In 2005 I accepted the position of Development Audiologist, at Bernafon Headquarters in Bern Switzerland. Did I have any idea of how a hearing aid family is developed and ultimately released into the market? No. But I do now.
It can take anywhere from 2 to 5 years to develop a brand-new high-end hearing aid family accompanied with accessories, new hearing aid styles and a new fitting software platform. It is a long, document-filled process involving a significant number of people, tests, evaluations, validations, verifications, proof-readings, problem solving, coding, countless meetings and decisions.
Once the management board approve the application for development, the project is ready to begin. At this time, the names for the hearing aid product, the new RIC or BTE style and the new fitting software platform are all undefined. Therefore, these individual projects are christened with a name - for example Project Foxtrot, Alpha and Primo, respectively - for documentation and internal communication purposes.
Each project has a defined timeline. This means that the company knows when the hearing aid family will be released to the global market - this is known as Release for Sales. To meet this deadline, the entire project is divided into smaller segments. At the end of each phase (known as a Milestone) the project must complete and submit a very long list of approved documents - such as electro-acoustic evaluations of receivers, microphones or amplifiers, clinical studies, test-cases, audiological, marketing and training concepts. The list is long. If milestones are not achieved or if things go wrong, then projects can be delayed. These are scenarios which are not ideal and create a great deal of stress. Ultimately there’s always a solution but achieving them may take a bit longer than planned.
So, who are the key players involved in keeping Projects Foxtrot, Alpha and Primo on track?
Firstly, you need someone who is capable of managing the entire project - the Project Leader. This person is highly skilled, very organized, a whizz at Excel, is responsible for coordinating timelines and knows what document is needed by whom and by when. The Project Leader must be in constant communication with all Product Managers, Team Leaders, Production, Quality, suppliers and management. It is common to have one dedicated Project Leader for the development of the hearing aid technology and marketing campaign, one for the development of the fitting software and one for the design and development of a new hearing aid style (e.g. RIC). These three Project Leaders must coordinate their planning so that all deliverables are achieved when required.
If Project Leaders coordinate the overall planning of the project, Product Managers are responsible for everything which accompanies the product and software. If, for example, the new product release includes new RIC, BTE or custom styles then it might mean new wax filters, receivers, ear hooks, thin tubes, thin tube adapters, domes, DAI/FM shoes etc.
Not only are they responsible for coordinating the introduction of these new styles and parts, but have a strong overview of every feature, accessory and programming device to be released.
The engineers and designers
Who builds and develops the exciting bits? A collection of incredibly smart, innovative, creative, quirky and hardworking engineers. What they know is scary and their explanations of signal processing or how these complex features work borders on the incomprehensible. Apart from development, their work also involves verification - is the feature working as defined? This is an incredibly important part of the project. Every feature must be verified.
The development of new hearing aid styles involves a team of Mechanical Engineers. Once the design of the BTE/RIC is approved, the engineers visually evaluate the placement of all components within the new RIC/BTE with sophisticated 3D software. The project then enters the “Tooling Phase” which can take up to six months. An example is a new battery door. To mechanically build it, a tool must first be constructed. This applies for every new mechanical component. Once these tools are built, BTE/RIC samples are developed, evaluated and components re-worked, if necessary.
Working alongside these software, electro-acoustic and digital signal processing engineers are the Development Audiologists. In Switzerland, Audiology does not exist as a profession. Therefore, Bernafon must employ audiologists from abroad and I worked alongside audiologists from America, Germany, France and Canada. Our views, knowledge, experiences and expectations of what absolutely must be included in a product differed widely and understanding the market needs of our global partners was essential.
As the project moves forward, they dive a bit deeper into the functionality of the feature and provide input on its representation within the software. The final stage of the project involves clinical validation – that is the evaluation of the feature on clients with a hearing loss. This requires strict planning, timelines, a clear objective and pages of documentation.
The marketeers and trainers
A month prior to launch, all key stakeholders must participate in a two-day training session on the upcoming release. Who is responsible for the creation of all training and support materials including the planning and running of these training sessions? The Team Leader for Training and Product Support - my role during the last seven of my twelve years at Bernafon.
The participants of this training session came to Bern, from all over the world, to learn about all the new features, accessories, styles and software. Planning the training materials for this event would start approximately six months beforehand. Multiple meetings with the Product Managers filled my calendar as it was imperative that my team and I understood the deliverables of this project. Given hearing aid technology is incredibly complex, the communication to the global sales teams, hearing care professionals and ultimately the client must be simplified. Therefore, I worked closely with the Marketing Communicator and Product Manager to convert the complexity of a newly-developed feature into an easy-to-understand message supported by presentations, graphs and animations. My last task, prior to returning to Australia, was to define the functionality of the DECS™ animation, released with Zerena.
The highly creative Marketing Communicator is pivotal in the development of the product name, the campaign, supporting visuals and materials such as brochures and sales flyers. To create the marketing campaign, the Marketing Communicator must develop a strong understanding of the new features and ultimately the client benefits.
It was common for the USA to request culturally-diverse models whereas the French wanted a more European look. What happens after the product is released? Apart from a monumental sigh of relief, my team and I entered our busiest period traveling the world to support our sales companies and train our international distributors. All inputs from the markets would be collected and directed to the appropriate teams in Bern for evaluation and quality.
However, as the world excitedly embrace these products, it is already old news at Headquarters. A new project has been approved and Project Leaders, Product Managers, Engineers, Audiologists, Marketing and Training teams have already moved on to developing the next big release.
But what about the end user – our clients?
Ultimately, the needs and requirements of the client must remain in focus throughout the project. It is important that everyone involved in the development of hearings aids and accessories continually ask - How does this benefit the client? What problem are we trying to solve? How do we expect the client to utilize this technology and how should it be implemented so that the usability is easy for the client and the clinician?
It is therefore common for engineers to meet regularly with audiologists to gain a better understanding of the expectations of the end user. These discussions are vital and can significantly influence the development of hearing aid features, accessories and the fitting software. Without this input, the voice of our clients would remain unheard.
This article was originally published in Audiology Now 75, 2019 and reprinted with permission of Audiology Australia.