Sound Exposure Monitoring for Hearing Loss

(AHS Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Richard L 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. ^{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 7 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

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)

Treatment Details

Interventions

• Apple Hearing Study (N/A)

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.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

University of Michigan School of Public Health Ann Arbor, MI

Who Is Running the Clinical Trial?

Apple Inc.

Lead Sponsor

Trials

24

Patients Recruited

1,792,000+

World Health Organization

Collaborator

Trials

236

Patients Recruited

1,620,000+

Findings from Research

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]

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]

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]

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]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

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]

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]

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]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

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]

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

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

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

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

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]