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Contents lists available at ScienceDirect

Auris Nasus Larynx
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Clinical practice guidelines for the diagnosis and managementof otitis media with effusion (OME) in children in Japan –2022 update ✩Hiroshi Hidaka a,∗, Makoto Ito b, Ryoukichi Ikeda c, Yosuke Kamide d,Haruo Kuroki e, Atsuko Nakano f, Haruo Yoshida g, Haruo Takahashi g, Yukiko Iino h,
Yasuaki Harabuchi i, Hitome Kobayashi ja Department of Otorhinolaryngology-Head and Neck Surgery, Kansai Medical University, 2-3-1 Shinmachi, Hirakata, Osaka 573-1191,

Japan
b Department of Pediatric Otolaryngology, Jichi Children’s Medical Center Tochigi, Jichi Medical University, Japanc Department of Otolaryngology-Head & Neck Surgery, Iwate Medical University, Japand Kamide Ear Nose and Throat Clinic, Japane Sotobo Children’s Clinic, Japanf Division of Otorhinolaryngology, Chiba Children’s Hospital, Japang Department of Otolaryngology Head and Neck Surgery, Nagasaki University School of Medicine, Japanh Department of Otolaryngology, Tokyo-Kita Medical Center, Japani Department of Otolaryngology-Head and Neck Surgery, Asahikawa Medical University, Japanj Department of Otorhinolaryngology, Showa University School of Medicine, JapanA R T I C L E

I N F O

Article history:
Received 13 October 2022
Accepted 9 December 2022
Available online xxx
Keywords:
Clinical guidelines
Otitis media with effusion (OME)
Middle ear (ME)Treatment algorithm
Tympanostomy tube insertion (TS tube
insertion)
Clinical Question (CQ)A B S T R A C T

This is an update of the 2015 Guidelines developed by the Japan Otological Society and OtoRhino-Laryngeal Society of Japan defining otitis media with effusion (OME) in children (younger
than 12 years old) and describing the disease rate, diagnosis, and method of examination. Recommended therapies that received consensus from the guideline committee were updated inconsideration of current therapies used in Japan and based on available evidence.
Method: Regarding the treatment of OME in children, we developed Clinical Questions (CQs)
and retrieved documents on each theme, including the definition, disease state, method of diagnosis, and medical treatment. In the previous guidelines, no retrieval expression was used todesignate a period of time for literature retrieval. Conversely, a literature search of publications
from March 2014 to May 2019 has been added to the JOS 2015 Guidelines. For publicationof the CQs, we developed and assigned strengths to recommendations based on the collected
evidence.
Results: OME in children was classified into one group lacking the risk of developing chronic
or intractable disease and another group at higher risk (e.g., children with Down syndrome, cleft
palate), and recommendations for clinical management, including follow-up, is provided. Information regarding management of children with unilateral OME and intractable cases complicatedby adhesive otitis media is also provided.

Abbreviations: Guidelines of OME, - 2022 update.

✩ Subcommittee of Clinical Practice Guidelines for the Diagnosis and Man-

agement of Otitis Media with Effusion in Children∗ Corresponding author.
E-mail address: ZAY00015@nifty.com (H. Hidaka).
https://doi.org/10.1016/j.anl.2022.12.004
0385-8146/© 2022 Japanese Society of Otorhinolaryngology-Head and Neck Surgery, Inc. Published by Elsevier B.V. This is an open access article under
the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/)
Please cite this article as: H. Hidaka, M. Ito, R. Ikeda et al., Clinical practice guidelines for the diagnosis and management of otitis media with effusion(OME) in children in Japan – 2022 update, Auris Nasus Larynx, https:// doi.org/ 10.1016/ j.anl.2022.12.004

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Conclusion: In clinical management of OME in children, the Japanese Clinical Practice Guidelines recommends management not only of complications of OME itself, such as effusion in the
middle ear and pathologic changes in the tympanic membrane, but also pathologic changes insurrounding organs associated with infectious or inflammatory diseases.
© 2022 Japanese Society of Otorhinolaryngology-Head and Neck Surgery, Inc. Published by
Elsevier B.V.
This is an open access article under the CC BY-NC-ND license(http://creativecommons.org/licenses/by-nc-nd/4.0/)

Chapter 1. Action statement and issues updated in thepresent Guidelines
1.1. Summary of action statement
Based on public comments presented after publication of
the 2015 JOS (Japan Otological Society) Guidelines, the update committee made revised plans, as follows. The committee also revised its plans reflecting discussions following
committee reports presented during the annual meetings of
the JOS in 2020 and 2021.
(1) Supplemental figures have been added to introductory
remarks regarding the pathology, diagnosis, and medical treatment of otitis media with effusion (OME) in
children.
(2) In the Introduction (1.4.: representing Chapter 1Section 4), international OME guidelines were reviewed
in Section 1.5).
(3) Terminology related to the topic has been added in thesection defining OME in children (1.18).
(4) Regarding the method for evaluating the quality of evidence and strength of recommendations, the committee
referred to a proposal described in the Medical Information Network Distribution Service Japan (MINDS)
Handbook for Clinical Practice Guideline Development2014 and 2020 and the method recommended by theAmerican Academy of Pediatrics (AAP). Again, themethod recommended by the AAP was applied to evaluate recommendations, with reference to methods recommended in the MINDS Handbook and Guidelines ofRecommendations Assessment, Development, and Evaluation (GRADE).
(5) In the 2015 JOS Guidelines, adenoidectomy was notrecommended as an initial procedure for treating OME
in children in the absence of clear indications withregard to upper airway lesions. The committee revised recommendations on this issue according to recent meta-analyses and categorized the recommendations for patients under or above 4 years of age. In
the latter group, adenoidectomy combined with tympanostomy (TS) tube insertion is expected to reduce therecurrence rate of OME. Therefore, the combination of
adenoidectomy and TS tube insertion may be considered (3.CQ9).
(6) In the 2015 JOS OME Guidelines (Clinical Question[CQ]-9), myringotomy alone was not recommended forthe treatment of OME in children. Based on recent evidence, however, the recommendation was revised asfollows (3.CQ5):(7) Myringotomy is recommended for the diagnosis and determination of treatment protocol for OME in children.
It is effective for short-term prognosis, but it is not recommended for the purpose of long-term treatment.
(8) In terms of indications for TS tube insertion attributed
to hearing difficulties, children with moderate or severe
hearing loss (≥40 dB) and those with hearing loss of
25-39 dB were graded with recommendations A andB, respectively. Conversely, the present guidelines have
simplified and updated the recommendation for patients
presenting with hearing difficulties, and hearing loss(≥30 dB) in the ear on the better-hearing side is documented (3.CQ6).
(9) The committee added a new CQ focusing on unilateral OME, titled “Is the tympanostomy tube effective
for unilateral OME?” (3.CQ10). Moreover, the Supplemental CQ titled “How do I take care of children withcomplicated adhesive otitis media?” was also added.
(10) In Chapter 4, which focuses on the management of
OME in children with Down syndrome (DS) or cleft
palate, commentary was updated with reference to recent evidence, and the practical guidelines were clarified.
(11) Supplemental notes referring to future prospects for improving diagnostic techniques have been added in the
final Chapter 5.
1.2. Guideline composers
All authors of this article represent the constituent members of the Clinical Practice Guideline Development Committee for OME in children. The Japan Otological Society
and the Pediatric Otorhinolaryngology Society of Japan composed this committee. The inaugural meeting of the committee was held on February 28, 2013, at which time theguideline-making process was begun. After publication of the2015 JOS Guidelines, plans for revising the Guidelines were
initiated at the 12th meeting held on May 18, 2017. Thereafter, the draft edition of the present Guidelines was evaluatedby external reviewers, including otolaryngologists and experts
in guideline development, and the Committee considered theirremarks at the 26th meeting, held on October 15, 2021.
The academic board of the Oto-Rhino-Laryngological Society of Japan offered comments for revisions, and these is-

