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Finished |

Clinical Trial for Nuheara IQbuds™2 PRO Hearing Aid

Key highlights
• Clinical trial of Nuheara’s self-fit hearing aid has concluded with final report from National
Acoustic Laboratories (NAL)
• Trial successfully validated the hearing benefits of the Nuheara self-fitted hearing aids
compared to unaided listening across a range of settings and situations
• Participants included those with normal hearing and those with mild to moderate hearing loss
• Clinical performance of self-fitting IQbuds Ear ID™ software has also been validated as
Software in a Medical Device (SiMD)
• Nuheara now well positioned to complete 510(k) FDA submission by end of March 2022 to
support the planned expansion into regulated medical devices market

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