Download Prudent HC Evidence Map Hearing loss Final (v1).

Public Health Wales – Health Intelligence/Observatory
Evidence mapping: Prudent healthcare – Hearing Loss
Mapping of potential evidence sources for the Prudent Healthcare Project:
Effectiveness of interventions for hearing loss
For further information please contact:
Public Health Wales Observatory,
36 Orchard Street,
Swansea
SA1 5AQ
Tel: 01792 607331
E mail: [email protected], [email protected]
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Date: 18/3/14
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Dinah Roberts, Eleri Tyler:
Evidence Service/Health Intelligence
Public Health Wales – Health Intelligence/Observatory
Evidence mapping: Prudent healthcare – Hearing Loss
Introduction
Evidence mapping is used to provide an understanding of the extent and distribution of available evidence, identify and sign-post to key evidence
sources. Evidence maps do not provide a synthesis of available evidence but indicate the source and nature of relevant evidence and where
there may be knowledge gaps. They provide a springboard for evidence review and synthesis for more focussed questions. The framework which has
been used to map available evidence relating to the Prudent Healthcare project priority topics is based on that put forward by the Bevan Commission
report1. Due to the tight time constraints for preparing the evidence maps the search conducted was restricted to secondary and tertiary level sources
(systematic reviews and guidelines) and not primary research. It is important to note that as the included sources are all reviews of some type, they
are not independent, meaning, they may have drawn on the same sets of primary studies. Evidence sources included in the map have not been subject
to formal critical appraisal. The ‘Status of Source’ statements provide a guide as to the likely robustness (reliability) of the source given the
methodology employed by the source authors. It is essential that the source is directly accessed and reliability fully assessed before use of the source
findings/recommendations on effectiveness or efficiency to inform decision-making regarding possible elimination or substitution of any intervention. A
protocol detailing the methodology followed for the evidence mapping process and full search details are available on request.
Background documents
Relevant Welsh documents
1. Health Foundation, 2012. Operational research modelling: transferring ENT/audiology services into a community setting- SHINE 2012 , Available at:
http://www.health.org.uk/areas-of-work/programmes/shine-twelve/related-projects/cardiff-and-vale-university-health-board/
2. Jader L, 2006. Access Project 2009 - Predicted Future Changes in General Surgery and ENT in Wales. Cardiff: NPHS.
Available at:
http://nww2.nphs.wales.nhs.uk:8080/HealthServiceQDTDocs.nsf/Public/C488D7043F9AD1128025722C004F63FE/$file/Horizon%20Scanning%20Report
%20(Gen%20surgery%20%20ENT)%20for%20Project%202009%20(3).pdf?OpenElement
1 Simply Prudent Healthcare – achieving better care and value for money in Wales – discussion paper Mansel Aylward, Ceri Phillips, Helen Howson. December 2013.
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Evidence Service/Health Intelligence
Public Health Wales – Health Intelligence/Observatory
Evidence mapping: Prudent healthcare – Hearing Loss
3. Public Health Wales Observatory, 2010. Drainage of middle ear and grommet insertion in Variation in Elective Surgery Procedures across Wales.
Cardiff: Public Health Wales.
Available at:
http://nww2.nphs.wales.nhs.uk:8080/PubHObservatoryProjDocs.nsf/61c1e930f9121fd080256f2a004937ed/2ece58ea6212e8d3802577ea003cf6fe/$FIL
E/Variation%20in%20elective%20procedures%20across%20Wales%20v1%2026112010.doc
4. Public Health Wales, 2014. Otitis Media with Effusion Grommets – INNU. Available at: http://howis.wales.nhs.uk/sitesplus/888/page/48748
5. Public Health Wales, 2014. Newborn hearing screening Wales , Available at: http://www.newbornhearingscreening.wales.nhs.uk/
6. Webb M, 2008. Rapid review of the evidence on the effectiveness of combined approach tympanoplasty for cholesteatoma. Cardiff: NPHS.
Available at:
http://nww2.nphs.wales.nhs.uk:8080/HealthServiceQDTDocs.nsf/Public/72030DB3938E81598025764900394468/$file/CAT%20doc%20Final.doc?OpenE
lement
7. Welsh Office. Direct referral to audiology clinics. Cardiff: WO; 1996.
Available at: http://wales.gov.uk/docs/phhs/publications/wsacguidance/091015audiologyen.pdf
8. Welsh Assembly Government. Quality Standards for Paediatric Audiology (Wales). Cardiff: WAG; 2010.
Available at: http://wales.gov.uk/docs/dhss/publications/100421qulaitystandardspaediatricaudiologyen.pdf
9. Welsh Health Specialised Services Committee. Cochlear Implants - INNU. 2006. Available at: http://howis.wales.nhs.uk/sitesplus/888/page/52483
Documents of general relevance
1. 2011 Annual Evidence update on Hearing disorders. 2011. NHS Evidence Available at:
https://arms.evidence.nhs.uk/resources/hub/35907/attachment
2. Audiology Improvement Programme. Pushing the boundaries: Evidence to support the delivery of good practice in audiology. NHS Improvement;
2010. Available at:
http://www.google.co.uk/url?sa=t&rct=j&q=&esrc=s&frm=1&source=web&cd=2&cad=rja&uact=8&ved=0CDEQFjAB&url=http%3A%2F%2Fsystem.imp
rovement.nhs.uk%2FImprovementSystem%2FViewDocument.aspx%3Fpath%3DAudiology%2FNational%2Fwebsite%2FPushing%2Bthe%2BBoundaries.
pdf&ei=O-EdU8PUNdOQhQefv4CoAw&usg=AFQjCNGVeMu88kQqEEw1qEdE1UypOzAvzw
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Evidence Service/Health Intelligence
Public Health Wales – Health Intelligence/Observatory
Evidence mapping: Prudent healthcare – Hearing Loss
3. Centers for Disease Control and Preventions, 2014. Hearing loss in children. Available at: http://www.cdc.gov/ncbddd/hearingloss/
4. Centers for Disease Control and Preventions, 2014. Noise and hearing loss prevention. Available at: http://www.cdc.gov/niosh/topics/noise/
5. ENT UK. ENT Services 2008 The Provision of Otorhinolaryngology and Head and Neck Surgery Services in England. London: RCS; 2008.
Available at: https://entuk.org/docs/prof/publications/ent_services
6. Glasziou P. Helping commissioners, managers and GPs make more use of Cochrane reviews: an investigation focussed by ENT disorders [NIHR
project]. Oxford: University of Oxford; 2012. Available at: http://www.nets.nihr.ac.uk/projects/sr/10400003
7. British Society of Audiology, 2007. Guidance on the use of real ear measurement to verify the fitting of digital signal processing hearing aids: BSA.
Available at: http://www.thebsa.org.uk/docs/RecPro/REM.pdf
8. National Institute for Health and Clinical Excellence, 2013. Ear, nose and throat pathway: NICE.
Available at: http://pathways.nice.org.uk/pathways/ear-nose-and-throat-conditions
9. Olusanya BO et al. The global burden of disabling hearing impairment: a call to action. Bulletin of the World Health Organization 2014
Available at: http://www.who.int/bulletin/online_first/BLT.13.128728.pdf
10. Royal College of Paediatrics and Child Health, Children's audiology services: a multi-professional review. London: RCPCH; 2005.
Available at: http://www.rcpch.ac.uk/sites/default/files/asset_library/Publications/C/Audiology.pdf
11. Royal College of Surgeons, 2013. Commissioning guide: Otitis media with effusion. London: RCS.
Available at: http://www.rcseng.ac.uk/healthcare-bodies/docs/published-guides/ome
12. World Health Organization, Multi-country assessment of national capacity to provide hearing care. Geneva: WHO; 2013..