Please cite this article as: H. Hidaka, M. Ito, R. Ikeda et al., Clinical practice guidelines for the diagnosis and management of otitis media with effusion(OME) in children in Japan – 2022 update, Auris Nasus Larynx, https:// doi.org/ 10.1016/ j.anl.2022.12.004

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3sues were investigated at the 27th meeting, held on February 1, 2022. The descriptions and recommendations of the
final version of the Guidelines were approved on February
25, 2022.
The committee requested that an incorporated nonprofit organization, the Japan Medical Library Association, retrieve
documents for preparing the first edition of the Guidelines.
1.3. Financial backers and sponsors
Production of the Guideline was funded by JOS operating expenses. The JOS does not receive support from any
specific organizations or companies. A list of organizations
and companies that posed non-personal financial conflicts ofinterest (COIs) to members of the Clinical Practice Guideline Subcommittee during production of the Guideline is provided (attachment). Members of the Subcommittee with a
COI were excluded from drafting the portion of the Guideline affected by the COI. To avoid undue influence of COIs
of certain Guideline Committee members, all Guideline Committee members confirmed and approved the descriptions andrecommendations contained in the final Guideline.
1.4. Background and history
1.4.1. Pathoetiology of OME
In the present Guidelines, OME is defined as “otitis media
with middle-ear effusion (MEE) without tympanic membrane(TM) perforation, which causes hearing loss but lacks signsof acute inflammation of the ear, such as otalgia and fever”(refer to Section 1.18). OME is a ME disease that affects
90% of preschool children at least once [1], and it is the mostfrequent cause of pediatric hearing loss. More than 50% ofchildren experience OME before the age of 1 year, and >60%
of children experience OME by the age of 2 years [2]. Whilemost cases resolve spontaneously within 3 months, 30–40%
of cases involve recurrent OME, and 5–10% of children have
episodes lasting 1 year or longer [1,3,4]. As OME sometimes
causes sequelae, long-term medical management is required(refer to Section 1.19).
OME in adults differs from that in children with regard
to its etiological background, such as Eustachian tube (ET)dysfunction and nasopharyngeal tumors in adults; thus, OME
in adults is outside the scope of the present Guidelines. The
present Guideline provides recommendations for the treatment
of OME in children younger than 12 years of age.
As many as 50% of children develop OME with a cold orafter acute otitis media (AOM) [5]. Common cold, inflammation in the nose and/or paranasal sinuses, and AOM, which
is characterized by ME infection with acute onset of symptoms and signs, may cause MEE. Particularly in cases involving tubal dysfunction and poor development of mastoid cells,
MEE can sometimes progress to OME (Fig. 1). Guidance isrequired regarding the timing and criteria for diagnosing OME
in cases involving MEE after AOM or previously unnoticed
MEE that is diagnosed by chance.
The primary symptoms of OME in children include hearing loss and aural fullness, whereas fever and otalgia are

Fig. 1. Schematic illustration of the middle ear. The middle ear is the partof the ear consisting of the tympanic membrane (eardrum), tympanic cavity,
ossicles, and Eustachian tube, which connects the middle ear with the nasal
cavity (nasopharynx). The ossicles transmit the vibrations of the tympanic
membrane to the inner ear. The mastoid cells and mastoid antrum are hollow spaces around the tympanic cavity that function in the ventilation andprotection of the middle ear as well as Eustachian tube.

rarely observed. Although some cases resolve spontaneously,
the absence of acute symptoms of inflammation can resultin the condition being overlooked for a long time. If OME
is left untreated for a long period, affected children are at
risk of hearing loss that can delay language development andinterfere with learning, as well as the risk of pathologicalchanges in the TM and ME, such as adhesive otitis media(refer to Sections 1.19. and 3.11. Supplemental CQ). Surgical intervention (TS tube insertion is the first-line treatment)is the preferred initial procedure, and although it is useful for
improving hearing loss, it may also cause persistent perforation of the TM and tympanosclerosis (refer to Section 1.19.,
3.CQ6–8).
1.4.2. Historical development of the OME guidelines
Existing overseas guidelines for diagnosing and managing
OME include the USA 2004 Clinical Practice Guideline [6],the UK 2008 National Institute for Health and Care Excellence (NICE) Guidelines for OME in children under 12 years[7], and the Korean 2012 Clinical Practice Guidelines [8], as
well as other similar guidelines published in the other countries (Table 1). Treatment guidelines for TS tube insertion inchildren have also been developed in the United States [9].
The main objective of the US and European guidelines is
to establish when children with OME should be referred to anear, nose, and throat (ENT) specialist for TS tube insertion.
In contrast, in Japan, otolaryngologists are generally responsible for the primary care of children with OME as well as
for surgery; OME is diagnosed and treated in conjunction
with related inflammatory lesions of surrounding organs. In
other words, clinical management of OME in children usually
involves treatment not only of direct OME-related conditions
such as MEE and pathological changes in the TM but also thepatient’s overall clinical state, and ENT specialists in Japan
treat any related lesions of the surrounding organs. In consideration of the current status of management of OME in
Japan, the JOS and the Japan Society for Pediatric Otorhino-

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Table 1. Guidelines in various countries.
Author

Journal informationYear

Affiliates

Bull et al. [7]London: RCOG Press. 1-74

2008

National Collaborating
Centre for Women’s andChildren’s Health• Working Group included nurses andpatients.
• Health economics are also discussed.

Lee et al. [8]

J Korean Med Sci.
27:835-48

2012

Korean Otologic Society• Guidelines for AOM and OME.
• Recommendations are graded.

Rosenfeld et al. [9]Otolaryngol Head Neck
Surg. 149(1):S1-35

2013

American Academy of
ORL-HNS• Guidelines for tympanostomy tubes inchildren.
• 15 systematic reviews or meta-analyses.
• 113 RCTs.

Ito et al. [10,11]

Tokyo, Kanehara Publishing,1-90 [in Japanese].
Auris Nasus Larynx.
44(5):501-8

2015
2017

Japan Otological Society,Japan Society for Pediatric
ORL• The first edition of the present
guidelines.
• Recommended management not only of
OME itself but also pathologicalabnormalities in surrounding organs.

Heidemann, et al. [12]Int J Pediatr
Otorhinolaryngol. 87: 154-63

2016

Danish Health andMedicines Authority, Danish
Society of ORL-HNS• Working group.
• Recommendations were gradedaccording to the GRADE system.

Rosenfeld et al. [13]Otolaryngol Head Neck
Surg.154: S1-41

2016• Update of 2004 guidelines.
• 4 new practice guidelines.
• 20 new systematic reviews.
• 49 RCTs.

Blanc et al. [14]Eur Ann Otorhinolaryngol
Head Neck Dis. 135(4):269-273.
Eur Ann Otorhinolaryngol
Head Neck Dis. 135(1S):
S33-S39.

2018

American Academy of
ORL-HNS, American
Academy of Pediatrics,
American Academy of
Family Medicine
Société Française d’ORL• Based on extensive review (1996-2016).

International consensus
assessment (France, UK,
USA, China, South Africa)• Guidelines specialists from each areaof the world recommended the bestpractices for OME management.

