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Grommets With or Without
Adenoidectomy
Definition
Grommets – A small bobbin-shaped tube used to keep open the incision made in the ear drum
as a ventilation of secretory otitis media. It acts as a ventilation tube by allowing the Eustachian
Tube to recover its normal function.
Adenoidectomy – Surgical removal of the adenoids. Adenoids are an overgrowth of glandular
tissue at the back of the throat, into which the nose opens.
Surgical Threshold Policy
Policy1
It is the responsibility of referring and treating clinicians to ensure compliance with this
policy. Referral proforma should be attached to the patient notes to aid the clinical audit
process and provide evidence of compliance with the policy. For patients not meeting
the policy criteria, clinicians can apply for funding to the Exceptional Cases Panel by
completing the exceptional funding section of the referral proforma: Click policies to
access the CCG clinical policies web page: policies – select the Ear, Nose & Throat (ENT)
Policies drop down option and select the Grommets With or Without Adenoidectomy Policy to
access the referral proforma.
The CCG will agree to fund treatment with grommets (combined with or without
adenoidectomy) for children less than 12 years of age with persistent bilateral otitis media with
effusion (OME) where:

The NICE clinical pathway has been adhered to, with regards to symptoms and a formal
assessment confirms a diagnosis of OME (page 2)1
AND

The hearing level in the better ear is 25–30 dBHL (decibels hearing level) or worse
averaged at 0.5, 1, 2 and 4 kHz (or equivalent dBA where dBHL not available). This should
be confirmed on two occasions separated by 3 months or more (results of initial formal
testing and tests done after at least 3 months should be included in the referral letter).
Funding will also be agreed if:

The child has persistent bilateral OME with a hearing loss less than 25–30 dBHL where the
impact of the hearing loss on a child’s developmental, social or educational status is judged
to be significant.

A second disability such as Down's Syndrome or cleft palate (insertion of ventilation tube
should be offered only as an alternative to hearing aids).

OME is overlaying sensorineural deafness or is delaying diagnosis or treatment with aids or
cochlear implants - this would be an indication for immediate grommets.
Adjuvant adenoidectomy is not recommended in the absence of persistent and/or
frequent upper respiratory tract symptoms (NICE CG 60).
Children who have undergone insertion of grommets should be followed up and their hearing
should be re-assessed. All referrals should be through an agreed pathway to optimise access
to conservative treatment and advice.
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NICE Care Pathway: Children Suspected with OME1
Children with Cleft Palate or Down’s Syndrome
Children with cleft palate are particularly susceptible to OME because of the impaired function of the
Eustachian tube that results from the palatal anomaly, which in turn leads to a failure of middle ear
ventilation. Similarly, children with Down’s Syndrome have a high incidence of OME, partly because of
their impaired immunity and mucosal abnormality, with resulting susceptibility to ear infection. These
groups of children need particular surveillance for OME so that proper action can be taken. Clinical
pathways specific to these children can found in NICE Guidance CG60
(http://www.nice.org.uk/nicemedia/pdf/CG60NICEguideline.pdf).1
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Background and Rationale
Grommets are of only marginal benefit in most children and watchful waiting is usually the most
appropriate treatment and there is no evidence that language or speech development is
improved. However, some children may benefit more from grommets than other children.
Evidence suggests that grommets only offer a short-term hearing improvement in children with
simple glue ear (otitis media with effusion or OME) who have no other serious medical
problems or disabilities.
There is limited but conflicting evidence that adenoidectomy (alone or combined with
grommets) improves hearing loss and reduces the duration of symptoms of otitis media with
effusion (OME).
Clinical evidence suggests that ventilation tubes (grommets) and adenoidectomy represents a
trade off between benefits and harms, and adenoidectomy on its own is of unknown
effectiveness.2 However, surgery is not without risks and the suitability of each child for surgery
should be considered on a case by case basis.
