Hearing Health and Technology -- Workshop, Project No. P171200 #00130

Submission Number:
00130
Commenter:
Ernestine Bennersdorfer
Organization:
TWo Pi GmbH
State:
Outside the United States
Initiative Name:
Hearing Health and Technology -- Workshop, Project No. P171200
Two Pi sees the improvement of US hearing healthcare explicitly as technology driven improvement. As in other medical branches, innovation is no longer only related to the hearing instrument itself, but increasingly to the regulation and utilization of novel health maintenance processes in app form. The result of our R & D project for app based, user-driven fitting of hearing aids, carried out together with the Academic Medical Center, Department for Clinical and Experimental Audiology (AMC), Amsterdam between 2011 and 2013, shows that a shift in delivery of audiology services from current procedures to automated app procedures makes sense. The app has been validated on test subjects within the clinical study at AMC and went through the FDA pre-sub 510(k) under ref. number Q130955 in 2013. We would appreciate if the novel, non-corporately invented app technology is taken as a serious contribution to the OTC discussion, in particular as it can not only be used as a full OTC supply but furthermore as an economic alternative for prescription based tele audiology supply. For us it is important to note that the OTC model is not necessarily and not exclusively to be seen as a new mechanism for delivering hearing devices. Considering the today's state of technology it is not officious to highlight that OTC hearing systems (devices) incorporating interactive app technologies are able to deliver a premium level audiology performance for hearing aid fitting too.