P4.A001: A novel auto-inflation device to treat young children with Otitis Media with Effusion at home: Preliminary clinical results

Background: Otitis media with effusion (OME) affects millions of children each year, with high prevalence rates in children of early school age. OME is characterised as having a build-up of fluid in the middle ear, due to negative middle ear pressure, usually resulting from eustachian tube dysfunction (ETD). This fluid accumulation can result in conductive hearing loss. Current clinical guidelines support the “Watchful Waiting” approach, with at least three months of monitoring without treatment. Should OME persist for more than three months, along with hearing loss, tympanostomy tube surgery is recommended. Whilst surgery can resolve an instance of OME, it can reoccur, requiring repeated surgery which has the potential for complications. Surgery wait times can lengthen the time with conductive hearing loss. This can lead to language delays and affect the child’s behavioural and learning capacities. This study aimed to examine the effect of ventilating the eustachian tube for patients with OME or ETD.

Methods: This take-home pilot study (HRE2020-0526) evaluated a prototype auto-inflation device disguised as a drinking bottle (Figure 1). When the child drinks from the device, their nose is aligned with a nasal mask which gently pressurises the nasal cavity, precisely coordinated with swallowing (Figure 2). This assists the eustachian tube opening, ventilating the middle ear to remove fluid and negative pressure. Children aged 1-12 years with OME or ETD were recruited, where patients used this device daily for four weeks. Baseline audiometry and tympanometry was performed during the initial consult, along with tympanometry after first use of the device. The patients underwent subsequent tympanometry testing at two, four, eight, and twelve weeks. At week four, an additional audiometry test was also conducted. Audiometry and tympanometry results were compared to baseline using a paired t-test.

Results: At the time of submission, 17 patients had completed the four-week follow-up, consisting of 8 girls and 9 boys, aged between 2-12 years. After a single session using the prototype device, 94% of patients had an immediate tympanogram improvement in at least one ear (p < 0.01). After four weeks of at-home use, 82% of patients had tympanogram improvement in at least one ear, since starting the trial (p < 0.01). At week four, 71% of patients who were initially diagnosed as having hearing loss, had improved hearing thresholds by at least 5dB in at least one ear (p < 0.01, n=14). 80% of these patients who improved, did so into the normal hearing threshold range in at least one ear (n=10). Full results are pending trial completion.

Conclusion: These preliminary results demonstrate significant improvements in both tympanometry and audiology after four weeks of using the prototype device. This indicates a strong potential benefit in ventilating the middle ear during swallowing for patients undergoing “Watchful Waiting”.