ENT-UK Guidelines on Common Conditions in ENT

Otitis media with effusion (glue ear): surgery in the

context of overall clinical management
Guideline commissioned and approved by the Clinical Audit and Practice Advisory
Group, ENT-UK
Authors: P Robb & M Haggard
Introduction
Otitis media with effusion (OME or glue ear) is the most common cause of hearing
impairment in children. Its incidence peak is from about 2 to 6 years of age, with a tail
of children recurrently or persistently affected into late childhood. About 85% of
children will experience an episode of fluid in the ears following an ear infection,
during childhood but many of these go unnoticed. About 50% of episodes of OME
resolve spontaneously within three months.
When the fluid leads to a bilateral hearing loss for longer than six months, there may
follow delay in development of speech and language and of social communication
skills. Behaviour problems of certain types are then not uncommon, due to both the
hearing loss and the associated poor physical health, chiefly vulnerability to
respiratory and ear infections. Mild vestibular disturbance may accompany OME but
is usually asymptomatic. All symptoms have a range of severity of manifestation.
When extreme and persistent, these problems can have a marked effect on the
quality of life of child and family. Audiometry is taken as a proxy measure for these
important developmental outcomes, because it is standard, free of reporting bias,
and of importance in its own right for those outcomes most directly affected by
communication. The relation to broader outcomes at the same time-point can be
weak in this fluctuating condition: behaviour and language can not improve instantly
when hearing improves, although they do in time. However, whatever wider
assessements are used audiometry should not be by-passed in assessing severity
and persistence
The public health challenges lie in efficient finding and routing of the most
appropriate and persistent cases. The GP service lacks the instrumentation and
concentrated specialised training that permits reliable referral of only the most
persistent cases from the continuum of disease presentation. The reduction of GP
consultations linked with reduction of antibiotic prescribing for acute otitis media has
probably also contributed to the great reduction in referrals and intervention rates for
OME since the early 1990s. There is an unfortunate absence of good evidence that
the hearing screen around school entry age (which many PCTs still provide) does an
efficient job of finding the most persistent cases of hearing loss due to OME.
A suitable and detailed evidence base has also been lacking for policy about
appropriate level and timely direction of treatments, i.e. targetting surgical
intervention at the more persistent or recurrent cases, whom it is inappropriate to
regard as having a normal condition of childhood. It is important when reading
international literature to realise that UK intervention rates are much lower than those
in comparable countries, hence the average clinical severity of cases seen is higher.
But this does not justify complacency: selection for intervention should go well
beyond mere diagnosis and can still improve.

Although the diagnosis with which this guideline is concerned is OME, super-added
RAOM with the OME occurs, and is one of the main co-morbidities to consider. Many
of the seriously affected children also have other contributing health or
developmental problems, for both biological and social reasons. Down syndrome and
cleft palate are two well-known ones, but the potential list is long. The difficulties of
research on conjunctions of conditions, because some of the conjunctions are very
rare, means that there could not be detailed evidence on the implications of comorbidity. Nevertheless, the impact of co-morbidity is a general argument for making
an overall clinical assessment. In those with confirmed co-morbidity, such impact has
usually been accepted as clinical reason for a stronger tendency to intervene.

