An observational study in Sensorineural Hearing Loss and Tinnitus, sponsored by University College, London. Enrolling by invitation at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-26.
Sponsored by University College, London · Observational
Background and study aims
Hearing problems are becoming more common. In the UK around 18 million adults have hearing loss or hear ringing or buzzing in their ears, which is called tinnitus. Many people wait a long time to be seen, partly because there are not enough audiologists - the specialists who test hearing and treat hearing problems.
The standard hearing test is called pure-tone audiometry. An audiologist plays quiet sounds at different pitches through headphones and the person presses a button each time they hear one. The test is accurate, but it takes 20 to 30 minutes to complete, and needs a trained audiologist for all of that time. For people with tinnitus and comorbidity it can be especially tiring and slow.
The research team has built a version of this test that uses artificial intelligence, called AI-PTA. Instead of following a fixed pattern, it chooses each sound based on the responses already given, which should mean fewer sound presentations are needed to find the same result. The audiologist stays with the person throughout and remains in charge of the test.
This study asks three questions.
Who can participate?
Adults aged 18 or over who have been diagnosed with sensorineural hearing loss, either with or without tinnitus, and who are due to attend the Royal National ENT \& Eastman Dental Hospital in London. Participants need enough English to read and complete questionnaires and to be able to give informed consent. People who have or report hyperacusis (an unusual sensitivity to everyday sounds), an active ear infection, or recent ear surgery cannot take part.
What does the study involve?
People who are interested are sent information about two weeks before a hospital appointment they already have. Those who decide to take part come in about 30 minutes early, meet a research audiologist, discuss the study, and if happy to take part, sign a consent form. They fill in a short questionnaire about their hearing health.
They then have two hearing tests at that visit: the standard test, which is part of their normal care, and the AI-PTA test. Half of the participants have the standard test first and half have AI-PTA first, so that the order does not affect the results.
They come back within a week for a shorter appointment, about 40 minutes, to repeat the AI-PTA test. This shows whether it gives the same response twice. They also fill in a questionnaire about what they think of using artificial intelligence in healthcare. That is the end of taking part, though participants are also invited to join an optional group discussion about their opinions on AI in healthcare later on.
What are the possible benefits and risks of participating?
There is no direct benefit to taking part. The results will help decide whether tests like this can shorten waiting times for hearing assessments in the NHS.
The risks are small. Both tests use the same clinical equipment at the same safe sound levels that ordinary hearing tests use, and a qualified clinical audiologist is present throughout and can stop at any point. The main cost to participants is time: about 45 minutes extra at the first appointment and a second visit of about 40 minutes. Some people find hearing tests tiring, and people with tinnitus sometimes notice their tinnitus more during or after a hearing test. Taking part is voluntary, and choosing not to take part, or stopping at any time, will not affect anyone's care.
Where is the study run from?
Royal National ENT and Eastman Dental Hospitals in London which is part of University College London Hospitals NHS Foundation Trust, and University College London.
When is the study starting and how long is it expected to run for?
The study was approved in August 2026 and the first participant took part in September 2026. It is expected to run for 12 months, finishing in August 2027.
Who is funding the study?
The British Society of Otology (part of ENT UK), and the National Institute for Health and Care Research University College London Hospitals Biomedical Research Centre.
Who is the main contact?
Dr Roulla Katiri, uclh.ahead@nhs.net
Pure-tone audiometry is the reference standard for measuring hearing thresholds, and the procedure recommended by the British Society of Audiology has been essentially unchanged for decades. It is reliable, but it is also slow: the level of each tone is chosen by a fixed rule rather than by what the previous answers have already established, so a substantial proportion of the presentations in a test carry little information about where the threshold lies. The cost falls on both the patients' and the audiologists' time, which is the binding constraint on access to hearing assessment in the NHS.
AI-PTA addresses this by replacing the fixed rule for choosing the next level. The procedure maintains a probability distribution over the threshold at each ear and frequency, updates it after every response using a psychometric model of hearing, and selects the level of the next tone to maximise the expected information gained about the threshold. Testing at each frequency stops when the standard deviation of that distribution falls below 4 dB and the participant has responded on an ascending run. The starting distribution is drawn from one of four sources, chosen before the test: the participant's own most recently measured audiogram, a clinic population of 75,452 adults seen at this trust, a general population of 19,051 respondents from NHANES (Centers for Disease Control and Prevention (CDC). National Center for Health Statistics (NCHS). National Health and Nutrition Examination Survey Data), or a uniform distribution carrying no assumption. Only aggregate tables are used; no individual record from either population is held by the system.
The stopping threshold of 4 dB was fixed before recruitment on the basis of in-silico evaluation across simulated listeners of six audiogram shapes, and is not adjusted during the study. Changing it, or any other parameter capable of moving a measured threshold, would make sessions recorded before and after the change non-comparable, so any such change requires the participants already tested to be treated as a pilot set.
Both procedures are delivered by an audiologist who presents each tone on the department's own calibrated audiometer and records the response in the software. The software instructs and records; it does not generate sound, and it does not decide a threshold that the audiologist cannot override. This is deliberate. The system is a decision support tool operating with a clinician in the loop, not an autonomous test, and every departure from the procedure it proposes is recorded with a reason so that the frequency of such departures can be reported.
Safety constraints are applied identically in both procedures and take precedence over the level selection. Above 80 dB HL the level rises in steps of no more than 5 dB, and no step may cross 80 dB HL without stopping on it, because loudness growth is not linear at high levels and an information calculation that proposes a large step at the top of the range would be correct about the information and wrong about the participant. Maximum output is capped per frequency at the audiometer's calibrated limit, and a clinician may enter lower limits for the equipment actually in the room. The first tone of every session is a familiarisation tone at 40 dB HL whatever the starting distribution suggests, and is excluded from the threshold estimate.
