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Professional User Agreement

Welcome to the Advanced Bionics (AB) online interface for hearing care providers and other hearing care professionals, (hereafter known as the “Site” or "Sites"). “AB” is the name we use to refer to our whole business, including Advanced Bionics AG, Advanced Bionics LLC, and their respective subsidiaries and affiliates. When we use the words “we” or “ours”, we mean AB.

By using this Site, you will be able to access information, training, and educational materials for correct usage of AB products or services, including access to signing up for e-learning, webinars or other educational content or offerings. Access to the Site also includes use of the Advanced Bionics Pro Portal, which can be used to register AB cochlear implant recipients and process orders, refunds, and replacements for their devices.

Users may receive Site news, educational updates and information via e-mail. Users may unsubscribe from such e-mails at any given time.

The Professional User Agreement includes any posted guidelines or rules applicable to particular Content or Services (as defined below) and, as updated by AB from time to time. This is a legally binding agreement. If you do not agree to the Professional User Agreement, you are not authorized to use the Site.

1. By using the Site:

(a) You confirm that you are a qualified hearing care professional, registering your HCP user account with us in your genuine identity and address.  If you register using a personal or non-professional e-mail address, you will not be granted access to patient-specific data without further verification.

 (b) You agree to keep confidential your password and other user account identifiers which you choose, and be solely responsible for all activities that occur under your account.  

 (c) You agree that AB is the sole owner of the Site, including ownership of copyrights, database rights, patents, trademarks, trade secrets, trade names, logos, and other intellectual property rights thereto of every kind, as well as contents such as texts, images, graphics, logos, audios, videos, and other materials recorded or appearing on the Site.

 (d) The Site is provided on "as available" basis, without warranty of any kind, either expressed or implied.  Without limitation, there are no warranties concerning appropriateness, usefulness, reliability, accuracy, or availability; no warranties on title, of non-infringement; and no warranties on merchantability or fitness for a particular purpose.  There are no warranties on the Site being free from virus, free from interference, or compatible with your computer, device, or system. This website may link to other websites that are not under the control of AB. These links are offered for your convenience, and you agree to read and adhere to the policies and terms of use applicable to those websites. AB is not responsible for the content of such websites and shall not be liable for any damages or injury arising from the content of any other website.

 (e) AB may stop support for the Site at any time, and may change the Professional User Agreement at AB’s sole discretion.  

(f) The information, views and opinions expressed in the content, this Site and in the materials presented are those of the individuals involved and do not necessarily represent those of AB. AB is not responsible and does not verify the accuracy of any of the information or material presented., Some information may be gathered from third party sources and is subject to change without notice and some presenters may have been compensated by AB to share the information. The information presented may not be appropriate for all jurisdictions.

 

2. Access to the Sites:

Access to the Site requires a valid user account.  To obtain a valid user account, you must register with the Site and provide the information requested, including a password defined by you in the registration process. The login and password are for the use of the designated person only and are not transferable or shareable.

You agree that you will be responsible for maintaining your password as confidential and for any activity that occurs as a result of your enabling or permitting another person or entity to use your password. You agree to immediately notify AB if (i) your password is lost or stolen, (ii) you become aware of any unauthorized use of your password or of any other breach of security related to the Sites, (iii) you receive a login and password that belong to another person (in which case you are not authorized to use that login account), or (iv) you are no longer affiliated with your registered center.

AB is not responsible for any loss or damage arising from your failure to comply with the provisions of this Section. Misuse of a login account, including, without limitation, unauthorized sharing of the login and password, may result, at AB’s sole discretion, in cancellation of the user’s password and other remedies, and AB shall have no liability to the user.

You may not share, distribute, copy, duplicate or sell the Site or other content to others without written permission or consent by AB. By using this Site, you agree that you will not copy or modify the Site or any part thereof or AB'’s own or licensed trademarks or content in any way.

 

3. Protection of Personal Data & Privacy:

(a) “Personal Data” is information relating to natural persons, commonly an individual private contact details (home address, telephone number, e-mail address), date of birth, copy passport or other identity documents, social security number, bank/credit card details, health relating information, biometric data, and genetic data.  

(b) In the context of the Site, the personal data collected primarily relates to you, the health care professional; however, the site may also process the personal data of cochlear implant recipients through the Pro Portal functionalities.  You represent and warrant that (1) the applicable privacy notice, appended below and incorporated by reference, has been duly provided to these cochlear implant recipients in relation the processing of their personal data, and (2) that, where required, valid consent has been obtained.

