Two Pi GmbH has entered the clinical trial stage on SelfFit, its mobile medical application for hearing aid fitting.
Developed with the support of the audiology division of the Amsterdam Medical Center (AMC), SelfFit combines the characterization of the individual hearing loss through the hearing aid with an advanced First-Fit protocol and a fine-tuning process using realistic sound samples.
Two Pi’s goal with the device is to help bring hearing aids to emerging markets and rural areas through mobile hearing aid fittings. The company says that the lack of audiology infrastructure in developing countries is the main obstacle for sufficient distribution of hearing aids.
In the emerging markets, providing suitable audiology services is hindered by the nonexistence of a network of brick-and-mortar shops and the lack of trained audiologists. If audiology services are offered through a mobile medical app that combines diagnostics and fitting, the cost for hearing aid distribution and service will be reduced significantly and the lack of audiology infrastructure will be no longer restrictive for distribution. As in the case of telephone and banking in India and Africa, the technological leap forward will efficiently bridge the infrastructure gap. SelfFit is being developed to deliver similar benefits.
The company compares its new app to successful mobile medical applications in other fields, such as the AliveCor iPhone ECG, the iBGStar’s glucose monitor, and the Sanadu’s Scout. All are mobile medical applications that have been approved by the US Food and Drug Administration. With FDA approval, the apps are confirmed as being substantially equivalent to prior medical devices.
In a press release announcing the clinical trial, Tarik Zukic, managing director of Two Pi, said, “During the entire development of SelfFit, we have been very cautious concerning effectiveness and safety of the fitting procedure. We need to provide the evidence that for mild to moderate hearing losses, SelfFit is as safe and effective as traditional hearing devices. This is a huge step forward in improving hearing healthcare in the emerging markets.”
SOURCE: Two Pi