Clinical Research Directory

Post-Market Registry Study for Vibrant Hearing Solutions

This observational registry collects retrospective and prospective, data from children and adults who use CE-marked MED-EL implantable (PMEI, BCI, or AMEI) or non-implantable (BCD) hearing solutions as part of routine care. Participants will be followed long term, potentially up to the lifetime of their hearing solution, to assess quality of life, hearing and speech performance, and device use. Data will be collected using routinely administered clinical tests and questionnaires to evaluate real-world outcomes across diverse populations and MED-EL hearing systems.

Clinical and Genetic Analysis of Enlarged Vestibular Aqueducts

This study will try to identify and understand the genetic factors that lead to an inner ear malformation called "enlarged vestibular aqueducts", that can be associated with hearing loss. Patients with sensorineural hearing loss with or without inner ear malformations and their parents and siblings may be eligible for this study. Participants and their immediate family members, may undergo some or all of the following tests and procedures: * Medical and family history, including questions about hearing, balance and other ear-related issues, and review of medical records. * Routine physical examination. * Blood draw or buccal swab (brushing inside the cheek to collect cells) - Tissue is collected for DNA analysis to look for changes in genes that may be related to hearing loss. * Hearing tests - The subject listens for tones emitted through a small earphone. * Balance test (VEMP) to see if balance functions of the inner ear are associated with the hearing loss Electrodes will be placed behind your ear and at the base of your neck. From a reclining position, you will be asked to raise your head while clicking sounds are played into your ears. - Ultrasound tests - An inner ear malformation called EVA (enlargement of the vestibular aqueduct) indicates that a genetic disorder called Pendred syndrome may be the cause. Because thyroid abnormalities are also associated with Pendred syndrome, an ultrasound examination of the thyroid gland may be done. * Computed tomography (CT) and magnetic resonance imaging (MRI) scans - These tests show the structure of the inner ear. For CT, the subject lies still for a short time while X-ray images are obtained. For MRI, the patient lies on a stretcher that is moved into a cylindrical machine with a strong magnetic field. The magnetic field and radio waves produce images of the inner ear. The radio waves cause loud thumping noises that can be muffled by the use of earplugs.

Genetic Analysis of Hereditary Disorders of Hearing and Balance

This study will try to identify the genetic causes of hereditary hearing loss or balance disorders. People with a hearing or balance disorder that affects more than one family member may be eligible for this study. They and their immediate family members may undergo some or all of the following procedures: * Medical and family history, including questions about hearing, balance and other ear-related issues, and review of medical records. * Routine physical examination. * Blood draw or buccal swab (brushing inside the cheek to collect cells) - Tissue is collected for DNA analysis to look for changes in genes that may be related to hearing loss. * Hearing tests - The subject listens for tones emitted through a small earphone. * Balance tests to see if balance functions of the inner ear are associated with the hearing loss In one test the subject wears goggles and watches moving lights while cold or warm air is blown into the ears. A second test involves sitting in a spinning chair in a quiet, dark room. * Photograph - A photograph may be taken as a record of eye shape and color, distance between the eyes, and hair color. * Computed tomography (CT) and magnetic resonance imaging (MRI) scans - These tests show the structure of the inner ear. For CT, the subject lies still for a short time while X-ray images are obtained. For MRI, the patient lies on a stretcher that is moved into a cylindrical machine with a strong magnetic field. The magnetic field and radio waves produce images of the inner ear. The radio waves cause loud thumping noises that can be muffled by the use of earplugs.

Effect of a Totally Implantable Cochlear Implant on Tinnitus Severity in Adults With Preoperative Tinnitus

The purpose of this study is to investigate the degree of benefit to tinnitus symptoms by using a Totally Implantable cochlear implant (TICI) in a group of patients who have moderate-to-severe tinnitus pre-operatively.