(c) Furthermore, you agree to comply with the provisions of the attached Data Protection Addendum, which is incorporated into and forms an integral part of this Agreement.

(d) Throughout your use of the Site, you represent and warrant that you will comply with data protection/privacy and consumer protection laws applicable to you and the persons whose data is processed by the Site. These laws include, but are not limited to, the Swiss Federal Data Protection Act (“FDPA”), the Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 (“GDPR”), U.S. state data privacy laws such as the California Consumer Privacy Act (CCPA) and the California Privacy Rights Act (CPRA), and the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) and its implementing regulations.

 

4. Opt-out:

You may contact AB and have your login and password information inactivated at any time. AB will accommodate requests for inactivation and opt-out. Opt-out may be accomplished by sending an e-mail to privacy@advancedbionics.com or writing to:

Advanced Bionics

28515 Westinghouse Place

Valencia, CA 91355

Phone: (661) 362-1400

 

The information AB obtains from the users will be used only in accordance with AB’s Privacy Policy.

 

5. Limitation of Liability and Disclaimers:

YOU AGREE THAT TO THE FULLEST EXTENT PERMITTED BY APPLICABLE LAW, REGARDLESS OF THE FORM OF ACTION INCLUDING NEGLIGENCE, AB AND THE SONOVA GROUP (EVEN IF INFORMED) WILL NOT BE LIABLE TO YOU OR TO ANY OTHER PARTY FOR ANY DIRECT OR INDIRECT LOSS, COST, OR LIABILITY OF ANY KIND (COLLECTIVELY "LOSS") IN CONNECTION WITH THE SOFTWARE. WITHOUT LIMITATION LIABILITY IS EXCLUDED FOR: (i) ERRORS OR INACCURACIES IN THE SOFTWARE, DAMAGES FOR BUSINESS INTERRUPTION, LOSS OF BUSINESS AND PROFITS, LOSS OF PROGRAMS, COST OF REPLACING EQUIPMENT OR SOFTWARE, LOSS OF RECORDS, INFORMATION OR DATA, DAMAGE TO REPUTATION AND GOODWILL, AND LOSS OF EVERY KIND; (ii) ANY INDIRECT, SPECIAL, EXEMPLARY, PUNITIVE, OR CONSEQUENTIAL LOSS.  IN JURISDICTIONS THAT PROHIBIT LIMITATION OF LIABILITY FOR PARTICULAR KINDS OF LOSS, SONOVA'S LIABILITY SHALL BE REDUCED TO THE LOWEST AMOUNT APPLICABLE LAW PERMITS.

AB does not provide medical professional advice and use of the Site is not professional medical advice and is not intended to substitute for the advice of a health care provider/professional. Any recommendations in the Site or educational resources are a general guide, to be evaluated, adapted and implemented by qualified healthcare professionals subject to clinical judgement and consideration of the patient’s individual needs, characteristics, and personal preferences. You should always consult a doctor or another qualified health care provider for diagnosis and treatment and other medical related questions or concerns.

6. Governing Law & Jurisdiction:

This Professional User Agreement is governed by the substantive provisions of California law and the parties agree to submit to the exclusive jurisdiction of the Superior Court of California.

Data Protection Addendum

Introduction

AB and the Hearing Care Professional (hereafter “HCP”) or together "the Parties" commit to comply with applicable data protection regulations, and in particular Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation) (the "GDPR") EU Directive 2002/58/EC of the European Parliament and of the Council of 12 July 2002 concerning the Processing of Personal Data and the protection of privacy in the electronic communications sector; UK General Data Protection Regulation (Regulation (EU) (2016/679) ('UK GDPR') and the Data Protection Act 2018; the Swiss Federal Act on Data Protection 235.1 of 25 September 2020; Swiss Federal Data Protection Act (“FDPA”), the Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 (“GDPR”), U.S. state data privacy laws such as the California Consumer Privacy Act (CCPA) and the California Privacy Rights Act (CPRA), or the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”); the Personal Information Protection Law of the People's Republic of China (“PIPL”); and all other relevant data protection regulations where the Parties operate (together the "Data Protection Laws") and in accordance with the following terms and conditions.

The Parties act may act as independent or joint Controllers according to the below roles agreed by both Parties.

Given Article 4(7) of the GDPR: the data controller is the legal person that alone determines the purposes and means of processing of the processing of personal data.