Available at: http://www.who.int/pbd/publications/WHOReportHearingCare_Englishweb.pdf
Relevant international guidelines
1. American College of Radiology, 2008. ACR appropriateness criteria: vertigo and hearing loss
Available at: http://www.acr.org/~/media/ACR/Documents/AppCriteria/Diagnostic/HearingLossVertigo.pdf
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Evidence Service/Health Intelligence
Public Health Wales – Health Intelligence/Observatory
Evidence mapping: Prudent healthcare – Hearing Loss
2. Moyer, V. A. & U.S.Preventive Services Task Force, 2012. Screening for hearing loss in older adults: U.S. Preventive Services Task Force
recommendation statement.[Summary for patients in Ann Intern Med. 2012 Nov 6;157(9):I-38; PMID: 23405388]. Annals of Internal Medicine 157 (9)
: 655-661.
3. Roland, P. S., Smith, T. L., Schwartz, S. R., Rosenfeld, R. M., Ballachanda, B., Earll, J. M., Fayad, J., Harlor, A. D., Jr., Hirsch, B. E., Jones, S. S.,
Krouse, H. J., Magit, A., Nelson, C., Stutz, D. R., & Wetmore, S., 2008. Clinical practice guideline: cerumen impaction. Otolaryngology - Head & Neck
Surgery 139 (3:Suppl 2) : Suppl-S21.
4. Stachler RJ et al. 2012. Clinical practice guideline: sudden hearing loss. Otolaryngology - Head & Neck Surgery 146 (3:Suppl) : Suppl-35.
Available at: https://www.entnet.org/Community/upload/Sudden-Hearing-Loss-Clinical-Practice-Guideline.pdf
5. US Preventive Services, 2008. Universal screening for hearing loss in newborns: US Preventive Services Task Force recommendation statement.
[Review] [66 refs][Reprint in Am Fam Physician. 2010 Jan 15;81(2):185; PMID: 20082514]. Pediatrics 122 (1) : 143-148.
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Evidence mapping: Prudent healthcare – Hearing Loss
Evidence Map: Hearing loss
Contents
Prevention - Workplace..........................................................................................................................................7
Prevention - Meningitis...........................................................................................................................................8
Prevention - Cancer treatment.................................................................................................................................9
Early Intervention - Paediatric Screening..................................................................................................................11
Management - Otitis Media.....................................................................................................................................13
Management - Hearing Aids....................................................................................................................................19
Management - Cochlear Implants............................................................................................................................22
Management - Brain Stem Implants.........................................................................................................................26
Management – Earwax...........................................................................................................................................27
Management - Idiopathic Sudden Sensorineural hearing loss (ISSHL)...........................................................................27
Management - Balloon Dilation of the Eustachian Tube...............................................................................................30
Management – Micropressure therapy for refractory Ménière's disease......................................................................... 31
Management - Inappropriate Referrals.....................................................................................................................32
NICE ‘Do not do’ interventions................................................................................................................................35
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Evidence Service/Health Intelligence
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Evidence mapping: Prudent healthcare – Hearing Loss
Evidence Map
Focus and main findings of source
Status of source
Reference
The authors followed the
standard Cochrane methodology.
Verbeek J et al. (2012)
Interventions to prevent
occupational noise-induced
hearing loss. Cochrane Database
Syst Rev Issue 10. Art. No.:
CD006396. DOI:
10.1002/14651858.CD006396.pu
b3.
Available at:
http://onlinelibrary.wiley.com/doi
/10.1002/14651858.CD006396.p
ub3/abstract
Prevention
Prevention - Workplace
Aim: To assess the effectiveness of non-pharmaceutical
interventions for preventing occupational noise exposure or
occupational hearing loss compared to no intervention or
alternative interventions.
Author’s Conclusions
There is low quality evidence that implementation of stricter
legislation can reduce noise levels in workplaces. Even though
case studies show that substantial reductions in noise levels in
the workplace can be achieved, there are no controlled studies
of the effectiveness of such measures. The effectiveness of
hearing protection devices depends on training and their proper
use. There is very low quality evidence that the better use of
hearing protection devices as part of Hearing Loss Prevention
Programmes (HLPPs) reduces the risk of hearing loss, whereas
for other programme components of HLPPs we did not find such
an effect. Better implementation and reinforcement of HLPPs is
needed. Better evaluations of technical interventions and longterm effects are needed.
The review included 25 studies.
No controlled studies on
engineering controls for noise
exposure were identified however
one study found evaluated
legislation to reduce noise
exposure in a 12-year timeseries analysis.
Eight studies with 3,430
participants evaluated immediate
and long-term effects of personal
hearing protection devices
(HPDs) and sixteen studies with
82,794 participants evaluated
short and long-term effects of
hearing loss prevention
programmes (HLPPs).
[Cochrane Syst Rev]
The overall quality of studies was
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Evidence mapping: Prudent healthcare – Hearing Loss
Focus and main findings of source
Status of source
Reference
low to very low.
Prevention - Meningitis
Aim: To examine the effect of adjuvant corticosteroid therapy
versus placebo on mortality, hearing loss and neurological
sequelae in people of all ages with acute bacterial meningitis.
The systematic review reports in its results that corticosteroids
were associated with lower rates of severe hearing loss (RR
0.67, 95% CI 0.51 to 0.88) and any hearing loss (RR 0.74,
95% CI 0.63 to 0.87).
It also notes that subgroup analyses for causative organisms
showed that corticosteroids reduced severe hearing loss in
children with H. influenzae meningitis (RR 0.34, 95% CI 0.20 to
0.59) but not in children with meningitis due to nonHaemophilus species. The authors however support the use
of adjunctive corticosteroids in children in high-income
countries with meningitis due to all micro-organisms; they base
this comment on the lack of evidence of adverse events (in
general and micro-organism specific) but acknowledge that
administration of corticosteroids to children with meningitis due
to bacteria other than H. influenzae remains controversial.
Author’s conclusions:
Corticosteroids significantly reduced hearing loss and
neurological sequelae, but did not reduce overall mortality.
Data support the use of corticosteroids in patients with
bacterial meningitis in high-income countries. We found no
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The authors followed the
standard Cochrane methodology.
25 randomised controlled trials
involving 4121 participants were
included. 19 studies had a
double-blind design; six studies
did not use blinding.
Hearing loss was defined as
severe when there was bilateral
hearing loss greater than 60 dB
or requiring bilateral hearing
aids.
Brouwer MC et al. (2013)
Corticosteroids for acute bacterial
meningitis. Cochrane Database
Syst Rev Issue 6. Art. No.:
CD004405. DOI:
10.1002/14651858.CD004405.pu
b4.
Available at:
http://onlinelibrary.wiley.com/doi
/10.1002/14651858.CD004405.p
ub4/abstract
[Cochrane Syst Rev]
Of the 25 randomised clinical
trials included in the metaanalysis four were of high
quality, 14 of medium quality
and seven of low quality.
Although the number of highquality studies was low, the
number of participants in these
studies accounted for 45% of
participants included in the metaanalysis. Studies were mostly
categorised as medium or low
Dinah Roberts, Eleri Tyler:
Evidence Service/Health Intelligence
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Evidence mapping: Prudent healthcare – Hearing Loss
Focus and main findings of source
Status of source
beneficial effect in low-income countries.
Implications for practice:
Authors recommend a four day regimen of dexamethasone (0.6
mg/kg daily) given before or with the first dose of antibiotics.
Further research required:
The role of corticosteroids in neonatal meningitis is currently
unclear due to the different spectrum of causative microorganisms and the lack of applicable RCT data. Additional RCTs
in neonatal meningitis are needed.
Reference
quality due to a lack of
addressing missing data or
because no intention-to-treat
analysis was performed.
For the analysis on severe
hearing loss, significant
heterogeneity between trials of
high, medium and low quality
was found. As studies of high
quality showed no effect the
results of this meta-analysis
should interpreted with caution.
The sensitivity analysis showed
that in a worst-case scenario
dexamethasone
would have no beneficial or
harmful effect on hearing loss or
neurological sequelae. However,
this analysis was heavily
influenced by a single study
accounting for 46% of missing
values. When this study was left
out a trend towards benefit of
dexamethasone on any hearing
loss was found.
