A Sheffield-based firm has found a therapy that may one day replace hearing devices
The world’s first human trial of a stem‑cell therapy designed to rebuild the auditory nerve and restore natural hearing has begun in the UK.
Developed by Rinri Therapeutics, which was spun out from the University of Sheffield, the therapy, called Rincell‑1, targets severe deafness caused by damaged auditory neurons, a condition that modern hearing aids or cochlear implants cannot correct.
How the trial works
The next stage of the trial will involve 20 participants undergoing cochlear implant surgery in select NHS centres at Birmingham, Cambridge and London. Half will have age‑related hearing loss; half will have auditory neuropathy spectrum disorder.
Within each group, some will receive an injection of Rincell‑1 at the time of implant surgery, while others will proceed with the implant alone. The cells used are derived from stem cells and programmed to mature into auditory neurons, delivered via a novel surgical method to ensure precise placement.
Regulatory green light
The MHRA, the UK's medicines and healthcare products regulator, has officially approved the trial, with proof‑of‑concept data expected within 12 months of initiation. Preliminary results could emerge as early as 2027.
Professor Doug Hartley, chief medical officer at Rinri Therapeutics, remains optimistic about the therapy’s potential. However, ENT experts like Professor Nish Mehta caution that injecting cells into the inner ear carries risks, such as further damage to residual hearing.
What success would mean
About 1.2 million people in the UK live with severe hearing loss, and 12,000 rely on cochlear implants, each costing around £20,000. While current devices provide sound perception, they don’t regenerate neural pathways and often fail in noisy settings. Rincell‑1 offers a chance to repair the underlying damage, moving toward restoration of hearing.
“Rebuilding the auditory nerve has the potential to redefine hearing care,” said Micaela Stonestreet, Clinical Audiologist at Hearology®. “This trial goes beyond simply promising improved hearing; it represents a step toward restoring natural hearing and delaying long-term reliance on external devices for severe sensorineural loss.”
References
UK MHRA approves first human trial for regenerative hearing therapy – University of Sheffield Details on the MHRA approval, trial structure, and timeline
Rinri’s Rincell‑1 approach explained – Labiotech Examines how auditory neural progenitor cells are designed to regenerate hearing
What the trial means for the future – Hearing Practitioner News Analysis of Rincell‑1’s potential in clinical practice
More on the company behind it – BioIndustry Association A third party case study on Rinri Therapeutics
