Communication EarSwitch - Phase B v1.0
Research type
Research Study
Full title
Technical Evaluation and Usability Analysis of a Novel Ear-worn Assistive Device
IRAS ID
333675
Contact name
Dario Cazzola
Contact email
Sponsor organisation
University of Bath
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
23/LO/0469, REC Reference Number
Duration of Study in the UK
0 years, 2 months, 31 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 Communication Earswitch is a demonstrated medical device that detects the voluntary contraction of a small muscle in the ear, called the tensor tympani muscle (TT), which can in turn be used effectively as a computer interface switch. The voluntary activation of the TT makes the eardrum move, and such movement (known as ear rumbling) 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, for whom other communication methods are limited.
This clinical investigation is being undertaken to provide supporting evidence towards regulatory approval of the medical device. We will collect data from participants with mild to moderate neuro-disabilities and healthy participants to make sure that the Communication EarSwitch is safe when used for its intended purpose. All participants will have the opportunity to use the Communication EarSwitch at home and will be asked to complete various ear rumbling tasks throughout a 4-week period. Collecting data about how well people can voluntarily contract the TT muscle, and if and how performance varies over time, is important for understanding what type of assistive interfaces, and applications, may be suitable for use with the EarSwitch. Feedback on the usability and comfort of the device will be gathered using validated questionnaires. This data will be analysed to inform final changes before launching the Communication Earswitch, adverse occurrences will be gathered and any reportable events will be reported.
REC name
West of Scotland REC 4
REC reference
24/WS/0095
Date of REC Opinion
20 Aug 2024
REC opinion
Further Information Favourable Opinion