Prevention - Cancer treatment
Aim: The primary objective was to assess the efficacy of
different otoprotective medical interventions in preventing
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The authors followed the
standard Cochrane methodology.
van-As, JW et al (2012) Medical
interventions for the prevention
Dinah Roberts, Eleri Tyler:
Evidence Service/Health Intelligence
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Evidence mapping: Prudent healthcare – Hearing Loss
Focus and main findings of source
Status of source
hearing loss in children with cancer treated with platinumbased therapy. Secondary objectives were to determine
possible effects of these interventions on anti-tumour efficacy,
toxicities other than hearing loss and quality of life.
Author’s conclusions:
At the moment there is no evidence from individual studies in
children with osteosarcoma and hepatoblastoma treated with
different platinum analogues and dosage schedules which
underscores the use of amifostine as an otoprotective
intervention as compared to no additional treatment. Since
pooling of results was not possible and all studies had serious
methodological limitations, no definitive conclusions can be
made. It should be noted that 'no evidence of effect', as
identified in this review, is not the same as 'evidence of no
effect'. Based on the currently available evidence, we are not
able to give recommendations for clinical practice. For other
possible otoprotective medical interventions and other types of
malignancies no eligible studies were identified, so no
conclusions can be made about their efficacy in preventing
ototoxicity in children treated with platinum-based therapy.
More high quality research is needed.
The review included 149
participants from two randomized
controlled trials and one
controlled clinical trial evaluating
the use of amifostine versus no
additional treatment. Two studies
included children with
osteosarcoma, the other study
included children with
hepatoblastoma. All studies had
methodological limitations.
Reference
of platinum-induced hearing loss
in children with cancer. Cochrane
Database Syst Rev Issue 5. Art.
No.: CD009219.
DOI:10.1002/14651858.CD0092
19.pub2.
Available at:
http://onlinelibrary.wiley.com/doi
/10.1002/14651858.CD009219.p
ub2/abstract
[Cochrane Syst Rev]
Note: There are current ongoing studies evaluating
cisplatin chemotherapy with or without sodium thiosulfate
in children with different types of tumours; among others,
childhood liver cancer, germ cell tumor, medulloblastoma,
neuroblastoma and osteosarcoma
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Focus and main findings of source
Status of source
Reference
Consensus guidelines formulated
by the Newborn Hearing
Screening Program (NHSP)
clinical group. References
included but no documented
systematic search for literature.
NHS Screening Programmes.
Newborn hearing, 2012.
Guidelines for surveillance and
audiological referral of infants &
children following the newborn
hearing screen. London: Public
Health England.
Available at:
http://hearing.screening.nhs.uk/
getdata.php?id=23226
Early Intervention
Early Intervention – Paediatric Screening
This document pertains to surveillance, referral and audiological
monitoring following newborn hearing screening. It identifies
which children should be followed up and monitored, how and
when this should be done, and by whom.
Refer to full-text for summary.
[National Guideline]
This document provides guidance on the early audiological
assessment and management of babies referred from the
newborn hearing screen. It describes some prerequisites for the
provision of the service, issues related to the timing and
organisation of the service and issues related to the choice,
timing and order of test procedures.
Refer to full-text for recommendations
Consensus guidelines formulated
by the Newborn Hearing
Screening Program (NHSP)
clinical group. References
included but no documented
systematic search for literature.
NHS Screening Programmes.
Newborn hearing, 2013.
Guidelines for the early
audiological assessment and
management of babies referred
from the Newborn Hearing
Screening Programme. London:
Public Health England.
Available at:
http://hearing.screening.nhs.uk/
getdata.php?id=23832
[National Guideline]
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Evidence mapping: Prudent healthcare – Hearing Loss
Focus and main findings of source
Status of source
Reference
This document outlines the recommendations of the Newborn
Hearing Screening Programme (NHSP) in England for the
assessment, diagnosis and management of infants suspected of
having Auditory Neuropathy Spectrum Disorder (ANSD)
Consensus guidelines formulated
by the Newborn Hearing
Screening Program (NHSP)
clinical group. References
included but no documented
systematic search for literature.
NHS Screening Programmes.
Newborn hearing, 2013.
Guidelines for the assessment
and management of auditory
neuropathy spectrum disorder in
young infants. London: Public
Health England.
Available at:
http://hearing.screening.nhs.uk/
getdata.php?id=23846
Refer to full-text for recommendations
The authors highlight that many
controversies and areas of
uncertainty remain in the
diagnosis and management of
ANSD.
The aim of these guidelines is to provide an evidence based
approach to medical evaluation of all children with bilateral
permanent sensorineural, conductive or mixed hearing loss
with average hearing level of 20‐69dB HL measured in the
better hearing ear at 0.5, 1, 2, 4kHz.
Refer to full-text for recommendations
Clinical Guideline including
graded recommendations based
on categories of evidence defined
according to research study
methodology. Medline, Embase,
and Cochrane searched by the
NLH Specialist Library for ENT
and Audiology with additional
hand search of journals.
[National Guideline]
British Association of
Audiovestibular Physicians,
2009. Aetiological investigation
into bilateral mild to moderate
permanent hearing loss in
children. London: BAAP.
Available at:
http://www.baap.org.uk/docs/Mil
d%20to%20Moderate%20Perma
nent%20Hearing%20Loss%20in
%20children%20Aetiological%20
Investigation%20BAAP%20BAPA
%20Guideline%202009.pdf
[Specialty guideline]
The aim of these guidelines is to provide an evidence based
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Clinical Guideline including
British Association of
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Evidence mapping: Prudent healthcare – Hearing Loss
Focus and main findings of source
approach to medical evaluation of all children with unilateral
• Permanent sensorineural hearing loss of prelingual or late
onset including fluctuating and progressive losses with two or
more thresholds greater than 40dbHL.
• Permanent conductive hearing loss
Refer to full-text for recommendations
Status of source
Reference
graded recommendations based
on categories of evidence defined
according to research study
methodology. Medline, Embase,
and Cochrane searched by the
NLH Specialist Library for ENT
and Audiology with additional
hand search of journals.
Audiovestibular Physicians,
2009. Medical evaluation of
children with permanent
unilateral hearing loss. London:
BAAP.
Available at:
http://www.baap.org.uk/docs/Un
ilateral%20Permanent%20Hearin
g%20Loss%20in%20Children%2
0Medical%20Investigation%20BA
AP%20BAPA%20Guideline%2020
09.pdf
[Specialty guideline]
Management
Management - Otitis Media
Aim: To assess the effectiveness of grommet insertion
compared with myringotomy or non-surgical treatment in
children with otitis media with effusion (OME).
Author’s conclusions
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
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The authors followed the
standard Cochrane methodology.
The review included 10 trials
comprised of 1728 participants.
Some trials randomised children
(grommets versus no
grommets), others ears
(grommet one ear only). The
severity of OME in children varied
between trials. Only one 'by
child' study (MRC: TARGET) had
Browning G et al. (2010)
Grommets (ventilation tubes) for
hearing loss associated with otitis
media with effusion in children .
Cochrane Database Syst Rev
Issue 10. Art. No.: CD001801.
DOI:10.1002/14651858.CD0018
01.pub3.
Available at:
http://onlinelibrary.wiley.com/doi
/10.1002/14651858.CD001801.p
ub3/abstract
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Evidence mapping: Prudent healthcare – Hearing Loss
Focus and main findings of source
Status of source
problems so no conclusions can be made regarding treatment
of such children.
Aim: To assess the effectiveness of autoinflation compared
with no treatment in children and adults with otitis media with
effusion.
Author’s conclusions
All of the studies were small, of limited treatment duration and
had short follow-up. However, because of the low cost and
absence of adverse effects it is reasonable to consider
autoinflation whilst awaiting natural resolution of otitis media
with effusion. Primary care could prove a beneficial place to
evaluate such interventions and there is ongoing research in
this area. Further research should also consider the duration of
treatment, the long-term impact on developmental outcomes in
children and additional quality of life outcome measures for
children and families.
Authors note in the discussion that the evidence for the use of
autoinflation in the treatment of glue ear in children is
conflicting but suggests that it may be of clinical benefit in the
short term.