Otitis media with effusion (OME) is a condition characterised by a collection of fluid within the
middle ear without signs of acute inflammation. It is most common in young children, with a
bimodal peak at 2 and 5 years of age. Eighty percent of children will have had at least one
episode of OME by the age of 10 years. At age 7–8 years, about 8% of children will have
middle ear effusions3 - this incidence increases in winter. The mean duration of effusions is
6–10 weeks, but some cases are more persistent.
OME is known to be a fluctuating condition with symptoms that vary with time and with age.
While most cases of OME will resolve spontaneously, some children will need intervention
because of the effects of hearing loss. No non-surgical intervention has yet been shown
conclusively to be of benefit for all cases. Surgical intervention decisions need to balance
potential benefits against potential risks, reflecting the fact that the degree of benefit usually
depends upon the severity and persistence of the condition.
Watchful waiting or ‘active monitoring’
Watchful waiting4 is a recognised period of observation with monitoring of hearing loss.
Research by ENTUK5 , funded by the MRC (the TARGET multicentre trial6) has shown that 50%
of children with a bilateral hearing loss of at least 20dB are likely to recover to normal with no
treatment in the first 3 months after diagnosis.
The National Institute for Health and Clinical Excellence (NICE) also recommended a period of
observation of hearing loss (with accurate audiometry) and its impact on the child’s
development over 3 months1 in order to determine whether resolution occurs or if further
treatment was required. There is some suggestion from published data of those subgroups of
patients with OME who are more likely to benefit from grommets and this is reflected in the
eligibility criteria recommended by NICE and laid out in this policy.
The Scottish Intercollegiate Guidelines Network (SIGN) recommends watchful waiting for
children under 3 years of age with persistent bilateral otitis media with effusion and hearing loss
equal to less than 25 dB, without speech and language, development or behavioural problems.
However, referral should be considered for children with persistent bilateral otitis media with
effusion who are over 3 years of age or who have speech and language, developmental or
behavioural problems.7
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Evidence
A Cochrane Review included 10 trials (1,728 participants). Authors concluded that grommets
were mainly beneficial in the first 6 months by which time natural resolution leads to improved
hearing in the non-surgically treated children also. No effect was found on other child
outcomes, but data on these were sparse. Researchers did not find any study performed in
children with established speech, language, learning or developmental problems so
conclusions could not be made regarding treatment of such children.8
Two other Cochrane Reviews reported small benefit to hearing for grommets with
improvements of up to 9dB in the first 6 months and no difference at 12 months.9, 10, 11, 12
There is some published evidence that suggests that prompt insertion of ventilation tubes in
children under 3 years of age does not significantly improve general and language
developmental outcomes. However, most trials have not studied children under 3 years of age
with a period of effusion longer than 6-9 months or those with moderate or severe hearing loss.
A comprehensive review that identified several systematic reviews and Randomised Controlled
Trials (RCTs) found that grommets did not significantly improve cognition, language
comprehension or expression compared with no grommets. The hearing benefits are reported
to be short term and diminish after 6 months.13-19
A recently published Cochrane meta-analysis of 14 RCTs, evaluated the effectiveness of
adenoidectomy in children with otitis media. Authors report that there was a significant benefit
of adenoidectomy for the resolution of effusion in the middle ear. However, the benefit to
hearing was small and the effects on changes in the tympanic membrane (ear drum) are
unknown. No significant benefit of adenoidectomy on Acute Otitis Media was found.20
Evidence from randomised trials for adenotonsillectomy for mild to moderate sore throat
suggests that the procedure does not produce clinically significant results and was not found to
be cost effective.21, 22, 23
NICE Guidance (IPG328)
NICE has published Interventional Procedure Guidance for suction diathermy adenoidectomy
and found that the evidence on the safety and efficacy of suction diathermy adenoidectomy was
adequate to support the use of this procedure provided that normal arrangements were in place
for clinical governance, consent and audit. NICE recommends that this procedure should be
carried out only by surgeons with specific training in the use of diathermy for adenoidectomy
because thermal damage to surrounding tissues can, rarely, cause Grisel’s Syndrome
(subluxation of the atlantoaxial joint).24
OPCS Codes
D151
D152
D153
D158
D159
E201
E204
E208
E209
Myringotomy with insertion of ventilation tube through tympanic membrane.
