Medical device and consumer electronics manufacturer, Nuheara Limited (ASX:NUH) is preparing to release its first shipment of its HP Hearing PRO hearing aids prior to the end of this month, having commenced the mass production phase for this hearing aid.
Over the past three months, Nuheara has:
- Achieved US FDA clearance for the world’s first self-fit over-the-counter (OTC) hearing aid1
- Obtained ISO 13485 medical device quality system certification for the Design and Development, Production, and Distribution for hearing aids
- Launched HP Hearing PRO to great acclaim at CES in Las Vegas, with substantial interest from, and multiple discussions with, US retailers, OEMs and healthcare providers as a result
- Completed all necessary pre-production manufacturing runs for the HP Hearing PRO
- Commenced mass production phase of the HP Hearing PRO
- Confirmed that the Company expects first shipment of the HP Hearing PRO to the US.
We are incredibly excited to have now entered mass production and will shortly see the first shipment of our world- first self-fit over the counter hearing aids to the US. Having built a strong back-order book of sales, we are looking forward to seeing our hearing aids on US retail shelves and growing revenues,” Co-founder and Managing Director, Justin Miller, said.
“With OTC Hearing Aids a new substantial retail category in the US covering 38 million people, retailers and other healthcare providers in that market responded very positively to our launch of the HP Hearing PRO last month at CES 2023 in Las Vegas.
“With first shipment about to occur, we have been busily acting on this interest and look forward to providing further updates on the expansion of our US retail footprint.”
