Advice

Summary

Summary

Otovent is a balloon device designed to relieve the symptoms of otitis media with effusion, commonly known as glue ear. An Otovent kit consists of a nose piece and 5 latex balloons that are inflated by blowing through the nose. Four randomised controlled trials, all in children, have shown that using the device causes significant improvements, compared with standard care, in middle ear function; 1 of the trials also reported a significant reduction in the need for ventilation tube (grommet) insertion surgery. Outcomes varied by compliance with (that is, adherence to) treatment, and standard care was not consistently described. The Otovent kit is available to buy or can be provided on a NHS prescription. The recommended retail price is £7.84 including VAT and the current Drug Tariff price is £4.90 excluding VAT. No additional consumables are needed.

Product summary and likely place in therapy

  • Otovent is designed to help open the Eustachian tubes and equalise the air pressure in the middle ear.

  • The device can be used in people with Eustachian tube dysfunction associated with glue ear (otitis media with effusion), or after flying, diving or pressure chamber treatment.

  • It would most likely be used in children with glue ear during or after an active observation period following diagnosis, to help avoid the need for surgery.

Effectiveness and safety

  • No relevant evidence was found for the use of Otovent in adults.

  • Four randomised controlled trials involving a total of 565 children showed statistically significant improvements in middle ear function with Otovent compared with standard care, as determined by tympanometry and pneumatic otometry. The comparator was not always fully described.

  • One study (n=320) reported that children having auto‑inflation were more likely to have normal tympanograms at 1 month (47.3% compared with 35.6%; relative risk 1.36) and 3 months (49.6% compared with 38.3%; relative risk 1.37) than those having standard care alone. Auto‑inflation also produced greater improvements in ear‑related quality of life assessed using a validated tool (the OMQ‑14).

  • One study (n=85) reported significant improvement in middle ear function, as assessed by tympanometry and pneumatic otoscopy, at 1, 2 and 3 months in those using Otovent with a compliance of more than 70% when compared with the control group.

  • One study (n=60) reported a significant reduction in the need for ventilation tube (grommets) surgery in the children having both Otovent and nasal saline irrigation compared with children having irrigation alone.

  • One study (n=100) reported that 65% of ears improved, 33% remained unchanged and 2% deteriorated after 2 weeks of auto‑inflation, compared with 15% of ears improving, 71% remaining unchanged, and 14% deteriorating in the control group.

  • No serious adverse effects associated with using the balloon were reported.

Technical and patient factors

  • Otovent can be used at home by children aged 3 years and over and by adults. Young children should be supervised by an adult during use.

Cost and resource use

  • The Otovent kit, comprising a nose piece and 5 latex balloons, has a Drug Tariff cost for the NHS of £4.90 (excluding VAT). The retail price is £7.84 (including VAT).

  • Initial treatment is 3 inflations per day for each affected nostril, and each balloon may be inflated 20 times before it needs replacing. Treatment normally lasts 2 to 3 weeks.