (HTT), a tablet-based hearing assessment available via iPad application that uses consumer-grade headphones, on a clinical sample of children and adults with varying degrees of hearing acuity. Electroacoustic analysis of the hearing assessment application and headphones demonstrated acoustic outputs within established conformity standards for hearing assessment. Twenty-seven children and 63 adults participated in a standard diagnostic hearing assessment and the experimental tablet-based assessment. The results showed that thresholds from the tablet-based assessment were highly correlated with thresholds from the clinical hearing assessment (r = .83-.93) for children and adults for all frequencies and across a range of levels of hearing acuity. The HTT also met clinical test-retest reliability standards (Cronbach's α > .86). The tablet-based hearing assessment provides acceptable estimates of hearing levels for children and adults when diagnostic audiometric assessment capabilities are not available.
AMTASTM and user-operated smartphone research application audiometry-An evaluation study. [2023]To evaluate two user-operated audiometry methods, the AMTASTM PC-based audiometry and a low-cost smartphone audiometry research application (R-App).
Considerations in the Development of a Sound Tolerance Interview and Questionnaire Instrument. [2020]Most clinicians approach the objective fitting of hearing aids with three goals in mind: audibility, comfort, and tolerance. When these three amplification goals have been met, the hearing aid user is more likely to adapt to and perceive benefit from hearing aid use. However, problems related to the loudness of sounds and reduced sound tolerance, which may or may not be reported by the aided user, can adversely impact adaptation to amplification and the individual's quality of life. Although there are several standardized questionnaires available to evaluate hearing aid benefit and satisfaction, there is no standardized questionnaire or interview tool for evaluating reduced sound tolerance and the related impact on hearing aid use. We describe a 36-item tool, the Sound Tolerance Questionnaire (STQ), consisting of six sections, including experience with hearing aids, sound sensitivity/intolerance, medical and noise exposure histories, coexisting tinnitus problems, and a final question to differentiate the primary and secondary problems related to sound intolerance, tinnitus, and hearing loss. In its current format as a research tool, the STQ was sensitive in pinpointing vague sound tolerance complaints not reported by the study participants in eligibility screening by Formby et al. A refined version of the STQ, the Sound Tolerance Interview and Questionnaire Instrument (STIQI), structured as a two-part tool, is presented in the appendix for prospective clinical use. The STIQI has potential utility to delineate factors contributing to loudness complaints and/or reduced sound tolerance in individuals considering hearing aid use, as well as those who have been unsuccessful hearing aid users secondary to loudness complaints or sound intolerance. The STIQI, when validated and refined, also may hold promise for predicting hearing aid benefit and/or assessing treatment-related change over time of hearing aid use or interventions designed to remediate problems of loudness and/or sound intolerance among hearing aid candidates or users.
The dose-response relationship between in-ear occupational noise exposure and hearing loss. [2021]Current understanding of the dose-response relationship between occupational noise and hearing loss is based on cross-sectional studies prior to the widespread use of hearing protection, and with limited data regarding noise exposures below 85 dBA. We report on the hearing loss experience of a unique cohort of industrial workers, with daily monitoring of noise inside of hearing protection devices.
Improving the accuracy of smart devices to measure noise exposure. [2018]Occupational noise exposure is one of the most frequent hazards present in the workplace; up to 22 million workers have potentially hazardous noise exposures in the U.S. As a result, noise-induced hearing loss is one of the most common occupational injuries in the U.S. Workers in manufacturing, construction, and the military are at the highest risk for hearing loss. Despite the large number of people exposed to high levels of noise at work, many occupations have not been adequately evaluated for noise exposure. The objective of this experiment was to investigate whether or not iOS smartphones and other smart devices (Apple iPhones and iPods) could be used as reliable instruments to measure noise exposures. For this experiment three different types of microphones were tested with a single model of iPod and three generations of iPhones: the internal microphones on the device, a low-end lapel microphone, and a high-end lapel microphone marketed as being compliant with the International Electrotechnical Commission's (IEC) standard for a Class 2-microphone. All possible combinations of microphones and noise measurement applications were tested in a controlled environment using several different levels of pink noise ranging from 60-100 dBA. Results were compared to simultaneous measurements made using a Type 1 sound level measurement system. Analysis of variance and Tukey's honest significant difference (HSD) test were used to determine if the results differed by microphone or noise measurement application. Levels measured with external microphones combined with certain noise measurement applications did not differ significantly from levels measured with the Type 1 sound measurement system. Results showed that it may be possible to use iOS smartphones and smart devices, with specific combinations of measurement applications and calibrated external microphones, to collect reliable, occupational noise exposure data under certain conditions and within the limitations of the device. Further research is needed to determine how these devices compare to traditional noise dosimeter under real-world conditions.
