Over 2 million grommet procedures are carried out globally each year, with more than 30,000 in England/Wales alone. However, a new surgical device, the V-Tube, is being developed to make insertion of grommets for the treatment of Otitis Media with Effusion (OME) a much simpler procedure with the potential to move grommet surgery from the operating theatre into the out-patient setting.
A first-in man collaborative research project between Nottingham University Hospitals NHS Trust, the University of Nottingham and NIHR Nottingham Hearing Biomedical Research Unit and Cork Institute of Technology (CIT), Ireland is to be undertaken to demonstrate safety and performance of the V-Tube device.
“Working on the V-tube project is really exciting for me. It’s great that modern technology has come up with something that could make a difference. Grommet surgery is so common, and this device could make a big difference, making grommet surgery much more convenient and accessible to patients” Mat Daniel, Nottingham Hearing BRU
OME, also known as glue ear, is a common cause of hearing loss in both children and adults. In children, it is the most common cause of hearing impairment in the developed world, and can lead to speech/educational delay or behavioural problems. The recommended treatment for persistent symptomatic OME is grommet (tympanostomy tube, ventilation tube) insertion; this involves making an incision in the ear drum, and the placement of a tube into the ear drum to allow middle ear ventilation.
In children grommet insertion is carried out under general anaesthetic, which in itself can create anxiety; the wait for theatre time, fasting, and absence from school or work for adults add to the inconvenience and distress, for both patients and carers. Therefore, any surgical strategy that could move grommet insertion away from theatre and into the outpatient setting, removing the need for a general anaesthetic would be welcomed by patients. The V-Tube deploys quickly, so it is anticipated that surgical insertion will be easier, and the procedure will be better tolerated by patients under local anaesthetic. Because the incision in the ear drum is only as big as the grommet itself (unlike standard surgery where incision is typically larger), it is also anticipated that the procedure will be less painful.
This project is being led by Mat Daniel and John Birchall of the Nottingham Hearing Biomedical Research Unit, and Olive O’Driscoll and John Vaughan of the Cork Institute of Technology. It is being supported by funding from Nottingham University Hospitals Research and Innovation in collaboration with CIT.