Simon et al. [15]2018

Outlines

Abbreviations: ORL, otorhinolaryngology; HNS, head and neck surgery; RCT, randomized controlled trial

laryngology developed evidence-based guidelines to support
the diagnosis and treatment of OME in children [10,11].
After publication of the 2015 JOS Guidelines, the Danish Guidelines on management of OME [12] were issued,
the US guidelines [13] were updated, and French guidelines[14] were also reported. Furthermore, an international consensus report was presented in the panel discussion during the2017 International Federation of Oto-rhino-laryngological Societies Congress, as guidelines specialists in each area of theworld met to recommend the best practices for OME management [15]. The content of the consensus report is broadly
consistent with the policies of the 2015 JOS Guidelines.
The committee preparing the 2022 JOS Guidelineschanged the criteria regarding judgment of the strength ofrecommendations according to recent advances in methodology in guidelines development. In the process of selecting theevaluation method, the committee referred to a proposal described in the MINDS Handbook for Clinical Practice Guideline Development 2014 [16] and MINDS Manual for Guideline Development 2017 [17] and ultimately decided to apply
the method recommended by the AAP [18]. This method enabled us to easily and comprehensively evaluate the qualityof evidence and place a high priority on the balance between
benefit and harm for patients when evaluating recommendations. During the process of revising the 2015 JOS Guidelines,

Fig. 2. Positional relationship between the middle ear (Eustachian tube) andthe adenoids. The adenoids are located just beside the pharyngeal orifice of
the Eustachian tube, and biofilm formation in the adenoids is responsible forthe pathogenetic mechanism of hypertrophic adenoids in otitis media with
effusion.

the committee changed some CQs and added new figures anda glossary to enhance user understanding (Figs. 1–4).
1.4.3. Value of OME guidelines
As shown in Fig. 4, findings regarding the TM and MEE inpediatric OME are diverse. The etiology and pathophysiology
are complex, and considerable inter-individual differences are

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Fig. 3. Differences of the eustachian tube in children and adults. In children, the eustachian tube is immature, shorter and more horizontal than that of adults.
Thus, dysfunction of the eustachian tube leads to less ventilation and protection of the middle ear, and therefore, infants are at increased risk of acute otitis
media and otitis media with effusion.

not always directly imply that the treatment is not effective orthat clinicians should not provide that treatment to patients.
However, it is necessary to closely assess the validity of clinical efficacy and to communicate clearly with patients andtheir guardians when applying management options that are
not included in the Guidelines. It is necessary to emphasizethat each recommendation in the Guidelines does not havelegal binding force for individual medical practice involving
patients with specific medical circumstances [19]. The 2022
JOS Guidelines will be periodically revised to reflect not only
the opinions of guideline-users and patients but also the results of external evaluations, as was done with the 2015 JOS
Guidelines.
∗
NOTE: Guideline hierarchy:
Regulations > Directives > Recommendations > Guidelines
1.5. Objective and aim of production
Fig. 4. Eardrum findings of normal ear (a) and ear with otitis media with
effusion (b-d). In otitis media with effusion, pathological conditions of the
tympanic membrane are observed, such as retraction (b), swelling (c), andthinning (d).

observed in terms of the mechanism of onset, prolongation,and recurrence of OME. In addition, there is no clear indicator
to determine to what degree lesions in the surrounding organs
affect the pathophysiology of OME in each case. We notethat the present Guidelines are based on evidence for pediatricOME in general and do not provide the best recommendations
for all individual cases.
These clinical practice guidelines are intended to support
clinical practice but are not intended to restrict the clinical judgment of individual clinicians in the management of
OME∗ . Clinicians can decide how to apply the present Guidelines to patients in various clinical settings, based on theirknowledge and experience and considering the intentions andpreferences of the children and their guardians. A lack ofsufficient evidence regarding the efficacy of a treatment does

The 2022 JOS Guidelines were produced to describe diagnostic and testing methods for childhood OME (below theage of 12 years∗ [refer to note 2]) and represent the evidencebased consensus of the members of the Subcommittee of Clinical Practice. The aim is that the present Guidelines be used
to assist clinical decision-making in the care of children with
OME and that the recommendations will prove beneficial in
the diagnosis and treatment of patients with OME.
∗NOTE 2: Pediatric OME often resolves spontaneously inthe latter half of childhood (2 years to 11 years). The numberof cases of OME is markedly reduced in adolescents (12–16
or 12–18 years). In the present Guidelines, we have used thegeneral criterion of children younger than 12 years of age.
1.6. Users and strategies for public dissemination
The present Guidelines are intended for all clinicians, including otolaryngologists and pediatricians, who engage inmedical treatment of pediatric OME. To be widely used inclinical settings, the present Guideline will be published as a

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Table 2. Subjects of the JOS 2022 Guidelines and patients not covered.
Subjects covered

Not covered• Children younger than 12 years (of either sex) with a definitive diagnosis of OME• OME with DS and all types of cleft palate• More than 3 weeks after the disappearance of symptoms of acute inflammation
Note: Indications for surgical intervention for pediatric OME in children less than 3 years old should be considered carefully.
• OME with immunodeficiency• OME with acute inflammation

booklet and on the websites of the JOS and MINDS. In theprevious 2015 JOS Guideline [10,11], the Committee published an article introducing important content. Additionally,a leaflet targeting patients and their families was publishedin 2016. The Committee will update the leaflet in the near
future.
Users themselves must determine whether the interventions noted in the Guideline are difficult to apply in consideration of their specialty area and experience. Because thepresent Guidelines includes surgical interventions generally
performed by otolaryngologists, clinicians should be prepared
to refer to specialists in case they cannot offer the recommended management options themselves, even when necessary.
For health care workers other than physicians (e.g., nurses,
laboratory technicians, speech therapists), the present guidelines are useful for learning more about pediatric OME.

1.7. Subjects
The subjects covered by as well as patients that are notcovered are listed in Table 2. The subjects of the present
guidelines are children younger than 12 years of age (of eithersex) with a definitive diagnosis of OME, including children
with DS and all types of cleft palate. In cases of post-AOM,
subjects include patients in which more than 3 weeks havepassed after the disappearance of symptoms of acute inflammation. In children less than 3 years old, AOM are more often
encountered than OME. Again, precise hearing tests are difficult to administer in these children. Therefore, indications for
surgical intervention for pediatric OME in children less than 3
years old should be considered carefully. Patients with the following conditions are excluded from the subjects covered by
the present guidelines: OME with immunodeficiency or acuteinflammation. The clinical management practices outlined in
the present guidelines cover the following three areas:
1 Clinical management with regard to diagnosis, such as
auditory functional tests (refer to Sections 2.1–2.9.)


2 Clinical management with regard to follow-up (refer to
Section 3.CQ1)

3 Clinical management regarding treatment, conservative
treatment such as medication or topical treatment, andsurgical treatment
Screening tests for OME and prevention management are
not covered by the present guidelines.