Comparing an AI-driven Hearing Test With the Standard Hearing Test in Adults With Hearing Loss and Tinnitus

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. 1. Does AI-PTA give the same hearing results as the standard test? 2. Is it quicker? 3. And do patients and staff find it acceptable? 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

Alpha-Tectorin, Interleukin-10 and Thiol-Disulfide Homeostasis in Children With Congenital Hearing Loss

Congenital hearing loss is one of the most common sensory disorders of childhood, and the structural, immunologic and oxidative mechanisms involved in its development are incompletely understood. This case-control study aims to evaluate serum alpha-tectorin and interleukin-10 (IL-10) levels and thiol-disulfide homeostasis in children with congenital sensorineural hearing loss (cochlear implant users and hearing aid users) compared with healthy children with normal hearing. The findings are expected to contribute to a better understanding of the mechanisms underlying congenital hearing loss and to the identification of potential diagnostic and prognostic biomarkers.

First In Human Randomised Trial of Rincell-1 in Adults With a Cochlear Implant

Rinri Therapeutics is conducting a clinical trial of a new cell therapy called Rincell-1. Rincell-1 is being developed to treat adults with neural hearing loss, either age related hearing loss or auditory neuropathy, who also meet criteria for a cochlear implant. The goals of this study are: * To learn about the safety profile of Rincell-1, the procedure used to inject it and the medications given to promote the growth of the cells * To evaluate how well Rincell-1 works by measuring changes in the function of auditory neurons. * To understand if Rincell-1 can be easily and successfully given at the same time as cochlear implant surgery Participants will be randomly assigned to one of two groups: one group that receives a standard care cochlear implant, and the other that will receive an injection of Rincell-1 at the same time as their standard care cochlear implant. Researchers will compare the safety of Rincell-1 in combination with a cochlear implant to a cochlear implant on its own. Participants will take part in the trial for 52 weeks after CI surgery. During that time, they will have regular follow-ups and will take daily measurements at home of their hearing health.

Genetic and Epigenetic Background of Inner Ear Dysfunction in Turner Syndrome

The goal of this case-control study is to pave the way for new revolutionary treatment measures within hearing loss that could either replace or delay the need for hearing aids. The study focuses on people with Turner syndrome (TS). The aim is to find out if there are specific DNA methylation patterns and/or RNA expression profiles linked to sensorineural hearing loss (SNHL) in people with TS. Additionally, the structure and function of the inner ear in these individuals will be examined to see if there is a connection to their epigenetic profile. The main question it aims to answer is: Does epigenetics constitute a common denominator for some of the unexplained SNHL cases? Turner Syndrome (TS) represents an ideal model for studying epigenetics related to sensorineural hearing loss (SNHL). Participants will undergo the following tests: * Ear examinations * Hearing tests * Balance tests * Blood tests * MRI scans * CBCT (cone-beam computed tomography) scans

Vestibular and Postural Function in an Unselected Group of Children With Sensorineural Hearing Loss

The goal of this prospective cohort study is to investigate the vestibular function in children with unilateral or bilateral sensorineural hearing loss. The main hypothesis of the study is that abnormal vestibular test results will be found in 20-30 % of the children with sensorineural hearing loss. The participants will be children in the age of 3-10 years with sensorineural hearing loss. The test protocol consists of questionnaires and vestibular and postural assessments.

Communication Training in Hearing Aid Users

The objective of the current research project is to investigate the effectiveness of communication training in first-time hearing aid users with mild to moderate hearing loss delivered in-person in groups or individually. In doing so, the project aims to strengthen evidence-based person-centered care for individuals with hearing loss and pave the path toward more holistic hearing healthcare. We hypothesize that participants receiving communication training will show improved hearing-related quality of life, communication strategies, and personal adjustment compared to controls. Moreover, group training is expected to yield greater benefits in communication strategies and adjustment than individual training, due to its interactive nature and peer support, leading to more positive evaluations in interviews. A pretest-posttest design will be used, with testing before and after the communication training sessions, and two experimental groups and a control group. The two experimental groups are the groups receiving in-person group and individual training. The control group does not receive the communication training nor an alternative. A mixed-method will be applied to collect quantitative and qualitative data. The quantitative data include screening measures, audiological tests, and questionnaires, while the qualitative data consist of a semi-structured interview.

Randomized Controlled Trial of Valganciclovir for Cytomegalovirus Infected Hearing Impaired Infants

The overall goal of this study is to determine the clinical benefit and safety of antiviral therapy for asymptomatic congenital cytomegalovirus (cCMV) infected hearing-impaired infants. We will conduct a multi-center double-blind randomized placebo-controlled trial to determine whether hearing-impaired infants with asymptomatic cCMV have better hearing and language outcomes if they receive valganciclovir antiviral treatment. We will also determine the safety of antiviral valganciclovir therapy for asymptomatic cCMV-infected hearing impaired infants. This study will be unique in that the cohort enrolled will only include hearing-impaired infants with asymptomatic cCMV. Primary Objective: To determine if treatment of cCMV-infected hearing impaired infants with isolated hearing loss with the antiviral drug valganciclovir reduces the mean slope of total hearing thresholds over the 20 months after randomization compared to untreated cCMV-infected infants with isolated hearing loss. Main Secondary Objectives: 1. To determine if valganciclovir treatment improves the following outcomes when compared to the control group: 1. The slope of best ear hearing thresholds over the 20 months after randomization. 2. The MacArthur-Bates Communicative Development Inventory (CDI) percentile score for words produced at 20 months of age. 2. To evaluate safety measures based on all grade 3 or greater new adverse events designated by the NIAID Division of AIDS (DAIDS) toxicity tables.

Perimodiolar Implant Performance in Adults With Low-Frequency Residual Hearing

The purpose of the feasibility study is to investigate hearing performance (audiometry and speech perception) using the CI632 in a group of adults (n=15) with low-frequency residual hearing who meet inclusion criteria.

Retrospectively Investigating Longitudinal Outcomes in MED-EL SONATA 2 Cochlear Implant Recipients.

MED-EL Cochlear Implants (CI) provide auditory sensations via electrical stimulation of the auditory pathways for severely to profoundly hearing-impaired individuals who obtain little or no benefit from acoustic amplification in the best aided condition. However, there is only few evidence from large long-term observational studies available to gain knowledge on clinical effectiveness of cochlear implants. With continued pressure on healthcare system budgets, there is an increasing demand for evidence-based research that demonstrates an intervention is effective in the real-world environment across large and diverse populations. Currently, there is a paucity of data concerning the long-term outcomes of subjects implanted with a SONATA 2 cochlear implant from representative samples of the population. This retrospective study aims at analyzing SONATA 2 cochlear implant data from clinical routine.

Clinical Evaluation of Hearing Aid OTC Self-Assessment Methods for Adults With Perceived Mild-to-Moderate Hearing Loss

The goal of this clinical trial is to compare two methods of self assessment of hearing with conventional audiometry in an OTC Hearing Aid for adults with perceived mild to moderate hearing loss. The main questions it aims to answer are: 1. To evaluate agreement between prescribed gain outputs generated from conventional audiometry and those generated from the self-assessment response method. 2. Determine whether either self-assessment response method provides acceptable estimated audibility. 3. Evaluate participant preference between the detection response method and the audibility-release response method. Researchers will compare the two novel methods with conventional audiometry to determine levels of agreement. Participants will self assess their hearing methods using two novel methods of hearing assessment as well as receive a conventional audiometric evaluation of hearing levels.

Middle Ear Optical Coherence Tomography Imaging and Vibrometry in Patients With Hearing Loss

This study involves imaging ears with hearing loss with a new system that allows the user to see the middle ear bones and measure their movement in response to sound.

The Effect of Anatomy-based Fitting on the Perception of Speech in Noise and Music in Single-sided Deaf Cochlear Implant Users

The present study evaluates the effect of anatomy-based fitting on speech perception in noise and music perception in newly implanted single-sided deaf (SSD) CI recipients. Speech perception in noise will be assessed using different spatial configurations of speech and noise. Music perception will be evaluated using objective measurements for melody, harmony, timbre and pitch and using a subjective questionnaire, the Music and Cochlear implant questionnaire (MCIQ). Furthermore, localization and self-reported hearing benefit (HISQUI19, SSQ12) will be assessed.

Anatomy-Based Fitting in Bimodal Cochlear Implant Users

The purpose of the study is to investigate the effect of an anatomy-based frequency distribution in comparison to a default frequency distribution in bimodal CI patients, i.e. wearing a cochlear implant and a contralateral hearing aid. Speech perception in quiet, speech perception in noise, consonant/vowel discrimination and pitch/timbre perception will be assessed in an acute set-up with both the default fitting map and the anatomy-based fitting map.

