While Americans battle to manage an array of health concerns sweeping the elderly, hearing loss may not be one of them with medtech company Nuheara (ASX: NUH) granted US Food and Drug Administration (FDA) approval for its new wireless hearing aid, IQbuds² PRO.

The PRO version expands the Company’s range of wireless, low cost hearing aids which was first launched back in 2016. This latest version has been designed to provide deeper levels of hearing technology sophistication, while delivering greater levels of hearing enhancement and amplification. The PRO is expected to be launched in the US later in the calendar year.

Granted Class 2 medical device classification, Nuheara’s PRO range can now be sold commercially in the US without the need to conduct new clinical trials.

“This is a significant development in Nuheara’s mission to make hearing health more accessible and affordable for all,” said Justin Miller, CEO of Nuheara.

“Over many years the business has invested tens of millions of dollars in our proprietary hearing
technology platform. The IQbuds² PRO as a hearing aid device represents further opportunities to expand Nuheara’s leadership position in both hardware and software of hearing health devices.

“This registration effectively enables Nuheara to meet the varied hearing needs of a growing base of underserved customers with a wider spectrum of hearing loss.”

Designed to support adults with higher (moderate) levels of hearing loss, the PRO will extend Nuheara’s Direct-to-Consumer strategy targeting the global USD $9billion per annum hearing aid market.

Nuheara’s strategy has been to maximise the Company’s global sales opportunities by offering multiple products that support varying degrees of hearing loss whilst optimising the Company’s sales strategy without relying entirely on distribution partners.

In 2020, Nuheara released its third generation IQbuds² MAX, which will continue to meet the needs of those with more mild hearing challenges and are sold via their own website but can also be purchased in major consumer electronics retailers, professional hearing clinics, pharmacies and optical chains around the world.

Having incurred substantial R&D expenses in recent years, the popularity of Nuheara’s IQbuds² branches has the Company on the verge of cash flow positivity.

For the Half-Year ending 31 December 2020, Nuheara reported a 406% increase in revenue on the previous corresponding period to $6.9 million. This resulted in a net loss of $842k but a substantial 85% improvement as the Company eyes profitability.