1.8. Collection of evidence
1.8.1. Document retrieval
To prepare the 1st edition of the Guideline [10,11], theCommittee contracted with a specified nonprofit corporation,
the Japan Medical Library Association support service, to cooperatively develop the medical guidelines and retrieve documents. PubMed, Ichushi Web (the website of the Japan Medical Abstracts Society), and the Cochrane Library were used.
Information was retrieved from February to April 2014 without using any retrieval expression designating period of publication time for retrieval, as that was the first edition of the
Guideline.
In preparing the present 2nd edition, a retrieval expression (refer to supplemental file indicating the formula for retrieval) was used to designate the period of publication timesince March 2014, corresponding to the retrieval period forthe 1st edition. The exceptions included newly developed CQs(3.CQ5,10. and 3.11.), where no retrieval expression wasused to designate period of time, similar to the 1st edition.
Evidence was retrieved regarding disease definition, causeof disease, disease state, complications, sequelae, methods ofdiagnosis and examination, treatments with regard to each relevant CQ, and DS and cleft palate. The retrieval expressions
used for searching PubMed and Ichushi Web consisted of keywords pertaining to diseases and primary keywords pertaining
to each theme. The target age was 0–18 years. The languagesof publications were limited to English and Japanese.
Although the Committee made it a fundamental policy not
to narrow the search results by research design or form of thesis, depending on the number of retrieved documents and on
the contents of the theme, thesis forms were limited to medical guidelines, systematic reviews, and meta-analyses, etc.
In the Cochrane Library, systematic reviews and randomized
controlled trials (RCTs) were searched using disease-specifickeywords.
In addition, for each theme, each member of the Guideline
Development Committee hand-searched through documents.
Documents were added based on collective decisions by the
Guideline Development Committee.
1.8.2. Policy for selecting documents
Based on the title and abstract of retrieved documents,
those that apparently deviated from the target theme were
excluded, and the contents of the remaining documents were
evaluated. For items concerning treatment, when the existenceof appropriate systematic reviews or meta-analyses was noted,
these were adopted as evidence, adding new RCTs publishedafter the research included in the remaining documents. When

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Table 3. Quality of evidence.
A.
B.
C.
D.
X.

Well-designed RCTs or diagnostic studies on relevant populations. [Strong evidence]
RCTs or diagnostic studies with minor limitations; overwhelmingly consistent evidence from observational studies.
[Sufficient (moderate) evidence]
Observational studies (case control and cohort design).
[Weak evidence]
Expert opinions, case reports, reasoning from first principles. [Insufficient (very weak) evidence]Exceptional situations in which validating studies could not be performed and there was a clear preponderance of benefit over harm.

neither systematic reviews nor meta-analyses were found,
RCTs were adopted as evidence, and when no systematic
reviews, meta-analyses, or RCTs were identified, non-RCTs
or observational studies (such as cohort/case-control studies)were adopted as evidence. Also with regard to items related
to treatment, the Committee made it a rule to adopt resultsof scientific investigations relating to adverse effects or complications, regardless of the level of evidence. With regard
to other items (except treatment), the Committee primarily
adopted existing systematic reviews, meta-analyses, and reviews as evidence and secondarily included epidemiologic
studies, RCTs, non-RCTs, observational studies, and basic experimental studies.

1.9. Evaluation of evidence
For each theme in the Guidelines, a 2-person subcommittee
excluded documents that deviated with regard to the condition of child patients targeted by the Guideline as mentionedin "7. Subjects" or that deviated from the theme. The Subcommittee then extracted primary information from the remaining documents and evaluated the methodological bias of
the research and developed the evidence tables. In addition,according to the above-mentioned policy for selecting documents, the Subcommittee selected documents to adopt as evidence. Each document was evaluated not only by the 2-person
Subcommittee but also by all members of the Committee.
In the process of preparing the present Guidelines, theCommittee referred to a proposal described in the MINDS
Handbook for Clinical Practice Guideline Development [20].
Specifically, we applied the method recommended by the
AAP [18] according to a previously published guideline regrading AOM [21,22], as shown in Table 3.
First, the quality of evidence was evaluated with regard to
the type of study and various factors that could reduce thequality of evidence, as follows.


1 Risk of bias (selection bias, performance bias [blindingof participants and personnel], detection bias [blindingof outcome assessors], attrition bias [against intentiontreat analysis or incomplete outcome data], selective
outcome reporting bias, early stopping bias, and otherbiases, including COIs).

2 Directness (external validity, generalizability, applicability): In the next step, studies were integrated in eachgroup with the same outcome and same study design todetermine the quality of the aggregate body of evidence.

3 Consistency (support from multiple studies).


4 Imprecision. In the case of observational studies, factors
as documented below were taken into consideration:◦ A large effect of the intervention;◦ A dose-dependent gradient;◦ Plausible confounders that reduced the effects.
Finally, the body of evidence was summarized by evaluating the strength of evidence according to the conducted
review related to each topic (Table 3). Moreover, the quality of evidence for recommendations regarding each CQ was
rated across outcomes as a summary of evidence.
1.10. Decision criteria for recommendations and degree ofrecommendation
Specifying recommendations and the degree of recommendation for each CQ is an important role that clinicians expect guidelines to play. However, considerable discussion has
focused on what factors should be taken into consideration
when adopting recommendations and when determining thedegree of recommendation. While developing CQs regarding
treatment, the Committee gathered and integrated members’
opinions regarding "what outcomes are focused on when deciding recommendations and the degree of recommendation"and extracted the following outcomes.
• Hearing• Language development• Quality of life (QOL)• Influence on school performance and daily activities• Transition to refractory otitis media with effusion (including adhesive otitis media, etc.)• Presence of ME effusion• Adverse events
When deciding recommendations for treatments, the Committee considered suggestions by Fukui and Tango (Procedure
for Clinical Practice Guideline Development, version 4.3) inthe MINDS Handbook for Clinical Practice Guideline Development 2007, 2014, and 2020 [20,23]. Moreover, the Committee referred to the GRADE concepts [24,25] and took into
consideration the following factors for judging recommendations:• Clinical applicability• Value of each patient• Evidence regarding harms and costs
The Committee finally applied the method recommended
by the AAP, following the strategies adopted by the Clinical Practice Guidelines for Acute Otitis Media–2018 update

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8

Table 4. Strength of recommendations [18,21,22].
Strong recommendation

Recommendation

OptionNo recommendation

A strong recommendation means the benefits of the recommended approach clearly exceed the harms (or that the harms
clearly exceed the benefits in the case of a strong negative recommendation), and that the quality of the supporting
evidence is excellent (grade A or B).
In some clearly identified circumstances, strong recommendations may be made when high-quality evidence is impossible
to obtain (X) and the anticipated benefits strongly outweigh the harms.
A recommendation means the benefits exceed the harms (or that the harms clearly exceed the benefits in the case of astrong negative recommendation), but the quality of evidence is not as strong (grade B or C).
In some clearly identified circumstances, strong recommendations may be made when high-quality evidence is impossible
to obtain (X) and the anticipated benefits strongly outweigh the harms.
An option means that either the quality of evidence that exists is suspect (grade D) or that well-done studies (A, B, or C)
show little clear advantage to one approach over another.
No recommendation means there is both a lack of pertinent evidence (grade D) and unclear balance between benefits andharms.

Table 5. Relationship between evidence quality and benefit-harm balance in determining the strength of a recommendation [21–23].
Evidence Quality

Preponderance ofBenefits over Harms

Balance between
Benefits and Harms

StrongRecommendation

OpinionA.

Well-designed RCTs or diagnostic studies on relevant populations

B.

RecommendationC.

RCTs or diagnostic studies with minor limitations; overwhelmingly
consistent evidence from observational studies
Observational studies (case-control and cohort design)

D.

Expert opinions, case reports, reasoning from first principles

OpinionX.

Exceptional situations in which validating studies cannot be
performed and there is a clear preponderance of benefit over harm

Recommendation(Tables 4 & 5) [21,22]. Several guidelines that used AAP
proposals to evaluate the evidence of quality and strengthof the recommendations have been published in recent years[26–29]. The AAP method, as well as the GRADE system,emphasize the balance between benefits and harms to patients
when judging the strength of a recommendation as well as theevidence quality. Moreover, strong recommendations are possible in clinical practice when the anticipated benefits strongly
outweigh the potential harms, even though the evidence may
be poor due to difficulties that prevented performance of ahigh-quality study.
These features of the AAP method fit members’ philosophy well, and the Guideline Committee reached a consensus
to use this method.
The above-mentioned recommendations were proposed by
the Guideline Committee and reviewed by the board members of Otology Japan and the Oto-Rhino-Laryngological Society of Japan. The Committee finally decided to adopt theserecommendations, and the degree of each recommendation
was ultimately decided based on discussions referring to theopinions and/or comments by the board members of Otology
Japan and the Oto-Rhino-Laryngological Society of Japan.
While the Committee attempted to maintain objectivity andtransparency in deciding these recommendations and the degree of recommendation, there is no guarantee of completeness.
With regard to revision of the present guidelines, the Committee will continue to improve the system to accept users’
opinions and suggestions regarding the recommendations andthe degree of each recommendation stated in the present
guidelines.

