Please read this information carefully.

If you have any questions after reading this information, you can always contact the Helpdesk. You will find the contact details at the end of this information letter (under the heading “Do you have any questions?”).

Why this pilot?

The Freequency app has been available in the Netherlands since 2025. User responses have been positive, and Freequency has already won several awards. The creators of Freequency want to expand to other countries so that more people can learn to cope with tinnitus on their terms. Freequency is currently investigating whether the current app and content are suitable for the U.S. market. Who better to assess this than experts with firsthand experience?

Purpose of the pilot:

The purpose of this pilot is to find out how American users rate the app and to investigate what additional steps Freequency app needs to take before it can definitively offer the app in America.

What is expected of me?

If you decide to participate, you must first complete the formal registration form, which explicitly asks you to accept the contents of this letter. It also contains a number of control questions to determine whether you meet the pilot conditions. After approval by Freequency, you will receive the initial questionnaire by email, which you can complete online.

After completing the initial questionnaire, you will receive an invitation to download the Freequency app on your own device (mobile phone or tablet). By downloading the app, you agree to the User Terms of the Freequency app.

The Freequency app consists of an online game that you play for about 10 minutes a day in your familiar surroundings, for example at home, over a period of 100 days. During this period, you will receive daily information, tips, and exercises to help you cope with your tinnitus on your own terms. Four times during this period, you will receive an invitation within the app to participate in the TFI Tinnitus Functional Index. This is a medically validated questionnaire that serves as a measuring tool for the impact of tinnitus on your life. The TFI questionnaire works as a self-report.

Freequency allows external researchers to analyze the responses to the TFI questionnaires in order to assess the effectiveness of the app and certify it as a medical device (as defined in European regulations). These researchers do not have access to your personal data. Researchers only see the answers to the TFI questions linked to your unique identifier code.

At three points during the pilot, you will be asked questions about what you think of the Freequency app, your tinnitus experiences and tinnitus symptoms, and any changes in your symptoms as a result of using the app. We refer to these as the start, intermediate and end questionnaires.

You may be approached for additional research, such as an interview with therapists or developers affiliated with Freequency. You will be informed separately about this; please note that you may also refuse to particpate in this interview.

How long will the pilot last?

The pilot will run from April 22, 2026, until November 1, 2026, at the latest. When you start the pilot, the duration is 100 days of using the app plus the time it takes to complete the start and end questionnaires. Completing the start, intermediate and end questionnaires takes approximately 30 minutes each time. Using the app over 100 days takes 10 minutes per day. Completing the TFI questionnaire takes approximately 20 minutes four times.

You will also be offered content in the form of videos and text, which will take a maximum of 5 minutes extra per day.

What are the possible advantages and disadvantages of participating in this study?

The Freequency app is based on exposure therapy. This means that the Freequency app exposes you to the annoying noise, beep, or tone and teaches you to cope with it by playing the game. The best results with the Freequency app are achieved when you complete the full 100-day cycle, playing for 10 minutes every day and ensuring that you only use the app in a quiet and comfortable environment. It is common for users to experience a worsening of symptoms during the first few weeks and only notice improvement later on. Many users find that perseverance pays off.

We know from Dutch users of the Freequency app that a significant proportion of respondents benefit from using the app and experience reduced tinnitus symptoms after completing the 100-day cycle. However, there is a risk that using the app may cause you to experience more tinnitus symptoms, either temporarily or permanently, precisely because you are focusing so strongly on them. Studies conducted thus far indicate that a smaller percentage of users experience an increase in symptoms after 100 days compared to the percentage who experience benefits, report no noticeable differences, or choose not to participate in the response questionnaire.

By participating, you will help increase knowledge about the Freequency app. You will share your experiences as a user, including what you like and dislike about technical improvements and therapeutic enhancements. Freequency can then use this information to implement improvements. Apart from the time you spend filling out questionnaires and playing the game, participating in the pilot program is free. However, you do accept the possibility that your tinnitus symptoms may change, either positively or negatively.

What happens if I decide not to participate or if I want to stop?