Suction clearance of middle ear.
Incision of ear drum NEC.
Other specified drainage of middle ear.
Unspecified drainage of middle ear operations on adenoid.
Total adenoidectomy.
Suction diathermy adenoidectomy.
Other specified operations on adenoid.
Unspecified operations on adenoid.
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References
1. National Institute for Health and Clinical Excellence (NICE). Surgical Management of otitis media
with effusion in children, NICE Clinical Guideline 60, February, 2008 (available online at
http://www.nice.org.uk/nicemedia/pdf/CG60NICEguideline.pdf).
2. BMJ Clinical Evidence: Otitis media with effusion (available online at
http://www.clinicalevidence.com/ceweb/conditions/ent/0502/0502.pdf, free registration required.
3. Zielhuis G A, Heuvelmans-Heinen E W, Rach G H and van den Broek P. Environmental risk factors
for otitis media with effusion in preschool children. Scand J Prim Health Care 1989;7:33–8.
4. Browning G G. Watchful waiting in childhood otitis media with effusion. Editorial. Clin Otolaryngol
2001; 26: 263-264.
5. ENT UK 2009 OME/Adenoid and Grommet Position Paper.
6. MRC Multi-Centre Otitis Media Study Group Surgery for persistent otitis media with effusion:
generalizability of results from the UK trial (TARGET). Trial of Alternative Regimens in Glue Ear
Treatment. Clin Otolaryngol 2001;26: 417-424.
7. SIGN (Scottish Intercollegiate Guidelines Network) Clinical Guideline No. 66 (2000).
8. Browning G G, Rovers M M, Williamson I, Lous J, Burton M J. Grommets (ventilation tubes) for
hearing loss associated with otitis media with effusion in children. Cochrane Database of Systematic
Reviews 2010, Issue 10. Art No: CD001801. DOI: 10.1002/14651858.CD001801.pub3.
9. Lous J, Burton M J, Felding J U, Ovesen T, Rovers M M, Williamson I, 2005. Grommets for hearing
loss associated with otitis media with effusion. Cochrane Systematic Review, 2005.
10. Lous J. Grommets (ventilation tubes) for hearing loss associated with otitis media with effusion in
child (Cochrane Review). In Cochrane database of systemic reviews, Issue 2, 2007. Chichester:
Wiley Interscience.
11. Stenstrom R. Hearing thresholds and tympanic membrane sequelae in children managed medically
or surgically for otitis media with effusion (erratum appears in Arch Perdiatr Adolesc Med 2006;
160:588). Archives of Pediatrics and Adolescent Medicine 2005; 159:1151-6.
12. Perera R. Autoinflation for hearing loss associated with otitis media with effusion. (Cochrane
Review). In: Cochrane database of systemic reviews, 2006. Issue 4. Chichester: Wiley Interscience.
13. Rovers, M et al (2000). The Effect of Ventilation Tubes on Language Development in Infants With
Otitis Media With Effusion: A Randomised Trial. Paediatrics (106);3.
14. Paradise, J L (2001). Effect of early or delayed insertion of tympanostomy tubes for persistent otitis
media on developmental outcomes at the age of three years. NEJM (344);16;1179-1187.
15. Paradise, J L (2005). Developmental Outcomes after Early or Delayed Insertion of Typmanostomy
Tubes. NEJM (353);6;576-587.
16. Oomen, K et al (2005). Effect of adenotonsillectomy on middle ear status in children. Laryngoscope
Apr;115(4):731-4.
