(Cyber) Safe and Sound: How Hearing Aids Became Medical Device Cybersecurity Targets

Hearing aids are no longer straightforward amplification devices; they are now sophisticated, internet-connected tools that store and transmit personal information. This connectivity opens the door to the types of potential cybersecurity threats that the FDA has specifically been trying to clamp down on since well before the release of their latest Medical Device Premarket Authorization Cybersecurity Guidelines. These devices can be susceptible to hacking, leading to unauthorized access to sensitive data and potential misuse.

Many hearing aids use Bluetooth Low Energy (BLE) for communication, which, while energy-efficient, can have vulnerabilities if not properly secured. As medical devices, it’s critical that they remain secure throughout their full product lifecycle, regardless of whether they are placed in secure medical facilities or on an unprotected home Wi-Fi network.

The FDA specifically recommends thinking ahead to where the device will be used to prepare it for its time in the field. During early development, teams must consider:

• The device’s intended use, indications for use, and reasonably foreseeable misuse;
• The presence and functionality of its electronic data interfaces;
• Its intended and actual environment of use;
• The risks presented by cybersecurity vulnerabilities;
• The exploitability of the vulnerabilities; and
• The risk of patient harm due to vulnerability exploitation.

So how can manufacturers ensure their products remain secure even if user habits aren’t?

As hearing aids become more advanced with Bluetooth and wireless connectivity, they offer immense benefits such as seamless smartphone integration, better sound quality, and personalized user experiences. However, this connectivity also makes them potential targets for cyberattacks. These devices’ cybersecurity threats are multifaceted and continually evolving, necessitating robust security measures.

Types of cybersecurity threats include:

1. Unauthorized Access and Data Breaches: Hearing aids often store and transmit sensitive personal information, including hearing profiles, health data, and personal preferences. Unauthorized access to this data can lead to privacy violations and misuse of personal information.
2. Ransomware Attacks: Ransomware attacks on medical devices, including hearing aids, can lock users out of essential functionalities unless a ransom is paid. This type of attack can be particularly harmful as it directly impacts the user’s quality of life and daily functioning.
3. Firmware and Software Vulnerabilities: Firmware and software in hearing aids can contain vulnerabilities that hackers can exploit. These vulnerabilities might stem from inadequate security testing or outdated software. Exploiting such vulnerabilities can allow attackers to gain control over the device, potentially altering its functions or rendering it inoperative.
4. Denial of Service (DoS) Attacks: Denial of Service attacks can flood a hearing aid’s Bluetooth connection with excessive traffic, making it impossible for legitimate devices to connect. This can disrupt the user’s ability to control and adjust their hearing aid settings, severely impacting its functionality.

In response to the growing cybersecurity threats, regulatory bodies like the FDA have established guidelines to ensure the safety of medical devices. The FDA’s 2023 Premarket Cybersecurity Requirements outline specific measures manufacturers must implement to secure their devices. Key elements include:

• Risk Management: Manufacturers must manage and maintain SBOMs (Software Bill of Materials) to identify and assess potential cybersecurity risks throughout the device’s lifecycle.
• Design Control: Security must be integrated into the design and development process.
• Postmarket Surveillance: Continuous monitoring and timely response to emerging threats are crucial.

According to the IEC 81001-5-1 standard, effective product security management involves receiving security testing findings and reports of potential vulnerabilities from various sources, such as Static Application Security Testing (SAST) and Dynamic Application Security Testing (DAST). SAST involves scanning for known vulnerabilities in third-party components based on SBOM and code scanning to identify security bugs and potentially unsafe programming patterns. 

The Product Security Platform helps teams by aggregating findings from multiple sources in a single management system, and in a a standard format, such as SARIF, and scanning for potentially insecure cloud resource configurations and container scanning. DAST includes product-specific, automated dynamic security tests, which can adapt the test result feeds to the format the tool accepts.

Compliance with these guidelines is not just a regulatory requirement but a critical aspect of protecting patient safety and maintaining trust in medical devices.

Product security has become a central focus in developing and deploying medical devices. Traditional approaches to security, which often involve manual processes and ad-hoc measures, are no longer sufficient. The complexity and scale of modern medical device software require a more systematic and automated approach.

Driven by the increasing connectivity of devices and the corresponding rise in cybersecurity threats, modern product security involves a multi-faceted approach that integrates security throughout the entire product lifecycle, from initial design to post-market monitoring.

Security assessments, penetration tests, and vulnerability reports allow product security teams to rapidly ingest vulnerability feeds, triage potential risks, and produce compliance-ready reports. Tracking the handling of vulnerabilities and documenting the vulnerability lifecycle, along with integration with tools like Jira and Polarion, help in generating vulnerability handling reports to demonstrate how vulnerabilities were handled over a given period. Scaling documentation with a centralized platform makes it easy to maintain and recall threat modeling artifacts, link vulnerabilities to them, and generate corresponding reports to view the overall security posture comprehensively.

Advanced security platforms also offer KPI monitoring capabilities that highlight critical information about overall security posture per organizational unit, group of products, and individual projects. These KPI capabilities track compliance with security policies such as secure coding standards, and can also track the FDA recommended KPIs. This systematic approach ensures that security is maintained throughout the device’s lifecycle, addressing both pre-market and post-market phases comprehensively​​.

Key features of advanced product security platforms include:

1. Automated Risk Assessment: Identifying and mitigating risks through automated tools reduces the likelihood of human error and accelerates the security assessment process.
2. Lifecycle Management: Continuous monitoring and updating of security measures ensure devices remain secure throughout their operational life.
3. Regulatory Compliance: These platforms help manufacturers adhere to regulatory requirements by providing up-to-date compliance checks and documentation.

Manufacturers can proactively address potential vulnerabilities by utilizing a comprehensive product security platform, ensuring their devices remain secure against emerging threats. This proactive approach is essential in maintaining the integrity and safety of medical devices in an increasingly connected world.

The integration of Bluetooth and wireless connectivity in hearing aids has revolutionized user experience but also introduced significant cybersecurity challenges. Ensuring the security of these devices requires a comprehensive approach that combines robust product security measures with adherence to regulatory guidelines. Automation and advanced security platforms are crucial in enhancing security and streamlining compliance.

As the landscape of medical device security continues to evolve, staying ahead of threats and regulatory changes will be essential for all stakeholders involved.

Ready to see how this can help your team comply and remain secure? Book a demo.