The Nuheara Ltd (ASX: NUH) share price opened 13% higher today after the company announced FDA approval for one of its flagship products.
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The Nuheara Ltd (ASX: NUH) share price opened 13% up today after the smart hearing technology company announced its IQbuds2 PRO (PRO) product has received US FDA registration.
The PRO is a hearing aid designed to provide high levels of hearing enhancement and amplification with up-to-date hearing technology.
The Nuheara share price has dropped since this morning but remains more than 2% higher than yesterday’s close.
More about Nuheara’s hearing aids
The PRO is the second product delivered from Nuheara’s IQbuds2 hardware platform. It is designed for those with moderate hearing challenges.
It’s expected to be launched in the US later this year, extending the company’s reach in the global US$9 billion per annum hearing aid market. The North American market alone is worth US$3.37 billion.
Nuheara advised that, as with all hearing aids with air conductions and wireless technology, the PRO is exempt from clinical trials. This means the product can go straight to market in the US.
IQbuds2 MAX (MAX) was the first product to be developed from Nuheara’s hardware platform. MAX is designed to meet the needs of those with mild hearing challenges.
Commentary from management
CEO of Nuheara Justin Miller said the development of the PRO and MAX are significant in making hearing health more accessible and affordable.
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.
Nuheara share price snapshot
The Nuheara share price is currently at 4.5 cents, up 2.27% from yesterday’s close. It is down 8% year to date but up 95% over the last 12 months.
Nuheara has a market capitalisation of $75.8 million and approximately 1.7 billion shares outstanding.
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Motley Fool contributor Brooke Cooper has no position in any of the shares mentioned. The Motley Fool Australia has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy. This article contains general investment advice only (under AFSL 400691). Authorised by Bruce Jackson.