This briefing describes the regulated use of the technology for the indication specified, in the setting described, and with any other specific equipment referred to. It is the responsibility of healthcare professionals to check the regulatory status of any intended use of the technology in other indications and settings.
Otovent is a Class 1 medical device. Abigo Medical AB received a CE mark for the device in 1998; the most recent renewal was in October 2015.
The Otovent kit consists of a nose piece and 5 latex balloons. Before use, a balloon is connected to the nose piece. The nose piece is placed against 1 nostril while the other nostril is held closed; nothing is inserted into the nasal cavity. The user inflates the balloon until it is the size of a grapefruit by blowing through their nose into the nose piece. The procedure, known as the Valsalva manoeuvre, is then repeated with the other nostril. The forced expiration against the closed airway leads to auto‑inflation of the middle ear, increasing the pressure in the nasopharynx. This helps to open the Eustachian tube to equalise the air pressure and allow the fluid in the middle ear to drain naturally down the back of the throat. The user may feel increased pressure in the ear or hear a 'click' during the procedure. Symptoms of glue ear usually resolve with this treatment.
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.
Otovent may be used by children aged 3 years and over and by adults. It would be used on the advice of a clinician in either primary or secondary care; children would normally be taught how to use the device by a clinician, after which they can be treated at home under parental supervision.
The first 3 months after diagnosis of glue ear is a period of active observation, because the condition usually resolves within this time. There is no medication available to shorten the length of time that the symptoms last. The NICE guideline on otitis media with effusion in under 12s recommends that advice on educational and behavioural strategies is offered during this period to reduce the effects of hearing loss. Auto‑inflation may also be considered during this period for children who are likely to be able to carry out the procedure. After 3 months, children with persistent symptoms and significant hearing loss should be considered for surgery. Children with less severe hearing loss may also be considered for surgery if the effect of hearing loss on the child's developmental, social or educational status is significant. Surgery involves inserting a small ventilation tube (grommet) into the eardrum to maintain normal air pressure in the middle ear. The surgery is carried out under general anaesthetic and takes about 15 minutes. The grommet usually falls out about 6 to12 months after surgery as the eardrum starts to heal. If a child's adenoids are swollen, they can block the Eustachian tubes and may also be removed during grommet insertion surgery. Adenoidectomy is not recommended if upper respiratory tract symptoms are not persistent or frequent. Hearing aids should usually be offered as an option, or if surgery is contraindicated or not acceptable to parents or carers.
NICE is not aware of any other CE‑marked devices that have a similar function to Otovent.
The Otovent kit consists of a nose piece and 5 balloons, and costs the NHS £4.90 (Drug Tariff cost excluding VAT) when prescribed by a GP. It can also be bought at pharmacies and online at a recommended retail price of £7.84 (including VAT). The kit is supplied as a self‑contained treatment and does not need any further consumables, maintenance or calibration.
The manufacturer recommends that people starting treatment with Otovent should use it at least 3 times a day with 1 inflation through each nostril on each occasion. After 1 week, it should be used at least twice a day. The normal duration of treatment is 2 to 3 weeks, after which a physician should decide whether or not to continue the treatment. After each use, the nose piece should be cleaned with a mild detergent and rinsed with clean water. When not in use, the balloons should be protected from light, and may be kept with the nose piece in the box provided with each kit. Each balloon may be inflated a maximum of 20 times.
Otovent is designed as a first‑line non‑surgical, drug‑free treatment option for glue ear during or after the period of active observation following diagnosis, to help avoid the need for surgery.
All 3 specialist commentators noted that parents are interested in using this treatment. One commented that many parents are disheartened when told, in line with NICE guidance, to wait for 3 months before any intervention can be considered. They are keen to try this treatment during this period, particularly because it is a non‑surgical option that does not need the high level of monitoring required for hearing aids. Two specialist commentators pointed out that Otovent can easily be incorporated into NHS clinics, along with information on the effectiveness and instruction on the method. Another commentator noted that if no clinician is available to show how to use it correctly, instructional videos are available on several internet sites.
One specialist commentator noted that, given the self‑limiting nature of glue ear, they would normally not prescribe Otovent unless symptoms have been present for several weeks or are causing distress. They would be particularly likely to consider the device in cases severe enough to need referral for possible grommet insertion surgery. Another specialist commentator highlighted the issue of infection control, especially when the balloon has mucus blown into it, or if there is more than 1 child in the same family being treated, and noted the need for advice on cleaning and device allocation.
NICE is committed to promoting equality, eliminating unlawful discrimination and fostering good relations between people with particular protected characteristics and others. In producing guidance and advice, NICE aims to comply fully with all legal obligations to:
promote race and disability equality and equality of opportunity between men and women
eliminate unlawful discrimination on grounds of race, disability, age, sex, gender reassignment, marriage and civil partnership, pregnancy and maternity (including women post‑delivery), sexual orientation, and religion or belief (these are protected characteristics under the Equality Act 2010).
Otitis media with effusion is a common childhood condition. Age is a protected characteristic, defined by the Equality Act (2010).