Hearing technology specialist Nuheara (ASX: NUH) has today obtained a US FDA (Foods and Drugs Administration) registration and medical device listing for its hearing aid, IQbuds2 PRO.

The device received the Class 2 (medical device) 510(k) exempt classification – meaning there is no requirement to conduct clinical trials prior to selling in the open market.

Specifically the IQbuds2 PRO has received OSM classification of “HEARING AID, AIR CONDUCTION WITH WIRELESS TECHNOLOGY”.

This classification is separate to the FDA’s new Over-the-Counter (OTC) hearing aid category, anticipated to be completed at some stage during 2021. Nuheara said it is well-placed to react to that new classification once it is made.

With the registration secured, the IQbuds2 PRO is now expected to be launched in US later in the calendar year.

What are IQbuds2 PRO?

Alongside IQbuds2 MAX, the IQbuds2 PRO is the second product derived from the IQbuds2 hardware platform. The devices are made to cater to a growing need of customers with a wider spectrum of hearing loss.

The PRO has been specifically designed to provide deeper levels of hearing technology sophistication, with higher levels of hearing enhancement and amplification. It’s targeted specifically at adults with moderate to higher levels of hearing loss.

The MAX version, meanwhle, meets the needs of those with milder hearing challenges.

The IQbuds technology was made in collaboration with technology giant, Hewlett Packard, and was initiated back in August last year. HP infused $2 million for the development of the product, and in December, the two companies signed a three-year manufacture and supply deal.

Nuheara has put together a multi-product sales strategy to capture global opportunities in hearing aids, which it estimated to be worth US$9billion per annum. North America alone accounts for USD $3.37 billion of that market.

Nuheara’s share price doubled

In late February, the company announced a massive 406 per cent increase in invoiced revenue to $6.9 million for the first half of 2021. That came on the back of the exponential sales of its IQBuds MAX product.

Despite that growth, the company still notched up a bottom-line loss of $0.84 million for the half, but still a big improvement compared to a loss of $5.72 million it sustained on pcp.

The Nuheara share price has more than doubled in the past 12 months. In March last year, it was trading at 2.2c, and is now much higher at 4.7c.

The share price jumped by almost 5 per cent today on this announcement. However, it has still a fair way to go before regaining its 52-week high of 6.6c reached in August 2020.


Nuheara’s share price chart: