World’s first self-monitored cochlear implant trial opens the door to future hearing loss therapies

A ground-breaking study by Rinri Therapeutics, a private biotechnology company developing the world’s first regenerative cell therapy for hearing loss, has been published in the latest issue of Frontiers in Neurology.

Sheffield, UK, December 2022: In a global first, cochlear implant users have been able to perform their own hearing health recordings from the comfort of their own homes.

Until recently, objectively measuring cochlear health was notoriously difficult. However, a ground-breaking study published in Frontiers in Neurology has overcome this challenge by using the electrode arrays of cochlear implants to gain direct insight into cochlear health. Importantly, since data collection in this study was via participant self-assessment, it enabled regular recordings to be made over long periods of time. Such high intensities of data collection would have been impossible if testing relied on participants attending clinics. The application of this technique has improved the medical understanding of how cochlear health influences the performance of implants, and importantly, may serve to overcome major hurdles in the development of advanced treatments for deafness, including the regenerative cell therapies being developed by Rinri Therapeutics. The approach pioneered by this study, cements Rinri’s position as a global leader in the design of effective clinical trials for hearing loss.

Rinri Therapeutics and Innovate UK funded the study which was conducted by the National Institute for Health and Care Research, Biomedical Research Centre (NIHR BRC) for Hearing Loss in Nottingham. The Active Insertion Monitoring (AIM) tablet required for the study, was provided by Advanced Bionics. The data was collected by experienced adult cochlear implant recipients. They were trained to use the AIM tablet to self-record electrode impedances, electrically-evoked compound action potentials (eCAPs) and electrochochleography (ECochGs). These measures, cumulatively, provide a comprehensive snapshot of an individual’s cochlear health and participants in this trial were able to record them independently, twice-daily over a 12-week period. They also completed behavioural hearing and speech assessments at the end of the study.

Participant compliance in the study was exceptionally high: over 98.9% for all measures across the participant group. The data generated by the study were of similar reliability and quality as those made in a clinic under direct supervision, demonstrating the utility of cochlear implant-derived measures, performed via participant self-assessment.

Professor Douglas Hartley, Rinri’s Chief Medical Officer and award-winning consultant of Otology, said: ‘We are delighted with these results and with the level of engagement from participants. This is a huge step closer to the development of safe regenerative hearing loss therapies and will allow us to advance our pioneering stem cell technology to reverse sensorineural hearing loss.’

Hearing loss is the most common global sensory disability, affecting more than 430 million individuals worldwide, and these numbers are expected to rise dramatically with increasing and ageing populations. Sensory cells in the inner ear are unable to repair or regenerate naturally. Current hearing devices are unable to restore natural hearing leading to an unmet need for a biological solution to treat hearing loss. Untreated hearing loss places significant pressure on global healthcare systems, costing the UK economy alone £25.5bn a year.

Rinri Therapeutics is at the forefront of global efforts to develop new biological treatments to treat hearing loss. Approaches include pharmacological treatments, and cell and gene-based therapies. The inner ear’s location has made it difficult to deliver these treatments and assess their safety and efficacy so the success of this clinical study means that the assessment of revolutionary therapeutic treatments through cochlear implants will make clinical development easier in the future.