Evaluation of a novel hearing screening device
Research type
Research Study
Full title
Evaluation of a novel hearing screening device Audimetroid in new patient referrals to audiology
IRAS ID
325651
Contact name
Claudia Freigang
Contact email
Sponsor organisation
Hearing Diagnostics Limited
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
0 years, 9 months, 2 days
Research summary
Hearing loss affects one out of five people. If left unmanaged, it can lead to depression, social isolation and facilitate premature cognitive decline and dementia. The best way to avoid the long-lasting consequences of hearing loss is the early detection of hearing loss and its management. Hearing screening is the ideal candidate for making early detection of hearing loss in the community more accessible. However, hearing screening is only effective and cost-efficient if it accurately detects hearing loss.
Hearing Diagnostics (HD) have developed a hearing testing technology - Audimetroid - that is purpose-built for enabling accurate and accessible hearing screening in community settings by individuals untrained in audiology. Accuracy is the key offering of Audimetroid, and has been estimated to be at least 99% based on theoretical computer simulations.
Validation of Audimetroid’s test accuracy requires the comparison of Audimetroid’s test results to the gold standard in audiology, the pure-tone audiogram (PTA). In order to validate the accuracy level of at least 99%, a sample of 1,000 patients is required.
The purpose of this feasibility study is to collect data from PTA and Audimetroid in 1,000 patients who are referred to audiology for the first time (test location: NHS Ayrshire and Arran). Audimetroid will be run alongside normal clinical practice by an audiologist in a testing room (but outside sound proofed booths). Patients will receive normal standard clinical practice and Audimetroid’s test results will not guide or influence clinical decision-making. The collected and fully anonymised data from both Audimetroid and PTA will be made available to HD, who will run the analysis of the test results to establish and validate Audimetroid’s test accuracy.
REC name
South Central - Oxford C Research Ethics Committee
REC reference
23/SC/0123
Date of REC Opinion
3 May 2023
REC opinion
Further Information Favourable Opinion