Clinical and technical evidence

A literature search was carried out for this briefing in accordance with the interim process and methods statement. This briefing includes the most relevant or best available published evidence relating to the clinical effectiveness of the technology. Further information about how the evidence for this briefing was selected is available on request by contacting

Published evidence

This briefing summarises 1 cross-sectional validation study that included 56 patients.

Table 2 summarises the clinical evidence as well as its strengths and limitations.

Overall assessment of the evidence

The only publically available evidence is a study done at a surgical hospital in a remote region of Nepal, which screened people attending a rural outpatient clinic for ear disease. Being a screening study, patients were recruited regardless of otological history. Because of this, and the study setting, it has limited generalisability to UK care pathways in which assessment and diagnosis is done in primary care.

Evidence is being generated to assess the resource impact of using the device in the NHS in ear, nose and throat (ENT) clinics, care homes, GP clinics and audiology home visits, with results expected by the end of 2018.

Table 2 Summary of selected studies

Mandavia et al. (2017)

Study size, design and location

56 patients (12 children and 44 adults). Within-subject cross-sectional validation study, screening for ear disease in a surgical outpatient clinic in Nepal.

Intervention and comparator(s)

Intervention: TYM smartphone otoscope.

Comparator: assessment with standard otoscope by 1 UK-trained ENT consultant.

Key outcomes

The overall prevalence of ear disease of any type was 35%.

Concordance in primary diagnosis (TYM versus standard assessment) was 95%.

TYM had sensitivity, specificity, and positive and negative predictive values for diagnosing any ear disease of 0.94, 0.96, 0.91 and 0.97 respectively.

Concordance in decision to refer for ENT consultation treatment (TYM versus standard assessment) was 100%.

Strengths and limitations

Patients were assessed by a UK-trained clinician, but the sample was non‑UK patients with a high prevalence of ear disease.

Four patients were excluded because the TYM smartphone otoscope images were inadequate.

Recent and ongoing studies

A pilot study of the TYM smartphone otoscope was done in 1 NHS trust between April 2016 and November 2016, including 275 patients in the ENT clinic, care home, GP clinic and audiology home visit settings. Peer-reviewed publication is planned for 2018.