No recommendation

It should be noted that the Committee judged that it is notsuitable to simply apply the above-mentioned evidence levels,
recommendations, and degrees of recommendation to "Chapter 2: Diagnosis and examinations" and showed neither theevidence level nor recommendations nor the degree of recommendation for the corresponding items. Instead, the meaningand point of each diagnosis and the method of examinationand outline regarding the clinical meaning are shown.
1.11. Reviews before the release
Prior to release of the present guidelines, the Committee
asked otolaryngologists and pediatricians engaged in the treatment of OME in children and experts in preparing guidelines to carry out an external review of the draft edition of
the present guidelines. The external reviewers are listed in
Supplementary-Table A. Three reviewers were asked to review the Guideline according to Appraisal of Guidelines for
Research & Evaluation II (AGREE II), and the other two
reviewers were free to review the Guideline as they saw fit.
1.11.1. Review according to AGREE II
AGREE II is a tool managed by the AGREE Research
Foundation and used to review the quality of a guideline fromthe point of view of how strictly the guideline was developed
and how much transparency occurred in the development process (http://www.agreetrust.org). The review table consists of
6 fields, with 23 items and 2 total evaluation items. In the
6 fields/23 items, reviewers evaluate each item according to"Scope and Purpose", "Stakeholder Involvement", "Rigor ofDevelopment", "Clarity of Presentation", "Applicability", and"Editorial Independence" and give each item a score from 1

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all reviewers to each field and calculated the percentage ofthe total score relative to the highest possible score for thefield. The two reviewers’ total score in each field was as follows: Field 1 (Scope and Purpose) = 100%, Field 2 (Stakeholder Involvement) = 65.1%, Field 3 (Rigor of Development) = 81%, Field 4 (Clarity of Presentation) = 76.2%,
Field 5 (Applicability) = 61.9%, and Field 6 (Editorial Independence) = 88.1%. Finally, all three reviewers offered arecommendation of high-quality guideline.

9
4 The evidence-practice gap of each statement and reasons for the gap
In parallel with those surveys, the Committee will also
administer a questionnaire survey to patients and their family members to solicit comments about penetration, userfriendliness, reflection of patients’ perspective, and areas for
improvement.
1.13.2. Validation
To evaluate quality indicators (QIs) incorporating thepresent Guideline in clinical settings, several QIs will be administered, as follows:
1 Period between initial visit to undergoing insertion of a
tympanostomy tube


2 Whether or not hearing evaluation and/or tympanogram
was conducted, and their measuring methods

1.11.2. Review in free style
Another two external reviewers were asked to review thedraft edition of the Guideline without designating the review
method. They reviewed the accuracy of medical statements,
the validity of the interpretation of evidence, and the validityof the developed recommendations primarily from the perspectives of otorhinolaryngology and pediatrics.


3 Whether patient’s case was complicated with patholog-

1.11.3. Issues pointed out by the external reviewers, andsolutions
The Committee gathered issues pointed out by the fiveexternal reviewers and discussed how to deal with them
(Supplementary-Table B). The Committee developed the final edition of the Guideline to reflect the results of these
discussions.

The above-mentioned criteria may be improved or modified according to the future studies. The corresponding data
will be surveyed among multi-institutional collaborative studies and/or nationwide studies using a large-scale database,evaluating changes in the quality of medical procedures.

1.12. Planned updates
The Guideline is scheduled to be updated in 3–5 years.
After publication of the Guideline, work will begin on theorganization of a new Clinical Practice Guideline Subcommittee. Newly published evidence will be systematically assessed
and reviews carried out, with a Working Group established tocontribute resources for the updated Guideline. Should partial
updates to the Guideline be required, these will be publishedon the societies’ websites as appropriate.
1.13. Monitoring and validation
1.13.1. Monitoring
After the publication of this 2022 Guideline, the Committee is planning to administer a questionnaire survey to otolaryngologists, pediatricians, and general physicians. Basedon the results, we will aim to spread the use of the present
guidelines. As standards for monitoring, the following issues
will be considered:
1 Penetration and utilization of the present Guidelines
2 Utilization compared with the previous version of the
Guideline3 Adherence to each statement

ical abnormalities in surrounding organs, such as infections or inflammatory diseases

4 The type, dosage, and administration of drugs used for
medical therapy

5 The prevalence of remission or recurrence, and the rateof developing adhesive otitis media.

1.14. Recommendations and explanation of reasons
The present Guidelines was formulated for all physicians
who treat childhood OME, including otolaryngologists andpediatricians as users, but it is also expected to be useful asa reference in all situations in which clinical judgments are
made concerning the diagnosis and treatment of childhood
OME by all medical professionals involved in the treatmentof this condition in a wide variety of clinical settings. The
specific relationships between recommendations and the literature on which they are based are described in each sectionof the Guideline. It must again be emphasized that the recommendation grades indicated in the present Guidelines do notconstitute an alternative to the judgment of an experienced
medical practitioner but are only provided to assist his or her
decision-making.
1.15. Patients’ wishes
In the process of formulating the recommendations in thepresent Guideline, the wishes of patients or their parents or
guardians were considered. The benefits and risks of doing
so were also taken into consideration. An important issue
to be noted when dealing with individual patients in clinical situations is that applying the recommendations without
exception in every case is to miss what is important in lightof the spirit of the Guideline as an aid to decision-making

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10in actual clinical situations. Again, it must be emphasizedthat decision-making in actual clinical situations must always
be carried out by taking into account the evidence and recommendations contained in the Guideline and elsewhere, theexperience and specialist knowledge of the medical practitioner, and the wishes and values of the patient and his or
her parents or guardians. Future revisions of the Guideline
will consider efforts to reflect the wishes of patients and theirparents and guardians to a greater extent.
1.16. Algorithms
The generally recommended algorithms for patients without risk factors for intractable disease are included in Fig. 5(also, refer to Chapter 3).
1.17. Practical consideration
In the present Guideline, medications and instruments are
essentially referred to by their generic names rather thanbrand names. The reasons for this include concerns that it
would be unfair to refer only to selected products by name in
the Guideline as well as the strong influence of expert opinion. In addition to which all generic products are fully included, and updating this information to include brand names
would pose too great a burden on the Clinical Practice Guideline Subcommittee. For this reason, we advise the preparation of clinical paths or manuals that take into accountthe status of medications used and other specific attributes
of individual facilities to enable the smooth acceptance ofFig. 5. Tympanogram. Tympanogram of type A in a normal ear, as the pressure in the middle ear cavity is equal to the pressure in the external auditory
canal, and the mobility of the eardrum and ossicles is normal. In otitis media
with effusion, however, the pressure in the middle ear becomes negative, andthe tympanogram shows no peak (type B) or a negatively shifted peak (typeC). On the boundary of 200 mm, the type C tympanogram is subdivided into
type C1, in which the peak is located on the positive-pressure side, and typeC2, in which the peak is located on the negative-pressure side.
∗ : At 25-30 dB, TS tube insertion may be performed, but indications should
be considered more carefully (refer to 3.CQ6). ∗∗ : Pathological changes inthe tympanic membrane that require TS tube insertion are as follows: severe
retraction in the pars tensa or flaccida of the tympanic membrane, destructionof the ossicles, and adhesive retraction of the tympanic membrane (refer toTable 6).

