Sound Exposure Monitoring for Hearing Loss

(AHS Trial)

Overseen By Call Center Research Studies Support Center

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Apple Inc.

Disqualifiers: Shared iCloud, Shared iPhone, others

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

Compensation: Varies

Number of Visits: 2

300000 Participants Needed

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. ^{1 2 3 4 5}

Is 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. ^{1 6 7 8 9}

How 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. ^{1 6 10 11 12}

Research Team

Richard L Neitzel, PhD, MS, CIH

Principal Investigator

University of Michigan

Lauren M Smith, MS, MPH

Principal Investigator

University of Michigan

Joyce M Daniels, MA

Principal Investigator

University of Michigan

Eligibility 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

Exclusion Criteria

No additional exclusion criteria

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)

Treatment Details

Interventions

• Apple Hearing Study

Trial Overview 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.

Participant Groups

Group I: Basic Active Control 1 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: Advanced Active Control 1 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.

Who Is Running the Clinical Trial?

Apple Inc.

Lead Sponsor

Trials

24

Recruited

1,792,000+

World Health Organization

Collaborator

Trials

236

Recruited

1,620,000+

Findings from Research

The Apple Hearing Study has collected extensive data from nearly 300 million hours of sound measurements and 200,000 hearing assessments, highlighting the feasibility of gathering health data outside traditional research settings.

Preliminary results show that environmental sound levels are generally higher than headphone audio levels, with about 10% of participants diagnosed with hearing loss and nearly 20% experiencing hearing difficulties, indicating significant public health concerns related to noise exposure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Toward a better understanding of nonoccupational sound exposures and associated health impacts: Methods of the Apple Hearing Study. Neitzel, RL., Smith, L., Wang, L., et al.[2022]

A significant portion of older adults (77% or 6.3 million) with high-frequency hearing loss do not recognize their impairment, highlighting a gap in awareness and self-reporting of hearing issues.

Regular screening for hearing loss is recommended to improve early detection and intervention, especially for individuals with mild or unilateral hearing loss who may not expect to have hearing problems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Unperceived hearing loss among Canadians aged 40 to 79. Ramage-Morin, PL., Banks, R., Pineault, D., et al.[2020]

The NIH Toolbox® Hearing Threshold Test (HTT) is a validated tablet-based hearing assessment that can accurately estimate hearing sensitivity in both children and adults, showing a strong correlation with traditional clinical assessments (r = .83-.93).

The HTT meets clinical reliability standards, making it a practical alternative for evaluating hearing acuity without the need for professional audiologists or specialized equipment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Validation of a tablet-based assessment of auditory sensitivity for researchers. Wiseman, K., Slotkin, J., Spratford, M., et al.[2023]

The AMTASTM PC-based audiometry and a low-cost smartphone audiometry app (R-App) demonstrated accuracy comparable to traditional manual audiometry, with mean threshold differences within ±1.5 dB for AMTASTM and ±1 dB for the R-App across tested frequencies (250-8000 Hz).

Both user-operated methods showed good test-retest reliability, with acceptable variations in results, indicating they can be effectively used in non-soundproofed environments for hearing assessments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

AMTASTM and user-operated smartphone research application audiometry-An evaluation study. Sørensen, CB., Adams, TB., Pedersen, ER., et al.[2023]

The Sound Tolerance Questionnaire (STQ) is a new 36-item tool designed to assess sound tolerance issues in hearing aid users, which can impact their adaptation and quality of life.

A refined version, the Sound Tolerance Interview and Questionnaire Instrument (STIQI), aims to identify factors contributing to loudness complaints and may help predict hearing aid benefit for users experiencing sound intolerance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Considerations in the Development of a Sound Tolerance Interview and Questionnaire Instrument. Sherlock, LP., Formby, C.[2020]

iOS smartphones and smart devices can potentially be used to reliably measure occupational noise exposure when paired with specific external microphones and measurement applications, as shown in a controlled experiment comparing results to a standard Type 1 sound level measurement system.

The study highlights the need for further research to validate the effectiveness of these devices in real-world settings, as many workers are at risk for noise-induced hearing loss and current evaluations of noise exposure in various occupations are lacking.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving the accuracy of smart devices to measure noise exposure. Roberts, B., Kardous, C., Neitzel, R.[2018]

In a study of industrial workers with a history of hearing loss, daily noise exposure measurements showed no significant relationship with high-frequency hearing loss when noise levels were below 85 dBA, suggesting that lower noise levels may not contribute to further hearing deterioration.

