The stock of Nuheara Ltd closed 115.38% higher at $0.1400 in the past session. During the session, Nuheara stock price ranged from $0.0450 to $0.1500, while 56.32K shares were traded. Despite the lack of current news, NUHRF stock has been soaring, however recent developments may provide us with greater insight into the Nuheara’s potential for development.
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Nuheara provides smart hearing technology that completes people’s lives by giving them more power to hear. Headquartered in Perth, Australia, NUHRF developed a proprietary hearing device that augments a person’s hearing with multi-functional, personalized intelligent hearing devices.
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In 2016, NUHRF developed a wireless earphone that augmented hearing, allowing people to connect their smart device hands-free to IQbuds. IQbuds MAX, Nuheara’s third generation, were released in 2020.
In addition to direct-to-consumer sales, NUHRF’s products are now also available through major consumer electronics retailers, professional hearing clinics, pharmacists, and optical chains around the globe.
It was recently announced by Nuheara that the United States Food and Drug Administration (FDA) has registered its IQbuds PRO as a medical device.
- The PRO will be the second product deriving from the IQbuds hardware platform, subsequent to the recently launched IQbuds MAX (MAX).
- With software development currently in progress, PRO has been designed to enhance hearing amplification and enhance sensory capabilities at a deeper level.
- PRO is due for launch later this calendar year in the US.
- A PRO has been designated by the FDA as a “HEARING AID, AIR CONDUCTION WITH WIRELESS TECHNOLOGY”, which means that it is a Device Class 2 Exempt under an OSM product code.
- The FDA classifies the PRO as 510(k) exempt, the same as it does with all hearing aids with the OSM product code.
- The PRO device is not required to undergo clinical trials or submit a 510(k) application to be sold in the U.S.
NUHRF’s potential in the U.S.:
By offering numerous products that support various degrees of hearing loss, Nuheara (NUHRF)’s Direct-to-Consumers strategy and the PRO will enable it to reach the $3.37 billion market of the United States, which currently has higher levels of hearing loss.