Earswitch - Phase A v1.0
Research type
Research Study
Full title
Technical Evaluation and Usability Analysis of a Novel Ear-worn Assistive Device
IRAS ID
317435
Contact name
Dario Cazzola
Contact email
Sponsor organisation
University of Bath
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 6 months, 1 days
Research summary
There are many people who have problems with communication leading to a reduced quality of life. Current communication technology for these groups involve interfaces triggered by manual, visible and/or audible actions (such as typing on a keypad), which inevitably interrupt the users’ activities. Additionally, voice interfaces, when available, are often problematic in social situations.
The Earswitch is a demonstrated proof-of-concept that detects the voluntary contraction of a small muscle in the ear, called the tensor tympani muscle, which can in turn be effectively used as an input switch. The voluntary activation of the tensor tympani makes the eardrum move, and such movement can be detected using a small camera inserted in the ear canal. A previously funded NIHR ‘i4i Connect’ research project showed how the Earswitch may be advantageous to populations with severe neuro-disabilities, where other communication methods are limited.
This project, funded by an NIHR i4i Product Development Award, aims to realise the Earswitch's potential as an assistive communication device. Before its deployment, we will ensure the optimal design from both hardware and software perspectives. The device is designed to be worn for prolonged periods (hours).
This clinical investigation is being undertaken to provide supporting evidence towards regulatory approval of the medical device. The aim is to collect data to inform the design of the Earswitch, and evaluate the robustness, usability, and comfort of the current device with individuals who use or need assistive technology. Interviews and questionnaires will be used to gather information and feedback on what assistive technologies people currently use. This is followed by a data collection using the Earswitch, including feedback on the usability and comfort of the device gathered using validated questionnaires. This data will be analysed to inform the design of future iterations of the Earswitch.
REC name
London - Brighton & Sussex Research Ethics Committee
REC reference
23/LO/0469
Date of REC Opinion
14 Jul 2023
REC opinion
Further Information Favourable Opinion