Aim: To assess the effectiveness of adenoidectomy versus nonsurgical management or tympanostomy tubes in children with
otitis media.
Date: 18/3/14
Eight studies, with a total of 702
participants, met the inclusion
criteria. None of the included
studies were considered high
quality. Only one study noted
that the outcome assessors were
blinded.
Version:1
[Cochrane Syst Rev]
Perera R et al. (2013)
Autoinflation for hearing loss
associated with otitis media with
effusion. Cochrane Database Syst
Rev Issue 11. Art. No.:
CD005234. DOI:
10.1002/14651858.CD005234.pu
b6.
Available at:
http://onlinelibrary.wiley.com/doi
/10.1002/14651858.CD006285.p
ub2/abstract
[Cochrane Syst Rev]
The authors followed the
standard Cochrane methodology.
Fourteen randomised controlled
trials, including 2712 children,
Author’s conclusions
14
particularly stringent audiometric
entry criteria. No trial was
identified that used long-term
grommets.
The authors followed the
standard Cochrane methodology.
Reference
Van-den-Aardweg-Maaike-TA et
al. (2010) Adenoidectomy for
otitis media in children. Cochrane
Database Syst Rev Issue 1. Art.
No.: CD007810. DOI:
Dinah Roberts, Eleri Tyler:
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Evidence mapping: Prudent healthcare – Hearing Loss
Focus and main findings of source
Status of source
Reference
studying the effectiveness of
adenoidectomy in children with
otitis media were evaluated. Most
of the trials were too
heterogeneous to pool in a metaanalysis. Loss to follow up varied
from 0% to 63% after two years
10.1002/14651858.CD007810.pu
b2.
Available at:
http://onlinelibrary.wiley.com/doi
/10.1002/14651858.CD007810.p
ub2/abstract
Aim: To assess the effects of antibiotics in children up to 18
years with OME.
The authors followed the
standard Cochrane methodology.
Author’s conclusions
The results of our review do not support the routine use of
antibiotics for children up to 18 years with otitis media with
effusion. The largest effects of antibiotics were seen in children
treated continuously for four weeks and three months. Even
when clear and relevant benefits of antibiotics have been
demonstrated, these must be balanced against the potential
adverse effects when making treatment decisions. Immediate
adverse effects of antibiotics are common and the emergence
of bacterial resistance has been causally linked to the
widespread use of antibiotics for common conditions such as
otitis media.
This guideline provides recommendations for best practice in
the management of acute otitis media and otitis media with
23 studies, including 3027
children, covering a range of
antibiotics, participants, outcome
measures and time points of
evaluation were evaluated. The
included studies were assessed
as being at low risk of bias.
van, ZA et al. (2012) Antibiotics
for otitis media with effusion in
children. Cochrane Database Syst
Rev Issue 9. Art. No.: CD009163.
DOI:
10.1002/14651858.CD009163.pu
b2.
Available at:
http://onlinelibrary.wiley.com/doi
/10.1002/14651858.CD009163.p
ub2/abstract
Our review shows a significant benefit of adenoidectomy as far
as the resolution of middle ear effusion in children with OME is
concerned. However, the benefit to hearing is small and the
effects on changes in the tympanic membrane are unknown.
The risks of operating should be weighed against these
potential benefits.
The absence of a significant benefit of adenoidectomy on AOM
suggests that routine surgery for this indication is not
warranted.
15
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Version:1
[Cochrane Syst Rev]
[Cochrane Syst Rev]
SIGN guidelines are developed
using an explicit methodology
Scottish Intercollegiate
Guidelines Network, 2003.
Dinah Roberts, Eleri Tyler:
Evidence Service/Health Intelligence
Public Health Wales – Health Intelligence/Observatory
Evidence mapping: Prudent healthcare – Hearing Loss
Focus and main findings of source
effusion. It provides evidence about detection, management,
referral and follow up of children with these conditions.
It excludes discussion of surgical management such as the
insertion of grommets and does not address issues beyond
childhood years.
In addition, the needs of children with genetic or facial
abnormalities are not considered.
Refer to full text for the detail of the guideline.
Status of source
Reference
based on three core principles:
 Development is carried out by
multidisciplinary, nationally
representative groups
 A systematic review is
conducted to identify and
critically appraise the
evidence
 Recommendations are
explicitly linked to the
supporting evidence.
Guideline 66: Diagnosis and
management of childhood otitis
media in primary care Guideline. Edinburgh: SIGN.
Available at:
http://www.sign.ac.uk/pdf/sign6
6.pdf
[National Guideline]
Readers should consider the
publication date of this document
and be mindful that there may be
more recent evidence in some
areas.
The aim of the guideline was to outline appropriate criteria for
referral, assessment and optimum surgical management of
children younger than 12 years with a suspected diagnosis of
OME and suspected hearing loss including:
– children with all types of cleft palate
– children with Down’s syndrome.
Guideline developed by
systematic review (SR) combined
with expert opinion: one or more
SRs conducted to address key
questions and the Guideline
Development Group (GDG) use
SR findings to generate evidence
Key recommendations
statements and
Formal assessment of a child with suspected OME should recommendations. Registered
include:
stakeholders are invited to
Clinical history taking, focusing on:
comment on the scope of the
16
Date: 18/3/14
Version:1
National Collaborating Centre for
Women's and Children's Health,
2008. Surgical management of
otitis media with effusion in
children. London: NCC-WCH.
Available at:
http://www.nice.org.uk/nicemedi
a/live/11928/39633/39633.pdf
[National Guideline]
Dinah Roberts, Eleri Tyler:
Evidence Service/Health Intelligence
Public Health Wales – Health Intelligence/Observatory
Evidence mapping: Prudent healthcare – Hearing Loss
Focus and main findings of source
Status of source





poor listening skills
indistinct speech or delayed language development
inattention and behaviour problems
hearing fluctuation
recurrent ear infections or upper respiratory tract
infections
 balance problems and clumsiness
 poor educational progress
Clinical examination, focusing on:
• otoscopy
• general upper respiratory health
• general developmental status
Hearing testing, which should be carried out by trained staff
using tests suitable for the developmental stage of the child,
and calibrated equipment.
Reference
guideline and on the draft
guideline. The draft is also
reviewed by an independent
Guideline Review Panel (GRP).
The comments made by the
stakeholders, peer reviewers and
the GRP are considered
systematically by the GDG.
3 care pathways are included in
the guideline, a general pathway
and two tailored pathways for
children with cleft palate and
children with Down’s syndrome.
Tympanometry.
Children with persistent bilateral OME documented over a
period of 3 months with a hearing level in the better ear of 25–
30 dBHL or worse averaged at 0.5, 1, 2 and 4 kHz (or
equivalent dBA where dBHL not available) should be considered
for surgical intervention.
Once a decision has been taken to offer surgical intervention for
OME in children, the insertion of ventilation tubes is
recommended. Adjuvant adenoidectomy is not recommended in
the absence of persistent and/or frequent upper respiratory
17
Date: 18/3/14
Version:1
Dinah Roberts, Eleri Tyler:
Evidence Service/Health Intelligence
Public Health Wales – Health Intelligence/Observatory
Evidence mapping: Prudent healthcare – Hearing Loss
Focus and main findings of source
Status of source
Reference
tract symptoms.
The following treatments are not recommended
management of OME:
• antibiotics
• topical or systemic antihistamines
• topical or systemic decongestants
• topical or systemic steroids
• homeopathy
• cranial osteopathy
• acupuncture
• dietary modification, including probiotics
• immunostimulants
• massage.
for
the
Hearing aids should be offered to children with persistent
bilateral OME and hearing loss as an alternative to surgical
intervention where surgery is contraindicated or not acceptable.
Hearing aids should normally be offered to children with Down’s
syndrome and OME with hearing loss.
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.
