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Nuheara hopeful others will follow US in approving sale of over-the-counter hearing aids

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Danielle Le MessurierThe West Australian
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Nuheara managing director Justin Miller.
Camera IconNuheara managing director Justin Miller. Credit: Jackson Flindell/The West Australian

The co-founder of smart-hearing company Nuheara is hopeful other regulatory bodies will follow the US Food and Drug Administration’s lead in approving the sale of over-the-counter hearing aids.

Justin Miller said the landmark decision was a “pivotal day” for Nuheara, which as of Thursday has waited exactly five years for the changes to be implemented after Congress passed legislation in 2017 requiring the FDA to create a category of OTC hearing aids.

From mid-October, an estimated 38 million Americans with mild to moderate hearing loss will be able to buy the devices without seeing an audiologist. The ruling is significant for Nuheara, which says it is in pole position to lead the way with OTC offerings having spent the last five years building the “self-fit” category through direct-to-consumer and retail sales channels.

“We’ve got some confidence now the FDA have this category, other regulatory bodies around the world will follow suit,” Mr Miller told The West Australian, also saying it could be the turning point for the company.

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The news excited the market and sent the Perth-based company’s shares up 6¢, or over 32 per cent, to close at 24¢. However, shares are down 91 per cent on the high of $2.70 in March 2018.

Mr Miller, also Nuheara’s managing director, said there was a massive unmet need when it came to servicing hearing loss globally. About 1.5 billion people have some form of hearing loss, yet large hearing aid companies only push out between 14 million and 15 million hearing aids each year, he said.

“A lot of that is to do with affordability. The average price of a hearing aid pair is about $US5000 and a good set is $US10,000 — a lot of people put it off until a time they desperately need it and pay the big bucks,” Mr Miller said.

“The whole ambition is to see so many more people be able to access it, educate themselves about treatment and have this self-fit process where they can control the hearing healthcare journey on their own.”

Nuheara is awaiting FDA clearance for its OTC hearing aids but is confident it will receive the green light by the end of the year following a successful clinical trial.

Mr Miller said regulation was the last piece of the puzzle for Nuheara — the company has already proven its technology and developed alternative channels to reach the consumer with major US retailers such as Best Buy and Walgreens. It also has a trademark licence agreement with computer manufacturer HP.

“The fact we can tick that box now gives us some confidence we’ve got all those three pillars built and ready to attack the market,” Mr Miller said.

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