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  • Nuheara (NUH) has welcomed a landmark proposal for hearing aids from the US FDA
  • In a world first, the proposal would establish a new category of over-the-counter (OTC) hearing aid, allowing the technology to be sold directly to consumers without a medical exam or fitting by an audiologist
  • Nuheara has clinical trials underway for a self-fit hearing aid and intends to file a 510(k) to become one of the first products available in this proposed new category
  • The proposed rule is now open for public comment for up to 90 days, after which the FDA will review the comments for a further 120 days
  • Company shares are trading in the grey at 2.5 cents at 1:22 pm AEDT

Nuheara (NUH) has welcomed a landmark proposal for hearing aids from the US FDA.

The US Food and Drug Administration’s (FDA) proposal is intended to improve access and reduce the cost of hearing aid technology for Americans.

As a result of this, the FDA has proposed a rule to establish a new category of over-the-counter (OTC) hearing aids. This marks a world first and would allow the OTC category to be sold directly to consumers without a medical exam or fitting by an audiologist.

Nuheara said it’s already well progressed to benefit from this proposal, with clinical trials underway for a self-fit hearing aid. The company intends to file a 510(k) to become one of the first products available in this proposed new category.

The company also noted the proposed rule opens up a very substantial market opportunity for Nuheara, with around 37.5 million American adults reporting some trouble hearing.

“In one sweep, the FDA has revolutionised the way people will be able to access hearing aids and hearing devices in the US,” Nuheara Co-founder & CEO Justin Miller said.

“The FDA hasn’t just created an extra category, it has completely overhauled the categorisation of all hearing aids into two categories: over-the-counter and prescription.”

“This is transformational for the hearing industry and advantageous to the hearing consumer who will be protected in the knowledge any OTC hearing aid has had a full FDA review with a 510(k) submission,” explained Justin Miller.

The proposed rule is now open for public comment for up to 90 days, after which the FDA will review the comments which could take a further 120 days.

Once the review is complete and the final rule published, an allowance of a further 60 days is made before the rule is in effect.

Nuheara said it was uniquely placed to rapidly grow once the new rule was finalised.

Company shares were trading in the grey at 2.5 cents at 1:22 pm AEDT.

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