18
Date: 18/3/14
Version:1
Dinah Roberts, Eleri Tyler:
Evidence Service/Health Intelligence
Public Health Wales – Health Intelligence/Observatory
Evidence mapping: Prudent healthcare – Hearing Loss
Focus and main findings of source
Management – Hearing Aids
Aim: To summarise and critically appraise the evidence
pertaining to the effectiveness of various types of digital
hearing aids and assistive listening devices in managing adults
with hearing loss.
Author’s conclusions
This systematic review concluded that adult patients with
hearing loss may benefit from using various styles of digital
hearing aids. In particular the authors found that satisfaction
was gained from the use of various styles and fittings of digital
hearing aids.
For patients with high‐frequency hearing loss, open canal
fittings were much more preferable than non‐open canal
devices. For patients with asymmetric severe‐to‐profound
hearing loss, contra‐lateral routing of signal digital hearing aids
may improve satisfaction (as shown by better acceptance rates
for the new hearing aids than the older models).
This systematic review did not identify relevant evidence to
support the routine use of the one‐to‐one communicator
(assistive listening devices).
19
Date: 18/3/14
Version:1
Status of source
Reference
The systematic review included
eight studies , one
pseudo-randomised controlled
trial with the remainder being
non randomised and with various
strengths and weaknesses.
Ali, W, Suebwongpat, A, Weston,
A. 2008 The effectiveness of
digital hearing aids and assistive
listening devices for adults with
hearing loss: A systematic review
of the literature. Christchurch:
Health Services Assessment
Collaboration (HSAC)
Reviewers only searched for
English language publications.
The methodological quality of the
included studies ranged from
good to poor. The two good
quality studies were limited by
the small number of the patients
included in one study and by the
inclusion of patients with tinnitus
but also have hearing loss in the
other.
http://onlinelibrary.wiley.com/o/
cochrane/clhta/articles/HTA32008100310/frame.html
The studies showed considerable
heterogeneity at all levels
(participant, intervention,
comparisons, and outcomes
measured), in particular the
interventions and comparisons
conducted varied across all the
studies.
[Systematic review]
http://www.healthsac.net/downlo
ads/publications/HSAC03%20Hea
ring%20Aids%20081008%20FIN
AL.pdf
Dinah Roberts, Eleri Tyler:
Evidence Service/Health Intelligence
Public Health Wales – Health Intelligence/Observatory
Evidence mapping: Prudent healthcare – Hearing Loss
Focus and main findings of source
Status of source
Aim: To assess the clinical effectiveness and cost-effectiveness
of bone-anchored hearing aids (BAHAs) for people who are
bilaterally deaf. The evaluation considered BAHAs compared
with conventional hearing aids [air conduction hearing aid
(ACHA) or bone conduction hearing aid (BCHA)], ear surgery
and the unaided condition, and the use of unilateral or bilateral
BAHAs.
Many of the studies relied mainly
on subjective measures (from the
subjects’ personal perspective)
rather than on objective
measures.
The systematic review included
12 studies of clinical
effectiveness; seven cohort pre–
post studies and five crosssectional audiological comparison
studies. No studies with a control
group were identified.
Author’s Conclusions
The findings suggest that hearing is improved with BAHAs
compared with no hearing aid, and although there are
audiological benefits of BAHAs when compared with
conventional BCHAs, the audiological benefits of BAHAs when
compared with ACHAs are less clear. Limited data suggest an
improvement in QoL with BAHAs when compared with
conventional aids, but there is an absence of evidence
regarding other potential benefits, such as length of time the
aid is able to be worn and improvement of discharging ears.
The evidence suggests that there are some benefits of bilateral
BAHAs compared with unilateral BAHAs.
The results of our cost analysis demonstrate that BAHAs are
significantly more costly than conventional BCHAs. The
20
Date: 18/3/14
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Seven studies compared BAHAs
with conventional hearing aids,
three of these and one additional
study compared BAHAs with
unaided hearing, and four studies
compared unilateral and bilateral
BAHAs. No prospective studies
comparing BAHAs with ear
surgery were identified.
Reference
Colquitt JL, Jones J, Harris P,
Loveman E, Bird A, Clegg AJ,
Baguley DM, Proops DW, Mitchell
TE, Sheehan PZ, Welch K.
Bone‐anchored hearing aids
(BAHAs) for people who are
bilaterally deaf: a systematic
review and economic evaluation.
Health Technology Assessment,
2011;1‐200.
Available at:
http://www.hta.ac.uk/1770
[Systematic review]
The overall quality was rated as
weak for all included studies and
meta-analysis was not possible
due to differences in outcome
measures and patient
Dinah Roberts, Eleri Tyler:
Evidence Service/Health Intelligence
Public Health Wales – Health Intelligence/Observatory
Evidence mapping: Prudent healthcare – Hearing Loss
Focus and main findings of source
Status of source
additional costs continue while individuals remain using their
BAHA and are not restricted to the initial processes of surgical
implantation and fitting of the BAHA sound processor. Our
exploratory cost-effectiveness analysis of BAHAs versus BCHAs
suggests that BAHAs are unlikely to be a cost-effective option
where the benefits (in terms of hearing gain and probability of
using of alternative aids) are similar for BAHAs and their
comparators. The greater the benefit from aided hearing and,
in particular, the greater the difference in the proportion of
people using the hearing aid for ≥ 8 hours per day, the more
likely BAHAs are to be a cost-effective option.
The inclusion of other dimensions of QoL may also increase the
likelihood of BAHAs being a cost-effective option.
Aim: To systematically review the outcomes of bilateral versus
unilateral bone-anchored hearing aids (BAHA) for individuals
with bilateral permanent conductive hearing loss.
Findings
Bilateral BAHA provided audiologic benefit compared to
unilateral BAHA (improved thresholds for tones [2 studies],
speech in quiet [5 studies] and in noise [3 studies], and
improved localization/lateralization [3 studies]) and patients'
perceived subjective benefit from bilateral BAHA (3 studies).
Disadvantages of bilateral BAHAs included listening in noise in
some conditions (3 studies), presumed additional cost, and
presumed increase in adverse event risk
21
Date: 18/3/14
Version:1
Reference
populations.
The authors note that the
available evidence is
methodologically weak and the
results have a high risk of bias
The systematic review included
11 observational studies and a
total of 168 patients.
In most studies, comparisons
between unilateral and bilateral
BAHA were intra-subject.
Studies were small; eight of the
studies had fewer than 13
subjects with bilateral BAHAs.
Janssen, R. M., Hong, P., &
Chadha, N. K., 2012. Bilateral
bone-anchored hearing aids for
bilateral permanent conductive
hearing loss: a systematic
review. [Review]. Otolaryngology
- Head & Neck Surgery 147 (3) :
412-422.
[Systematic review]
Likely selection bias in earlier
studies favouring bilateral BAHA
implantation.
Dinah Roberts, Eleri Tyler:
Evidence Service/Health Intelligence
Public Health Wales – Health Intelligence/Observatory
Evidence mapping: Prudent healthcare – Hearing Loss
Focus and main findings of source
Status of source
Reference
Meta-analysis was not possible
due to heterogeneity of studies
Management - Cochlear implants
1.1 Unilateral cochlear implantation is recommended as an
option for people with severe to profound deafness who do not
receive adequate benefit from acoustic hearing aids, as defined
in 1.5.
If different cochlear implant systems are considered to be
equally appropriate, the least costly should be used.
Assessment of cost should take into account acquisition costs,
long-term reliability and the support package offered.
1.2 Simultaneous bilateral cochlear implantation is
recommended as an option for the following groups of people
with severe to profound deafness who do not receive adequate
benefit from acoustic hearing aids, as defined in 1.5:
• children
• adults who are blind or who have other disabilities that
increase their reliance on auditory stimuli as a primary sensory
mechanism for spatial awareness.
Acquisition of cochlear implant systems for bilateral
implantation should be at the lowest cost and include currently
available discounts on list prices equivalent to 40% or more for
the second implant.
1.3 Sequential bilateral cochlear implantation is not
recommended as an option for people with severe to profound
deafness.
