Parent-led Assessment and Recognition of AOM Using Digital Ear Imaging (PARENT-EAR)

Acute otitis media (AOM) is the most common bacterial infection in young children and a major contributor to healthcare utilization and costs. Diagnosis relies on otoscopy and identification of tympanic membrane (TM) bulging, yet physician-performed otoscopy has variable diagnostic accuracy and depends heavily on clinical expertise.

Digital otoscopy combined with artificial intelligence (AI)-based image analysis has demonstrated high diagnostic accuracy in previous studies. In a recent study by our group, digital otoscopy with an automated neural network classifier reliably ruled out otitis media in children.

The PARENT-EAR randomized controlled pilot trial aims to evaluate whether parent-performed digital otoscopy at home, combined with retrospective AI analysis of captured TM images, can reduce physician visits due to suspicion of AOM. The study also assesses feasibility, diagnostic accuracy of parents after training, and potential effects on antibiotic use and healthcare utilization.

Methods and outcomes The PARENT-EAR trial is a randomized controlled pilot trial conducted at Vaasa Central Hospital and Turku University Hospital. Recruitment will occur between September and December 2026 (extended if necessary), with follow-up ending May 31, 2027 (5-9 months per participant).

Children aged 12 to 47 months with at least one AOM episode in the past 12 months will be randomized 1:1 using permuted block randomization. Exclusion criteria include tympanostomy tubes, tympanic membrane perforation, middle ear effusion at recruitment, immunosuppression, previously diagnosed hearing loss or anatomical abnormalities predisposing to AOM, and otoscopy experience of the parent.

Intervention group:

Parents receive a digital otoscope (The Ear Penguin by Sibbo Medical Devices, MDR EU Class I device) and training on TM image interpretation. They complete a TM image classification quiz before and after the training. During follow-up, parents perform home otoscopy when suspecting AOM, capture TM images/videos, interpret findings, and record symptoms in a diary. If AOM is suspected or the child appears ill, medical evaluation is instructed.

Control group:

Standard care without home otoscopy. Parents complete the same symptom diary and seek care according to usual practice.

Statistical analyses will compare outcomes between groups. AI-based TM classification will be compared against expert panel evaluation.

This is a pilot study with a target sample size of 20 children per arm, limited by device availability.

Ethical aspects, data collection and handling The study will be conducted in accordance with the Declaration of Helsinki. Written informed consent will be obtained from all parents after provision of oral and written information. Participation is voluntary, and families may withdraw at any time. Investigators may discontinue participation if deemed in the child's best interest.

The digital otoscope is a CE-marked Class I medical device used solely for visual inspection of the tympanic membrane. Pneumatic pumps are not provided. Potential risks include minor ear canal abrasions or discomfort; serious adverse events are considered rare. Any adverse events will be managed according to standard clinical practice and reported to relevant authorities when required. The study is investigator-initiated. The device manufacturer provides the otoscopes but has no role in study design, data access, or analysis.

Data will be collected via paper symptom diaries, monthly REDCap questionnaires (University of Turku), and national electronic health records (Kanta). TM images and videos will be securely stored and imported into a research database with relevant metadata.

All data will be handled in accordance with the EU General Data Protection Regulation (GDPR 2016/679). Study data will be pseudonymized and identified only by study ID numbers. The key linking personal identifiers to study IDs will be stored separately and securely. Paper diaries will be destroyed after digitalization. Consent includes permission to access health records and to use collected images and data for scientific purposes. Results will be published in peer-reviewed journals and as part of a doctoral thesis.

Study Overview

• Status: Not yet recruiting
• Conditions: Otitis Media; Acute Otitis Media
• Intervention / Treatment: Device: Assigning of a digital otoscope to the families in the intervention group

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Simo Nuuttila, MD; Phone Number: +35823130000; Email: simo.c.nuuttila@utu.fi
• Study Contact Backup: Name: Paula A Tähtinen, MD, PhD; Phone Number: +35823130000; Email: paula.tahtinen@utu.fi

