CR focus areas
Product quality, safety and reliability
Regulatory and standards
Sonova’s medical devices are regulated globally by government agencies, healthcare authorities, and other regulatory bodies who verify that we are complying with applicable health and safety regulations throughout our products’ life cycle. We work to maintain transparent, constructive, and professional relationships with all applicable regulatory authorities on matters of policy, product submission, compliance, and product performance. The requirements we meet include design controls, marketing approvals, good manufacturing practices, vigilance systems, clinical studies, and other relevant product regulations, standards, and normative documents specified by these agencies.
We evaluate potential product-related risks using a systematic method to estimate, evaluate, control and monitor risks, governed by the ISO 14971 standard, which specifies the application of risk management to medical devices. We ensure up to date knowledge of regulatory and statutory requirements through initial and maintenance training programs.
Each national healthcare authority has specific requirements for products that are made available in its national territory. Requirements for hearing instruments in Europe are mostly centered around European legislation, including the Medical Device Directive 93/42/EEC, the Radio Equipment Directive 2014/53/EU, and requirements for conformity to other applicable international standards. In the US, hearing instruments are regulated by the United States Food and Drug Administration (FDA) and classified as class I medical devices (hearing aids) and class II (wireless hearing aids). Both categories are exempt from the requirement to submit premarket notification submissions and can be introduced into commercial distribution without a premarket FDA clearance notification.
Cochlear implants and their respective accessories from Advanced Bionics are classified in Europe as Active Implantable Medical Devices (AIMDs), regulated by the EU Active Implantable Medical Devices Directive 90/385/EEC; prior to market launch, AIMDs must undergo a formal premarket submission-type process. In the US, they are classified as class III medical devices and must also therefore undergo a separate premarket submission procedure prior to market launch.
All our operation centers and major group companies are certified according to the ISO 13485 standard and fulfill the requirements for quality management systems of the US FDA Quality System Regulation, Title 21 CFR Part 820.
Sonova carefully monitors changes in the relevant worldwide regulatory environment to ensure the conformity of its products at all times. In 2019/20, Sonova has been working on its compliance with recently published changes in European medical device regulation represented by the transition from Medical Devices Directive 93/42/EEC to Medical Devices Regulation (EU) 2017/745.
All products brought into commercial distribution by Sonova group companies are continuously assessed to improve safety and effectiveness. Sonova uses tools such as complaint handling, post-market surveillance, vigilance reporting, reliability and trending analysis, and post-launch engineering to achieve and maintain regulatory compliance.
Advanced Bionics implant reliability
As part of our commitment to providing clear and accurate information, Advanced Bionics reports all device failures in adherence to global standards, as defined by ISO 5841-2:2014 and the principles outlined in the European & Global Consensus on Cochlear Implant Failures and Explantations. Although all CI manufacturers adhere to these standards, other manufacturers may report using different definitions of what constitutes a device failure, and therefore not include the same types of information in their reliability statistics. Advanced Bionics is committed to providing patients and professionals with the most complete reports on all of our returned devices, with data presented clearly and transparently, so they can make fully informed decisions about their hearing needs.
The prime concerns at Advanced Bionics are the safety and hearing experience of recipients, and the reliability of our products. It is in this spirit that we undertook a voluntary field corrective action in February 2020 and retrieved from the market the unimplanted units of the initial version of our HiRes™ Ultra and Ultra 3D cochlear implants. The vast majority of these devices function correctly, but we took this step in an abundance of caution, having observed an increase in reports of reduced hearing performance. Most importantly, there have been zero reported safety events relative to this issue with these devices. The initial version of the HiRes™ Ultra 3D implant has been superseded by a new version, which includes several improvements to support consistently good hearing performance.
Product reliability global targets
Sonova has set as a priority target the improvement, by more than 20% year-on-year, of its average product reliability rate for both hearing instruments (HI) and cochlear implants (CI). We define the HI product reliability rate as the ratio between the annualized number of in-warranty product returns over the past three months and the number of hearing instruments in the market and within warranty (installed base). We define the CI product reliability rate as the Naìda pediatric system monthly product returns divided by the number of registered Naìda processors used by pediatric recipients. The target focuses on the Naìda pediatric processors, because external parts constitute the vast majority of all product returns, and return rates for pediatric products are comparatively higher than for adults.
In 2019/20, we improved the average HI product reliability rate by 4% and the CI product reliability rate by 27% compared to the previous year. We are working towards achieving the target next year for both HI and CI. Measures have already been initiated, such as the redesign of product components, continuous quality improvements, training and awareness raising activities, and specific root-cause analysis of product returns.
Data privacy and digital ethics
Data privacy and protection
Sonova protects the confidentiality and integrity of the data it holds, including the data of employees, customers, patients, and business partners using technical and organizational means. We adhere to applicable data protection laws and regulations. We closely monitor developments in data protection law and incorporate its principles into our business processes and product design. We continue evolving our data protection program to meet the changing demands of the digital environment.
Sonova issued a Group Data Protection Policy, effective June 1, 2018. The policy covers all personal data collected or processed by Sonova, and applies to all Sonova legal entities and their employees and contractors on a worldwide basis. The policy is complemented by standard operating procedures and guidelines that break down the various data protection and privacy topics and provide more detailed guidance.
