Clinical Data

‘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.’

NICE Medtech Innovation Briefing, March 2016

Summary

Otovent is the only clinically effective, non-surgical, drug-free treatment for glue ear. It is a proven first-line treatment option in which up to 50 percent of patients can avoid the insertion of tympanoplasty tubes, otherwise known as grommet surgery. The device has been the subject of extensive clinical trials, the most recent being Dr Ian Williamson’s 2015 study ‘Effect of nasal balloon autoinflation in children with otitis media with effusion in primary care: an open randomized controlled trial’.

On this page, you can access all the clinical data pertaining to Otovent in one place.

Clinical Data Downloads

As the number to treat is 9*, every £44.10 spent saves the NHS £802

Key Quotes

'Four randomised controlled trials, all in children, have shown that using the device causes significant improvements, compared with standard care, in middle ear function'

NICE Medtech Briefing 2016

'Otovent may be used in situations for people who cannot equalise air pressure in the middle ear, including those with glue ear. The technology can also be used for Eustachian tube dysfunction which may follow an upper respiratory tract infection, an episode of acute otitis media, or air pressure changes associated with flying, diving or pressure chamber treatment.'

NICE Medtech Briefing 2016

'The first 3 months after diagnosis of glue ear is a period of active observation, because the condition usually resolves within this time. (...) Auto-inflation may also be considered during this period for children who are likely to be able to carry out the procedure.'

NICE Medtech Briefing 2016

Key Quotes

'Autoinflation in children aged 4 - 11 years with otitis media with effusion is feasible in primary care and effective both in clearing effusions and improving symtpoms and ear-related child and parent quality of life.'

Williamson et al, 2015

'Autoinflation using a nasal balloon device is a low-cost intervention with the potential to be used more widely in primary care.'

Williamson et al, 2015

'The method has scope to be used in many symptomatic children, and is capable of producing better management and outcomes in primary health care systems. Wider use of nasal balloon autoinflation could address the present lack of treatment options for children with symptomatic otitis media with effusion.'

Williamson et al, 2015

Key Quotes

'This quick reference guide is for healthcare professionals and other staff who care for children under 12 years with otitis media with effusion.'

NHS Quick Reference 2008

Key Quotes

'Autoinflation may be considered during the active observation period for children with OME who are likely to cooperate with the procedure.'

NHS Guidelines 2008

'On combining results of five studies and using improvement in either tympanogram or audiometry as a binary variable, significant improvement with autoinflation was seen at more than 1 month.'

NHS Guidelines 2008

Key Quotes

'We conclude that autoinflation could be added to medical treatment of secretory otitis media and reduce the need for insertion of ventilation tube not only in short term but also in long term as well.'

Ercan et al, 2005

Key Quotes

'We recommend nasal balloon autoinflation in aircraft passengers who have difficulty clearing their ears during and after flying.'

Stangerup et al, 2004

Key Quotes

'We conclude that autoinflation is an effective short-term treatment for children with OME when used regularly under supervision.'

Blanshard et al, 1993

'The increasing number of children treated by ventilation tube insertion, has both practical and cost implications to the health service.'

Blanshard et al, 1993

'Our findings support those of Stangerup who demonstrated a beneficial effect after 2-4 weeks of regular use.'

Blanshard et al, 1993

'Autoinflation provides a short-term alternative to surgery and may avoid the need for surgery altogether in some.'

Blanshard et al, 1993

Key Quotes

'After 2 weeks of autoinflation, the tympanometric conditions were improved in 64% of ears.'

Stangerup et al, 1992

Key Quotes

'Otomicroscopic examination revealed that the number of ears judged as OME was reduced by 62% in the treatment group in comparison with 20% in the control group.'

Bidarian-Moniri, 2013

'The device was efficient in ventillation of the middle ear with normalization or improvement of the negative middle ear pressure and otomicroscopic findings in young children with persistent OME.'

Bidarian-Moniri, 2013

'86% of the children with type B tympanogram at inclusion achieved either improvement or normalization of the middle ear pressure with the new device.'

Bidarian-Moniri, 2013

Key Quotes

'The device demonstrated efficiency in improving both middle-ear pressure and hearing thresholds in most children after four weeks of treatment. It might therefore be possible to consider this method of autoinflation in children with persistent OME during the watchful waiting period.'

Bidarian-Moniri, 2014

'The new device for autoinflation provides promising results in treatment of persistent OME in children. The device demonstrated efficiency in improving both middle-ear pressure and hearing thresholds in most children after four weeks of treatment in a randomised controlled cross-over study.'

Bidarian-Moniri, 2014

Proven Success in Primary Care

The latest clinical trial by Southampton University conducted on 320 children aged 4 to 11 years (Williamson et al. 2015) found that children using Otovent experienced fewer days with any glue ear related symptoms compared to those that didn’t at both one and three months.

‘We have found use of auto inflation in young, school-aged children with Otitis Media with Effusion to be feasible, safe and effective in clearing effusions, and in improving important ear symptoms, concerns and related quality of life over a 3-month watch-and-wait period. We are confident in our results and it looks like a very good method for improving symptoms and quality of life while reducing harmful treatments. It should be more widely used now.’

Dr Ian Williamson*

Clinical data shows that Otovent autoinflation treatment is an effective glue ear treatment that can reduce the need for surgical intervention. Where compliance with the treatment is high, data also shows that Otovent increases the chances of a shorter recovery time from glue ear.

Autoinflation and ‘Watchful Waiting’ Period

Is is recommended in the NICE guidelines to try using autoinflation with Otovent during the “watchful waiting” or “active observation” period. If there is an improvement within the treatment period, then referral to an ENT specialist is necessary to obtain the surgical treatments for severe glue ear cases: grommet insertion and adenoidectomy.

Read more about treatments here

Application for Barotitis Sufferers

Whilst predominantly used to treat glue ear or Eustachian tube dysfunction, the Otovent device can also be used to equalise middle ear pressure during flights. The clinical trial “Point Prevalence of Barotitis and Its Prevention and Treatment with Nasal Balloon Inflation: A prospective, Controlled Study” by Stangerup et al ** was published in 2004. The report notes

‘The most common cause of barotitis is pressure changes induced during descent in aviation. The incidence after air flight has been reported to vary from 8% to 17%.’

In the study 134 passengers were measured via tympanometry and otoscopy before and after their flights. They were split between a control group and a balloon inflation group.

‘Passengers who were unable to equalize [using the valsalva maneuver unaided] inflated a nasal balloon, and in 69%, this maneuver cleared the middle ear pressure.’

Content Reference *

*Williams I, Vennik J, Harnden A, Voysey M, Perera R, Kelly S, Yao G, Raftery J, Mant D, Little P. Effect of nasal balloon autoinflation in children with otitis media with effusion in primary care: an open randomized controlled trial. CMAJ, July 2015 DOI: 10.1503/cmaj.141608.

**Stangerup S, Klokker M, Vesterhauge S, Jayaraj S, Rea P, Harcourt J. Point Prevalence of Barotitis and Its Prevention and Treatment with Nasal Balloon Inflation: A Prospective, Controlled Study. Otology & Neurology, 25:89-94, 2004

Ercan I, Cakir B, Kayaoğlu S. Long Term Effect of Autoinflation in The Treatment Of Otitis Media With Effusion, 2005

Stangerup S, Sederber-Olsen J, Balle V. Autoinflation as a Treatment of Secretory Otitis Media, Arch Otolaryngol Head Neck Surg – Vol 118, February 1992

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