1.4 People who had a unilateral implant before publication of
this guidance, and who fall into one of the categories described
22
Date: 18/3/14
Version:1
Technology Appraisal Guidance
developed by systematic review
(SR) and cost effectiveness
analysis combined with expert
opinion. One SR was conducted
to address key questions and the
appraisal committee used the SR
findings to generate
recommendations and evidence
summary. Registered
stakeholders, including
manufacturers,
specialist/professional and
patient/carer groups were invited
to comment on the scope of the
assessment report and the
appraisal consultation document
(ACD). Selected professionals
also provided expert opinion. The
comments made by the
stakeholders are considered
systematically by the appraisal
committee.
National Institute for Health and
Clinical Excellence, 2009.
Cochlear implants for children
and adults with severe to
profound deafness. London:
NICE.
Available at:
http://www.nice.org.uk/nicemedi
a/live/12122/42854/42854.pdf
[National Technology Appraisal]
Dinah Roberts, Eleri Tyler:
Evidence Service/Health Intelligence
Public Health Wales – Health Intelligence/Observatory
Evidence mapping: Prudent healthcare – Hearing Loss
Focus and main findings of source
Status of source
Reference
in 1.2, should have the option of an additional contralateral
implant only if this is considered to provide sufficient benefit by
the responsible clinician after an informed discussion with the
individual person and their carers.
1.5 For the purposes of this guidance, severe to profound
deafness is defined as hearing only sounds that are louder than
90 dB HL at frequencies of 2 and 4 kHz without acoustic
hearing aids. Adequate benefit from acoustic hearing aids is
defined for this guidance as:
• for adults, a score of 50% or greater on Bamford–Kowal–
Bench (BKB) sentence testing at a sound intensity of 70 dB SPL
• for children, speech, language and listening skills appropriate
to age, developmental stage and cognitive ability.
1.6 Cochlear implantation should be considered for children and
adults only after an assessment by a multidisciplinary team. As
part of the assessment children and adults should also have
had a valid trial of an acoustic hearing aid for at least 3 months
(unless contraindicated or inappropriate).
When considering the assessment of adequacy of acoustic
hearing aids, the multidisciplinary team should be mindful of
the need to ensure equality of access. Tests should take into
account a person’s disabilities (such as physical and cognitive
impairments), or linguistic or other communication difficulties,
and may need to be adapted. If it is not possible to administer
tests in a language in which a person is sufficiently fluent for
the tests to be appropriate, other methods of assessment
should be considered.
Aim: The technology assessment evaluated the clinical
effectiveness of unilateral cochlear implants and bilateral
23
Date: 18/3/14
Version:1
A systematic review of the
literature largely following
Agency for Healthcare Research
and Quality (AHRQ), 2011.
Dinah Roberts, Eleri Tyler:
Evidence Service/Health Intelligence
Public Health Wales – Health Intelligence/Observatory
Evidence mapping: Prudent healthcare – Hearing Loss
Focus and main findings of source
Status of source
cochlear implants in adult patients (≥ 18 years of age) with
sensorineural hearing loss. It examined communication-related
health outcomes as well as quality-of-life outcomes, and also
preoperative characteristics associated with successful
implantation.
methods used for AHRQ
comparative effectiveness
reviews. Detail of the
methodology is available
at:http://www.effectivehealthcar
e.ahrq.gov/index.cfm/search-forguides-reviews-andreports/?pageaction=displayprod
uct&productid=318
Author’s conclusions
In summary, unilateral cochlear implantation with or without
additional use of hearing aids has been an effective method of
hearing assistance. Published studies show improved speech
perception and health-related quality-of-life in adults with
sensorineural hearing loss. Bilateral cochlear implantation
provides added improvements in speech perception outcomes
in noisy environments over unilateral cochlear implantation.
With future improvements in implant device technology and
implant programming, the number of patients implanted
bilaterally will continue to increase. Further studies with longer
follow-up duration are needed to assess the additional benefits
in terms of improved health-related quality-of-life and potential
risks of bilateral cochlear implantation compared with unilateral
implantation. Additionally, none of the studies have been able
to quantify the sensation described by patients of fusion of
bilateral sound into a stereo perception within one’s head.
There is a need to develop better measures of performance and
disease-specific quality-of –life instruments that may reflect the
significance of these subjective benefits.
Reference
Effectiveness of cochlear
implants in adults with
sensorineural hearing loss.
Available at:
https://www.cms.gov/Medicare/C
overage/DeterminationProcess/d
ownloads/id80TA.pdf
[Systematic Review]
The strength of the evidence
found for each key question is
graded as high, moderate, low or
insufficient
Refer to full text for summaries relating to each of the key
questions considered.
24
Date: 18/3/14
Version:1
Dinah Roberts, Eleri Tyler:
Evidence Service/Health Intelligence
Public Health Wales – Health Intelligence/Observatory
Evidence mapping: Prudent healthcare – Hearing Loss
Focus and main findings of source
Status of source
This document describes considerations prior to this
intervention being considered appropriate in both children and
adults. These include the duration of a trial of hearing aids, the
degree of hearing loss and demonstrable speech and language
difficulties.
The position statement arose
from consideration of published
evidence in conjunction with
clinical experience and outcome
data shared with the British
Cochlear Implant Group. No
systematic review of clinical
studies is documented. The
technology appraisal guidance
from NICE was published
subsequent to this statement.
Reference
British Cochlear Implant Group,
2007. Proposed position
statement on guidelines for
paediatric cochlear implantation:
BCIG.
Available at:
http://www.bcig.org.uk/downloa
ds/pdfs/BCIG%20position%20sta
tement%20%20Guidelines%20for%20Cochle
ar%20Implantation%20APril%20
07.pdf
[Position Statement]
The same group have created a document specifies quality
standards for various aspects of a cochlear implantation
programme including
 Service Structure
 Accommodation
 Clinical Facilities
 Referral and Selection Criteria
 The Assessment Process
 Liaison with other services
 Pre-operative Information and Counselling
 The Cochlear Implant Device
 Surgery and In-patient Care
25
Date: 18/3/14
Version:1
Consensus document
British Cochlear Implant Group &
Royal National Institute for the
Deaf, 2009. Quality standards
for adult cochlear implantation:
BCIG.
Available at:
http://www.bcig.org.uk/downloa
ds/pdfs/BCIG%20Adult%20Qualit
y%20Standards%202010.pdf
[Best Practice guidance]
Dinah Roberts, Eleri Tyler:
Evidence Service/Health Intelligence
Public Health Wales – Health Intelligence/Observatory
Evidence mapping: Prudent healthcare – Hearing Loss
Focus and main findings of source
Status of source
Reference
The Interventional Procedure
guidance was based on a rapid
review of published literature in
conjunction with review of the
procedure by a specialist advisor.
National Institute for Health and
Clinical Excellence, 2005.
Auditory brain stem implants.
London: NICE.
Available at:
http://www.nice.org.uk/nicemedi
a/live/11086/30959/30959.pdf

Post-operative Fitting and Programming of the Speech
Processor
 Post-operative Rehabilitation and Assessments
 Follow-up and Long Term Maintenance
 Device Failure
 Audit and Service Monitoring
 Transfer of Care
 Patient and Other Feedback and Complaints
Management – Brain stem implants
Focus is the safety and efficacy of auditory brain stem implants
for the indications of


total deafness in both ears caused by damage to the
vestibulocochlear nerve as a result of tumours or
surgery.
in people with vestibulocochlear nerve damage, hearing
is not improved by hearing aids or cochlear implants.
The interventional Procedure guidance notes
“Current evidence on the safety and efficacy of auditory brain
stem implants appears adequate to support the use of this
procedure by surgical teams experienced in this technique,
provided that normal arrangements are in place for consent,
audit and clinical governance.”
26
Date: 18/3/14
Version:1
No systematic reviews or
randomised controlled trials or
non-randomised controlled
studies were identified. Published
literature comprised of 12
uncontrolled case-series all of
which were small and unable to
give a precise estimate of risks of
complications. There may be
overlap of patients amongst
published case-series.