17. Grommets (ventilation tubes) for hearing loss associated with OME in children. Cochrane Database
of Systematic Reviews.
http://www.mrw.interscience.wiley.com/cochrane/clsysrev/articles/CD001801/pdf.fs.html
18. Ryan, C F (2005). Sleep 9: An approach to treatment of obstructive sleep apnoea/hypopnoea
syndrome including upper airway surgery. Thorax (60);595-604.
19. Williamson I. Otitis media with effusion. BMJ Clinical Evidence, 2006.
20. van den Aardweg M T A, Schilder A G M, Herkert E, Boonacker C W B, Rovers M M.
Adenoidectomy for otitis media in children. Cochrane Database of Systematic Reviews 2010, Issue
1. Art No: CD007810. DOI: 10.1002/14651858.CD007810.pub2.
21. Buskens E, van S B, van d AJ, Hoes A W, Schilder A G. Adenotonsillectomy or watchful waiting in
patients with mild to moderate symptoms of throat infections or adenotonsillar hypertrophy: a
randomized comparison of costs and effects. Arch Otolaryngol Head Neck Surg 2007;133(11):
1083-8.
22. Paradise J L, Bluestone C D, Colborn D K, Bernard B S, Rockette H E,Kurs-Lasky M. Tonsillectomy
and adenotonsillectomy for recurrent throat infection in moderately affected children. Pediatrics
2002; 110(1 Pt 1):7-15.
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23. Lock C, Wilson J, Steen N, Eccles M, Mason H, Carrie S, et al. North of England and Scotland Study of
Tonsillectomy and Adenotonsillectomy in children (NESSTAC): a pragmatic randomised controlled trial
with a parallel non-randomised preference study. Health Technol Assess 2010;14(13). [cited 8 April
2010]. Available from url: http://www.hta.ac.uk/fullmono/mon1413.pdf
24. NICE Interventional procedure guidance for suction diathermy adenoidectomy (IPG 328).
http://www.nice.org.uk/nicemedia/live/12127/46633/46633.pdf
25. Black’s Medical Dictionary. 42nd Edition. A & C Black. London 2010.
Glossary25
Adenoidectomy:
Surgical removal of the adenoids. Adenoids are an overgrowth of tissue at the back of
the throat, into which the nose opens.
Adjuvant:
Any substance given in concert with another to boost its activity.
Diathermy:
A process by which electric currents can be passed into the deeper parts of the body so
as to produce internal warmth and relieve pain; or by using powerful currents to destroy
tumours and diseased parts bloodlessly.
Down's Syndrome:
A genetic disorder in which the affected person usually carries an extra chromosome - 47
instead of the usual 46.
Glue Ear:
Another name for secretory otitis media (infection of the middle ear) - persistent sticky
fluid in the middle ear.
Grisel’s Syndrome
A syndrome is a term applied to a group of symptoms regularly occurring together. In this
instance, Grisel’s Syndrome is a severely restricted movement of the neck; often the
head will be held to one side and is associated with pharyngeal (throat) infection. It
occurs more often in children.
Grommet:
A small bobbin-shaped tube used to keep open the incision made in the ear drum in the
treatment of secretory otitis media. It acts as a ventilation tube by allowing the
Eustachian tube to recover its normal function.
Myringotomy:
An operation to cut open the drum of the ear to provide drainage for an infection of the
middle ear.
Otitis Media:
Infection of the middle ear.
Otolaryngologist:
A specialist in ear, nose and throat disorders.
Tympanosclerosis:
A pathological hardening or thickening of the ear drum.
Policy effective from
New policy – merging of Adenoidectomy and Grommets policies.
Approved by Cambridgeshire and Peterborough shadow CCG on 1 May 2012
March 2012
Policy to be reviewed:
March 2014
Reference:
PHN/CCPF Pols & working Area/Surg Threshold Pols - Draft and Agreed/CCG Policies/Grommets
and Adenoidectomy/GROMMETS ADENOIDECTOMY FEB 2015 V3
Policy originated:
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