Frequently Asked Questions
- General
- Participant Requirements
- Procedures
- Reconsent
- Technical Support
- Participation
- Privacy
- Apple Research App
- Changing Devices?
- Contact Information
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
and health.
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 further the scientific understanding or noise exposure, 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 hearing-related tests, such as a tone exercise, 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.
Additionally, we will post copies of our published scientific papers that describe our study results on our study website. These papers will also never include your name or other directly identifying information.
Finally, we will regularly post study updates on the study website, and will notify study participants of these updates via the Apple Research app.
Why am I being asked about COVID-19 as part of the study?
There is some evidence that people who have gotten COVID-19 may experience hearing
changes after infection. We will periodically ask you whether you have had COVID-19
during the course of the study in an attempt to better understand the possible hearing
impacts of infection. Additionally, our analyses have already shown that the COVID-19 government lock-down resulted in lower noise exposures among Apple
Hearing Study participants.
How do I find my research ID number for the study?
Click your profile, scroll to the bottom and click the Get Help link. A Research ID
for each study you are participating in will show up.
Participant 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 least 19 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 running the Research app.
- 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, but you will be able to complete other hearing-related tasks.
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 hearing
tasks, and to contribute noise levels measured by your Apple Watch (if you have one).
However, you will need to disconnect and remove your hearing aids and use a supported
listening device to take the hearing tests. 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
and tinnitus task requires the use of Apple AirPods Max, AirPods Pro, AirPods, or
EarPods, but if you do not have any of these supported listening devices, you can
still participate in other aspects of the study. Other hearing tasks in the study
can be taken with any earphone or headphone style listening device. If you wear hearing
aids, please remove them and use a supported device to complete the tasks.
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.
Periodically, you will be asked to complete short surveys regarding your hearing health
and other background information. 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. Every few months and/or following high sound exposure you will be asked
to complete various hearing tasks.
Are AirPods or EarPods required to participate in this study?
No. You do not need AirPods or EarPods to measure your sound levels as part of this
study. The tone exercise and tinnitus task of the study can only be completed with
Apple AirPods Max, AirPods Pro, AirPods, or EarPods while the SIN task allows you
to use any earphone or headphone style listening device. If you do not have AirPods
Mas, AirPods Pro, AirPods, or EarPods you can still participate in all other aspects
of the study.
Why are AirPods Max, AirPods Pro, AirPods, or EarPods required for the tone exercise
and tinnitus tasks?
The tone exercise and tinnitus tasks are the only tasks in the study that requires
use of AirPods Max, AirPods Pro, AirPods, or EarPods. These listening devices have
been calibrated to perform the tests. If you do not have AirPods Max, AirPods Pro,
AirPods, or EarPods, you may skip the task or finish the task later when you do have
compatible headphones available.
Why can't I complete the hearing tasks with my hearing aids?
The tone audiometry and tinnitus tasks are only supported by AirPods Max, AirPods
Pro, AirPods, or EarPods while the speech-in-noise task is supported by any earphone/headphones
style listening device. If you have hearing aids and have these products, you can
complete the tasks by removing your hearing aids and using the corresponding listening
device instead.
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, initial survey and the
Your Hearing and COVID-19 survey, but I don’t have any current tasks in the Research
app. Is that normal?
After you complete the onboarding process, the initial survey and the Your Hearing
and COVID-19 survey, your next scheduled task will not become available for 2 months.
If you have an Apple Watch, it is possible that you may be prompted to complete a
triggered task before 2 months based on your environmental sound level. It is also
possible that you may be prompted to complete a triggered task before 2 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. After you begin using an implant, 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. However,
you will be able to complete other hearing-related tasks.
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. Please remember to download the signed informed consent for
your records.
Where can I find my signed informed consent?
Your signed consent form can be found under the studies tab. Click the profile icon
and then click consent documents. Each study you are participating in will have its
own consent document stored here with a date indicating when you signed it. By clicking
on the desired consent document you can review it and/or save it.
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. Please remember that
just deleting the Apple Research app WILL NOT withdraw you from the study.
Reconsent
Why is there a new consent form?
When research studies are changed or expire, the consent form may be updated to include
new information that is important to you, as a participant. Changes may clarify current
study procedures, add new procedures, provide information about changes in the risk
of participation, or design of the study.
Why do I need to sign the updated consent form?
The updated consent form is provided to inform you of changes to the study. The changes
will not take effect until you have provided your informed consent. Signing the updated
consent form indicates that you understand what you are being asked to do in the study
and want to continue participation.
