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.

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At the time of writing, the hearing solutions provider's shares are swapping hands for 5.3 cents, up 6%.

What did Nuheara announce?

Investors are pushing Nuheara shares higher following the company's latest update.

According to this morning's release, Nuheara advised it has begun mass production of HP Elite Wireless Earbuds for HP Inc (NYSE: HPQ). This follows HP's recent approval of the initial samples, paving the way for commercial production.

Nuheara highlighted that this will be the first product to be manufactured under the umbrella supply agreement. Both parties entered into a partnership arrangement in late December last year.

The Elite Wireless Earbuds will be offered as bundled options to customers with the purchase of select HP notebook computers.

Large-scale manufacturing of the Elite Earbuds has started, with shipment to take place in early May 2021.

What did the CEO say?

Nuheara CEO Justin Miller commented on the partnership agreement:

We are incredibly proud to be working and developing products for HP, a global technology leader. Nuheara's co-development of the new HP Elite Wireless Earbuds has seen this new product delivered, from concept to mass production, in record time.

Our strong working relationship with HP has been critical in developing and manufacturing this product seamlessly. As global leaders in our respective markets of PCs and Hearables, Nuheara anticipates the strengthening of this partnership over the next three years to continue the supply of innovative audio solutions to HP's customers.

About the Nuheara share price

The Nuheara share price has accelerated to more than 200% in the last 12 months, particularly from July 2020 onwards. The company's shares reached a 52-week high of 6.6 cents in August before moving in circles thereafter.

On valuation grounds, Nuheara commands a market capitalisation of around $86.1 million, with 1.7 billion shares on issue.

The post Why the Nuheara (ASX:NUH) share price is soaring 6% today appeared first on The Motley Fool Australia.

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.

The post Why the Nuheara (ASX:NUH) share price is up today appeared first on The Motley Fool Australia.

Four shares that are climbing more than most today are listed below. Here's why they are charging higher:

A2 Milk Company Ltd (ASX: A2M)

The a2 Milk share price is up 4% to $11.38. Investors have been buying the infant formula company's shares after they were sold off earlier this month following a guidance downgrade. It appears as though they believe the selling was overdone and the headwinds it is facing in the daigou channel are only temporary.

Adacel Technologies Limited (ASX: ADA)

The Adacel share price has jumped 8% to 96 cents. This morning the air traffic management systems provider announced its intention to conduct an on-market share buy-back during the period from 11 January 2021 to 10 January 2022. According to the release, the company will acquire up to approximately 7.6 million or up to 10% of its shares on issue.

Dusk Group Ltd (ASX: DSK)

The Dusk share price is up a sizeable 12% to $2.02. Investors have been buying the home fragrance product retailer's shares after it provided a positive trading update. Management expects sales for the first half of FY 2021 to be in the range of $90 million to $90.5 million. That compares to $58.7 million in the first half of FY 2020. Earnings before interest and tax (EBIT) is estimated to be between $26 million and $27 million. This is up materially on FY 2020's first half EBIT of $9.7 million.

Nuheara Ltd (ASX: NUH)

The Nuheara share price has rocketed 13.5% higher to 5 cents. The catalyst for this was a big announcement by the smart and affordable hearing solutions provider. Nuheara has signed an agreement to manufacture HP-branded products for American multinational information technology company HP Inc (NYSE: HPQ). According to the release, the hardware product purchase agreement has a contracted initial term of three years with automatic renewals for successive one-year periods.

The post Why a2 Milk, Adacel, Dusk, & Nuheara shares are charging higher appeared first on The Motley Fool Australia.

In morning trade the Nuheara share price is rocketing 23% higher to 5.4 cents.

What did Nuheara announce?

This morning the smart and affordable hearing solutions provider released two big announcements.

The first announcement revealed that Nuheara has signed an agreement to manufacture HP-branded products for American multinational information technology company HP Inc (NYSE: HPQ).

According to the release, the hardware product purchase agreement has a contracted initial term of three years with automatic renewals for successive one-year periods.

This umbrella agreement is designed to manage the design, manufacture, and supply of multiple products throughout the life of the contract. The first Nuheara manufactured product to be supplied under the agreement is a HP branded True Wireless Earbud with charging case.

Utilising Nuheara-owned and developed intellectual property, this product is designed as a premium, compact audio earbud that will enhance the user's ability to be productive, provide a personalised experience and can be used comfortably in dynamic and ever-changing physical environments. The product will also carry a Nuheara co-brand.

Management advised that the product is on schedule to commence mass shipment to HP in the third quarter of FY 2021. Nuheara has already manufactured and supplied HP the validation units of the product. There are no minimum or maximum supply volumes.

CEO Justin Miller commented: "We are delighted to extend our partnership with HP to a long-term supply agreement. This agreement is another pillar in Nuheara's diversification of revenue streams, building on our growing Direct to Consumer sales with OEM partnerships. With an embedded strategic partner the size of HP, it provides the potential of significant upside to our global reach and scale."

Institutional placement.

In a separate announcement, Nuheara revealed that it has raised $11.5 million before costs through an oversubscribed placement of 287.5 million new shares at an issue price of $0.04 per share.

Net proceeds from the placement will be principally used to fund the acceleration of direct to consumer sales and activities, as well as supporting credit terms for Nuheara's manufacturing and production costs associated with the HP agreement.

The post Why the Nuheara (ASX:NUH) share price is rocketing 23% higher today appeared first on The Motley Fool Australia.

On Wednesday the hearing solutions company requested a trading halt whilst it conducted a bookbuild for a placement of ordinary shares to institutional, sophisticated, and professional investors.

Ahead of the placement the company provided a market update which revealed that a "large multinational consumer electronics company" launched a takeover approach in April.

According to the release, Nuheara received an indicative non-binding letter of intent to acquire the company by way of a scheme of arrangement for 8.4 cents per share. This is a ~53% premium to its last close price.

This proposal was subject to a number of conditions, including satisfactory completion of due diligence, Nuheara divesting all of its mining interests, a unanimous recommendation from the Nuheara Board, and entry into a mutually acceptable scheme implementation agreement.

After which, any scheme implementation agreement would also have been subject to a number of further conditions, including shareholder, court, and regulatory approvals.

However, unfortunately for shareholders, the proposal did not get to that stage and was withdrawn after Nuheara advised the suitor that it needed to conduct a capital raising and would be required to provide a cleansing notice which would disclose the letter of intent and its name.

According to the AFR, the company in question is global electronics giant Samsung.

It appears to have been impressed with Nuheara's technology and particularly its revolutionary wireless earbuds, IQbuds, which allow consumers to augment their hearing according to their personal hearing preferences and connect hands free with their voice-enabled smart devices.

Will Samsung return?

Management advised that there is no indication that the suitor or any other party will present an offer for the company in the future.

So for now, it will continue its focus on the development of its technology and products and pursuing its aspiration to be the global hearing leader by providing more functional, affordable and accessible hearable products.

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