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- Hearing technology company Nuheara (NUH) provides a 510(k) submission to the US Food and Drug Administration (FDA) for its self-fitting hearing aid
- The FDA submission marks the final step in Nuheara’s expansion into the regulatory medical device market
- Once approved, the 510(k) clearance will confirm Nuheara’s hearing aid is a safe and effective product and is substantially equivalent to a legally marketed device
- Nuheara’s hearing device, IQbuds² MAX, features hybrid active noise cancellation and unique features for personalising and enhancing the wearer’s soundscape
- Shares in Nuheara are up 7.69 per cent and are trading at 1.4 cents
Hearing technology company Nuheara (NUH) has provided a 510(k) submission to the US Food and Drug Administration (FDA) for its self-fitting hearing aid.
The FDA submission marks the final step in Nuheara’s expansion into the regulatory medical device market which aligns into the US over-the-counter hearing aid final rule publication in the Federal Register.
Once approved, the 510(k) clearance will confirm Nuheara’s hearing aid is a safe and effective product and is substantially equivalent to a legally marketed device.
The 510(k) submission follows the clinical trial by National Acoustic Laboratories in January that successfully validated the effectiveness of Nuheara’s self-fitted hearing aids compared to unaided listening.
“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,” Co-Founder, CEO and Managing Director Justin Miller commented.
“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.”
“Creating and manufacturing self-fit hearing aid technology that is clinically validated to perform as effective as a professionally fit hearing aid has been a feat which incumbent hearing aid companies have not yet proven.”
Nuheara’s hearing device, IQbuds² MAX, features hybrid active noise cancellation and unique features for personalising and enhancing the wearer’s soundscape.
Key features include situational sound, sonic accuracy and advanced digital signal processing.
Shares in Nuheara were up 7.69 per cent and were trading at 1.4 cents at 1:16 pm AEST.