Independent controllers: AB and the HCP each collect personal data for their own purposes. AB collects personal data for the purposes of complying with the Medical Devices Regulation (“MDR”) (Regulation (EU) 2017/745 of the European Parliament and the Council of 5 April 2017 on medical devices) and the HCP collects personal data for the purposes of managing its commercial relationship with its customers.

Joint controllers: The Parties acknowledge that their relationship in the context of using the Site shall be determined in accordance with the applicable privacy notice, which is incorporated by reference into this Agreement. Where both Parties jointly determine the purposes and means of processing, as defined in Article 2 of the Data Protection Addendum (DPA), they shall be considered Joint Controllers.

Article 1 – Definitions

For the purposes of this Contract, the terms "Supervisory Authority", "Data Protection Officer", "Personal Data", "Data Subjects", "Pseudonymisation", "Controller", "Processing", "Transfer", "Processor" and "Personal Data Breach" have the same meaning as given to them in the GDPR.

Article 2 – Characteristics of Personal Data Processing

The Parties agree that the Processing of Personal Data, the purposes and means of which they define together, shall have the characteristics set forth in the applicable privacy notice, which is incorporated by reference into this Agreement.

 

AB may aggregate or deidentify Personal Data such that the resultant data no longer constitutes Personal Data under Data Protection Laws and provided such data is incapable of being identified to or associated with AB (“Aggregated Data”) and may use such Aggregated Data for its own internal purposes (e.g., research and service improvement, generative artificial intelligence) to the extent permitted in the Professional User Agreement and Applicable Data Protection Laws. Neither party will re-identify, attempt to re-identify, or permit any third party to re-identify any Aggregated Data and each Party shall remain responsible for complying with Applicable Data Protection Laws for so long as it Processes Aggregated Data.

 

Article 3 – General obligations of the Parties

The Parties undertake to:

·       Ensure that the personnel having access to or being involved in the Processing of Personal Data, by virtue of this Contract, are bound by an obligation of confidentiality, and receive the necessary training in the protection of Personal Data;

·       Keep a register of Processing activities in accordance with Article 30 of the GDPR;

·       Carry out its own impact assessments considering the nature, scope, context and purposes of the Processing operation in question, in accordance with Article 35 of the GDPR;

·       In the event of subcontracting the Processing activities, ensure that the Processor complies with the obligations arising from the Contract.

Article 4 – Rights of the Data Subjects

The Parties agree that:

·       The HCP must provide information on the Processing of Personal Data to the Data Subjects concerned by such Processing, in accordance with Articles 13 and 14 of the GDPR.

·       The Data Subjects concerned by the Processing of Personal Data are able to exercise their rights as provided for in the Personal Data Legislation with AB or the HPC. In all cases, the Parties undertake to cooperate and inform each other of the requests made by the Data Subjects, so that they can provide an adequate response within the time limits laid down, in accordance with the Personal Data Legislation.

Article 5 – Security of Personal Data

Each Party undertakes to:

·       Guarantee a level of security of Personal Data, in its respective area of responsibility, in accordance with the Personal Data Legislation;

·       Implement appropriate technical and organizational measures such as:

a) Pseudonymization and encryption of Personal Data;

b) Means to ensure the continued confidentiality, integrity, availability and resilience of the Processing systems and services;

(c) Means to restore the availability of and access to Personal Data in a timely manner in the event of a physical or technical incident;

(d) Have a procedure to regularly test, analyse and evaluate the effectiveness of the technical and organisational measures to ensure the security of the Processing.

Article 6 – Subprocessors

The Parties may use subprocessors subject to compliance with the provisions in Article 6. All Processing by subprocessor shall be subject to a written agreement between the relevant Party and the subprocessor that requires the subprocessor to comply with the same obligations and restrictions as provided for in this DPA, including express guarantees by the subprocessor to implement technical and organizational measures to ensure that Processing satisfies all requirements of Data Protection Laws. Each Party shall remain responsible for the Processing of Personal Data and for any acts and omissions of its subprocessors to the same extent as if such acts or omissions were performed by relevant Party.

Article 7 – Personal Data Breach

In the event of a Personal Data Breach, the Parties undertake to cooperate and to inform each other as soon as possible.

