Frequently Asked Questions

 

 

General

What is the Apple Hearing Study? 
The Apple Hearing Study is a first of its kind research study to collect sound exposure data over time and advance the understanding of how sound levels can impact your hearing.

Why is this study being done and why should I participate? 
Your hearing could be impacted over time by exposure to certain sound levels. This study aims to collect headphone and environmental sound exposure data over time, and determine how it impacts your hearing health, stress levels and cardiovascular health. This will ultimately help develop new products to optimize your hearing experience and reduce the likelihood of hearing loss.

How does this study work? 
You can participate in this study with your iPhone and the Apple Research app. The study will ask you to:

  • Provide your consent to collect data from your iPhone and Apple Watch (if applicable), such as your Health app data, sound exposure data, and other Apple Research app related data.
  • Complete occasional, short surveys about your demographic, medical history, and headphone and environmental sound exposure.
  • Complete a pure-tone hearing test task and a second listening test within the Apple Research app.

Who is the sponsor of this study?
Apple.

Who are the Principal Investigators of this study?
Dr. Richard Neitzel at the University of Michigan is the principal investigator of this study. Under Dr. Neitzel’s direction, researchers in the Department of Environmental Health Sciences at the University of Michigan will analyze the study data to understand how sound levels may impact your hearing health, stress levels and cardiovascular health.

Who are the research collaborators of this study?
Apple is collaborating with the University of Michigan to conduct this study. Certain study data will also be shared with researchers at the World Health Organization (WHO) to advance its Make Listening Safe initiative, including development of hearing health policies.

How long will this study last?
This study is expected to last at least two years. We will ask you to renew your consent to continue in the study every two years. You can withdraw from the study at any time.

What is the last day I can join this study?
You are welcome to join this study any time, as long as you meet the participation requirements.

Will I be able to see the results of this study?
As study findings are published (for example, in a scientific journal), they will be posted on ClinicalTrials.gov. Note that your name and other directly identifying information will not be used in any study results.

Participation Requirements

Who can participate in this study?
Anyone who meets all of the participation requirements may participate:

  • You are at least 18 years old (at least19 years old in Alabama and Nebraska, at least 21 years old in Puerto Rico)
  • You live in the United States of America
  • You are comfortable communicating in written and spoken English
  • You have an iPhone 6s or later running iOS 13.2 or later, and you have installed the Apple Research app on the phone. If you wish to participate using your Apple Watch 4 or later, the Watch will need to be running the latest version of watchOS.
  • You do not share your iCloud account or iPhone with anyone else
  • You are willing and able to provide informed consent to participate in the study

I wear a cochlear, middle ear, or direct bone conduction implant, can I participate?
Yes, this information will be captured as part of your medical history profile when you answer the survey questions. You will be able to complete the study surveys, and to contribute noise levels measured by your Apple Watch (if you have one). We will not be able to evaluate your exposure to sounds from music, games, and other media that you stream to your cochlear implant, and you will not be able to complete the tone exercise task.

I have hearing aids connected to my iPhone by Bluetooth.  Can I participate? 
Yes, you can participate. You will be able to complete the study surveys and tone exercise task, and to contribute noise levels measured by your Apple Watch (if you have one). You can also take the tone exercise if you remove your hearing aids and use your AirPods/EarPods. We will not be able to evaluate your exposure to sounds from music, games, and other media that you stream to your hearing aids.

Is this study available in languages other than English?
The study is currently only available in English.

Can I use a friend or family member’s iPhone to participate?
No, you can only use your own iPhone with your own iCloud account. This is to ensure data integrity.

What headphones are required to participate in the study?
Any headphones can be used to measure your sound levels in the study. The tone exercise task requires the use of Apple AirPods or EarPods (which you received when you purchased your iPhone), but if you do not have AirPods and EarPods you can still participate in all other aspects of the study.

Do I need an Apple Watch to participate in this study?
No, an Apple Watch is not required to participate in this study.

Can I enroll if I am already participating in another research study?
Yes.

Procedures

How do I enroll in this study?
You will need to download the Apple Research app from the App Store and install it on your iPhone. In the Research app, you’ll find the studies you can enroll in. You will need to select the Apple Hearing Study and go through the introduction and consent process.

