Nuheara Limited (ASX: NUH), Perth, Australia, announced that the company has received US Food and Drug Administration (FDA) establishment registration for a medical device listing of a new hearing aid, IQbuds² PRO (PRO).
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The PRO, alongside IQbuds² MAX (MAX), will be the second product to be derived from the recently developed IQbuds² hardware platform, according to the company. The PRO has been designed to provide what Nuheara describes as “deeper levels of hearing technology sophistication, while delivering higher levels of hearing enhancement and amplification.” The PRO is expected to be launched in the US later in the calendar year.
The PRO has received FDA classification as a “Hearing Aid, Air Conduction with Wireless Technology,” Device Class 2 (medical device) 510(k) exempt with an OSM product code (Classification). As with all hearing aids classified with the OSM product code, the FDA has classified the PRO as 510(k) exempt. This means the PRO can be sold in the US without the need to conduct clinical trials or submit a 510(k) application.
According to the announcement, Nuheara’s multi-product strategy has been planned to maximize the company’s global sales opportunities by offering multiple products that support varying degrees of hearing loss. MAX will “continue to meet the needs of those with mild hearing challenges.” The PRO is designed to support adults with higher (moderate) levels of hearing loss and will extend Nuheara’s cirect-to-consumer (DTC) strategy to the global USD $9 billion per annum (North America USD $3.37 billion) hearing aid market¹.
“This is a significant development in Nuheara’s mission to make hearing health more accessible and affordable for all,” said Justin Miller, CEO of Nuheara.
“Over many years the business has invested tens of millions of dollars in our proprietary hearing technology platform. 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. This registration effectively enables Nuheara to meet the varied hearing needs of a growing base of underserved customers with a wider spectrum of hearing loss.”
“The FDA Classification we have received for PRO is separate to the FDA’s proposed Over-the-Counter (OTC) hearing aid category, which was due to be issued as a new category in August 2020, but has since been delayed. It is now anticipated that the FDA will complete this at some stage during 2021. Nuheara is well placed to react once it is made. Utilizing Nuheara’s connected hearing technology platform, the company’s aspiration is to create an end-to-end hearing healthcare company by efficiently delivering hearing products, accessories and services across the Hearables, Medical Device, and OTC markets,” he said.
- Fortune Business Insights, Hearing Aid Market Research Report, December 2020.