The Party concerned by the Personal Data Breach will carry out an investigation and an analysis in order to determine the consequences of the Personal Data Breach and in particular whether it is likely to create a risk for the rights and freedoms of the Data Subjects. In this regard: 

·       If the analysis shows that there is a risk to the rights and freedoms of the Data Subjects, the Party will inform the other Party within 48 hours at the latest, in order to decide on the follow-up to be given and in particular to define who will notify the National Supervisory Authority and according to what modalities it will be appropriate, in case of high risk, to communicate to the Data Subjects impacted by the Personal Data Breach;

·       The concerned Party shall implement as soon as possible the measures necessary to remediate the Personal Data Breach;

·       The concerned Party shall document the Personal Data Breach in order to ensure its traceability, whether or not the analysis shows that there is a risk to the rights and freedoms of the Data Subjects.

Article 8 – Cross-border data transfers

The Parties undertake, in the event of the Transfer of Personal Data outside the of the country where the Personal Data is collected and if the importing country is not considered to have an adequate level of data protection according to the relevant Data Protection Law, both Parties agree to cooperate to ensure:

-          The implementation of adequate procedures to comply with the Personal Data Legislation, and in particular when a request for authorization from the competent Supervisory authority is necessary;

-          The implementation of appropriate organisational, technical and legal safeguards to govern the said transfer and to ensure the necessary and adequate level of protection under the Personal Data Legislation;

-          If necessary, the implementation of Standard Contractual Clauses as adopted by the European Commission (Decision 2010/87/EU of 5 February 2010 of the Commission or more recent), including among all relevant subsidiaries as necessary.

Depending on the importing third country, the Parties undertakes to take supplementary measures such as completing a data transfer adequacy assessment if, after evaluation of the circumstances of the transfer, and after evaluation of the legislation of the third country, it is necessary for the protection of the transferred Personal Data.

Article 9 – Data Protection Officer

The Parties shall provide each other with the contact details of their Data Protection Officer upon request

Privacy Notice

Last updated: February 28, 2025

This Privacy Notice describes how your personal data, including sensitive data, are collected and processed, related to the use of your cochlear implant or hearing device (“HD”). In this context, this Privacy Notice covers the processing of your personal data carried out via the Advanced Bionics Pro Portal website (“Site”) with all related technology to access or otherwise use the Site as described below. The processing of your personal data comply, according to your country, with local law requirements, including the Swiss Federal Data Protection Act (“FDPA”), the Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 (“GDPR”), U.S. state data privacy laws such as the California Consumer Privacy Act (CCPA) and the California Privacy Rights Act (CPRA), or the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) for personal data qualified as Protected Health Information.

This Privacy Notice may be updated from time to time. In this case, we will inform you that this Privacy Notice has been modified and the “last updated” date on top of this document will be modified. We recommend that you periodically review the latest version of this Privacy Notice.

1.      Who we are

This Site is operated by Advanced Bionics AG and its subsidiary, Advanced Bionics, LLC (collectively, “Advanced Bionics”) both owned and operated by Sonova AG, a public limited company, registered in the Commercial Registry of Zurich, under number 101 989 881, whose registered office is at Laubisrütistrasse 28, 8712 Stäfa, Switzerland. Advanced Bionics may be contacted at the addresses below:

Advanced Bionics AG

Laubisrütistrasse 28 8712

Stäfa, Switzerland

Advanced Bionics, LLC

28515 Westinghouse Place

Valencia, CA USA 91355

Other Advanced Bionics affiliates and locations can be viewed at https://www.advancedbionics.com/us/en/home/contact-us/f/ab-global-offices.

Advanced Bionics acts as a Joint or Independent Controller for the processing, as described in the following section. A given Hearing Care Professional (“HCP”) user may also act as Joint or Independent Controller for the processing described in the applicable paragraphs below.

2.      Personal data we collect from you and why

As Controller, Advanced Bionics processes your personal data for the following purposes:

-          To uniquely identify professionals who work with Advanced Bionics’ devices and cochlear implant recipients, so we can provide you with the correct and appropriate data (including, but not limited to, patient data warranty, insurance status, and device lists)

o   This activity is based on our legitimate interest to ensure the security and integrity of user accounts and the protection of personal data.

-          To provide relevant contact information to Advanced Bionics’ staff in the country or region  

o   This activity is based on consent

-          To tailor the content and user experience of the site for the user’s country and language—specifically, utilizing the backend of the Site (supported by Salesforce, Inc.) which stores the user's location and language preferences. When a user logs in, this information is used to determine what features of the portal are available to them.

o   This activity is based on your consent for all but necessary cookies, provided through our cookie's preference center. Please also note that you may adjust your location and language preferences at any time.