The role of watchful waiting

The clinical challenge in OME is not one of applying the diagnostic label otitis media
with effusion, but of selecting the few cases in whom the condition is sufficiently
severe and recurrent or persistent to cause further problems.
It is impractical to do objective tests frequently, so this requires careful elicitation of
the past history from parents and a scheduled re-consultation. A period of active
clinical monitoring is recommended for three months following initial diagnosis of
OME. Watchful waiting (WW) has been the term for this, although in an increasingly
consumer-led NHS, that term may become unacceptable to parents, and especially
so unless the watching is as evident as the waiting. Formal WW has usually been
defined in ENT as occurring in the secondary care setting, (e.g. in a childrens ENT
clinic). However in the highly gate-kept and resource-restricted NHS, informal WW
has generally taken place in a primary care setting, (which for present purposes is
defined as including community paediatric audiology services).
It is anticipated that new service developments, including explicit pathways, will
increasingly undertake formal WW in primary care. It is intended that targets for
shortened waiting times (18 weeks) should not preclude WW, by permitting clockstopping, but it is also clear that this facility could be abused. There is no evidence
on extra selectivity for the ability to benefit arising from WW periods longer than 3
months, so otolaryngologists will still be required to exercise judgement upon
whether or not in the light of the current presentation and total history, further WW at
ENT is appropriate in individual cases. Continued waiting on a child with evident
problems who has already undergone WW is counterproductive, and can undermine
families confidence in the NHS as a whole.
To make this decision on WW in effective and balanced fashion will be more difficult
in future. It will require balancing both of parental frustrations at previous waits and a
detailed understanding of the operation of clock-starting and clock-stopping
arising from the targets that express government pressures for rapid throughput. For
these reasons it is not possible to recommend that all children with OME arriving at
secondary care must undergo a (further) 3 months waiting. However it is essential
that clinical notes make explicit the total waiting history, and that clinical audits
address WW both before and at ENT.
National audit data indicate that secondary care is not optimally resourced to respond
rapidly and consistently with appropriate specialist intervention, when indicated.
Effort is therefore both justified and necessary in primary and secondary care to
make case-finding and case-selection appropriate and rigorous. Where WW
confirms persistence of the condition, in order to balance this initial restraint in an

effective way, there then has to be prompt access to secondary care outpatient and
surgical services. This is needed if the treatments that can improve physical health
and development are to be effective throughout a significant part of the remaining
natural history.
In recent years intervention rates have reduced and their variation from place to
place has narrowed. Therefore, any proposal for greater selectivity than in the past in
a particular commissioner/provider environment should be made in the light of local
standardised intervention rates in relation to national averages, and should start from
clinical criteria for intervention, not from arbitrary numbers or the blind imposition of
yet further formal waiting (e.g. 6 rather than 3 months).
Referral orientation for primary care
Where OME is strongly suspected to have occurred irrespective of a known ear
infection or to have continued for more than 1 month after one,
REFER:
Under 4 years of age:
To the second tier community audiology clinic for hearing assessment.
Subject to resources and efficiency of booking, this is usually the most direct route to
valid audiometry. Many community services have local arrangements for direct
access to ENT if the OME persists after watchful waiting at this level.
Over four years of age:
To childrens ENT clinic for hearing assessment
Watchful waiting is the initial management, unless there are overriding concerns
about hearing, speech or language development accompanying an established
history, or unless this has already occurred as set out above.
Management orientation for secondary care, on exit from formal watchful
waiting (wherever it may occur)
IF RESOLUTION DOES NOT OCCUR DURING A THREE-MONTH PERIOD OF
WATCHFUL WAITING, DISCUSS SURGICAL MANAGEMENT AND THE
ALTERNATIVES
Under three years of age:
General advice on family support and behavioural management of the condition and
provision of explanatory and rehabilitative information
Insertion of bilateral ventilation tubes (grommets) and advice on parental vigilance
and action in the event of infection or early extrusion etc
Over three years of age:
General advice on family accommodation to the condition and provision of
explanatory and rehabilitative information

Insertion of ventilation tubes (grommets) with advice on on parental vigilance and

action in the event of infection or early extrusion etc, plus adenoidectomy, particularly
if there is a history of frequent upper respiratory tract infections.
Adenoidectomy is recommended because it extends the improvement in hearing
levels and leads to an enduring reduction in subsequent consultations (including
primary care) and in tube re-insertions (hence in further general anaesthetics), plus a
measurable improvement in general respiratory health.
For all ages:
Follow-up as described below:
Children receiving grommets should routinely receive post-operative follow-up, to
check that the tubes have remained in situ, that there is no discharge, and that the
hearing is near-normal. A postoperative interval of not less than 3 months is
recommended, as parents will have been advised to re-consult earlier in the event of
specific problems occurring.
It is also desirable to make a final hearing assessment after grommet extrusion,
typically 6 - 9 months later, to assess possible return of middle ear fluid and hearing
impairment. At this point, a proportion (typically 20-30%) will be found to have
persisting problems. If adenoidectomy was not performed on the first insertion of
ventilation tubes, it should be considered and only withheld where there is explicit
justification (e.g. still very young age, cleft palate repair).
Treatment for post-grommet infection
A common problem following grommet surgery is otorrhoea (discharge from the ear,
through the inserted ventilation tube). Quinolone antibiotic drops are effective and
non-ototoxic in managing post-grommet otorrhoea. In the UK these are licensed for
aural use on a named patient basis. In the absence of systemic signs and symptoms
(e.g. respiratory) reasonably attributable to bacterial infection, oral antibiotic
treatment is not indicated.

