Nuheara Limited (ASX:NUH) announced that it has successfully concluded its hearing aid clinical trial with the final report received from the National Acoustic Laboratories (NAL). The clinical trial completes “a very complex and important milestone for Nuheara on its pathway to an FDA 510(K) submission¹ and pending entrance into the regulated US hearing aid market segment with world-leading hearing aid products,” according to the company’s announcement.
The clinical trial was conducted in Australia using audiology best practices on participants with normal hearing and those with mild and moderate hearing loss by professional clinical audiologists and clinical researchers at NAL. The trial “successfully validated the hearing benefit of the Nuheara self-fitted hearing aids compared to unaided listening” with benefits including:
- Improved speech understanding in noise;
- Improved ability to follow conversations;
- Ability to reduce background noise levels;
- Overall hearing improvement when listening in everyday conversations.
In relation to the unaided listening condition, the study data “provided evidence of the superiority of Nuheara hearing aids with FOCUS enabled over unaided listening, and of substantial effectiveness of the Ear ID self-fitted hearing aid devices in the overall experience of listeners,” the company said. Furthermore, clinical assessment showed “improvement in speech understanding by 30% in noise when the Nuheara hearing aids FOCUS feature was enabled.” This outcome is reportedly consistent with other studies showing advantages in speech understanding in noise with conventional directional microphones in hearing aids ranging from 25% to 30% improvement, depending on the familiarity to the speech, physical fitting, and design of the hearing aids² ᶾ.
The effectiveness of the Nuheara Ear ID self-fitting method was also “validated, as Software in a Medical Device (SiMD), through clinical and real-world data demonstrating positive outcomes as compared to the expected NAL-NL2 clinical targets that would be performed by an audiologist fit hearing aid in a clinic.”
Commenting on Nuheara’s progress in relation to its expansion plans into regulatory approved hearing aids, Co-founder, Managing Director, & CEO, Justin Miller said: “This clinical study is a further critical step in the transformation of Nuheara into a medical device manufacturer of hearing aids. With the five major hearing aid companies commanding 99% of the worlds hearing aid market⁴, there are very few emerging companies who have successfully completed hearing aid clinical trials and gone on to commercialize.
“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.”
- Refer to previous NUH ASX announcements of August 17, September 15, October 15, and November 25, 2021, and January 6, 2022.
- Keidser G, Dillon H, Convery E, Mejia J. Factors influencing individual variation in perceptual directional microphone benefit. J A Acad Audiol. 2013;24(10):955-968.
- Ricketts TA. Directional hearing aids. Trends in Amplification. 2001;5(4):139-176.
- Towart L, Meyer SR. Longer Term Investments – Medical Devices. UBS Report. https://www.ubs.com/content/dam/WealthManagementAmericas/cio-impact/Medical%20Devices.pdf. Published April 11, 2019. Page 13.