The Role of the Consumer in Hearing Aid Development

By Jennifer Groth

Although hearing aids are classified as medical devices, there is no regulation or mandate for consumer testing as with invasive medical devices or  pharmaceuticals. Hearing aid manufacturers decide for themselves how to seek and use consumer input. ReSound places a high value on the experiences of consumers with our products. Therefore we have established formal processes – many of which are included as part of our ISO 9001 certification – to involve consumers in all phases of product conception, development and evaluation.

Testing with consumers at various phases of product definition and development is critical not only in making the best design choices, but also in finding and fixing or mitigating defects and shortcomings before products are released. At ReSound, we conduct research in five general areas, four of which involve consumers.

Market Research
The general purpose of market research is to learn about consumers, their needs and satisfaction with current technology and hearing aid delivery models. This information feeds into decisions that ultimately are made about what products and product features to develop, as well as decisions about how to market these products. Market research is typically carried out via focus groups, surveys or interviews. For such research participants are most often recruited through contacts with hearing care professionals. In addition, external market researchers have access to consumer panels, and can recruit participants who meet a defined demographic profile.

Translational Research
We use this term to describe in-house research that proves concepts and investigates feasibility issues. An example might be qualification of a new feedback cancellation algorithm. Investigations would begin with computer simulations, and advance to robotic testing in order to fine-tune parameters. Finally, consumers would be fitted with actual hearing aids using the new algorithm to test performance, as well as to determine the best parameter settings from among a winnowed subset. It is not unusual for concepts tested in the translational research phase to be cancelled entirely or shelved until technology “catches up” enough to make them feasible in hearing aids.

Product Development
Product development refers to the process by which hardware and software platform technologies are combined to build a commercial product. Our process includes a series of in-house consumer trials which we call “pre-alpha” and “alpha” trials. Pre-alpha trials are carried out with prototype or otherwise non-final product elements. For example, fitting software may not be ready at a time when it is desired to trial a new form factor design with consumers. In this case, testing can still be carried out using development tools for programming of the devices. The final proposed hardware and software – including signal processing and fitting software – are tested in the alpha trial. Each of these pre-alpha and alpha trials will enlist the aid of anywhere from 10 to more than 100 participants, and will last from 6 to 12 weeks.

Proof-of-Benefit Testing
Because product development research is heavily focused on validating product quality and usability, it is desirable to further investigate certain product characteristics for the purpose of demonstrating that consumers derive benefit from them that is consistent with the intention. In addition, proof of benefit testing is part of the learning loop that feeds information back to the development process in order to improve hearing instruments. We often outsource proof of benefit trials to an external site. This is to reduce the positive bias that consumers who participate in in-house trials typically exhibit toward the products.