Sound-level Monitoring Earphones With Smartphone Feedback as an Intervention to Promote Healthy Listening Behaviors in Young Adults. [2022]More than a billion adolescents and youngsters are estimated to be at risk of acquiring recreational noise-induced hearing loss (RNIHL) due to the unsafe use of personal audio systems. RNIHL is preventable; therefore, the present study aimed to determine (i) the accuracy and reliability of dbTrack (Westone) sound-level monitoring earphones and (ii) the effect of sound-level monitoring earphones with smartphone feedback and hearing-health information as an intervention to promote healthy listening behaviors in young adults.
Amplified music exposure carries risks to hearing. [2018]To investigate the association between changes in the outer hair cells and exposure to amplified music in a group of high-school students.
Tutorial on the potential deterioration in hearing due to hearing aid usage. [2019]This manuscript examines the issue of potential decline in hearing sensitivity due to hearing aid usage through an analysis of data obtained from the temporary threshold shift (TTS) paradigm. Following a critique of the traditional measures of TTS, the concept of integrated TTS (ITTS) is reviewed and data on hearing-aid-induced ITTS are presented. In addition, a series of equations relating permanent threshold shift (PTS) to a recently developed measure of noise dose (Dn) is derived and predictions for hearing-aid-induced PTS are made. Recommended gain settings established to protect the hearing of a person wearing a hearing aid from further decline following various durations of hearing aid usage are also provided.
Validity of hearTest Smartphone-Based Audiometry for Hearing Screening in Workers Exposed to Noise. [2021]This article investigates the validity of a smartphone-based audiometry for hearing screening to identify hearing loss in workers exposed to noise.
Analysis of the Actual One-Month Usage of Portable Listening Devices in College Students. [2021]Although contemporary researchers are concerned about overexposure of portable listening devices (PLD) for adolescents and young adults who often prefer listening to music at high levels for a long time, many of these studies have focused on either comparing sound pressure levels of various kinds of earphones or evaluating the recognition of noise-included hearing loss and listening habits through surveys. Further still, current criteria were developed for occupational noise-induced hearing loss, so there are only a few published guidelines for hearing insults due to recreational noise exposure. The present study, therefore, measures actual listening levels and PLD time in college students using a real-time measurement system and applying that gathered scientific data to the internationally recommended noise exposure standards. Thirty-four college students were asked to listen to music similar to their daily lifestyles for 4-weeks. After installing the application, the Google account that linked to the user's mobile phone was logged into the server communication. When a subject listened to music, the average and maximum listening levels and listening time could then be recognized as his or her Google account ID and stored in the database for analysis. User data was measured at 1-s intervals and delivered to the main server system every 5 s. The data were analyzed as LZeq for mean levels and LCpeak for maximum levels, and also for PLD use time. The mean of the preferred listening level was 68-70 dB SPL for 4 weeks with long enough break times. That is, the listening levels of college students were not high enough to induce instant hearing loss when they used PLD. However, there was a large individual difference in the listening levels and use times. When applied to three recommended noise exposure criteria, the number of exceeded subjects also differed from 0 to 56.72% depending on the criterion. We thus suggest that appropriate and standardized criteria for music-induced hearing loss might be proposed for recreational PLD users.