The findings indicate that maintaining noise levels below 85 dBA could potentially reduce the risk of occupational hearing loss in workers who already have substantial past exposure, highlighting the need for ongoing research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The dose-response relationship between in-ear occupational noise exposure and hearing loss. Rabinowitz, PM., Galusha, D., Dixon-Ernst, C., et al.[2021]

The dbTrack sound-level monitoring earphones were found to be highly accurate and reliable, measuring sound levels within 1 dB of professional sound level meters, making them effective for monitoring personal audio exposure.

Using the dbTrack earphones with smartphone feedback for just 4 weeks led to significant reductions in average daily sound intensity (by 8.7 dB), listening duration (by 7.6 minutes), and sound dose (by 4128.4%), suggesting they can effectively promote safer listening habits among young adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sound-level Monitoring Earphones With Smartphone Feedback as an Intervention to Promote Healthy Listening Behaviors in Young Adults. Knoetze, M., Mahomed-Asmail, F., Manchaiah, V., et al.[2022]

A study of 86 high-school students found that those exposed to amplified music had significantly reduced function in their outer hair cells, particularly starting at 8 kHz.

Exposed students were 9.33 times more likely to show alterations in their outer hair cells compared to those who were not exposed, indicating a strong association between amplified music exposure and potential hearing damage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Amplified music exposure carries risks to hearing. da Silva, VG., de Oliveira, CA., Tauil, PL., et al.[2018]

The study investigates the potential decline in hearing sensitivity associated with hearing aid use, focusing on integrated temporary threshold shift (ITTS) as a new measure to assess this risk.

It provides equations to predict permanent threshold shift (PTS) from noise exposure and recommends specific gain settings for hearing aids to help protect users' hearing over time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tutorial on the potential deterioration in hearing due to hearing aid usage. Humes, LE., Bess, FH.[2019]

The smartphone-based hearTest demonstrated high sensitivity (93.8%) and specificity (83.9%) for identifying hearing loss in a study of 232 workers exposed to noise, making it a reliable screening tool.

While the hearTest is effective for detecting hearing loss, it should be used as a supplementary tool rather than a replacement for conventional audiometry, especially for more comprehensive assessments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Validity of hearTest Smartphone-Based Audiometry for Hearing Screening in Workers Exposed to Noise. Rodrigues, LC., Ferrite, S., Corona, AP.[2021]

A study involving 34 college students over 4 weeks found that their average preferred listening level on portable listening devices was 68-70 dB SPL, which is generally safe and not high enough to cause immediate hearing loss.

However, there was significant individual variation in listening levels and usage times, with up to 56.72% of participants exceeding recommended noise exposure criteria, highlighting the need for standardized guidelines for safe listening practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Analysis of the Actual One-Month Usage of Portable Listening Devices in College Students. Kim, G., Shin, J., Song, C., et al.[2021]

References

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

Toward a better understanding of nonoccupational sound exposures and associated health impacts: Methods of the Apple Hearing Study. [2022]

2. Canada pubmed.ncbi.nlm.nih.gov

Unperceived hearing loss among Canadians aged 40 to 79. [2020]

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

Validation of a tablet-based assessment of auditory sensitivity for researchers. [2023]

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

AMTASTM and user-operated smartphone research application audiometry-An evaluation study. [2023]

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

Considerations in the Development of a Sound Tolerance Interview and Questionnaire Instrument. [2020]

6. England pubmed.ncbi.nlm.nih.gov

Improving the accuracy of smart devices to measure noise exposure. [2018]

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

The dose-response relationship between in-ear occupational noise exposure and hearing loss. [2021]

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

Sound-level Monitoring Earphones With Smartphone Feedback as an Intervention to Promote Healthy Listening Behaviors in Young Adults. [2022]

9. Ireland pubmed.ncbi.nlm.nih.gov

Amplified music exposure carries risks to hearing. [2018]

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

Tutorial on the potential deterioration in hearing due to hearing aid usage. [2019]

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

Validity of hearTest Smartphone-Based Audiometry for Hearing Screening in Workers Exposed to Noise. [2021]

12. Switzerland pubmed.ncbi.nlm.nih.gov

Analysis of the Actual One-Month Usage of Portable Listening Devices in College Students. [2021]