FDA takes steps to improve hearing aid accessibility

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The U.S. Food and Drug Administration (FDA) have announced important steps to better support consumer access to hearing aids. The FDA will consider creating a category of OTC hearing aids that could deliver new, innovative and lower-cost products to millions of consumers.

The agency also announced important steps to better support consumer access to hearing aids. In a guidance document, the agency explains that it does not intend to enforce the requirement that people aged 18+ years receive a medical evaluation or sign a waiver prior to purchasing most hearing aids. Under the new guidance, the FDA will continue to enforce the medical evaluation required for people under 18 years of age.

The agency also requires that consumers are provided with information and instructions about hearing aids before any purchase from a licensed hearing aid dispenser. This guidance is effective immediately.

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FDA Commissioner Robert Califf, M.D commented “Today’s actions are an example of the FDA considering flexible approaches to regulation that encourage innovation in areas of rapid scientific progress,”Califf continued “The guidance will support consumer access to most hearing aids while the FDA takes the steps necessary to propose to modify our regulations to create a category of OTC hearing aids that could help many Americans improve their quality of life through better hearing.”

The FDA has cited that hearing loss affects some 30 million people in the United States and can have a significant impact on communication, social participation and overall health and quality of life.

What Causes the INNOVATION Slowdown in OTC from OTC INSIGHT Europe

Chris INSIGHT Header 2014The April edition of OTC INSIGHT Europe contains a full round-up from Nicholas Hall’s 25th European OTC Conference & Awards, held in the beautiful city of Luzern, Switzerland, last month. Innovation – or the lack of it – was the core theme, with the majority of delegates in agreement that a new approach is required in order to boost growth in our industry.

Several expert speakers reminded us that true innovation is about a whole lot more than traditional product line extensions or marketing campaigns; at its core is the desire to solve an unmet need and make a real difference to the consumer experience. How much successful innovation of this kind have we seen in the European OTC market over the past few years?

Frustrating regulatory issues undoubtedly play a part in limiting change of this kind, especially a risk-averse approach to Rx-to-OTC switch alongside a lack of incentives such as marketing exclusivity. As well as lobbying regulators and governments to explain the real public health and economic benefits offered by OTC, healthcare companies should also embrace problem solving, creative thinking and calculated risk-taking in order to have the best chance of nurturing game-changing innovation.

You can read more on about the the events within the OTC industry in Europe in our month OTC INSIGHT Europe periodical.