[National Interventional
Procedure Guidance]
Dinah Roberts, Eleri Tyler:
Evidence Service/Health Intelligence
Public Health Wales – Health Intelligence/Observatory
Evidence mapping: Prudent healthcare – Hearing Loss
Focus and main findings of source
Management- Earwax
Aim: To offer guidance to nursing staff with responsibility for
various aspects of ear care. The Best Practice Statement
includes sections on







Educational preparation of healthcare staff undertaking
ear care
Ear care assessment
Cerumen management
Instrumentation
Ear irrigation
Use of microscope and microsuction
Infection control
Status of source
Reference
This is a best practice statement
developed where variation in
practice exists. The document
was developed to promote a
consistent, cohesive and
achievable approach to care. A
literature search was conducted
but the breadth and detail of the
search strategy is not
documented. A reference group
was used to consult on drafts of
the document.
NHS Quality Improvement
Scotland, 2006. Ear Care. Best
practice statement. Edinburgh:
Health Care Improvement
Scotland.
Available at:
http://www.healthcareimprovem
entscotland.org/idoc.ashx?docid=
95aeda29-930d-4c88-a7a0e532c48d9f4c&version=-1
[Best Practice Statement]
This evidence summary on earwax covers diagnosis and
management of earwax and provides detailed information on
how to irrigate the ear and when irrigation is contraindicated.
NICE CKS summaries provide
primary care practitioners with a
synopsis of the current evidence
base and practical guidance on
best practice on a variety of
topics.
CKS, 2012. Earwax
http://cks.nice.org.uk/earwax
[Evidence summary]
Management – Idiopathic Sudden Sensorineural hearing loss (ISSHL)
Aim: To determine whether steroids in the treatment of
idiopathic sudden sensorineural hearing loss (ISSHL) improves
hearing (primary) and reduce tinnitus (secondary) and also to
determine the incidence of significant side effects from the
27
Date: 18/3/14
Version:1
The authors followed the
standard Cochrane methodology.
The review included three trials,
Wei-Benjamin PC et al. (2013)
Steroids for idiopathic sudden
sensorineural hearing loss.
Cochrane Database Syst Rev
Dinah Roberts, Eleri Tyler:
Evidence Service/Health Intelligence
Public Health Wales – Health Intelligence/Observatory
Evidence mapping: Prudent healthcare – Hearing Loss
Focus and main findings of source
medication.
Author’s conclusions:
The value of steroids in the treatment of idiopathic sudden
sensorineural hearing loss remains unclear since the evidence
obtained from randomised controlled trials is contradictory in
outcome, in part because the studies are based upon too small
a number of patients.
Aim: To determine the effectiveness and adverse effects of
vasodilators and other vasoactive substances in improving
hearing in patients with ISSHL.
Status of source
Reference
involving 267 participants. The
included studies were of poor
quality and contained relatively
small numbers of participants.
No meta-analysis conducted
because of heterogeneity in
definition of hearing
improvement, differences in the
formulations, duration and
dosage of the steroid
intervention, variations in the
participants’ geographic
background, differences in the
means of assessing the outcomes
and variations in the
methodological quality of the
studies.
Issue 7. Art. No.: CD003998.
DOI:
10.1002/14651858.CD003998.pu
b3.
Available at:
http://onlinelibrary.wiley.com/doi
/10.1002/14651858.CD003998.p
ub3/abstract
Design of research studies
complicated by low incidence of
ISSHL and the highly variable
natural history of condition which
includes early spontaneous
resolution in some patients.
The authors followed the
standard Cochrane methodology.
Three trials, involving 189
participants were identified, all of
28
Date: 18/3/14
Version:1
[Cochrane Syst Rev]
Agarwal L & Pothier DD. (2009)
Vasodilators and vasoactive
substances for idiopathic sudden
sensorineural hearing loss.
Cochrane Database Syst Rev
Dinah Roberts, Eleri Tyler:
Evidence Service/Health Intelligence
Public Health Wales – Health Intelligence/Observatory
Evidence mapping: Prudent healthcare – Hearing Loss
Focus and main findings of source
Status of source
Author’s conclusions
The effectiveness of vasodilators in the treatment of ISSHL
remains unproven. The included studies were of relatively poor
quality and the number of patients included was small.
Moreover, there were differences in the type, dosage and
duration of vasodilator used in each study. Due to the degree of
heterogeneity the results could not be combined to reach a
conclusion.
low quality.
Meta-analysis was not possible
due to heterogeneity of studies
arising from differences in the
type, dosage and duration of
vasodilator treatment and in the
definition of hearing
improvement.
Aim: To determine the effectiveness and side effect profile of
antivirals in the treatment of ISSHL.”
Design of research studies
complicated by low incidence of
ISSSHL and the highly variable
natural history of condition which
includes early spontaneous
resolution in some patients.
The authors followed the
standard Cochrane methodology.
Author’s conclusions
There is currently no evidence to support the use of antiviral
drugs in the treatment of ISSHL. The four trials included in this
review were, however, small and with a low risk of bias. Further
randomised controlled trials with larger patient populations,
using standardised inclusion criteria, antiviral regimes and
outcome measures, are needed in order for adequate metaanalysis to be performed to reach definitive conclusions. A
uniform definition of ISSHL should also be established, together
with what constitutes adequate recovery.
The review included four
randomised trials comprising of
257 participants. Three out of the
four included studies were
prospective, randomised,
double-blinded, placebocontrolled trials with a low risk of
bias. One study had high risk of
bias, with unclear description of
allocation, blinding and patient
29
Date: 18/3/14
Version:1
Reference
Issue 4. Art. No.: CD003422.
DOI:
10.1002/14651858.CD003422.pu
b4.
Available at:
http://onlinelibrary.wiley.com/doi
/10.1002/14651858.CD003422.p
ub4/abstract
[Cochrane Syst Rev]
Awad Z et al. (2012) Antivirals
for idiopathic sudden
sensorineural hearing loss.
Cochrane Database Syst Rev
Issue 8. Art. No.: CD006987.
DOI:
10.1002/14651858.CD006987.pu
b2.
Available at:
http://onlinelibrary.wiley.com/doi
/10.1002/14651858.CD006987.p
ub2/abstract
Dinah Roberts, Eleri Tyler:
Evidence Service/Health Intelligence
Public Health Wales – Health Intelligence/Observatory
Focus and main findings of source
Evidence mapping: Prudent healthcare – Hearing Loss
Status of source
Reference
exclusions.
[Cochrane Syst Rev]
Aim: To assess the benefits and harms of hyperbaric oxygen
therapy (HBOT) for treating ISSHL and/or tinnitus.
The authors followed the
standard Cochrane methodology.
Author’s conclusions
For people with acute ISSHL, the application of HBOT
significantly improved hearing, but the clinical significance
remains unclear. We could not assess the effect of HBOT on
tinnitus by pooled analysis. In view of the modest number of
patients, methodological shortcomings and poor reporting, this
result should be interpreted cautiously. An appropriately
powered trial is justified to define those patients (if any) who
can be expected to derive most benefit from HBOT.
The review included Seven trials
comprising 392 participants. The
studies were small and of
generally poor quality.
Bennett MH et al. (2012)
Hyperbaric oxygen for idiopathic
sudden sensorineural hearing
loss and tinnitus. Cochrane
Database Syst Rev
Available at:
http://onlinelibrary.wiley.com/doi
/10.1002/14651858.CD004739.p
ub4/abstract
There is no evidence of a beneficial effect of HBOT on chronic
ISSHL or tinnitus and we do not recommend the use of HBOT
for this purpose.
The authors note variability and
poor reporting of entry criteria,
variable nature and timing of
outcomes, and poor reporting of
both outcomes and methodology.
Also noted is that given the high
rate of spontaneous recovery
from ISSHL, there is a possibility
of bias due to different times to
entry in these small trials, as well
as from non-blinded
management decisions in all
trials.
[Cochrane Syst Rev]
Management– Balloon dilation of the Eustachian Tube
The document examined the safety and efficacy of balloon
dilatation of the Eustachian tube used for persistent blockage of
the Eustachian tube.