the recommendations in the Guideline in actual clinicalsettings.
1.18. Definition of OME in children (Table 6)
In the present Guidelines, OME is defined as follows: Otitis media with ME effusion without TM perforation, whichcauses hearing loss. In addition, OME lacks signs of acute

Table 6. Definitions of terms.
Otitis media with effusion (OME) This is a condition in which there is fluid in the ME without acute inflammation: "otitis media without perforationof the tympanic membrane (TM), resulting in fluid in the ME cavity and causing hearing loss, but without acuteinflammatory symptoms, i.e., otalgia or fever" (refer to Sections 1.4. and 1.19). The term OME can also betranslated as serous/secretory otitis media in English.
Acute otitis media (AOM)
An acute infection of the ME accompanied by otalgia, fever, and otorrhea (refer to Section 1.4).
Middle-ear effusion/fluid
Pathological changes in the TM

TM atelectasis
Adhesive otitis media

Conductive hearing loss
Sensorineural hearing loss
Adenoids

Nasal and paranasal sinuses
Pneumatic otoscope
Tympanometry

Fluid collection in the ME behind the TM for some reason, such as inflammation. It may also be present in acuteotitis media and may persist for weeks or months after the symptoms have resolved (refer to Section 1.19).
Pathological conditions affecting the TM, such as severe retraction of the TM at the pars flaccida or tensa,
destruction of the ossicles, thinning of the TM (phimosis), tympanosclerosis, or severe retraction in the TM thatcauses it to adhere to the promontory (refer to Sections 1.20. and 3.11).
A pathological change in the TM, particularly involving thinning and adhesion to the walls of the tympanic
chamber, called atelectatic TM (refer to Sections 1.20 and 3.11).
This is a condition in which the TM becomes immobile due to adhesion to the promontory or the ossicles, which
is often associated with the presence of prolonged otitis media and functional or organic disturbance of the ET(refer to Sections 1.20 and 3.11).
Caused by a disturbance in the process of sound transmission, often due to a disorder of the external auditory canalor ME, such as cerumen or OME.
Caused by a disturbance in the process of perceiving sound, often due to a disorder of the inner ear, such as
age-related hearing loss.
Also known as pharyngeal tonsils, these are part of the same tonsillar tissue as the palatine tonsils. They are locatedin the nasopharynx near the nasopharyngeal orifice of the ET (behind the nasal cavity). The adenoids are thought tobe the site of bacterial infection and are involved in the development of OME (refer to Sections 2.7 and 3. CQ9).
A general term for the nasal cavity and the paranasal sinuses (which include the maxillary, ethmoid, sphenoid, andfrontal sinuses) (refer to Sections 2.7. and 3. CQ2–4).
Similar to tympanometry, an otoscope is used to observe the movement of the TM while changing the pressure in
the external auditory canal (refer to Section 2.3).
A device that pressurizes and decompresses the sealed external auditory canal to check the TM’s mobility and theME’s condition. The results are called a tympanogram (Fig. 5, Section 2.5).

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inflammation of the ear, such as otalgia and fever. In the US
Guideline, "Clinical Practice Guideline: Otitis Media with Effusion” [6], OME is defined as fluid in the ME without signs
or symptoms of acute ear infection.
OME is classified into three stages: (1) acute phase: within
3 weeks after onset, (2) subacute phase: between 4 weeks and3 months, (3) chronic phase: more than 3 months after onset[30]. The differential diagnosis between AOM and OME isvery important. In the Guideline "The Management of Acute
Otitis Media in Children" in Japan, AOM is defined as follows: AOM is an acute inflammation of the ME, accompanied by otalgia, fever, and otorrhea [21,22]. It is sometimes
difficult to diagnose OME and AOM via otoscopic findings,
particularly in young children. Therefore, symptoms such as
fever, crying at night, and emotional upset are critical signs
to diagnose AOM.
Persistent ME effusion is frequently found in children after
resolution of acute inflammation in AOM. In a meta-analysisof 7 articles regarding the natural course of AOM, MEE wasfound in 41% at 4 weeks and 25% at 12 weeks after onset of
AOM [31]. In addition, in cases involving administration of
antibiotics, MEE was found in 45% at 4–6 weeks and 21%
at 3 months after onset [5]. Therefore, persistent MEE after
AOM in the subacute and chronic phases is also included in
the category of OME.
A summary of terms related to the present Guidelines isprovided in Table 6.
1.19. Pathogenesis of OME in children
The main feature of the pathogenesis of OME in children
has long been considered the hydrops ex vacuo theory: theproduction of inflammatory exudate and negative ME pressure
due to the stenosis or obstruction of the ET. However, infection is now considered a primary cause of the formation of
OME, similar to AOM. The pathogens associated with OME
are the same as those in AOM. Immune complexes, endotoxins, viruses (rhinovirus and respiratory syncytial virus), andbacteria (Streptococcus pneumonia, Haemophilus influenzae,and Moraxella catarrhalis) have been detected in MEEs frompatients with OME [32–35]. OME occurs directly after AOM
in approximately 50% of children, although OME can also
occur in the absence of previous AOM [35].
In the presence of ET dysfunction, the ME pressure becomes gradually negative. As a result, a prolonged pathological state in which both negative pressure and fluid retention coexist in the ME is established. Thus, tubal dysfunction
plays an important role in the prolongation of the pathologicalstate of OME [36]. In contrast, ET closing dysfunction, whichsounds rather opposite to the pathogenesis of OME, has been
detected in some patients with OME, especially in intractablecases [36–43]. These patients obtain temporary relief from theaural symptoms by sniffing, because sniffing closes the patulous ET, but it seems to be related to susceptibility to OME
by creating negative ME pressure and/or enabling infection
through the ET [36,43].
The risk factors of OME in children are quite varied: cleft
palate, craniofacial abnormality, DS, hypertrophy of adenoids,

11

upper respiratory tract infection, and rhinosinusitis. As to thepathogenetic mechanism of hypertrophic adenoids in OME,
biofilm formation in the adenoids is responsible more than themechanical obstruction of the ET [44]. With regard to allergic
rhinitis, allergic inflammation of the mucosa is more likely tobe related to the pathogenesis of OME than to the mechanicalinfluence of nasal mucosal swelling [45]. The prevalence ofallergic rhinitis among children with OME is approximately
5 times greater than that among non-affected children. Thereis insufficient evidence on gastroesophageal reflux disease inchildren with OME from previous reports of meta-analyses,
but its incidence in children with OME is considered to behigher than in normal children [46]. In addition, the following
factors are reportedly related to the intractability of OME inchildren: immunodeficiency, use of pacifiers [47] and artificial
milk [48], poor social environment, numerous opportunities tocome in contact with other children [49], and passive smoking
exposure.
Considering the high incidence of recurrent AOM with
OME in young children under the age of 3 years, we describe several important points in determining the surgicaltreatment of these patients (refer to Addendum). For children between the ages of 3 and 9 years, the focus should beon management to improve hearing loss due to MEE, whereas
for children over 10 years of age, the focus should be on theprevention of morbid changes in the TM and intractable otitis
media, including adhesive otitis media (refer to Section 3.11).
 Addendum: Management of OME in younger children(under 3 years old)
As previously mentioned above in “Definition of OME”,
differential diagnosis from AOM is important in the diagnosis of OME. Differential diagnosis from AOM or from prolonged MEE after AOM is sometimes difficult based only
on TM findings as well as the precise evaluation of hearing
level in children, especially at younger ages. Moreover, treatment for AOM rather than OME is sometimes necessary inyounger children, because young age is a risk factor for recurrent otitis media. Therefore, physicians should be careful
in determining the indications for surgery to treat OME inchildren under the age of 3 years. Surgery should not necessarily be recommended in children of this age with only MEE
but instead recommended for those with obvious hearing impairment or severe pathological changes in the TM (refer to
Section 3 CQ5–10).
Moreover, a differential diagnosis should address the possibility of causes of hearing loss other than OME when children
have more than a moderate degree of hearing loss. Particularly in cases where the coexistence of other diseases suchas congenital cholesteatoma or sensorineural hearing loss issuspected, drainage of MEE through surgery should be considered during differential diagnosis.
1.20. Complications and sequelae of OME
The main goals of interventions to treat pediatric OME
should focus on preventing hearing impairment attributed to
MEE and irreversible changes in the ME. Although OME

