Join our daily newsletter At The Bell to receive exclusive market insights
- Nuheara (NUH) has obtained establishment registration and medical device listing from the U.S. Food and Drug Administration for hearing aid IQbuds PRO
- Alongside IQbuds2 MAX, IQbuds2 PRO is the second product derived from the Nuheara’s IQbuds hardware platform
- The new device is designed to support adults with higher levels of moderate hearing loss
- IQbuds2 PRO has received Class 2 (medical device) 510(k) classification
- This means it can be sold in the US without needing to undergo clinical trials
- Nuheara’s multi-product strategy is set to broaden sales opportunities in the US
- IQbuds2 PRO is expected to launch in the US later in 2021
- Nuheara shares are up 3.41 per cent, trading at 4.6 cents cents each
Nuheara (NUH) has obtained establishment registration and medical device listing for its hearing aid IQbuds2 PRO from the U.S. Food and Drug Administration (FDA).
After IQbuds2 MAX (MAX), PRO is the second product to come from Nuheara’s IQbuds hardware platform.
While MAX was created to meet the needs of people experiencing mild hearing challenges, PRO has been designed to support adults with higher levels of moderate hearing loss.
Nuheara envisages PRO will provide deeper levels of hearing technology sophistication, while delivering higher levels of hearing enhancement and amplification.
Additionally, PRO’s classification by the FDA as a class two medical device, means the product can be sold in the U.S. without the need to conduct clinical trials or submit a standalone application.
Nuheara Chief Executive Officer Justin Miller said Nuheara’s multi-product strategy has been planned to maximise global sales opportunities by offering products that support varying degrees of hearing loss.
“This is a significant development in Nuheara’s mission to make hearing more accessible and affordable for all,” Justin said.
“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,” he added.
“The registration effectively enables Nuheara to meet the varied hearing needs of a growing base of underserved customers with a wider spectrum of hearing loss.”
PRO will extend the company’s direct-to-consumer strategy to the global hearing aid market, which is valued at $9 billion (around A$11.7 billion) per annum. The product is expected to launch in the U.S. later this year.
Nuheara shares are up 3.41 per cent, trading at 4.6 cents at 2:14 pm AEDT.