-          To allow HCPs and other professionals to determine and adjust their communication preferences, including communications for marketing purposes

o   This activity is based on your consent.

-          To allow professionals to purchase equipment (including cochlear implant accessories and other technology) create online requests for replacement/programming of processors, and review past order history

o   This activity is based on performance of a contract, and AB’s contractual obligation to fulfill the business relationship with HCPs, as well as consent if Advanced Bionics asks for more data than is strictly necessary (for example, if you wish to ship a product to a specific address). Additionally, AB has a legitimate interest in providing HCPs and other affiliated professionals with their order histories.

-          To facilitate and fulfil regulatory registration requirements when it comes to the deployment and use of Advanced Bionics’ cochlear implants

o   This activity is based on legal obligation where consumer laws or consumer safety regulations require it.

-          To allow Advanced Bionics to ingest anonymized data collection for statistical tracking to improve products and services.

o   This activity is based on Advanced Bionics’ legitimate interest.

If you are located in the USA, Pro Portal can facilitate collaboration between audiologists, surgeons, and cochlear implant recipients/patients (as designated by the HCP or ordering provider) through the web order and kit selection process. This process involves the use of personal information to process the order appropriately. This functionality is limited to the USA and is not required.

Insofar as Advanced Bionics and you as HCP act as Joint Controllers, you may use the Pro Portal site to process additional personal data for the following purposes:

-          To track recipients of Advanced Bionics’ cochlear implants and their information (including, but not limited to, patient data warranty, insurance status, and device lists), to provide ongoing clinical support

-          To purchase equipment (including cochlear implant accessories and other technology) or create online requests for service, replacement, or programming of processors on behalf of your patients/recipients, as well as reviewing past order history

If you are located in the USA, Pro Portal can facilitate collaboration between audiologists, surgeons, and cochlear implant recipients/patients (as designated by HCP or ordering provider) through the web order and kit selection process. This process involves the use of personal information to process the order appropriately. This functionality is limited to the USA and is not compulsory.

All of the above activities in which the HCP acts as Controller are governed by consentWe rely on our HCP partners to appropriately collect this consent from the applicable data subjects prior to processing their data with the Site. A copy of this consent is attached to this Privacy Notice, and incorporated by reference.

3.      How we share your personal data

Your personal data will be processed according to the instructions we provide to our employees who have received the necessary training in data protection and are subject to an obligation of confidentiality.

Your personal data may also be disclosed to:

-          Other companies in our group of companies, such as our subsidiaries, all of which are required to protect personal data in accordance with applicable privacy and data protection laws;

-          Our business partners, contractors and third-party service providers. These third parties only process personal data that are strictly necessary for the services they provide to us, according to our instructions and in compliance with our privacy and security requirements.

-          Other organizations and public bodies, supervisory and control authorities, including law enforcement agencies, as may be required by law.

By using the Site, only personal data that are strictly necessary for the following purposes are shared (the location(s) of your shared personal data may vary depending your country):

-          Microsoft Ireland Operations Limited - Microsoft Azure (The Netherlands): provides cloud infrastructure hosting our services

-          Salesforce, Inc. (United States, European Union): provisions of customer account and administering the account database.

-          SAP AG (European Union): internal Advanced Bionics tool managing orders, devices sold and warranties

-          Global Healthcare Exchange, LLC (USA): provides technical support and integration for the Pro Portal programming center and ordering functionalities

-          Google LLC / Google Ireland Limited - Google Analytics: analytics

-          Google LLC / Google Ireland Limited - Google Firebase: crash analytics, remote configuration. 

Please see https://www.google.com/about/datacenters/locations/ for more information.

Before we disclose any personal data to other third parties than those listed above, we will explicitly ask you for your consent. However, if we are obliged to disclose personal data without your consent, we will only disclose personal data that are strictly necessary for that purpose to fulfil our legal obligations.

4.      International personal data transfers

Please note that some of the above-mentioned third parties can be located outside your country. Therefore, your personal data may be transferred to countries that do not provide the same level of protection of personal data as your own country. In such cases, we undertake to:

-          implement adequate procedures to comply with applicable law;

-          adopt appropriate organizational, technical and legal safeguards in order to ensure an adequate level of protection of the personal data transferred;

-          implement, if necessary, and according to applicable law, standard contractual clauses as adopted by the European Commission;

-          depending on the country of the importing third party, take additional measures such as a transfer impact assessment.

