AI-assisted Diagnosis, Triage and Assessment of Hearing Loss and Tinnitus
Artificial Intelligence for the Automated Diagnosis, Triage, and Assessment of Patients With Hearing Loss and Tinnitus: A Pilot Comparative Study With Clinical Evaluation by Otolaryngologists
1 other identifier
observational
1,500
1 country
1
Brief Summary
Hearing loss affects approximately 11 million people in the UK, while tinnitus impacts around 7 million. Both conditions can significantly reduce quality of life and are linked to poorer mental health and employment challenges. Each year, tinnitus alone accounts for more than one million GP appointments, and patients referred to hospital ear, nose and throat (ENT) services often face long delays, sometimes exceeding a year, before their first assessment. To address this demand, the Royal Cornwall Hospitals NHS Trust has developed a virtual ENT clinic. Patients undergo a validated hearing test in person and complete online questionnaires. Clinicians then review these data to determine next steps, which may include discharge with advice, referral for imaging, or a face-to-face consultation. Initial trials demonstrated that the majority of patients could be managed virtually, substantially reducing waiting times. However, clinicians must still review every case, limiting capacity for patients who require direct care. This project builds on the virtual clinic by introducing artificial intelligence (AI) to support the assessment process. Using explainable AI methods, the system will be trained to replicate clinician-level decision-making while providing transparent reasoning for its recommendations. The study will evaluate how closely AI-generated outcomes align with clinician assessments, with all cases continuing to receive a clinician's final review. Clinicians will not be aware of the recommendations produced by the AI tool, but the study aims to measure how concordant AI recommendations are with clinician assessments. If the AI tool's clinical recommendations closely align with clinician recommendations (the gold standard for care), the AI tool could be introduced as a clinical recommendation assistant tool, streamlining the triage and management of hearing loss and tinnitus, enabling clinicians to focus on complex cases, accelerating access to care, and improving efficiency.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2026
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 7, 2026
CompletedFirst Posted
Study publicly available on registry
May 14, 2026
CompletedStudy Start
First participant enrolled
May 30, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
August 13, 2026
Study Completion
Last participant's last visit for all outcomes
August 31, 2027
May 14, 2026
May 1, 2026
3 months
May 7, 2026
May 7, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
MRI internal auditory meatus (IAM) referral recommendation
Agreement between the clinical outcomes generated by the AI clinical decision support system and the clinician-derived "gold standard" outcomes within the virtual hearing loss and tinnitus clinic. Agreement will be evaluated for: MRI internal auditory meatus (IAM) referral recommendation (binary outcome: yes/no). Agreement will be quantified using sensitivity and specificity with 95% confidence intervals, derived from contingency tables and one-vs-rest analyses for categorical outcomes, as specified in the statistical analysis plan.
March 2026 - August 2026
Clinical triage outcome
Agreement between the clinical outcomes generated by the AI clinical decision support system and the clinician-derived "gold standard" outcomes within the virtual hearing loss and tinnitus clinic. Agreement will be evaluated for: Clinical triage outcome (categorical outcome: refer to face-to-face ENT clinic, refer to audiology, refer to audiology plus hearing therapy, or discharge). Agreement will be quantified using sensitivity and specificity with 95% confidence intervals, derived from contingency tables and one-vs-rest analyses for categorical outcomes, as specified in the statistical analysis plan.
March 2026 - August 2026
Secondary Outcomes (2)
Patient experience and satisfaction with the AI-assisted virtual hearing loss and tinnitus clinic
August 2026 - August 2027
Staff experience, usability, and acceptability of the AI-assisted clinical decision support system
August 2026 - August 2027
Study Arms (3)
Phase 1 - Patients undergoing the standard virtual hearing loss and tinnitus clinic
Phase 1 consists of a retrospective and prospective observational evaluation of consecutive adult patients managed through the virtual hearing loss and tinnitus clinic at the Royal Cornwall Hospitals Trust, between August 2025 and August 2026. No additional interventions.
Phase 2 - Patients undergoing the AI-assisted virtual hearing loss and tinnitus clinic
Phase 2 consists of a prospective observational evaluation of consecutive adult patients managed through the AI-assisted virtual hearing loss and tinnitus clinic at the Royal Cornwall Hospitals Trust, between August 2026 and August 2027. The AI-assisted clinic is the intervention.
Phase 2 - Staff involved in providing an AI-assisted virtual hearing loss and tinnitus clinic
Staff involved in running the artificial intelligence-assisted virtual hearing loss and tinnitus clinic at the Royal Cornwall Hospitals Trust from August 2026 to August 2027. They include doctors, healthcare assistants, administrative staff and nurses. The AI-assisted clinic is the intervention.
Interventions
An explainable AI-based clinical decision support tool within an existing virtual hearing loss and tinnitus clinic. The tool provides non-binding triage and investigation recommendations based on routinely collected patient data, with all final clinical decisions remaining the responsibility of the clinician and no change to standard care pathways
Eligibility Criteria
The study population comprises adult patients managed through the virtual hearing loss and tinnitus clinic, in the Ear, Nose and Throat Department at the Royal Cornwall Hospitals Trust. Patients included are seen in the virtual clinic during the study period, as well as clinical staff involved in reviewing and making decisions within the service. Patient data are analysed observationally, and a subset of patients and clinicians may be invited to provide questionnaire or interview data to explore experiences of the AI-assisted clinic. Patients will comprise of those living in the county of Cornwall and considered under the care of the Royal Cornwall Hospitals Trust.
You may qualify if:
- Patients assessed in the RCHT virtual hearing loss and tinnitus clinic.
- Presenting symptoms of hearing loss and/or tinnitus.
- Ability to provide informed consent to participate in the study.
You may not qualify if:
- Individuals under 18 years of age.
- Patients unable to provide informed consent.
- Patients without sufficient English proficiency where translation services cannot be arranged.
- Cases where data quality is insufficient for analysis.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Royal Cornwall Hospitals Trustlead
- University of Exetercollaborator
- University of Birminghamcollaborator
Study Sites (1)
Treliske Hospital
Truro, Cornwall, TR1 1LJ, United Kingdom
Related Publications (1)
Baron T, Whinney D, Reddy V. Virtual clinic for hearing loss and non-pulsatile tinnitus: initial experience of 210 cases. J Laryngol Otol. 2024 Jan;138(1):38-42. doi: 10.1017/S0022215123000518. Epub 2023 Mar 20.
PMID: 36938822RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- OTHER
- Target Duration
- 1 Year
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 7, 2026
First Posted
May 14, 2026
Study Start (Estimated)
May 30, 2026
Primary Completion (Estimated)
August 13, 2026
Study Completion (Estimated)
August 31, 2027
Last Updated
May 14, 2026
Record last verified: 2026-05