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persists in only 5% of children, suggesting a high incidenceof spontaneous remission, it also carries risks for additional
disorders or structural changes in the TM or ME, including
atelectatic TM, adhesive otitis media, tympanosclerosis, ossicular fixation, and cholesteatoma [50,51].
In cases of persistent OME, surgical interventions suchas TS tube insertion are usually considered. However, evenafter TS tube insertion, some complications and developmental sequelae should be considered in some patients.
Specifically, TM calcification is a common complication, followed by persistent TM perforation and cholesteatoma formation [50,51]. Considering the relatively higher prevalenceof spontaneous remission, a benefits-harms assessment (preponderance of harm over benefit) of proposed medical treatment should be mandatory in the management of pediatricOME.
1.20.1. Atrophic TM, atelectatic TM, and adhesive otitis
media(Refer to Fig. 4 and Section 3.11).
Long-term inflammatory sequelae of OME can lead to thedisappearance of the organized collagenous layer of the TM,
deteriorating its elasticity and stiffness [52,53]. Some chemical mediators of MEE have been found to play roles in thesepathological changes [54,55]. Congenital vulnerabilities in the
TM have also been reported as pathogenic factors [56].
On the other hand, segmental atrophy of the TM is a common morphologic and functional disorder associated with TS
tube insertion. The prevalence of segmental atrophy ranges
from 16 to 75% in ears with a history of TS tube insertion,
whereas it lies between 3 and 31% in ears without such history [50]. A prospective, randomized clinical trial reported
an estimated risk ratio of developing segmental atrophy inoperated ears of 17.4 [57].
Segmental atrophy would not manifest as a complication inears with normal ventilation and/or pressure-regulating functions of the ME. However, segmental atrophy may contributeto more serious complications, including adhesive otitis media and cholesteatoma, specifically in conditions such as laterecovery or long-term ET dysfunction. The latter contributes
to sniffing habits and may induce formation of a retraction
pocket predisposed from the segmental atrophic area, in turnleading to development of adhesive otitis media or acquiredcholesteatoma.
Atelectatic TM is defined as a ME condition in which
the atrophic TM touches the incudo-stapedial joint and/or
the promontrium of the ME (refer to Section 3.11). Regarding low-grade atelectatic TM, surgical intervention is
not recommended for the following reasons: (1) low risk(<2%) of developing cholesteatoma, (2) small chance ofworsening the patient’s hearing, and (3) a good chance of
spontaneous remission or at least long-term stability of thedisease [58].
Conversely, adhesive otitis media results from long-lasting
and/or acute inflammatory ME disease complicated by thedisappearance of mucosal layers covering the inner layer of
the TM and the medial wall of the tympanum. The TM ad-

heres partially or totally to the medial wall of the tympanum(refer to Fig. 4) [33,53,59]. In describing such a condition,
several reports have advocated surgical interventions becauseof the higher risk of developing acquired cholesteatoma orinterrupting the ossicular chain [59,61–63]. Specifically foradhesive otitis media in pediatric patients, the degree of adhesion or retraction is usually milder than in adult patients.
Therefore, several reports have recommended tympanoplasty
to interfere effectively before deleterious and irreversible adhesive changes have set in [64,65].
1.20.2. Myringosclerosis
Myringosclerosis represents a formation of sclerotic
plaques in the TM. While myringosclerosis has been attributed to sub-epithelial hyalinization of the ME mucosa following an inflammatory process, current data indicate thattissue trauma caused by TS tube insertion is possibly a key
factor contributing to formation. Indeed, the prevalence of
myringosclerosis is much higher in TMs with a history of TS
tube insertion than those without such history (39-65% vs.
0-10%) [50]. Sclerotic plaques are also more frequent in ears
that have had several tube insertions compared with a single
insertion [50].
Despite its frequent occurrence, myringosclerosis rarely
develops into sclerotic changes of the ossicle, and the impact
on hearing is not significant, as it does not usually exceed 0.5
dB [50]. Observational follow-ups are thus recommended incases with a mild air-bone gap in hearing tests.
1.20.3. ME cholesteatoma
Formation of cholesteatoma is the most serious sequelae
and/or complication of pediatric OME. However, the prevalence of cholesteatoma is reportedly less than 1% [66]. The
above-mentioned segmental atrophy and retraction of the TM
would presumably contribute to the pathogenesis. Preventing
these conditions has been a goal of treatment for OME. However, the role of TS tube insertion in preventing the development of cholesteatoma has yet to be determined. Only a few
recent studies have reported the influence of the procedureon the formation of cholesteatoma by comparing the prevalence of cholesteatoma surgery before and after the use of aventilation tube. These studies concluded that the number ofoperations declined after the induction of TS tube insertion,
but they also reported that other factors might be responsible
for the decline in surgery for cholesteatoma [67,68]. Other
population-based retrospective large cohort studies showedthat the rate of development of cholesteatoma increases 10%
for each additional year in age before the first ventilation
tube insertion [69]. These results indicate that early prompt
surgical intervention, including TS tube insertion, is helpful for preventing cholesteatoma, specifically for cases inwhich the development of ET dysfunction is difficult toanticipate.
Conversely, cholesteatoma formation following tube insertion has been reported, and this issue is addressed below (refer
to Section 3 CQ7, Addendum 2).

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Chapter 2. Diagnosis and examinations
2.1. Is it necessary to ask for a patient’s history todiagnosis OME?
It is useful to ask for a background and the history ofa patient to understand the risk factors for prolongation anddegree of OME and to predict the possibility of refractorydisease.
2.1.1. BackgroundOME is seen mostly in infants. The staging and pathological condition of OME are marked by considerable change
and affected by diseases and function of the ME, ET anddiseases affecting surrounding organs. It is useful to ask thepatient (or patient’s parent or guardian) about the presence ofdisease and function of the ME, ear canal, and surroundingorgans, as this will facilitate examination of the etiology andmay be useful in the treatment of OME. Also, OME patients
may have various long-term risk factors that could provide
valuable data for analysis and consideration.
2.1.2. Commentary
The Eustachian tubes (ET) are sites of OME in childhood.
Rhinosinusitis and adenoids also affect the pathology of OME
and function of the ear tubes. Therefore, medical staff should
ask about the presence of rhinosinusitis and adenoids. The
purpose of the interview is as follows (Table 7):(1) Estimate the onset of OME;
(2) Estimate the risk factors of OME;
(3) Estimate intractable risk factors of OME.
It has been reported that the course of otitis media is related to the age of the first AOM episode and the history of

13

AOM. The interview assessing the history of AOM is also
important for the management of OME [10,70,71]. However,
it is not possible to make a diagnosis of OME only by interview. The questionnaire for a child with OME is shown in
Table 7.
2.2. What TM findings aid in the diagnosis of OME?
2.2.1. Background
Although it is sometimes difficult to differentiate between
OME and AOM based on TM findings alone, ME effusion
without acute inflammatory symptoms (e.g., otalgia and fever)is seen in OME. Detailed observation of the TM is important
to definitively diagnose OME [6,23,72,73].
2.2.2. Commentary
In a patient without signs of acute inflammation, a diagnosis of OME is made when the TM findings described below
are observed:
1 Presence of MEE: MEE sometimes fills the entire ME
cavity, and bubbles and effusion lines are sometimesseen.

