Two Pi: FDA channels hearing aid industry innovation

SelfFit, Two Pi’s mobile medical app for hearing loss diagnostics and fitting has successfully embarked on the FDA approval process, the essential benchmark for medical products in the US market.

Shortly after, in September 2013 FDA released guidelines for Mobile Medical Apps. These guidelines recognize diverse new intended uses for medical apps – among them:

‘[…] for use in conducting diagnostic hearing evaluations and assisting in the diagnosis of possible otologic disorders (i.e., an audiometer) […]
Possible product code: EWO (21 CFR 874.1050)*’

This regulatory definition officially marks a turn towards opening novel technological possibilities for cost-effective hearing aid distribution and increased involvement of the user in the fitting procedure.

A mobile medical app running on a Smartphone turns a hearing aid into a diagnostic and fitting tool. The combination will be a Class II product, regulated more closely than wireless hearing aids, because it includes the functionality of the audiometer. This is in contrast with the popular features for in-situ audiometry in conventional hearing aids that are not subject to regulations (representing possibly an off-label use).

The FDA approval will depend upon determined safety and effectiveness of the technological solution. In the case, where the intended usage involves self-adjustment by the user, the key issue to consider will be usability. It is the usability that will determine the limits for intended use, but in any case the regulation will include much more use scenarios than possible with today’s hearing aids.  By carefully validating SelfFit mobile app Two Pi and its research partner Academic Medical Center Amsterdam are determined to satisfy the safety and effectiveness requirements of FDA.

Building on top of up-and-coming standardization of Bluetooth Low Energy for hearing aids, the FDA regulations will accelerate emergence of entirely new product classes. That development will surely become a leading trend in the hearing aid market in the next years. It is interesting to note here that in developing clear regulations, it is the FDA and not the industry that leads the technological advance in hearing aids. This is a sign that the hearing aid industry will have to welcome new entrants who will bridge the hearing aid with smartphone technology.

* Mobile Medical Applications: Guidance for Industry and FDA staff, September 25, 2013

About Two Pi
Two Pi is an innovative technology company developing advanced intellectual property for the hearing healthcare, personal communications and professional communications markets. Two Pi's algorithm catalogue results from a  streamlined scientific program carried out with university partners.

About AMC
The Academic Medical Center (AMC) is one of the foremost research institutions in the Netherlands, as well as one of its largest (teaching) hospitals. Over 7000 employees provide integrated patient care, do fundamental and clinical scientific research, and educate students in Medicine and Medical Informatics.

For further information visit

The sender takes full responsibility for the content of this news item. Content may include forward-looking statements which, at the time they were made, were based on expectations of future events. Readers are cautioned not to rely on these forward-looking statements.

As a life sciences organization based in Vienna, would you like us to promote your news and events? If so, please send your contributions to news(at)