You decide for yourself whether or not you want to participate in the pilot program. Participation is voluntary. Your decision not to participate will not have any further consequences for you. If you choose not to participate, you do not need to take any further action. Although we greatly appreciate it, you do not need to explain why you do not want to participate. If you decide to participate and then change your mind during the pilot, you can withdraw. Any data collected up to that point will still be used for the pilot.

What happens to my data?

Are you participating in the pilot? By participating, you also give permission for your data to be collected, used and stored. This is necessary in order to answer the questions asked and to publish and use the results for research into the certification of the app as a medical device.

The Freequency app processes as little data as possible from its users. This is also stated in the privacy policy that has been drawn up for the European market and complies with the GDPR, the comprehensive EU law protecting the personal data and privacy of individuals.

As an exception or addition to the privacy statement, we ask for additional information about you for the pilot. With your consent, we link the answers to the start, intermediate and end questionnaires to information you provide via the Freequency app with the TFI questionnaire. For this purpose, we use the email address you used to register for participation in the pilot.

We collect and store this data during the pilot period:

• Age
• Gender
• Email address
• A description of your tinnitus symptoms
• Responses to the start, intermediate and final questionnaires
• If applicable: responses from any additional interviews you decide to participate in
• If applicable: information about the reason for discontinuing the pilot program early, if you wish to share this information with Freequency

All your data will be anonymized at the end of the pilot period. This means that we will remove your name and email address and combine the appropriate responses (closed questions) from the questionnaires of all users into a single database for analysis by researchers.

The answers to open questions about your experiences will be disconnected from the database and deleted to prevent any personal data you share from remaining in it.

To protect your privacy after the pilot, your response to the TFI questionnaire will be given a code. We will use this code to process your data and link the four TFI questionnaire moments together. Data that can directly identify you (such as your email address) will be deleted immediately after linking. The key to the code will remain securely stored with Freequency app for the duration of the pilot. No one will be able to identify you in reports and publications about the pilot.

Pilot results

After the pilot program ends, you will receive a final update from the Freequency app with information about how it went. If Freequency decides to make the app permanently available in the USA, you will be asked if you would like to share a review of your experience using the app. You will also be asked if we can contact you to participate in the marketing campaign, subject to agreements to be made at that time. In the meantime, if you wish to stop receiving messages, please send an email to info@freequency.app so that we can remove your email address from our mailing list. Every email you receive from Freequency contains an opt-out link for this purpose.

You can find more information about your rights regarding data processing below.

You registered with Freequency in response to the call for pilot participants in the USA. If you meet the conditions, you will be selected by the Freequency app selection team to participate.

For general information about the processing of your personal data, consult the general privacy statement of the Freequency app and the website of the Dutch Data Protection Authority. If you have any questions about your rights in this pilot, contact the person responsible for processing your personal data using the contact details below.

If you have any questions or complaints about the processing of your personal data, we recommend that you first contact the helpdesk. You can also contact Freequency's Privacy Coordinator via the helpdesk.

Do you have any further questions?

Then contact the pilot helpdesk at info@Freequency.app. You can also contact the helpdesk if you have any complaints about the pilot. During the pilot, you will be in direct contact with the creators of Freequency in the Netherlands. You can, of course, submit your comments in English. However, due to the time difference, it may take half a day longer to receive a response.

Consent

When you formally register, you will be explicitly asked for your consent to participate in this pilot. We ask you to confirm your consent at the beginning of the questionnaire. By giving your consent, you indicate:

• that you have understood the information in this letter,
• that you accept the risks outlined, and
• that you wish to participate in this pilot voluntarily and without remuneration.

Please note that the User Terms and Privacy Statement of the Freequency EU app also apply to this pilot, However, please be aware that these legal documents were drawn up for the European market. Because Freequency is a pilot project in the USA, the documents have not yet been fully adapted to the local market. The agreements in this letter sometimes deviate from the agreements in the terms of use and the explanation in the privacy policy. In case of any discrepancy, this Informed Consent takes precedence over the User Terms and the privacy policy.