30
Date: 18/3/14
Version:1
The Interventional Procedure
guidance was based on a rapid
review of published literature in
National Institute for Health and
Clinical Excellence, 2011.
Balloon dilatation of the
Dinah Roberts, Eleri Tyler:
Evidence Service/Health Intelligence
Public Health Wales – Health Intelligence/Observatory
Evidence mapping: Prudent healthcare – Hearing Loss
Focus and main findings of source
Guidance
Current evidence on the efficacy and safety of balloon dilatation
of the Eustachian tube is inadequate in quantity and quality.
Therefore, this procedure should only be used in the context of
research, which should address the efficacy of the procedure in
the short and longer term, and also document safety outcomes.
Research studies should clearly describe which parts of the
Eustachian tube are being treated and report subjective
measurements of symptom improvement and objective
measurements of Eustachian tube function.
Status of source
Reference
conjunction with review of the
procedure by 3 specialist
advisors. The review identified 1
small case series published as a
full article and two further small
case series were described in
published conference abstracts.
There is a lack of long-term
data.
Eustachian tube. Manchester:
NICE.
Available at:
http://www.nice.org.uk/nicemedi
a/live/13423/57219/57219.pdf
Supporting overview document
available at
http://www.nice.org.uk/nicemedi
a/live/13423/55152/55152.pdf
[National Interventional
Procedure Guidance]
Management– Micropressure therapy for refractory Ménière's disease
The document examined the safety and efficacy of
micropressure therapy for refractory Ménière's disease
Guidance
Current evidence on the safety of micropressure therapy for
refractory Ménière's disease is inadequate in quantity. There is
some evidence of efficacy, but it is based on limited numbers of
31
Date: 18/3/14
Version:1
The Interventional Procedure
guidance was based on a rapid
review of published literature in
conjunction with review of the
procedure by 3 specialist
advisors.
National Institute for Health and
Clinical Excellence, 2012.
Micropressure therapy for
refractory Ménière's disease.
Manchester: NICE.
Available at:
http://www.nice.org.uk/nicemedi
This overview is based on 240
Dinah Roberts, Eleri Tyler:
Evidence Service/Health Intelligence
Public Health Wales – Health Intelligence/Observatory
Evidence mapping: Prudent healthcare – Hearing Loss
Focus and main findings of source
Status of source
patients. Therefore this procedure should only be used with
special arrangements for clinical governance, consent and audit
or research.
patients from 2 randomised
controlled trials (RCTs), 1
comparative study and 3 case
series. Quality of Included RCTs
was questionable. In addition
there was no long-term follow-up
(longer than 2 years) and a lack
of safety data. No mention of
complications in 4 of the 6
studies reported.
a/live/13440/58918/58918.pdf
Consensus document
British Academy of Audiology,
2009. Guidelines for referral to
audiology of adults with hearing
difficulty: BAA.
Dinah Roberts, Eleri Tyler:
Evidence Service/Health Intelligence
1.2 Clinicians wishing to undertake micropressure therapy for
refractory Ménière's disease should take the following actions.
Inform the clinical governance leads in their Trusts.
Ensure that patients understand the uncertainty about the
procedure's efficacy and provide them with clear written
information. In addition, the use of NICE's information for
patients ('Understanding NICE guidance') is recommended.
Reference
Supporting overview document
available at:
http://www.nice.org.uk/nicemedi
a/live/13440/55575/55575.pdf
[National Interventional
Procedure Guidance]
Audit and review clinical outcomes of all patients having
micropressure therapy for refractory Ménière's disease (see
section 3.1).
1.3 NICE encourages further research into micropressure
therapy for refractory Ménière's disease. Research studies
should report long-term outcomes, in particular the need for
subsequent surgical treatment.
Management - Inappropriate Referrals
This document lists situations where adult patients should NOT
be referred directly to audiology for hearing assessment and
rehabilitative treatment from either primary care or other intrahospital consultant pathways.
32
Date: 18/3/14
Version:1
Public Health Wales – Health Intelligence/Observatory
Evidence mapping: Prudent healthcare – Hearing Loss
Focus and main findings of source
Status of source
Available at:
http://www.baaudiology.org/files
/3513/5898/2984/BAA_Direct_Re
ferral_Criteria_0909_amended1.
pdf
Contra-indications
History:










Reference
Persistent pain affecting either ear (defined as earache
lasting more than 7 days in the past 90 days before
appointment)
History of discharge other than wax from either ear
within the last 90 days
Sudden loss or sudden deterioration of hearing
(sudden=within 1 week, in which case send to A&E or
Urgent Care ENT clinic)
Rapid loss or rapid deterioration of hearing (rapid=90
days or less)
Fluctuating hearing loss, other than associated with colds
Unilateral or asymmetrical, or pulsatile or distressing
tinnitus lasting more than 5 minutes at a time
Troublesome, tinnitus which may lead to sleep
disturbance or be associated with symptoms of anxiety
or depression
Abnormal auditory perceptions (dysacuses)
Vertigo
Normal peripheral hearing but with abnormal difficulty
hearing in noisy backgrounds; possibly having problems
with sound localization, or difficulty following complex
auditory directions.
[Specialty Guidance]
Ear examination:
33
Date: 18/3/14
Version:1
Dinah Roberts, Eleri Tyler:
Evidence Service/Health Intelligence
Public Health Wales – Health Intelligence/Observatory
Evidence mapping: Prudent healthcare – Hearing Loss
Focus and main findings of source
Status of source

Complete or partial obstruction of the external auditory
canal preventing proper examination of the eardrum
and/or proper taking of an aural impression.

Abnormal appearance of the outer ear and/or the
eardrum (e.g., inflammation of the external auditory
canal, perforated eardrum, active discharge).
Reference
Audiometry:
34

Conductive hearing loss, defined as 25 dB or greater airbone gap present at two or more of the following
frequencies: 500, 1000, 2000 or 4000 Hz.

Unilateral or asymmetrical sensorineural hearing loss,
defined as a difference between the left and right bone
conduction thresholds of 20 dB or greater at two or more
of the following frequencies: 500, 1000, 2000 or 4000
Hz.

Evidence of deterioration of hearing by comparison with
an audiogram taken in the last 24 months, defined as a
deterioration of 15 dB or more in air conduction
threshold readings at two or more of the following
frequencies: 500, 1000, 2000 or 4000 Hz.
Date: 18/3/14
Version:1
Dinah Roberts, Eleri Tyler:
Evidence Service/Health Intelligence
Public Health Wales – Health Intelligence/Observatory
Evidence mapping: Prudent healthcare – Hearing Loss
Guidance
ID
NICE 'do not do' recommendation
Interventions
CG60
Once a decision has been taken to offer surgical intervention for otitis media with
effusion (OME) in children, insertion of ventilation tubes is recommended. Adjuvant
adenoidectomy is not recommended in the absence of persistent and/or frequent
upper respiratory tract symptoms.
adjuvant adenoidectomy
CG60
Antibiotics are not recommended for the management of otitis media with effusion
(OME).
antibiotics
CG60
Topical or systemic antihistamines are not recommended for the management of
otitis media with effusion (OME).
topical or systemic antihistamines
CG60
Topical or systemic decongestants are not recommended for the management of
otitis media with effusion (OME).
topical or systemic decongestants
CG60
Topical or systemic steroids are not recommended for the management of otitis
media with effusion (OME).
topical or systemic steroids
CG60
Homeopathy is not recommended for the management of otitis media with effusion
(OME).
homeopathy
CG60
Cranial osteopathy is not recommended for the management of otitis media with
effusion (OME).
cranial osteopathy
CG60
Acupuncture is not recommended for the management of otitis media with effusion
(OME).
acupuncture
CG60
Dietary modification, including probiotics is not recommended for the management of dietary modification, including
otitis media with effusion (OME).
probiotics
CG60
Immunostimulants are not recommended for the management of Otitis media with
effusion (OME).
35
Date: 18/3/14
Version:1
Dinah Roberts, Eleri Tyler:
Evidence Service/Health Intelligence