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Technical Evaluation and Usability Analysis of a Novel Ear-worn Assistive Device

Trial Status: Open

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.

In line with our objectives,our research plan is focussed on core technology development and evidence gathering to support adoption. At all stages we incorporate co-design into our activities and our research plan has been built to maximise opportunities for participant involvement and feedback.

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 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