Jorge Mejia
Finished | Clinical trials
Clinical Trial for Nuheara HP Hearing PRO: self-fitting and OTC Hearing Aid
Published: February 2022
Key highlights
• Clinical trial of Nuheara’s self-fit hearing aid 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)
• Outcome: Nuheara well positioned to complete 510(k) FDA submission by end of March 2022 to
support the planned expansion into the regulated medical devices market
Post-project update
Updated on the 1st November 2022
Nuheara Receives Historic FDA Clearance for Self-Fitting OTC Hearing Aids and Launches HP Hearing PRO!
31 October 2022Nuheara has received the historic and first of its kind FDA 510(k) premarket clearance for both an 874.3325 Self-fitting Hearing Aid and the 800.30 Over The Counter (OTC) hearing aid classification, making this notable clearance for what is termed as a “Self-Fitting Air-Conduction Hearing Aid, Over The Counter” with the unique product code “QUH”
Nuheara plans to launch its Self-Fitting OTC Hearing Aid as the HP Hearing PRO
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