Sonova has established a Global Privacy Office, which provides subject matter guidance and training to the management, business functions and employees. The Global Privacy Office is also responsible for the support and monitoring of the Sonova Data Protection Program. The implementation of the Program is part of the regularly conducted internal audits, and the Global Privacy Office and the Internal Audit Team are working closely together when conducting the audits and monitoring deriving actions.
In addition, an important part of the Global Privacy Office’s work is to raise awareness and provide training on all levels across the Group. A mandatory online training for all employees has been developed and deployed by the Global Privacy Office, complemented by on- and offline trainings for specific departments and teams (e.g. Marketing, HR, R&D), webinars and communication platforms for knowledge exchange. These trainings contain the essential legal principles and requirements, taking into consideration Sonova’s Data Protection Policy and legal frameworks like the EU General Data Protection Regulation (GDPR), the Health Insurance Portability and Accountability Act (HIPAA), the California Consumer Privacy Act (CCPA), the Personal Information Protection and Electronic Documents Act (PIPEDA) or Data Protection and Security laws in China.
IT and cyber security
Securing information assets is a priority for Sonova. We are committed to secure digital and non-digital files, records, and information to prevent unauthorized access, modification and loss. IT and cyber security is supported by guidelines issued by the Vice President Corporate IT who acts as Chief Information Officer (CIO) and reports directly to the Group CFO. The guidelines on IT security determine security standards for all functional or business applications controlled by Sonova.
Sonova issued an IT Acceptable Use Directive in 2012/13, which is regularly revised and was last updated in 2018/19 and effective January 1, 2019. The guideline defines the use of IT assets, the secure use of systems and programs, as well as the appropriate and secure management of data. The Information Security Guideline, effective October 31, 2019, specifies processes and responsibilities to ensure IT and cyber security, including digital information processed and stored on our products.
Relevant global and local staff receives training to secure implementation of the guidelines. Our continuing efforts to ensure IT security and cyber security were underpinned during the 2019/20 financial year with further mandatory IT security online training for all employees worldwide. In areas with significant risk of un-detected data security breaches or areas of very sensitive information penetration tests are applied from time to time by qualified external providers. We have not identified substantiated complaints concerning breaches of customer privacy in 2019/20.
Ethical marketing and sales practices
Policies and guidelines
Sonova adheres to strictly ethical marketing practices in all our businesses and takes active steps to prevent inappropriate practices or false claims. We ensure that our advertising, packaging and promotional material provide accurate, balanced, and non-misleading information. This commitment is laid out in our Group Code of Conduct and further refined in policies, guidelines, and standard operating procedures, e.g. on claims management.
Interactions with healthcare professionals
Sonova is committed to ethical interactions with healthcare professionals (HCPs). We interact with HCPs on a daily basis, in a variety of roles and settings. They include audiologists and acousticians, professors, surgeons, ear nose and throat specialists, or researchers. The following “Four-Leaf Clover Principles” govern our cooperation with healthcare professionals:
- we must strictly separate our sales activities from our engaging of healthcare professionals to provide services to Sonova;
- we must properly document their services to us;
- we must not pay them more than the fair market value of their services; and
- we must be transparent about our collaboration with them.
More detailed information on how we ensure ethical interactions with healthcare professionals is provided in the Sonova Global Antibribery Policy as well as internal standard operating procedures and country-specific guidelines for interactions with HCPs.
Sonova is committed to ensure that statements declaring or implying that a product or service will provide a benefit to customers or consumers are truthful, non-misleading and fair. We have established a claims management process that defines how to identify, substantiate, and administer a claim for products from all Sonova brands. Claims go through a standardized review and approval process by a dedicated committee before being disseminated. The purpose is to ensure both compliance with global regulatory requirements and a high quality standard of claims. Relevant employees have to complete annual training on the claims management standard operating procedure. In 2019/20, the internal audit function performed an audit of the claims management process and systems.
As a manufacturer of medical devices, Sonova is required by regulatory authorities to demonstrate the biological safety of any product with body contact by complying with the international standard ISO 10993-1. According to this standard, animal tests need to be considered in biological safety evaluations; in some cases, they cannot be completely avoided. Sonova also provides components of cochlear implants to cochlear implant research centers and universities, where these are tested on animals for basic research concerning e.g. safety, feasibility or efficacy of new technologies.
Sonova does not carry out any animal testing in-house and only works together with third parties. We are committed to the “Three Rs” principle – replacement, reduction, and refinement – to limit animal testing as far as possible.
- We use non-animal testing methods (in particular testing with cell cultures) or chemical constituent testing in situations where these methods are accepted by the respective regulatory bodies and yield information as relevant as that obtained from in vivo models.
- We monitor the development and regulatory acceptance of new in vitro methods.
- We apply strategies to reduce the number of animals used in testing.
- We use previously evaluated or historically established biologically safe materials whenever possible, by taking advantage of shared research between the different Sonova companies around the world. We strive to avoid completely any unnecessary or duplicated testing.
- We emphasize risk assessment to evaluate clearly any need for animal testing.
- We select those test methods that minimize the distress caused to animals.
- We conduct all animal testing for biological safety evaluations through appropriately accredited testing laboratories. All tests are conducted according to recognized valid and current best laboratory and quality practices, such as the OECD Principles of Good Laboratory Practice.
- We conduct animal testing for research collaborations only through universities and research laboratories where experiments are reviewed, approved and overseen by the respective ethics committees.