The Earswitch: NIHR i4i PDA: taking proof-of-concept via co-design and objective technical/ user validation to a user ready assistive technology switch, incorporating wider health and care innovative sensor applications

Research question This project will co-design then validate a novel assistive-technology switch; The Earswitch. Undertaking more formalised product development, the device will be trialled with health/quality-of-life outcomes documented alongside usability, health economic impacts and technology validation via a co-design process. Intent is to create a MHRA approval ready product. Background The Earswitch is a sensor within an earpiece that detects intentional movement of the eardrum. It detects voluntary movement of the ear-drum from intentional contraction of a middle ear muscle (tensor tympani), a trainable, controllable skill in most people. It represents probably the last, undeveloped, non-invasive human-computer-interface. It has enormous potential due to its position as a completely unique (therefore highly competitive) communication option. As earphones are already validated user-acceptable devices, immediate benefit can be derived. Ongoing NIHR-funded validation studies indicate ~80% of people are aware of tensor tympani movement and >50% report an innate ability to control this in isolation from facial movements. The associated ear-drum movement, detected by miniature camera sensors mounted in earphones, generate an output signal that controls interfaces. A working prototype demonstrates people controlling an assistive “on-screen” keyboard via Earswitch. NIHR funded validation work-to-date provides strong indication of widespread usefulness and user desirability of The Earswitch. Aims/Objectives: This project will co-design a user acceptable, desirable and reliable assistive Earswitch mounted in a comfortable earphone device, insensitive to head/jaw movements, which allows superior communication for people with motor neurone disease/ALS, “Locked-in syndrome” (from brainstem-stroke), and severe cerebral palsy with involuntary movements, including when no other methods are available. Objective is to have advanced the Earswitch device and commercial offering such that, following regulatory approval, it can enter commercial trials with clinical partners supported by a comprehensive suite of health-outcome and health-economic data. Methods: The project phases both incorporate PPI/user co-design across device and protocol design work: Phase A: Expanding prototype and user feedback from i4i Connect validation study to assemble 100 “Modular” Earswitches, from consumer modules. Utilising existing neuro-disability cohort, focus is on gaining user feedback from assistive technology users, ensuring appropriate design for Phase B. Phase B: Design and manufacture of “Bespoke” Earswitches using custom-made components/software with iterative small scale testing & re-design. The subsequent Earswitch will be tested in home and trial clinic environment in 2 streams; i) ~100 via PTTU clinical trials unit (both general population and people with motor neurodisabilities) with formal training, assessment and subsequent 4-week home trial, ii) “real-world” home scenario for assistive users, assessing usability, acceptability and desirability, and to gain feedback on the use of Earswitch without intensive training. Results will create a data-pack providing evidence on quality-of-life, user experience and health economic outcomes Timelines: Phase A runs Month1-Month12 of the 2-year project. Parallel Phase B iterative design runs Month1-Month18. Phase B trials commence from 18 months, data-analysis from Month22. Impact/Dissemination: We will develop a low-cost, unique assistive technology switch for communication and environmental control (e.g. smart-homes). Validation/trial work will enable CE marking, allowing Earswitch NHS entry to benefit patients. Non-commercially sensitive research outcomes will be academically published.