text: Abstract: A significant number of conscious hospitalized patients are unable to independently activate standard nurse call systems, and over 50% of mechanically ventilated ICU patients need assistance to communicate with their caregivers. Based on those estimates and the annual U.S. hospital discharge rate, one can extrapolate that at least 3.9 million American patients may have required some form of assistive technology (often unavailable) to be able to summon help and communicate with their healthcare providers. It is clearly essential that solutions be found that allow intubated and physically weak patients to summon help and to effectively communicate. To address that need, Iowa Adaptive Technologies (Voxello) is developing next-generation solutions to improve patient-provider communication and to allow patients to better manage their symptoms and effectively participate in their care as well as in medical decision-making and end-of-life conversations. Patients who cannot communicate with doctors, nurses, other health professionals and caregivers are at a threefold risk of experiencing adverse medical outcomes. Reducing communication barriers has the potential to annually reduce nearly 700,000 preventable adverse events and to save nearly $7 billion in healthcare costs each year. In its successful Phase I SBIR project, the Voxello team demonstrated the feasibility of using the noddleTM which allows patients to activate the nurse call and to simultaneously control a communication app with a small intentional gesture. The noddleTM uses a patented signal-processing algorithm to detect small intentional gestures such as tongue clicks, an eye blink, or any other small motor movement. Voxello has also developed the noddle-chatTM communication app to allow patients who are unable to speak to effectively communicate with their healthcare providers, thereby reducing the risk of adverse medical outcomes and increasing patient satisfaction. Voxello used an iterative design approach that was informed by feedback from patients, nurses and family members. Preliminary clinical data indicated that patients who use the Voxello technology report greater ease in summoning nurses and being able to effectively communicate. Voxello is proposing a Phase II SBIR project focused on broad-based validation and testing designed to produce the type and volume of data required to engage Phase III commercialization partners/investors. Phase II work will increase the number of intentional gestures that the noddleTM can detect and will expand the communication templates in noddle-chatTM to support medical decision-making as well as the needs of non-English-speaking patients. Voxello will conduct clinical trials during Phase II to determine how easily the noddleTM and noddle- chatTM can be implemented across clinical settings to enable patients to summon their nurses and effectively communicate. Voxello has applied to the FDA to obtain clearance for the noddleTM as a Class II medical device, and we intend to manufacture the noddleTM at our manufacturing partner's US-based certified medical device facility and develop distribution channels to serve the hospital, long-term care and home-care markets.