Guess which ASX biotech share is soaring 32% on a ‘landmark’ FDA ruling

The Nuheara Ltd (ASX: NUH) share price is rocketing on Wednesday afternoon.

This comes after the company announced the US Food and Drug Administration’s (FDA) landmark ruling for over-the-counter (OTC) hearing aids in the United States.

At the time of writing, the hearing solutions provider’s shares are leaping to 24.5 cents, up 32.43%.

FDA opens Nuheara OTC hearing aids to US market

Investors are driving Nuheara shares higher following the company’s positive release.

In today’s statement, Nuheara advised that the US FDA is allowing hearing aids within the OTC category. Thus, they can be sold directly to consumers in stores or online without a medical exam or fitting by an audiologist.

It noted that the FDA received over 1,000 public comment submissions on the proposed rule change. Most of these submissions were in favour of OTC hearing aids being more accessible for the 38 million Americans experiencing hearing loss.

Currently, hearing aids are considered expensive in the country, with the average cost at around US$4,726 for a pair. However, they can fetch for US$10,000 if going through a licensed audiologist or a licensed hearing aid retailer.

With the landmark ruling, OTC purchases for a pair of hearing aids could cost less than US$1,000 per pair.

At the moment, there’s a 60-day enactment period until OTC hearing aid consumer retail sales can commence. It is likely this will come into effect in mid-October.

Management commentary

US-based Nuheara CEO John Luna said:

The US hearing aid market is forever changed with this OTC hearing aid final rule publication. We’re very excited in the knowledge that the US consumer could very soon be making the decision to self-care, self-fit with affordable non-prescriptive hearing aids available over-the-counter in traditional retail and online.

This historic change will save consumers with perceived mild-to-moderate hearing loss thousands of dollars on a pair of hearing aids.

Nuheara is well positioned with our OTC hearing aids (pending FDA clearance), through our trademark license agreement with HP Inc. that will be initially available at Best Buy retail stores in the US. OTC hearing aids will become a significant part of Nuheara’s future as we continue to innovate to bring new hearing products to market.

Nuheara share price snapshot

Despite rocketing 32% today, the Nuheara share price has fallen by more than 60% over the last 12 months.

After reaching a 52-week high of 72 cents in August 2021, the shares gradually began treading lower throughout the year.

Based on today’s price, Nuheara presides a market capitalisation of approximately $25.38 million.

The post Guess which ASX biotech share is soaring 32% on a ‘landmark’ FDA ruling appeared first on The Motley Fool Australia.

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Motley Fool contributor Aaron Teboneras has no position in any of the stocks mentioned. The Motley Fool Australia’s parent company Motley Fool Holdings Inc. has no position in any of the stocks 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 Scott Phillips.

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