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Hearing Loss, Adult-OnsetNCT07586098

AI-assisted Diagnosis, Triage and Assessment of Hearing Loss and Tinnitus

An observational study of Hearing Loss, Adult-Onset and Tinnitus, run by Royal Cornwall Hospitals Trust at 1 site in United Kingdom.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hearing Loss, Adult-Onset, Tinnitus
What is being tested?
Artificial Intelligence (AI) Assisted Clinical Decision Support Tool for managing Hearing Loss and Tinnitus
Type of treatment
Medical device
How many people
1,500 participants
Where
1 siteUnited Kingdom
Study dates
30 May 2026to 31 Aug 2027
How long will I take part?
1 Year
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: 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.

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Neil C Tan, MEd PhD FRCS(ORL-HNS) contact

+441872 253404

neil.tan@nhs.net

Christian JW Grimes, BMBS MRCS (ENT) PGCert ClinEd contact

+447970780502

christian.grimes@nhs.net

United Kingdom1 site
  • Treliske Hospital

    Truro, Cornwall, TR1 1LJ

Other trials in United Kingdom

About this study

Official title: 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

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.

Read more

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.

Read the detailed description

BACKGROUND

Hearing loss affects approximately 11 million people in the UK, while tinnitus impacts around 7 million.1,2 Both conditions can significantly reduce quality of life and are linked to poorer mental health and employment challenges.3 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.4 This was exacerbated even further following the coronavirus (COVID-19) pandemic.5

To address this demand, the Royal Cornwall Hospitals NHS Trust has developed a virtual ENT clinic to manage patients with hearing loss and/or non-pulsatile tinnitus. 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. Inclusion criteria for the virtual clinic for hearing loss and non-pulsatile tinnitus were: ≥16 years of age; subjective bilateral hearing loss and/or tinnitus that did not fulfil the criteria for direct referral to audiology (they would see patients ≥50 years of age); subjective asymmetrical sensorineural hearing loss; and subjective unilateral non-pulsatile tinnitus. Exclusion criteria for the virtual clinic for hearing loss and non-pulsatile tinnitus were: cognitive, motor or visual impairment that may preclude use of an iPad®; patients who had been referred back to ENT having previously been fully medically assessed (redirected to audiology or hearing therapy where appropriate); and symptoms that required a face-to-face appointment (conductive hearing loss, pulsatile tinnitus, vertigo or dizziness, pain, discharge, infections, abnormal ear examination, and history of ear disease, surgery or ear injury).6

Published results demonstrated that most patients could be managed virtually, substantially reducing waiting times.6 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, as a clinical decision support system (CDSS). Using explainable AI methods, the system is trained to replicate clinician-level decision-making while providing transparent reasoning for its recommendations. This retrospective and prospective observational feasibility pilot study aims to evaluate how closely AI-generated outcomes align with clinician assessments, with all cases continuing to receive a clinician's final review. Clinicians will be blind to 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.

RATIONALE

The primary rationale for the study is to assess the concordance between AI-generated and clinician-generated outcomes within a real-world virtual hearing loss and tinnitus clinic environment. Demonstrating strong alignment would support the future integration of AI-assisted clinical decision support systems into routine clinical workflows, with the potential to improve service capacity, reduce waiting times, and allow clinicians to focus on more complex cases requiring direct specialist expertise.

In parallel with this work, the research team is undertaking a systematic review examining the use of artificial intelligence in the diagnosis, triage, and management of patients with hearing loss and tinnitus within otolaryngology settings. Although this review has not yet reached the stage of full-text screening, preliminary scoping suggests that, to date, there are no published studies directly evaluating an AI tool used to diagnose, triage, and manage hearing loss and tinnitus patients within an ENT outpatient pathway overseen by otolaryngologists. While the use of AI as a clinical decision support tool is a recognised and growing field, there remains a notable evidence gap in its application to this specific clinical context.

The study design ensures patient safety and ethical integrity by maintaining full clinician oversight for all cases. During this evaluation phase, the AI system will function solely as a research tool and will not influence clinical decision-making, i.e. a shadow implementation. This phased, comparative approach enables a rigorous assessment of feasibility, safety, and acceptability before any consideration of broader clinical implementation.

Ultimately, the findings will help determine whether AI-assisted clinical triage could offer a sustainable and scalable response to rising demand in hearing loss and tinnitus services, enhancing patient access, efficiency, and satisfaction while maintaining the highest standards of clinical care.

THEORETICAL FRAMEWORK

This study is grounded in the intersection of clinical decision-making theory, artificial intelligence (AI) in healthcare, and health systems efficiency models. Its theoretical foundation integrates concepts from evidence-based medicine, human-AI collaboration, and service redesign in healthcare delivery.

  1. Clinical Decision-Making and Diagnostic Reasoning Clinical decision-making in otolaryngology involves interpreting complex data from hearing tests, patient histories, and symptom questionnaires to generate diagnostic and management recommendations. According to dual-process theory, clinicians use both analytical (systematic reasoning based on evidence) and non-analytical (pattern recognition and intuition) approaches.7 These cognitive processes underpin expert clinical judgement but are also limited by human variability, cognitive load, and time constraints-particularly in high-demand services within the NHS. By modelling clinician decision-making algorithmically, AI systems can emulate these cognitive processes, providing structured, data-driven, explainable recommendations that complement human expertise. This study therefore builds on clinical reasoning theory, assessing whether AI can achieve concordance with clinician judgement within a controlled, supervised framework.
  2. Artificial Intelligence and Explainability in Medicine The study applies explainable AI (XAI) principles, which emphasise transparency, interpretability, and accountability in algorithmic decision-making. Traditional "black box" AI models have raised ethical concerns about opacity and trust in clinical contexts. Explainable AI provides interpretable outputs that allow researchers and clinicians to understand why an AI system reached a particular decision, supporting both clinical safety and regulatory compliance. This theoretical stance draws on socio-technical systems theory, which views AI not as a replacement for clinicians but as part of an "intervention ensemble approach".8 Within this framework, AI serves as a clinical decision support tool designed to augment human expertise, reduce administrative burden, and enhance diagnostic efficiency, while clinicians retain final authority over all patient care decisions.
  3. Health Systems Efficiency, Virtual Care, and National AI Strategy