Safety of Autologous Stem Cell Infusion for Children With Acquired Hearing Loss

To determine if autologous human umbilical cord blood infusion in children with acquired hearing loss is safe, feasible, improves inner ear function, audition and language development.

Evaluation of Electrode-modiolus Distance and Cochlear Fibrosis Using Depth Sounding and Spectroscopy Tools

Cochlear fibrosis development can compromise the success and the outcomes of the cochlear implantation (CI) thus affecting the quality of life of the implanted patient. Correlating the results of the Transimpedance Matrix (TIM) measurements to the implant electrode location determined by the Cone Beam Computer Tomography (CBCT), this study aims to identify a range of TIM profiles within the implanted population, certain profiles suggesting the growth of the fibrosis tissue in cochlea

Long-term Follow-up of a Cochlear Implant With Dexamethasone Eluting Electrode Array

A long-term follow-up of Cochlear's cochlear implant electrode array which passively elutes dexamethasone for a defined period of time to help reduce inflammatory responses.

Perceptual Adaptation Following Cochlear Implantation (Aim 3a)

The goal of this study is to study the adaptation process in newly implanted Single-Sided Deaf Cochlear Implant (SSD-CI) users. Subjects will use four frequency maps for the first month after CI activation. One of these maps will be standard of care and the other three will have higher low frequency edges than the standard of care default maps. These maps will alternate daily during the first month (with exceptions made for situations when the subject is allowed to use a preferred map rather than the map predetermined for use that day), and after that point each subject will make a selection at the beginning of the week to compare all four maps and decide which one to use at the beginning of the following week. The goal of this study is to investigate how reducing place-pitch mismatch in SSD CI users affects 1) sound quality, 2) device use, and 3) speech perception.

Anatomy-Based Fitting in Unexperienced Cochlear Implant Users

Severe to profound hearing loss affects 0,8% of the global population. For these people, a conventional hearing aid often does not provide sufficient benefit. However, these people can benefit from a cochlear implant (CI). A CI needs to be individually programmed (fitted) for each recipient. A fitting "map" is defined as a set of electrical parameters that are individually adapted to a recipient's needs to achieve optimal sound perception. At present, most CI recipients are fitted with a default frequency allocation map that doesn't take individual variability in size and shape of the cochlea into account. In this study, a fitting strategy based on the post-operative CT scan, that will allow the audiologist to set a frequency-band distribution for CI fitting that may be more closely aligned to the natural tonotopic frequency distribution of a normal hearing cochlea, will be evaluated.

Protein Biomarkers and Host RNA Expression Profiles in Congenital Cytomegalovirus Infection

This study seeks to identify and test host protein biomarkers and RNA expression profiles in dried blood spot samples as novel diagnostic markers of congenital cytomegalovirus sequelae and to improve the understanding of the pathogenesis of the disease.

Yiyuancong for the Treatment of Sudden Sensorineural Hearing Loss

This project aims to evaluate the clinical efficacy of Yiyuancong, an independently developed traditional Chinese medicine (TCM) formula based on the homology of medicine and food, in participants with sudden sensorineural hearing loss (SSNHL) and to elucidate its potential underlying mechanisms. This study is designed as a multicenter, randomized controlled trial (RCT), utilizing dynamic randomization for participant allocation. Due to the requirement for the experimental group to continuously administer the TCM preparation for 1-2 months, this study is conducted as an open-label (non-blinded) trial. All participants will undergo audiological evaluations at baseline, day 7 of treatment, and upon completion of the first and second treatment courses. Based on previous research regarding integrated traditional Chinese and Western medicine for SSNHL, the estimated effect size (ES) for the improvement of pure-tone thresholds compared with Western medicine alone ranges from 0.5 to 0.8. Assuming an effect size of 0.5 for the difference in pure-tone audiometry (PTA) improvement between the experimental and control groups, with a significance level (α) of 0.05 (one-tailed) and a statistical power (1-β) of 0.8, the required sample size calculated via G\*Power software is 51 per group. Accounting for a 20% dropout rate, the investigators plan to enroll 64 participants per group (total N = 128).