Perth’s Nuheara lands ‘monumental’ FDA approval for self-fitting hearing aids, but Australia won’t get them anytime soon

Perth tech company Nuheara just got us a step closer to democratising hearing aids, after scoring approval from the Food and Drug Administration (FDA) approval to sell its over-the-counter (OTC) HP Hearing PRO device in the US.

In addition to being a hearing aid, the device also works like a modern earbud. It has Bluetooth functionality for phone calls and streaming media, a charging case and active noise-cancellation.

The accompanying HP Hearing app also allows for personal customisation, including switching the directional microphone settings for improved speech understanding.

The HP Hearing PRO has been a long time coming for Nuheara

Nuheara has been selling hearing health products for over five years and it was the first Australian consumer wearables technology company to be listed on the Australian Securities Exchange, back in 2016.

The majority of its consumer products have been in the earbud space, such as its IQBuds. These have been dubbed ‘hearables’ due to their particular focus on hearing health features, such as active noise-cancellation and personal hearing calibration.

The company is now taking this a step further with the HP Hearing Pro, an OTC consumer hearing aid that is self-fitting and doesn’t require a medical exam.

A first of its kind product in the US, the device is considered medical-grade and has been classified by the FDA as Self-Fitting Air-Conduction Hearing Aid, Over The Counter (QUH).

And it’s been a long time coming, with the Over-the-Counter Hearing Aid Act 2017 was signed into law over five years ago. Since then, work has been done to ensure high standards for safety, consumer labelling and manufacturing protection that all other FDA-approved medical devices are required to meet.

The biggest call for this bill to be passed was due to accessibility. In the US, hearing aids sold through audiologists and licensed hearing aid retailers cost an average of US$4,726 per pair, but can go as high as US$10,000. Nuheara’s HP Hearing Pro is said to come in under US$1,000. While that’s certainly not cheap, it’s at least three-quarters less expensive.

“In one sweep, the FDA has revolutionised the way people can access hearing aids in the US. The FDA hasn’t just created an extra OTC category, it has completely overhauled the categorisation of all hearing aids into two categories: OTC and prescription,” Nuheara co-founder and managing director Justin Miller said in a statement.

It’s also worth noting that when Nuheara stated back in 2017 OTC hearing aids weren’t designed to replace traditional devices.

“The purpose of the OTC Act is not to replace traditional hearing aids. For those individuals with advanced or severe hearing loss, a prescription-grade hearing aid is better. These devices should be accompanied by an examination and fitting by a trained audiologist,” a 2017 Nuheara blog post reads.

“The intended benefit of this legislation is to improve accessibility to a critical medical device needed by millions.”

According to Nuheara, not everyone agreed with the ruling. Public comments on the bill from hearing manufacturers are said to have strongly opposed it.

The company also reported that an industry-funded ‘astroturf’ campaign was enacted to “distort public opinion”.

“Despite the incumbent hearing aid manufacturers’ efforts to jeopardise such an important ruling, the FDA formally ruled in favour of the OTC category for hearing aids,” a Nuhera spokesperson said in a statement.

“This historical rule change will forever upend the hearing aid industry and unlock historical barriers to entry for the estimated 38 million Americans who experience some hearing loss.”

Australians won’t benefit anytime soon

Sadly, Australians won’t benefit from Nuheara’s HP Hearing Pro anytime soon. While the device has been approved by the FDA in the US, Australia’s equivalent governing body, the Therapeutic Goods Administration (TGA), has different rules, regulations and standards.

For example, electrocardiography (ECG) functionality was first introduced to the Apple Watch in September 2018. This allowed the smart watch to monitor for low heart rate detection and irregularities.

These features weren’t approved by the TGA in Australia until March 2021, two-and-a-half years and several devices later.

A Nuheara spokesperson confirmed to SmartCompany that the HP Hearing Pro has not been TGA approved. This is because the company hasn’t submitted it and doesn’t yet have plans to.

According to the spokesperson, it’s difficult to get devices like this approved in Australia in part due to the dominance of large hearing aid companies.

They stated that Europe and the UK are more likely to be the next markets for the HP Hearing Pro to move into, but there’s no current timeline on that.