Perth-based manufacturer Nuheara has requested that the US Food and Drug Administration (FDA) expedite an act that would make over-the-counter (OTC) hearing aids more affordable and accessible.
The company has directly petitioned the FDA commissioner Scott Gottleib to accelerate the OTC Hearing Aid Act, and has also encouraged the FDA to consider a set of standards already prepared by the US Consumer Technology Association (CTA) that it claims would regulate OTC hearing devices.
Nuheara is a global manufacturer of smart, personal hearing devices that augment a person’s hearing, and in 2016 released its wireless IQbuds, which are now sold worldwide.
The company will be launching IQbuds Boost, which, according to an ASX statement, is the only product on the market at this time that adheres to the OTC Act requirements.
The major impact of the OTC Hearing Aid Act would be to enable products to be sold directly to the consumer, without a prescription from a doctor.
However, before OTC hearing aids can be sold, the FDA must develop standards and a plan to regulate them within three years, which Nuheara hopes to expedite.
“We are committed to implementing the legislation through a deliberative, transparent process, informed by notice and comment rule making as required by law,” said William Maisel, from the FDA’s Center for Devices and Radiological Health.
“We share Nuheara’s enthusiasm for the tremendous potential of the legislation to increase access and quality of life for hearing impaired Americans.”
The American Association of Retired Persons (AARP) estimates that more than 30 million people in the US experience challenges with hearing while only 20 per cent of those are using hearing aids.
“We are already providing significant hearing accessibility benefits to consumers with our game-changing products,” said Nuheara CEO Justin Miller.
“We are as one with the FDA on our mutual objective to provide more accessible and affordable hearing health care.”