Nuheara Limited announced that is has successfully concluded its hearing aid clinical trial with the final report received from National Acoustic Laboratories. The clinical trial completes a very complex and important milestone for Nuheara on its pathway to an FDA 510(K) submission and pending entrance into the regulated U.S. hearing aid market segment with world leading hearing aid products. 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 IDTM self- fitted hearing aid devices in the overall experience of listeners. Furthermore, clinical assessment showed improvement in speech understanding by 30% in noise when the Nuheara hearing aids FOCUS feature was enabled.

This outcome is 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 aids. The effectiveness data of the Nuheara Ear IDTM 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.