What will I be expected to do if I participate?
You will be asked to provide your permission to collect your headphone and environment (if applicable) sound exposure data. You will control exactly what data you share. Every six months, you will be asked to complete a short survey regarding your hearing health. Apple Watch is not required for this study, but if you own an Apple Watch, wear it as much as possible to enhance your contribution to the study.

Are AirPods or EarPods required to participate in this study?
No. You do not need AirPods or EarPods (which you received when you purchased your iPhone) to measure your sound levels as part of this study. The tone exercise task of the study can only be completed with Apple AirPods or Earpods, but if you do not have AirPods or Earpods you can still participate in all other aspects of the study.

Why are AirPods or EarPods required for the Tone Exercise and other listening tasks?
The tone exercise task is the only task in the study that requires use of AirPods or EarPods as these devices are calibrated to perform the test. If you do not have AirPods or EarPods, you can end the task by pressing cancel and exiting the task.

I notice on the baseline survey you ask about hours spent using headphones.  Does this include time spent using headphones to talk on the phone, or only headphones used to listen to music, games, and other media? 
We are only interested in your use of headphones for things other than talking on the telephone. Your use of the telephone is not monitored in any way as part of this study.

I just enrolled and completed the study onboarding process and initial survey, but I don’t have any current tasks in the Research App.  Is that normal? 
After you complete the onboarding process and the initial survey, your next scheduled task will not become available for 3 months. If you have an Apple Watch, it is possible that you may be prompted to complete a triggered task before 3 months based on your environmental sound level. It is also possible that you may be prompted to complete a triggered task before 3 months based on your headphone audio levels.

What is the Noise app on my Apple Watch?
With the Noise app on Apple Watch Series 4 or later, you can enable Noise notifications to alert you when your Apple Watch identifies sound levels in your environment that could affect your hearing. Visit the support page to learn more about Noise notifications on your Apple Watch.

What happens if I start wearing a cochlear, middle ear, or direct bone conduction implant during the study?
The Apple Hearing study will have annual surveys questions that will capture any changes to your hearing.

What happens if I have health issues while participating in the study?
Participation in this study is not a substitute for medical care or medical advice you get from your doctor or other health care provider. You should continue to see your regular doctor and keep any scheduled physical exams, screening procedures, and medical appointments. Always seek professional medical advice whenever you need it.

Do I have to sign an informed consent form?
You do not have to sign an informed consent form, but if you do not sign, you will not be able to participate in the study. The informed consent form will be available for you to read and sign in the Apple Research app. If you choose to join the study, a copy of your signed informed consent form will be made available to you in the Apple Research app as well.

What happens if I change my mind about being in this study?
You can stop participating in the study at any time by opening the Apple Research app, tapping on the Studies tab, and then selecting the Apple Hearing Study. “Withdraw from this study” appears at the bottom. If you withdraw, we will not delete study data that we have already collected about you, but we will stop collecting any new information about you and will turn off further notifications. If you delete the Apple Research app, you will not be withdrawn from the study. 

Participation

Will participation in this study cost me anything?
There is no direct cost to you for participating in the study. There may be an indirect cost because the data collected as part of the study and transmitted to the study team will count against your phone’s data plan. Additionally, standard phone usage and text messaging rates may apply if you communicate with study staff via phone or text message. This study does not provide medical care, and the sponsor is not financially responsible for any treatment you seek from your own health care provider.

Do I get compensated for my time involved in this study?
No, you will not be compensated for taking part in this study.

What is the commercial gain associated with this study?
Study data may be used for health-related product development and improvement. The sponsor has no plans to offer you financial compensation or share any profits from the commercialization of any products, technologies, processes, or services developed using the study data. You will not, however, lose any legal rights to which you are entitled by agreeing to participate in this study.

Privacy

What data will be collected?
With your permission, the study may collect or access data such as your demographic information, Health app information, sensor and usage data from your iPhone and Apple Watch (if applicable), and survey responses. You control what data you share and can stop sharing data with the study at any time. Please refer to “What data will be collected?” in the informed consent form for more information on the specific data types that may be collected.

