An Auditory Evoked Response-Based Objective Tinnitus (AER-BOT) Diagnostic Device: Phase II

In 2010 tinnitus became the most common service-related disability among veterans, with disability benefit costs projected to exceed $2.26 billion by 2014. Methods for objective diagnosis of tinnitus are currently nonexistent and direly needed by the military. QUASAR and Otosound are partnering on this SBIR project to develop an efficient and objective tinnitus diagnostic device. This device will integrate Otosound"s patented Auditory Evoked Responses-Based Objective Tinnitus (AER-BOT) diagnostic methodology with QUASAR"s practical dry EEG sensor technology into a turn-key device intended for audiologists. In Phase I of this project, QUASAR and Otosound demonstrated the ability to interface a sound player with QUASAR"s EEG system in order to produce the relevant brain AER signals. The team also defined efficient analysis methods as well as user requirements and system specifications. In the process, six technical challenges were identified: 1) Patient Attentiveness, 2) Sound Range, 3) Spectral Resolution, 4) Sound Quality, 5) Signal Quality, and 6) Audiological Information. In Phase II, these challenges will be addressed, a prototype device that meets the requirements built, and pilot clinical trials conducted to validate performance of the system. Finally, a regulatory strategy towards obtaining FDA approval on an AER-BOT system will be drawn.