Masking, where the rules indicate it, follows the plateau method of the British Society of Audiology in both procedures. The three indication rules, the 10 dB steps of masking noise and the criterion for a plateau are identical; what differs is only how the threshold is re-established at each level of noise, which is the same difference the study is measuring everywhere else. Bone conduction is likewise handled identically in both.
The design is within-participant and counterbalanced. Each participant receives both procedures, so each acts as their own control and the comparison is not vulnerable to between-participant variation in hearing. The order is randomised to prevent an effect of fatigue, learning or familiarity being attributed to either procedure, and randomisation is stratified by the presence or absence of concurrent tinnitus because tinnitus is expected to affect how reliably a participant responds near threshold, and an imbalance between the groups would otherwise be indistinguishable from a difference between the procedures.
Every presentation is recorded: the level, the response, the state of the estimate at that point, and the time between the instruction appearing and the answer being recorded. Each session also records the version of the procedure that produced it, the version of the software, and the specific build, so that any recorded threshold can be interpreted against the behaviour that produced it. These records support the error analysis, the assessment of agreement between the procedures, and the examination of whether performance differs across age, sex and tinnitus status.
The study is an early-stage clinical evaluation. It is powered to compare the two procedures within participants and is not designed to establish clinical outcomes, cost-effectiveness, or performance in settings or populations other than the one described.
375 studies on the registry are indexed under Hearing Loss, Sensorineural; 108 are open to participants now.
This study's planned enrollment of 84 is close to the median of 78 across 95 observational studies indexed under Hearing Loss, Sensorineural.
Browse Hearing Loss, Sensorineural studies →University College, London is the lead sponsor of 648 studies on the registry; 146 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) have results posted.
Counted across the registry records on this site, refreshed daily.
Participants are drawn from adults attending outpatient Ear, Nose and Throat (ENT) and Audio-Vestibular Medicine (AVM) clinics at the Royal National ENT and Eastman Dental Hospital, part of University College London Hospitals NHS Foundation Trust in central London. This is a tertiary referral centre, so the clinic population is weighted towards people referred for specialist assessment rather than drawn from the general community.
Potential participants are identified by clinical research audiologists, who are members of the same Audiology team that delivers manual pure-tone audiometry to these clinics as part of routine care, by pre-screening upcoming clinic lists on the Epic electronic patient record. Those identified are sent study information approximately two weeks before an outpatient appointment they are already scheduled to attend, and are recruited by invitation at that appointment.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Participants randomly allocated to receive Standard PTA before Intelligent PTA at visit 1, and the reverse order at visit 2. Randomisation is stratified by tinnitus status, so this arm contains participants from both clinical groups.
Diagnostic Test: Intelligent PTA · Diagnostic Test: Standard pure-tone audiometry (BSA modified Hughson-Westlake)
Participants randomly allocated to receive Intelligent PTA before Standard PTA at visit 1, and the reverse order at visit 2. Randomisation is stratified by tinnitus status, so this arm contains participants from both clinical groups.
Diagnostic Test: Intelligent PTA · Diagnostic Test: Standard pure-tone audiometry (BSA modified Hughson-Westlake)
Air-conduction pure-tone audiometry in which the level of each presentation is chosen to maximise expected information about the hearing threshold, from a prior distribution and the responses so far. Testing at a frequency stops when the posterior standard deviation falls below 4 dB with a response on an ascending run. Tones are presented by the audiologist on their own calibrated audiometer; the system instructs and records. Masking follows the BSA plateau method with the same engine establishing the threshold at each masking level.
Air-conduction pure-tone audiometry by the British Society of Audiology's recommended procedure: descending 10 dB steps until no response, ascending 5 dB steps until a response, threshold taken from two responses out of three on ascending runs, with a 1 kHz repeat in the first ear tested. Tones are presented by the audiologist on their own calibrated audiometer.
Agreement between hearing thresholds measured by AI-PTA and by Standard PTA
Mean absolute difference in air-conduction hearing threshold (dB HL) between the two procedures, across all tested frequencies and both ears, measured within the same visit.
Time frame: Visit 1 (day 1)
Test-retest reliability of each procedure.
The difference in threshold for the same ear and frequency between visit 1 and visit 2
Time frame: Visit 1 to visit 2, up to 7 days
Number of tone presentations, by procedure
Number of tones presented to establish a threshold at every tested frequency, counted separately for each of the two audiometry procedures. Counts are recorded by the system for each test session.
Time frame: visit 1 (day 1) and visit 2 (within 7 days of visit 1)
Test duration, by procedure
Time in minutes from the participant's first response to their last.
Time frame: Visit 1 (day 1) and visit 2 (within 7 days of visit 1).
Features of AI-assisted healthcare devices that matter to healthcare users, measured by the importance subscale of the Attitudes toward Artificial Intelligence in Healthcare - Adult questionnaire (AAIH-A)
Mean of the 33 importance items of the Attitudes toward Artificial Intelligence in Healthcare - Adult questionnaire, each answered on a five-point scale from 1 (not important) to 5 (extremely important). The subscale score is the mean of the answered items and ranges from 1 to 5. Higher scores indicate greater importance placed on these device features. The subscale describes respondents' priorities and is reported descriptively; it has no better or worse direction.
Time frame: Visit 2 (within 7 days of visit 1)
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — De-identified individual participant data underlying the published results, together with the analysis code, will be made available to researchers whose proposed use has been approved by the chief investigators. Requests should be made to the chief investigators. Data will be available from publication for ten years.
Supporting information: Study protocol, Statistical analysis plan, Clinical study report, Analytic code
Time frame: From study completion (estimated August 30th, 2027) for ten years.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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