- Nuheara (NUH) wraps up its hearing aid clinical trial after receiving a final report from National Acoustic Laboratories
- Professional clinical audiologists and researchers validated the hearing benefit of the Nuheara self-fitted hearing aids compared to being unaided, through testing volunteers with normal hearing and moderate hearing loss
- The company says the clinical trial is an important milestone on its pathway to an FDA 510(k) submission and pending entrance to the US hearing aid market segment
- Nuheara aims to complete a US FDA 510(k) submission by the end of March 2022 and, pending FDA clearance, enter the US regulated hearing aid market with its hearing aid products
- NUH up 3.13 per cent to 1.7 cents
Nuheara (NUH) has wrapped up its hearing aid clinical trial after receiving a final report from National Acoustic Laboratories.
The company said the trial was conducted in Australia using audiology best practices on participants with normal hearing and those with mild and moderate hearing loss.
It said professional clinical audiologists and clinical researchers successfully validated the hearing benefits of the Nuheara self-fitted hearing aids compared to unaided listening.
Nuheara said the benefits included an improved ability to follow conversations, an ability to reduce background noise levels and an overall improvement in hearing during everyday conversations.
Clinical assessments also showed improvement in speech understanding by 30 per cent in noise when the Nuheara hearing aids FOCUS feature was enabled.
The effectiveness of the Nuheara Ear ID self-fitting software was also validated through clinical and real-world data demonstrating positive outcomes, compared to the expected NAL-NL2 clinical targets performed by an audiologist fitted hearing aid in a clinic.
Nuheara said the clinical trial was an essential step on its pathway to an FDA 510(k) submission and pending entrance to the US hearing aid market segment.
“This clinical study is a further critical step in the transformation of Nuheara into a medical device manufacturer of hearing aids,” Managing Director and CEO Justin Miller said.
“This is a pivotal development for Nuheara as we position ourselves to complete a US FDA 510(k) submission by the end of March 2022 and, pending FDA clearance, entering the US regulated hearing aid market with world leading hearing aid products.”
NUH shares were up 3.13 per cent at 1.7 cents at 11:09 am AEDT.