Nuheara Limited (ASX:NUH) (Company or Nuheara) announced that it has taken the final step in its plans to secure US Food and Drug Administration (FDA) clearance for its self-fitting hearing aids by providing its 510(k) submission to the FDA.

This follows completion of Nuheara’s “successful clinical trial” by National Acoustic Laboratories (NAL) in January 2022, the company said. The trial “successfully validated the effectiveness of the Nuheara self-fitted hearing aids compared to unaided listening across a range of settings and situations.”

The Nuheara hearing aids are designed to be self-fitted by the user, with a software application interface for both iOS and Android smartphones, intended for direct-to-consumer sale and use without the assistance of a hearing care professional. They are intended for individuals 18 years of age or older with perceived mild-to-moderate hearing loss, according to the company’s announcement.

The FDA submission for clearance of the hearing aids is the final step of Nuheara’s expansion plans into the regulatory approved medical device market, which also aligns with the Over-The-Counter Hearing Aid final rule publication in the Federal Register by the FDA expected for northern hemisphere mid-summer 2022.

Co-founder, Managing Director & CEO Justin Miller said: “Over the last seven years Nuheara has shifted its focus from being a consumer electronics hearables company to driving an entirely new market in medical device technology with its self-fitting hearing aids. Our ambition to enter the US regulated medical device market has been pursued tirelessly by the Nuheara team and their commitment is evidenced by the sheer fact Nuheara embarked on this 510(k) journey only 12 months ago.

“This submission could not have been achieved without all the progress we made in pioneering hearable products to underserved customers in the global hearing market. This was supported by decisions we made along the way to clinically validate our proprietary technology such as Ear ID. Once FDA clears our submission, we will have overcome the three major barriers to entering the hearing aid market. These are, world leading hearing product and technology, alternative non-traditional paths to distribution, and lastly meeting strict regulatory standards.

“Creating and manufacturing self-fit hearing aid technology that is clinically validated to perform as effectively as a professionally fit hearing aid has been a feat which incumbent hearing aid companies have not yet proven. Nuheara’s in-market innovation has been building towards this for five years.”

Chief Revenue Officer and President Americas, John R. Luna, said: “Nuheara’s submission sets the foundation to expand Nuheara’s footprint in the US and globally in the regulated medical device markets. Positioning Nuheara’s self-fit hearing aid with FDA regulatory clearance now will enable us to take full advantage of the 800.30 US FDA Over the Counter market opening expected later this year.

“Our year-on-year growth which has been established through our Direct-to-Consumer and omnichannel approach will also support stronger gains in our mainstream retail partnerships, once cleared, then growth opportunities with our hearable partners will extend to our OTC hearing aid. Nuheara is prioritizing its marketing initiatives in the US to ensure that these growth opportunities will be capitalized upon in the short-term.”

Clinical trial summary of Nuheara’s self-fit hearing aids by National Acoustic Laboratories (NAL)

  • Clinical assessment showed improvement in speech understanding by 30% in noise when the Nuheara IQbuds 2 PRO hearing aids FOCUS feature was enabled. 
    • This outcome is consistent with industry standard clinical studies showing speech understanding in noise advantages with conventional directional microphones in hearing aids ranging from 25% to 30%, depending on the familiarity to the speech, physical fitting and design of the hearing aids (Ricketts, 20011; Keidser et al, 20132)
  • Substantial evidence of the benefit of the Nuheara IQbuds 2 PRO self-fitted hearing aids compared to unaided listening with the following benefits: 
    • Improved speech understanding in noise;
    • Improved ability to follow conversations;
    • Ability to reduce background noise levels;
    • Overall frequent improvement when listening in everyday conversations.
  • Clinical performance of self-fitting IQbuds Ear ID software found effective.
  1. Ricketts TA. Directional hearing aids. Trends in Hearing. 2001;5(4):139-176.
  2. Keidser G, Dillon H, Convery E, Mejia J. Factors influencing individual variation in perceptual directional microphone benefit. J Am Acad Audiol. 2013;24(10):955-968.

Source: Nuheara