An initial validation study of DigiBel, a web-application enabling self-assessment of air and bone-conduction audiometry in the community

Abstract

80% of primary school children suffer from glue ear which may impair hearing at a critical time for speech acquisition and social development. An online application, DigiBel, has been developed primarily to identify individuals with conductive hearing impairment who may benefit from temporary use of bone-conduction (BC) assistive technology in the community. This preliminary study aims to determine the screening accuracy and usability of DigiBel self-assessed air-conduction (AC) pure tone audiometry (PTA) in adult volunteers with simulated hearing impairment prior to formal clinical validation.

Healthy adults, each with one ear plugged, underwent standard automated AC PTA (reference test) and DigiBel audiometry in quiet community settings. Threshold measurements were compared across six tone frequencies and DigiBel test-retest reliability was calculated. The accuracy of DigiBel for detecting more than 20 decibels of hearing impairment was assessed.

30 adults (30 unplugged ears and 30 plugged ears) completed both audiometry tests. DigiBel had 100% sensitivity (95%CI 87.23-100) and 72.73% (95%CI 54.48-86.70) specificity in detecting hearing impairment. Threshold mean bias was insignificant except at 4000 and 8000Hz where a small but significant over-estimation of threshold measurement was identified. All 24 subjects completing feedback rated the DigiBel test good or excellent and 21(87.5%) agreed or strongly agreed that they would be able to do the test at home without help.

This study supports the potential use of DigiBel as a screening tool for hearing impairment. The findings will be used to improve the software further and undertake a formal clinical trial of AC and BC audiometry in individuals with suspected conductive hearing impairment.

Author Summary Hearing loss is a major global health issue. It can affect many aspects of life such as education, employment, communication, and result in social isolation. Two thirds of people with severe hearing loss live in low and middle countries with poor access both to hearing testing (audiometry) or conventional hearing aids.

Several software applications (apps) like DigiBel, studied here, have been developed to enable individuals to test their own hearing in the community. Uniquely, DigiBel has the additional potential to identify individuals with hearing loss who could derive immediate hearing support from an affordable and rechargeable bone-conduction headphone / microphone kit while waiting specialist care.

This initial study of DigiBel provides confirmation that the app is easy to use and accurate at detecting simulated hearing impairment. It lays the groundwork for future clinical studies to assess DigiBel’s performance in children and adults with hearing impairment.

Competing Interest Statement

Louise Allen is the inventor of the DigiBel app and founding director of Cambridge Medical Innovation Ltd. We confirm that these competing interests will not alter adherence to PLOS policies on sharing data and materials.

Funding Statement

This study received no funding.

Author Declarations

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

Yes

The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

1. Non-abbreviated, full names and affiliations of all ethics oversight bodies that ruled on ethics of your study - Patient Outcomes Department, Safety and Quality Support of Cambridge University Hospitals NHS Foundation Trust 2. Decision made, i.e. whether ethical approval was given or waived - “This project has been reviewed and approved with the Patient Outcomes Department and confirmed as a Service Evaluation. This project has been approved via a 4 stage approval process by the projects Audit Lead, Specialty Audit Lead, Directorate Audit Lead and Clinical Audit Coordinator for this Specialty/Directorate. This project was reviewed and approved with no ethical review required.” Signed by Mrs Amy Baker (Patient Outcomes Manager, Cambridge University Hospitals NHS Foundation Trust)

I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.

Yes

I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).

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I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable.

Yes

Data Availability

All relevant data are within the manuscript.

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