Study Locations

• Finland
  • Pohjanmaa
    • Vaasa, Pohjanmaa, Finland, 65130
      • Vaasa Central Hospital
      • Contact: Simo Nuuttila, MD; Phone Number: +35862181111; Email: simo.c.nuuttila@utu.fi
      • Contact: Lisa Kulppi, MD; Phone Number: +35862181111; Email: lisa.kulppi@ovph.fi
  • Southwest Finland
    • Turku, Southwest Finland, Finland, 20521
      • Turku University Hospital
      • Contact: Paula A Tähtinen, MD, PhD; Phone Number: +35823130000; Email: paula.tahtinen@utu.fi
      • Contact: Lotta E Ivaska, MD, PhD; Phone Number: +35823130000; Email: lesaar@utu.fi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• At least one episode of AOM within the last 12 months
• Family speaks fluent Finnish

Exclusion Criteria:

• Tympanostomy tubes or perforation of the TM, or scheduled for upcoming tympanostomy
• Middle ear fluid at the time of recruitment
• Previously diagnosed hearing loss
• Immunosuppressive disorder or medication, excluding inhaled corticosteroids
• Anatomic defect or anomaly affecting the susceptibility to AOM
• Previous otoscopy experience of the participating parent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; Intervention group to receive the digital otoscope	Device: Assigning of a digital otoscope to the families in the intervention group; Parents receive a digital otoscope (The Ear Penguin by Sibbo Medical Devices, MDR EU Class I device) and training on TM image interpretation. They complete a TM image classification quiz before and after the training. During follow-up, parents perform home otoscopy when suspecting AOM, capture TM images/videos, interpret findings, and record symptoms in a diary. If AOM is suspected or the child appears ill, medical evaluation is instructed.
No Intervention: Control group; Control group with no intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of physician visits due to suspected AOM	Number of physician visits due to suspected AOM	5 to 9 months, depending on date of recruitment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Agreement between parent interpretation, AI classifier, and expert gold standard	Parent's interpretation of the tympanic membrane image is retrospectively compared to the expert's gold standard and classification by an artificial intelligence classifier	5 to 9 months, depending on date of recruitment
Antibiotic prescription rates	Antibiotic prescription rates for AOM in both arms	5 to 9 months, depending on date of recruitment
Adverse events related to otoscopy	Adverse events, such as abrasion, related to otoscopy in the experimental group	5 to 9 months, depending on date of recruitment
AOM-related complications	AOM-related complications, such as mastoiditis, in both arms	5 to 9 months, depending on date of recruitment
Daycare absence	Child's absence from daycare due to suspected AOM	5 to 9 months, depending on date of recruitment
Parental work absenteeism	Parental work absenteeism due to suspected AOM	5 to 9 months, depending on date of recruitment
Parental satisfaction on a visual analog scale (VAS)	Parental satisfaction in the experimental group of AOM management with parent-led digital otoscopy	5 to 9 months, depending on date of recruitment

Collaborators and Investigators

• Sponsor: Turku University Hospital
• Collaborators: Vaasa Central Hospital, Vaasa, Finland
• Investigators: Principal Investigator: Paula A Tähtinen, MD, PhD, Department of Paediatiatrics and Adolescent Medicine, Turku University Hospital and University of Turku, Finland

Publications and helpful links

General Publications

• Nuuttila S, Vallin A, Klockars T, Ruohola A, Laine M, Ivaska LE, Tahtinen PA. An artificial intelligence classifier as a screening tool to rule out otitis media in children. Int J Pediatr Otorhinolaryngol. 2026 May 9;205:112847. doi: 10.1016/j.ijporl.2026.112847. Online ahead of print.

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): August 31, 2027

Study Registration Dates

• First Submitted: May 27, 2026
• First Submitted That Met QC Criteria: June 6, 2026
• First Posted (Actual): June 10, 2026

Study Record Updates

• Last Update Posted (Actual): June 10, 2026
• Last Update Submitted That Met QC Criteria: June 6, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: telemedicine; otitis media; acute otitis media; digital otoscopy
• Additional Relevant MeSH Terms: Otorhinolaryngologic Diseases; Ear Diseases; Otitis; Otitis Media
• Other Study ID Numbers: VARHA/4418/13.02.01/2026

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Deidentified participant data will be made available upon reasonable request from the corresponding author.
• IPD Sharing Time Frame: Study protocol will be published as supplementary material alongside the study manuscript alongside publication.
• IPD Sharing Access Criteria: Deidentified participant data will be made available to fellow researchers upon reasonable request from the corresponding author.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No