Australian hearing aid firm starts clinical trial of affordable hearing product – will seek FDA approval in 2022

Hearing health company Nuheara, which is based in Australia, has so far primarily dealt with the market for earbuds with hearing enhancing features. Now, they have commenced a clinical trial to gain a foothold in the established market for medically approved hearing aids. The company plans to apply for FDA approval in the first quarter of 2022.

A modern hearing aid. | Photo: Thomas Frey/AP/Ritzau Scanpix

The second hearing aid of its type to be approved by the US Food and Drug Administration (FDA) for direct-to-consumer sales in the US is taking its first steps towards the future US over-the-counter (OTC) sales channel.

Australian-based Nuheara, which has so far mostly concerned itself with the market for earbuds with different degrees of hearing enhancing technology, has recently begun a clinical trial to test the safety and effectiveness of its newly developed series of hearing aid products, it writes in a press release. In August, the company aired its plans to have its product series Iqbuds clinically validated and approved.

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