5.      How long we keep your personal data

Advanced Bionics will retain your personal data for a minimal period proportional to the time required to fulfil the purposes outlined in Section 2. For example, relevant personal data will no longer be retained if you delete your account or if our contractual obligations are fulfilled. In the event applicable law or other regulations require a longer retention period, we will apply the longer retention period in order to fulfill our legal obligations.

6.      Your legal rights

Within the framework of the collection and processing of your personal data, and as per applicable law, you may have the right to request access, rectification, erasure of your personal data, or restriction of processing. In addition, you may object to the processing, request data portability and withdraw your consent at any time. According to your country, you may have other rights such as providing instructions for how your personal data should be processed posthumously.

You may exercise your rights by using the contact details in the “How to contact us” Section below. Please note that the exercise of such rights is subject to the limitations provided by applicable law.

If you consider that the processing of your personal data infringes applicable law then you may also lodge a complaint with the local supervisory authority or the competent regulator.

Pro Portal Patient User Privacy Notice

 

Last updated: February 28, 2025

This Privacy Notice describes how your personal data, including sensitive data, are collected and processed, related to the use of your cochlear implant or hearing device (“HD”). In this context, this Privacy Notice covers the processing of your personal data carried out via the Advanced Bionics Pro Portal website (“Site”) with all related technology to access or otherwise use the Site as described below. The processing of your personal data comply, according to your country, with local law requirements, including the Swiss Federal Data Protection Act (“FDPA”), the Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 (“GDPR”), U.S. state data privacy laws such as the California Consumer Privacy Act (CCPA) and the California Privacy Rights Act (CPRA), or the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) for personal data qualified as Protected Health Information.

This Privacy Notice may be updated from time to time. In this case, we will inform you that this Privacy Notice has been modified and the “last updated” date on top of this document will be modified. We recommend that you periodically review the latest version of this Privacy Notice.

1.      Who we are

This Site is operated by Advanced Bionics AG and its subsidiary, Advanced Bionics, LLC (collectively, “Advanced Bionics”) both owned and operated by Sonova AG, a public limited company, registered in the Commercial Registry of Zurich, under number 101 989 881, whose registered office is at Laubisrütistrasse 28, 8712 Stäfa, Switzerland. Advanced Bionics may be contacted at the addresses below:

Advanced Bionics AG

Laubisrütistrasse 28 8712

Stäfa, Switzerland

Advanced Bionics, LLC

28515 Westinghouse Place

Valencia, CA USA 91355

Other Advanced Bionics affiliates and locations can be viewed at https://www.advancedbionics.com/us/en/home/contact-us/f/ab-global-offices.

Advanced Bionics acts as a Joint or Independent Controller for the processing described in the following section. A given Hearing Care Professional (“HCP”) user may also act as Controller for the processing described in the applicable paragraphs below.

2.      Personal data we collect from you and why

As Joint Controllers, Advanced Bionics and your HCP process your personal data for the following purposes:

-          To register and track recipients of Advanced Bionics’ cochlear implants and their information (including, but not limited to, patient data warranty, insurance status, and device lists), to provide ongoing clinical support. (See “Registration Consent” below)

-          To purchase equipment (including cochlear implant accessories and other technology) or create online requests for servicing, replacement or programming of processors on your behalf. (See “Servicing Consent” below)

o   If you choose to have your product shipped to a specific address (for example, your home address) Advanced Bionics will request consent before processing that information

-          If you are located in the USA, Pro Portal can facilitate collaboration between audiologists, surgeons, and cochlear implant recipients/patients (as designated by HCP or ordering provider) through the web order and kit selection process. This process involves the use of personal information to process the order appropriately. This functionality is limited to the USA and is not compulsory.

All of the above activities are governed by consent. We rely on our HCP partners to appropriately collect this consent from applicable data subjects (like you) prior to processing your data with the Site. Before your HCP processes this information, s/he must have you sign below.

Additionally, Advanced Bionics as a Controller processes your personal data for the following purpose:

-          To facilitate and fulfil regulatory registration requirements when it comes to the deployment and use of Advanced Bionics’ cochlear implants

o   This activity is based on legal obligation where consumer laws or consumer safety regulations require it.

