EarSwitch - Phase A

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

UK Chief Investigator

Dr Dario Cazzola

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.

Current status

Active – recruiting

Key dates

Actual opening date: 01 December 2023

Planned recruitment end date: 30 April 2025

Recruitment groups

1. People who require assistive technology

2. Healthy controls (people who do not require assistive technology)

Recruitment target

110 participants

Click here to see how many participants have been recruited into this study to date (external link to the NIHR public study search)

Locations

• University of Bath (Principal Investigator: Dr Dario Cazzola)

Information about study sites

Contact details

Study email address: earswitch@bath.ac.uk

Inclusion / exclusion criteria

Inclusion criteria

• Age range: 18 and older

• Able to voluntarily contract the tensor tympani muscle

We will be recruiting participants who require assistive technology, as well as people who don't. For the former there will be the requirement that:

• The individual requires the use of an assistive device. This includes using a communication aid and/or technology to assist with feeding, mobility, or controlling of their environment. 

Exclusion criteria

• Those who do not have the capacity to understand the study and consent (e.g. severe learning disabilities)

• Inability to communicate either directly to the researcher or through a carer or communication partner and therefore inability to provide consent.

Funder

NIHR Central Commissioning Facility (CCF)

Sponsor

University of Bath

Study design

Observational