How will my data be protected?
Any information collected or accessed by the Research app is stored with encryption if you have a passcode on your iPhone. Information from the Research app will be shared with the study only after you have joined the study by signing the informed consent form, and authorized the study to collect or access information in the Research app. Your information will be encrypted when transferred to and stored on Apple’s servers.

Who will have access to my data?
Only certain authorized people and institutions will have access to the study data. These include Apple, the University of Michigan School of Public Health, the World Health Organization, and the Research Studies Support Center. Advarra Institutional Review Board and certain regulatory or government agencies may also have access to the study data. 

Most will only have access to Research app data with directly identifying information (such as your name, email address, and phone number) removed. However, if required for study-related purposes, Research app data that includes directly identifying information will be accessed by the principal investigators at the University of Michigan School of Public Health, and may be accessed by the Research Studies Support Center, Advarra Institutional Review Board, and certain regulatory or government agencies. Please refer to “Who will have access to my study data?” in the informed consent form for more information about who has access to the study data and what types of study data they may access.

Will Apple have access to any information that directly identifies me or know that I’m participating in a study?
Apple will not be able to access any information that directly identifies you (such as your name, email address, and phone number) that is collected through the Research app. However, if you call the Research Studies Support Center regarding a technical issue with the Research app, the Research Studies Support Center may ask you if you want to be transferred to AppleCare for additional support. With your consent, you may be transferred to help address your technical question(s), in which case Apple may have access to certain information that directly identifies you and may know that you are participating in a study.

Apple Research App

What is the Apple Research app?
The Apple Research app can be used to find available Apple research studies, understand the goals of the study, see the data it will collect, and enroll and participate in the studies by providing consent.

How do I install the Apple Research app?
You can install the Apple Research app by searching for it in the App Store on your iPhone. Apple Research app requires an iPhone 6s or later with iOS 13.2 or later.

How can I control the notifications from the Apple Research app?
Notifications from the Apple Research app can be controlled in your iPhone by going to: Settings > Notifications.

What happens if I upgrade or downgrade my iPhone?
Please ensure that you backup your iPhone information, and then restore from backup in order to prevent loss of any information. Visit the support page to learn more about how to backup your iPhone information. If you do not backup your iPhone information, and wish to continue to participate in the study, you will need to complete the onboarding and consent process for the study again. If you have iCloud Keychain enabled, your participant identifier may be preserved, allowing researchers to link your previously collected data with the new data after you re-join.

What happens if I delete the Apple Research app?
If you delete the Apple Research app, it will disable notifications and end all study data collection. Please note that deleting the Apple Research app will not withdraw you from the study. If you re-install the Apple Research app after deleting it and wish to continue participating in the study, you may complete the onboarding and consent process for the study again. If you have iCloud Keychain enabled, your participant identifier may be preserved, allowing researchers to link your previously collected data with the new data after you re-join.

Contact Information

Who can answer my questions about this study?
If you have questions about the study that are not covered by the FAQs or you think you have an injury or illness as a result of the study, please call the Research Studies Support Center at 833-237-3881 (a toll-free number staffed 24/7). The Research Studies Support Center is hosted by Apple’s third-party service provider and is staffed by employees of the service provider who are trained to handle study issues and certain technical issues related to the Research app. Please do not reach out to Apple directly with any questions about the study. If you experience a technical issue related to the Research app, the Research Studies Support Center may ask you if you want to be transferred to AppleCare for additional support.

Who should I contact for medical emergencies?
For medical emergencies, please call 911 or local emergency services.

What is an IRB? How can I contact it?
An institutional review board (IRB) is an independent research ethics committee established to help protect the rights of research participants. If you have any questions about your rights as a research participant, and/or concerns or complaints regarding this research study, contact:

  • By mail: Study Subject Adviser, Advarra IRB, 6940 Columbia Gateway Drive, Suite 110, Columbia, MD 21046
  • or call toll free: 877-992-4724 (M-F between 8:00 am to 6:00 pm ET)
  • or by email: adviser@advarra.com
  • Please reference the following number when contacting the Study Subject Adviser at Advarra IRB: Pro00037864.