Treatment alternatives
There is no good evidence that medical treatments developed so far, including
decongestants, antibiotics, antihistamines, have any clinically worthwhile effect on
resolution of established middle ear effusion. A minority of cases, in whom there is an
allergic component to their disease may benefit from topical (nasal) steroids. Various
complementary remedies, (e.g. cranial osteopathy), are no more effective than the
same period of watchful waiting.
Vaccines with meningitis as their main target are emerging, efficacious against the
main Pneumococcus serotypes and, more recently, against these together with nontypable Haemophilus influenzae, another major pathogen for otitis media. The new
population vaccination schedule now includes the former, and this is likely to
influence the pattern of childrens middle-ear disease seen in the near future.
Individual case vaccination (i.e. in 2-3 year olds with continuing histories) has not
been subjected to appropriate trials yet, and the scope for it may be limited by
reduced immunocompetence being the source of the problem. In the foreseeable
future there may also be effective mucolytics but there is as yet not an adequate
evidence base for use in practice.

The physical therapy of Eustachian auto-inflation may be helpful in some cases, but
difficulties over adherence (i.e. regular performance by the child as achievable in
most families) do not make it a generally useful treatment, or an alternative regimen
in the usual sense.
Hearing aids have a place in the management of OME, due to the lack of clear
medical alternatives. The issues in aiding are also far from clear-cut, due to lack of
good trials on their overall cost-effectiveness, and. Many departments will offer this
option after two or three sets of ventilation tubes where parents may not wish further
operations, or where there is reason to be concerned about long-term effects on the
eardrum. Use of amplification in this long-term history group is not very contentious,
as the group is not large, and it may become smaller with an increasing use of
adenoidectomy. In contrast, the range of opinion in ORL on aiding in OME while
waiting for or as an alternative to surgery is very wide. Where hearing aids are
provided in early history OME, there needs to be a clear understanding with the
sensory support/educational audiology service about the further support that can be
provided or otherwise; where it can be provided, there has to be an efficient
mechanism for notification of individual cases. Counselling of parents should confirm
that they are happy about the possibilities of stigmatisation, and possible future
dependency on an aid, when it may no longer be required to manage a hearing loss
that has resolved.
Parents should be asked about the presence of sound-field amplification systems in
the childs school or nursery. Where these are reliably present and physical health
problems do not predominate in the childs presentation, this may tip the balance to
watchful waiting rather than surgery. Where an overall local NHS policy is being
developed for children with OME, the educational authority needs to be brought into
discussions about classroom amplification as an option. Its widespread benefits have
been demonstrated. These benefits may be expected to be slightly greater in OME,
or in permanent hearing-impairment, but their relevance does not require specifically
large benefits to be demonstrated.
OME in adults
In adults, OME may be due to neoplasm in the nasopharynx. Referral falls within the
two-week rule protocol. Outpatient assessment, nasendoscopy and audiology are
carried out at the first clinic visit. EUA/biopsy of the nasopharynx is required urgently
if there is clinical suspicion of neoplasm. Insertion of ventilation tube(s) is performed
at the same time. If there is an obvious preceding cause for the OME such as URTI
after a flight, and if outpatient examination of the nasopharynx is normal, many
specialists would offer medical management: vasoconstrictors, steroids or antibiotics
as initial treatment. Although the effectiveness of these is unlikely to be high, the
incidence is low.
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