This study is grounded in the framework of health service efficiency and equitable access to care. Virtual clinics have already proven effective in reducing waiting times and improving access for patients with hearing loss and tinnitus.6 However, efficiency remains constrained by the requirement for clinicians to personally review every case in detail. Integrating AI-assisted triage models offers a mechanism to streamline this process, supporting clinicians by automating routine assessments while preserving human oversight. This approach aligns with lean healthcare principles, which emphasise reducing non-value-adding steps and directing clinical expertise toward complex or high-risk cases.9

The study also aligns with national healthcare policy promoting digital transformation. The UK Government's "Fit for the Future: 10-Year Health Plan for England" identifies AI and data-driven technologies as central to improving NHS capacity, efficiency, and patient experience through innovation and smarter service delivery.10 In parallel, NHS England's Artificial Intelligence Information Governance Guidance outlines the ethical and governance standards for deploying AI in clinical settings-framing AI as a decision-support tool that complements rather than replaces clinician judgement, ensuring accountability, transparency, and patient trust.11

The integration of AI in this study therefore reflects not only a local initiative to enhance virtual care, but also a broader policy-aligned commitment to digital innovation within the NHS. This framework is informed by the Technology Acceptance Model (TAM), which suggests that successful adoption of new technologies depends on perceived usefulness, ease of integration, and professional trust.12 By evaluating the concordance between AI-generated and clinician-generated outcomes-and later, patient satisfaction-the study contributes empirical evidence on the acceptability, feasibility, and safety of AI-assisted clinical workflows within the NHS.

This study is a prospective and retrospective observational mixed-methods service evaluation study, with elements of a diagnostic accuracy and implementation evaluation framework.

Being tested
Artificial Intelligence (AI) Assisted Clinical Decision Support Tool for managing Hearing Loss and Tinnitus
Keywords
Artificial Intelligence, Hearing Loss, Tinnitus, Clinical Decision Support Systems, Computerized, Telemedicine, Otolaryngology, Patient Satisfaction, Feasibility Studies
Medical subject headings
Hearing Loss, Tinnitus, Patient Satisfaction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Artificial Intelligence (AI) Assisted Clinical Decision Support Tool for managing Hearing Loss and TinnitusDevice

    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

Study groups in NCT07586098
Study groupRoleWhat they receive
Phase 1 - Patients undergoing the standard virtual hearing loss and tinnitus clinicPhase 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.
Receives: Device: Artificial Intelligence (AI) Assisted Clinical Decision Support Tool for managing Hearing Loss and Tinnitus
Phase 2 - Patients undergoing the AI-assisted virtual hearing loss and tinnitus clinicPhase 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.
Receives: Device: Artificial Intelligence (AI) Assisted Clinical Decision Support Tool for managing Hearing Loss and Tinnitus
Phase 2 - Staff involved in providing an AI-assisted virtual hearing loss and tinnitus clinicStaff 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.
Receives: Device: Artificial Intelligence (AI) Assisted Clinical Decision Support Tool for managing Hearing Loss and Tinnitus

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: March 2026 - August 2026

  2. 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.

    Measured: March 2026 - August 2026

Secondary outcomes (2)
  1. Patient experience and satisfaction with the AI-assisted virtual hearing loss and tinnitus clinic

    Patient experience and satisfaction with the AI-assisted virtual hearing loss and tinnitus clinic, assessed using structured satisfaction questionnaires administered by telephone. Outcomes will include:

    Quantitative measures (e.g. Likert-scale ratings of confidence, satisfaction, and acceptability), and

    Qualitative data from open-ended responses and semi-structured interviews, analysed using a directed content analysis informed by the NASSS framework.

    Measured: August 2026 - August 2027

  2. Staff experience, usability, and acceptability of the AI-assisted clinical decision support system

    Staff experience, usability, and acceptability of the AI-assisted clinical decision support system, explored through qualitative interviews with clinicians and relevant stakeholders involved in delivering or implementing the virtual clinic pathway.

    Measured: August 2026 - August 2027

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 May 2026
  2. Study start30 May 2026 (estimated)
  3. Primary completion13 Aug 2026 (estimated)
  4. Study completion31 Aug 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Other
Enrolment
1,500 participants (estimated)
Target duration
1 Year
IDs, dates and publications
ClinicalTrials.gov ID
NCT07586098
Sponsor's protocol ID
363272
Other IDs
363272
Status last verified
May 2026
First submitted
7 May 2026
Last updated
14 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 36938822

Questions about this trial

What is this clinical trial studying?

An observational study of Hearing Loss, Adult-Onset and Tinnitus, run by Royal Cornwall Hospitals Trust at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Neil C Tan, MEd PhD FRCS(ORL-HNS) (+441872 253404, neil.tan@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

MRI internal auditory meatus (IAM) referral recommendation (time frame: March 2026 - August 2026). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07586098, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.

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