Myringotomy/Grommets – Criteria Led Commissioning Statement

Scope

This commissioning statement refers to:

  • Myringotomy/grommets - Otitis media with effusion (OME) in children under 12
  • Glue ear which is a common childhood condition where the middle ear becomes filled with fluid (otitis media with effusion or OME).
  • At least 50% of OME causing bilateral hearing loss of at least 20dB will resolve spontaneously within 3 months therefore a period of watchful waiting for at least 3 months is required.
  • Parents should be advised on educational and behavioural strategies to minimise the effects of hearing loss.
  • Treatment is usually only recommended when symptoms last longer than three months and the hearing loss is thought to be significant enough to interfere with a child's speech and language development.
  • For children with recurrent severe middle ear infections, grommets can be inserted into the eardrum under GA to help drain fluid, as a day case procedure, which helps keep the eardrum open for several months.
  • As the eardrum starts to heal, the grommet will slowly be pushed out of the eardrum and will eventually fall out, usually within 6 to 12 months. This process happens naturally and should not be painful.

This commissioning statement does not refer to:

  • Urgent referral for suspicion of cholesteatoma (atypical features and persistent foul discharge) or
  • if OME is complicating sensorineural deafness (eg with excessive hearing loss) or is delaying diagnosis or
  • the patient has treatment with aids or cochlear implants (this would be an indication for immediate grommets)

Status

Eligibility Criteria

  • There has been a period of at least three months watchful waiting* from the date of diagnosis of OME (by GP/primary care referrer/audiologist/ENT surgeon)
  • OME persists after three months
  • The child suffers from persistent bilateral OME with a hearing level in the better ear of 25 dBHL (averaged at 0.5, 1, 2, and 4 kHz) or worse, confirmed over three months
  • OR Persistent bilateral OME with a hearing level better than 25 dBHL (averaged at 0.5, 1, 2, and 4 kHz) in the better ear but where the impact of the hearing loss on a child's developmental, social, or educational status is judged to be significant.

* During the watchful waiting period, advice on educational and behavioural strategies to minimise the effects of hearing loss should be offered. The child's hearing should be re-tested at the end of this time.

Down's Syndrome

  • Hearing aids should normally be offered to children with Down's syndrome and OME with hearing loss. Before myringotomy/grommets are offered as an alternative to hearing aids for treating OME in children with Down's syndrome, the following factors should be considered:
    • The severity of hearing loss
    • The age of the child
    • The practicality of ventilation tube insertion
    • The risks associated with ventilation tubes
    • The likelihood of early extrusion of ventilation tubes

Cleft Palate

  • Insertion of ventilation tubes at primary closure of the cleft palate should be performed only after careful otological and audiological assessment. Insertion of ventilation tubes should be offered as an alternative to hearing aids in children with cleft palate who have OME and persistent hearing loss.

Note:

  • In children with additional disabilities such as Down's Syndrome or cleft palate, involvement of a specialist multidisciplinary team with expertise in assessing and treating OME in these children is essential.
  • Do not perform adenoidectomy at the same time unless evidence of persistent and/or frequent upper respiratory tract symptoms/infections

Patients should make shared decisions with clinicians, using Shared Decision-making Aids for Glue Ear


Evidence/Rationale

At least 50% of otitis media with effusion (OME) causing bilateral hearing loss of at least 20dB will resolve spontaneously within 3 months therefore a period of watchful waiting for at least 3 months is required1. Parents should be advised on educational and behavioural strategies to minimise effects of hearing loss. The RCS guidance also states that care should be provided via an integrated care pathway, which should include "prevention through public health programmes to decrease exposure to cigarette smoke during infancy and childhood"1.

NHS choices points out that factors which increase the risk of getting glue ear include2:

  • growing up in a household where adults smoke
  • being bottle fed rather than breastfed as a baby

NICE CKS3 points out that:

  • OME has a very good prognosis. It is a self-limiting illness and 90% of children will have complete resolution within 1 year.
  • Active observation for several months (previously known as 'watchful waiting') rarely results in long-term complications.
  • There is no proven benefit from treatment with any medications or any complementary or alternative therapies.

NICE clinical guideline 60 4supports the above criteria and covers:

  • The surgical management of OME in children younger than 12 years.
  • Guidance for managing OME in children with Down's syndrome and in children with all types of cleft palate.
  • It does not specifically look at the management of OME in:
    • Children with other syndromes (for example, craniofacial dysmorphism or polysaccharide storage disease).
    • Children with multiple complex needs.

The NICE pathway is available at here5.

A Cochrane review6 concluded in 2010 that "In children with OME the effect of grommets on hearing, as measured by standard tests, appears small and diminishes after six to nine months by which time natural resolution also leads to improved hearing in the non-surgically treated children. No effect was found on other child outcomes but data on these were sparse. No study has been performed in children with established speech, language, learning or developmental problems so no conclusions can be made regarding treatment of such children."

NB: Leeds health pathways include the following rarer indications for grommets

  • Severe otalgia in otitis media requiring admission, and unresolved with conservative treatment over 3 days
  • In immunocompromised patients with otitis media where microbiologic specimens are required
  • Complications of otitis media such as meningitis, facial nerve paralysis, coalescent mastoiditis, or brain abscess
  • Chronic retraction of the tympanic membrane
  • Adults with otitis media with effusion where conservative management has failed over 6 weeks or where malignancy is suspected
  • Autophony due to patulous eustachian tube
  • As part of treatment for vestibular disorders either alone or with gentamicin

References

  1. Royal College of Surgeons - Commissioning guide: Otitis media with effusion (2013) https://www.rcseng.ac.uk/standards-and-research/nscc/commissioning- guides/topics/
  2. NHS Choices – Glue ear http://www.nhs.uk/Conditions/Glue-ear/Pages/Introduction.aspx
  3. NICE CKS Otitis media with effusion (2011) http://cks.nice.org.uk/otitis-media-with-effusion#!scenario
  4. NICE Clinical Guideline 60 Otitis media with effusion in under 12s: surgery (2008) http://www.nice.org.uk/guidance/CG60
  5. NICE Pathway – Surgical management of Otitis Media with effusion in children (2012) OME with effusion pathway
  6. Cochrane Ear, Nose and Throat Disorders Group 2010. Grommets (ventilation tubes) for hearing loss associated with otitis media with effusion in children http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD001801.pub3/abstract
  7. NICE OTITIS MEDIA WITH EFFUSION IN UNDER 12s :SURGERY https://www.nice.org.uk/guidance/cg60/chapter/1-Guidance#clinical-presentation
  8. NICE CKS OTITIS MEDIA WITH EFFUSION – October 2016 https://southwest.devonformularyguidance.nhs.uk/referral-guidance/policies/myringotomy-grommets-with-or-without-adjuvant-adenoidectomy-for-the-management-of-otitis-media-in-children-under-12-years
  9. http://www.rotherhamccg.nhs.uk/Downloads/Governing%20Body%20Papers/October%202016/Enc%207%20-%20Implementing%20Clinical%20ELIGIBILTY CRITERAs.pdf

Assurance & Governance

  • This policy was developed on: 05.2017
  • This policy was approved by: Clinical Strategy Group (NK) and Clinical Cabinet (WK)
  • Date approved: 05.2017
  • Publication Date: 05.2017
  • Review Date: 04.2018
  • Ref No: PA13 - 05.2017
Any feedback or suggestions to improve this guidance should be sent to: oscaradmin@this.nhs.uk
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