What has changes in this consent form?
- New Surveys and Study Data: You may see new data types and questions related to hearing features as well as medical history relevant to hearing health.
- Security Recommendations: Setting a passcode can further protect your Study data.
- Re-consent and Withdrawal: Removed the requirement to provide your consent every two years to remain in the Study. However, you may be asked to consent again, including if the Study changes further. Added clarifications to withdrawal process.
- Study Contact: Updated the Study Support Center hours of operation and the circumstances under which we may contact you regarding the Study.
Prior to signing, please carefully review the entire consent form.
How long will this consent for be valid?
Your consent form will be valid until it expires, the Study ends, or until there are
significant changes to consent which require re-consent. You can revoke your consent
at any time, by withdrawing from the Study.
What happens to my data if I do not sign this new consent form?
If you do not sign the new consent form, collection of your data will continue until
your initial consent expires, the Study ends, or you withdraw form the Study.
Who can I contact with questions?
Please call the Study support team toll-free at 833-237-3881.
Technical Support
How do I enable VoiceOver or Mono Audio?
To use VoiceOver with Research app, go to Settings > Accessibility > enable VoiceOver,
and navigate iOS using the VoiceOver. When you open the Research app, you would use
the same gestures and commands as you do elsewhere. Click here for additional Accessibility learning resources.
What is Water Lock and when should I use it?
Water Lock is a feature on the Apple Watch Series 2 or later that, when turned on
while you’re in water, locks your watch’s screen so you don’t inadvertently activate
the screen or get water inside the device. Disabling Water Lock when you’re out of
the water will eject any water that remains in the watch’s speaker. See “How to use Water Lock and eject water from your Apple Watch” for instructions to turn the feature on or off.
Can wind or water affect the noise measurements on my watch? If so, what do I do about
it?
Wind or water moving across the microphone on your Apple Watch can result in sound
levels that are artificially high. This can make it appear that you are receiving
higher environmental sound exposures than you actually are. To prevent this from happening,
please use the Water Lock feature on your Apple Watch whenever your Watch is going
to be immersed in water or under running water. In situations where air may move across
your Watch at high speeds (for example, riding a bicycle or motorcycle), please consider
covering your watch with clothing or removing it from your wrist during that activity.
Can I access an expired task?
No, once a task is expired it is no longer available to complete. Please wait for
the prompt for the next task. To complete tasks before their expiry, turn on Research
app notifications by going to Settings > Notifications > Research app > enable Allow
Notifications.
Can I use my Beats Headphones on the hearing tasks?
You can use the Beats headphones for the speech-in-noise task only. You must use Apple
AirPods Max, AirPods Pro, AirPods or EarPods for the tone audiometry and tinnitus
tasks.
Will I be able to see the results of my hearing tests?
At this time, per the terms of the informed consent form you signed to enroll in the
study, we cannot share individual results of the hearing tests with you. We will periodically
share findings from the data collected across all participants. When we do this, you
will receive a notification through the app to check out the update.
Will you be recording my conversations?
No, the Watch does not collect any data about what is contributing to the environmental
sound being monitored. We are only measuring the sound level at which you are being
exposed, a measure of energy.
Can all Noise Control modes be used when preforming listening tasks in the study?
- If using AirPods Pro v2, Noise Cancellation mode is required when performing listening tasks. Use of Adaptive mode may cause task errors.
- If available on other listening devices, Noise Cancellation mode is required when performing listening tasks.
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. You can also view and manage the types of data you share with the
study in the Research app by tapping the Your Data tab.
Some data types may be modified over time. For example, the Workout Activity data type was updated in September of 2022 to include Multisport Workouts.
How do I share data with the study?
Data types will only be shared with the study after you provide your permission and
complete the consent forms to enroll in the study. Once you have enrolled in the study,
the study will begin to collect the types of data you have permitted. 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. You can also view and manage the
types of data you share with the study in the Research app by tapping the Your Data
tab.
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 investigator and study coordinator 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.
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 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 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.
Changing Devices
What happens if I upgrade or downgrade my iPhone?
If you're thinking about changing your device please first briefly read this and the article from Apple to make sure that you don't interrupt your participation in the study(s).
Specifically, remember to back-up your iPhone and back-up your health information from the Health Kit. If you do not back-up 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 researcher 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).
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.
If you want to communicate directly with the study staff, you can contact them via email at applehearingstudy@umich.edu.
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, 6100 Merriweather Drive, Suite 600, Columbia, MD 21044
- 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.
Get the app. Join the study. Download the Research app