-          To send you promotional and/or advertising and marketing materials or newsletters about Advanced Bionics' products or services

o   This activity relies on your free and explicit consent, which you can revoke at any time. (See the “Advanced Bionics Marketing Consent” below)

3.      How we share your personal data

Your personal data will be processed according to the instructions we provide to our employees who have received the necessary training in data protection and are subject to an obligation of confidentiality.

Your personal data may also be disclosed to:

-          Other companies in our group of companies, such as our subsidiaries, all of which are required to protect personal data in accordance with applicable privacy and data protection laws;

-          Our business partners, contractors and third-party service providers. These third parties only process personal data that are strictly necessary for the services they provide to us, according to our instructions and in compliance with our privacy and security requirements.

-          Other organizations and public bodies, supervisory and control authorities, including law enforcement agencies, as may be required by law.

By using the Site, only personal data that are strictly necessary for the following purposes are shared (the location(s) of your shared personal data may vary depending your country):

-          Microsoft Ireland Operations Limited - Microsoft Azure (The Netherlands): provides cloud infrastructure hosting our services

-          Salesforce, Inc. (United States, European Union): provisions of customer account and administering the account database.

-          SAP AG (European Union): internal Advanced Bionics tool managing orders, devices sold and warranties

-          Global Healthcare Exchange, LLC (USA): provides technical support and integration for the Pro Portal programming center and ordering functionalities

-          Google LLC / Google Ireland Limited - Google Analytics: analytics

-          Google LLC / Google Ireland Limited - Google Firebase: crash analytics, remote configuration. 

Please see https://www.google.com/about/datacenters/locations/ for more information.

Before we disclose any personal data to other third parties than those listed above, we will explicitly ask you for your consent. However, if we are obliged to disclose personal data without your consent, we will only disclose personal data that are strictly necessary for that purpose to fulfil our legal obligations.

4.      International personal data transfers

Please note that some of the above-mentioned third parties can be located outside your country. Therefore, your personal data may be transferred to countries that do not provide the same level of protection of personal data as your own country. In such cases, we undertake to:

-          implement adequate procedures to comply with applicable law;

-          adopt appropriate organizational, technical and legal safeguards in order to ensure an adequate level of protection of the personal data transferred;

-          implement, if necessary, and according to applicable law, standard contractual clauses as adopted by the European Commission;

-          depending on the country of the importing third party, take additional measures such as a transfer impact assessment.

5.      How long we keep your personal data

Advanced Bionics will retain your personal data for a minimal period proportional to the time required to fulfil the purposes outlined in Section 2. For example, relevant personal data will no longer be retained if you delete your account or if our contractual obligations are fulfilled. In the event applicable law or other regulations require a longer retention period, we will apply the longer retention period in order to fulfill our legal obligations.

The personal data processed by HCPs will be retained in accordance with applicable laws. For more information on their specific retention periods, please contact your HCP.

6.      Your legal rights

Within the framework of the collection and processing of your personal data, and as per applicable law, you may have the right to request access, rectification, erasure of your personal data, or restriction of processing. In addition, you may object to the processing, request data portability and withdraw your consent at any time. According to your country, you may have other rights such as providing instructions for how your personal data should be processed posthumously. Under HIPAA you may also have the right to request an accounting of disclosures of your personal data, and the right to receive a paper copy of this notice upon written request.

You may exercise your rights by using the contact details in the “How to contact us” Section below, or you should contact your HCP if your rights concern personal data processed by him or her.

Please note that the exercise of such rights is subject to the limitations provided by applicable law.

If you consider that the processing of your personal data infringes applicable law then you may also lodge a complaint with the local supervisory authority or the competent regulator.

7.      How to contact us

In the event of questions about this Privacy Notice, or the processing of your Personal Data, please contact our Data Privacy Team at privacy@advancedbionics.com.

Patient Consents

Registration Consent

I consent to the collection and processing of my personal data for the purpose of registering me and my cochlear implant with the Advanced Bionics Pro Portal

________________________________________

Signature

 

Date: ________________

Servicing Consent

I consent to the collection and processing of my personal data by the Advanced Bionics Pro Portal for the purpose of equipment (including cochlear implant accessories and other technology) and/or creation of online requests for servicing, replacement or programming of processor(s)

________________________________________

Signature

 

Date: ________________

Advanced Bionics Marketing Consent

I consent to the collection and processing of my personal data for the purpose of receiving marketing materials or newsletters about Advanced Bionics’ products or services 

  

________________________________________

Signature

 

Date: ________________

Effective Date: 04/01/2025