Bose SoundControl Hearing Aids Owner’s Guide
Project focus
Ensure that users can safely and effectively wear, adjust to, and maintain over-the-counter hearing aids without the help of traditional audiology appointments.
Challenges
Per the design team's goals, the printed owner’s guide needed to be easily accessible, navigable, and reassuring for the intended user.
To support the product's clinical claims, the documentation needed to provide the context and support that users would typically receive from an audiologist when fitting and tuning a traditional hearing aid.
As Bose's first Class 2 medical device, the development process and product had to comply with strict FDA regulatory requirements to ensure safety.
Solutions
Worked alongside the project illustrator, UX designer, and human factors engineer to provide creative input on a new layout and visual design that prioritized usability, discoverability, and clarity.
Interviewed Clinical team members, conducted research, and analyzed competitor documentation to understand and explain hearing aid adjustment and maintenance.
Updated instructions to improve clarity and effectiveness based on feedback from multiple formative studies.
Worked in a Quality Management System and collaborated with Clinical, Regulatory, Human Factors, and other stakeholders to ensure that documentation met all internal and FDA regulatory requirements.
Completed training to understand relevant regulations and their impact on product labeling, including 21 CFR Part 820, IEC 60601-1, and IEC 60601-2.
