Page Banner
Finished | Clinical trials

Clinical Trial for Nuheara HP Hearing PRO: self-fitting and OTC Hearing Aid

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!

Nuheara 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

31 October 2022
Nuheara logo
Related Projects & news

Contact us

Start a clinical trial
Collaborate now
Work with NAL Clinical Trial team to take your project to market
Contact us
NAL Clinical Trials team
Our expertise
Study design
Advanced Audiological assessments
Clinical trial execution
Study monitoring
Find out what we do