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.
BY ALBERT RØNNING ANDERSSON, TRANSLATED BY CATHERINE BRETT AND DANIEL PEDERSEN
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.