2 Color of MEE: a yellow or brownish-red color of theeffusion is observed most often. Blackish-brown MEE
can also be observed, although this is seen at a low
frequency.

3 Thickness of the TM and buckling: various findings canbe observed, such as thinning, thickening, calcification,and partial adhesion of the TM.
The nature of the MEE in this disease varies but is largely
classified into 3 types: serous, viscous, and mucopurulent.
Retraction, bulging, or opacity of the membrane, diminishedor absent light reflex, presence of MEE (e.g., presence ofTable 7. Objectives and details of questionnaire for a child with OME.
Purpose of questionnaire
1) Estimate the onset of OME
2) Estimate the risk factors of OME
3) Estimate intractable risk factors of OME
Questionnaire item
1. Family history (parents and siblings, presence or absence of the following diseases)
1) Ear diseases (long-term morbidity and/or surgical history of OME, chronic otitis media including the ME cholesteatoma)2) Allergies (allergic rhinitis, including hay fever, bronchial asthma, atopic dermatitis, or food allergies)
3) Chronic rhinosinusitis (including surgical history)4) Cleft palate (including the soft palate cleft)
5) Adenoids or tonsils surgical history
2. Disease, morbidity and treatment history1) Allergies (allergic rhinitis, including hay fever, bronchial asthma, atopic dermatitis, or food allergies)
2) Acute otitis media (recurrent or intractable, initial onset, history of treatment)
3) Past treatment for OME
4) Gastroesophageal reflux disease5) Cleft palate (including the soft palate cleft)
6) Systemic disease (such as chromosomal abnormalities, craniofacial developmental abnormalities, or metabolic abnormalities)
3. Growth and life history
1) Day care (age when first started attending a nursery)2) Smoking by family members
4. Questionnaire for estimating the onset of OME
1) OME-related diseases (rhinosinusitis, acute otitis media, upper respiratory inflammation, allergic rhinitis, others)2) Symptoms corresponding to OME (hearing loss, asking to repeat many times, touching one’s ear, shaking one’s head, cocking one’s
head to the side to listen more closely, slow development of language, abnormal pronunciation)

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bubbles and gas or a liquid phase), variously colored MEE,
etc., can be observed on examination of the TM in cases of
OME. Furthermore, diminished or reduced mobility of the
TM can be confirmed with a pneumatic otoscope.
In the examination of patients with OME, it is desirable
to observe the TM in detail using an operating microscope,otoendoscope, or pneumatic otoscope# . In observation of theTM, the positions of the tense and flaccid parts of the TM, andthe color, transparency, mobility, and thinning/thickening of
the TM are examined. Furthermore, the examiner also looks
through the TM to check for MEE behind the TM and to
estimate its nature and amount.
#“Pneumatic otoscope” as referred to in the text collectively represents a conventional pneumatic otoscope usedwith an operating microscope, pneumatic magnifying otoscope (magnifying otoscope with a pneumatic attachment),
and pneumatic otoendoscope (otoendoscope with a pneumatic
attachment).
2.3. Is pneumatic otoscopy useful for observation of thepathological condition of OME?
Diagnosis of OME in children is made when effusion ispresent in the middle ear cavity in the absence of acute inflammatory findings.
Visual inspection of the TM via pneumatic otoscopy is
the first examination performed to diagnose OME in children(check for MEE).
2.3.1. BackgroundA pneumatic otoscope is used to observe the mobility of
the TM by compressing and decompressing the external auditory canal. An otoscope is usually utilized along with a pneumatic device. When an operating microscope is used instead,an otoscope without a magnifying lens is employed.
2.3.2. Commentary
Visual inspection via pneumatic otoscopy is the first examination performed to diagnose OME in children, and this isperformed before tympanometry. Use of both examinations
improves the diagnostic accuracy. Pneumatic otoscopy can
detect abnormal TM findings, enabling the differentiation of
OME from AOM [74,75].
A systematic review of 52 articles regarding different diagnostic methods for OME in children (including myringotomy[refer to Section 3 CQ5], pneumatic otoscopy, tympanometry, etc.) revealed the highest diagnostic accuracy for pneumatic otoscopy, with a sensitivity of 93.8% and specificityof 80.5% [76]. Although the diagnosis can be affected by
the level of examiner experience, the reported correct diagnosis rate for OME in children aged 1 to 3 years by experienced examiners using pneumatic otoscopy is 70 to 79% [77].
An RCT conducted by Al-Khatib et al., in which 29 pediatric residents watched pneumatic otoscopy and otoendoscopy
videos to learn to diagnose OME found that the rate of correct OME diagnosis was significantly higher in the pneumatic
otoscopy group (91%) than the otoendoscopy group (78%)(p = 0.0003). Pneumatic otoscopy, which allows examinationof the mobility of the TM, is a useful tool for the accurate
diagnosis of OME [78]. In addition, it has been reported thatpneumatic otoscopy is particularly useful for the diagnosis ofrefractory or persistent OME, because loss of TM mobility
is highly correlated with filling of the entire ME cavity with
effusion in cases of OME; thus, pneumatic otoscopy could
serve as a guide for surgical treatment [79].
2.4. Is pure-tone audiometry useful for diagnosing OME?
Pure-tone audiometry is an examination for diagnosing theseverity and type of hearing loss, and it is also performed
when confirming hearing loss before and after TS tube insertion, determining surgical indications, and testing for thepresence of sensorineural hearing loss.
2.4.1. BackgroundAn age-appropriate audiometric test should be performed
before TS tube insertion when OME in children persists andthere is obvious hearing loss, as well as when delayed language development is observed.
2.4.2. Commentary
The tympanostomy tube guidelines of the American
Academy of Otolaryngology-Head and Neck Surgery recommend performing an age-appropriate audiometric test before
TS tube insertion when OME has persisted for ≥3 months[9,13]. An audiometric test is also necessary when delayed
language development is seen in children, when there is alearning disorder problem, or when clear hearing loss is suspected. Pure-tone audiometry is performed to measure air
and bone conduction [73]. Ungkanont et al. performed pneumatic otoscopy examinations and hearing tests in 63 casesof OME in children and reported an average hearing loss of
31.7 ± 10.3 dB in 92.1% of the examined cohort. Specifically,
the threshold had increased 7.2 dB in cases in which the TM
was thickened and opacified and 5.1 dB in cases in which
the TM had retracted. The authors advised performance ofan audiometric test, especially when TM status is poor [80].
In addition, improvements in hearing acuity after treatment
should be evaluated by pure-tone audiometry.
 NoteIn children ≤4 years of age, conditioned auditory response audiometry (COR) or play audiometry are performed
as needed instead of pure-tone audiometry [75,77].
2.5. Is tympanometry useful for diagnosing OME?
After OME in children has been diagnosed by otomicroscopy, otoendoscopy, pneumatic otoscopy, etc., tympanometry may be used to confirm MEE.
2.5.1. BackgroundTympanometry measures changes in the compliance of the
TM and ME by changing the air pressure in the external

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auditory canal after it has been sealed shut. It is a reliable
test to identify the presence of MEE in the tympanic cavity.
2.5.2. Commentary
Type B tympanograms indicate the presence of MEE underconditions in which TM mobility is reduced (Fig. 6). Type C
tympanograms are associated with severe negative pressure in
the ME and a severely retracted state of the TM [74]. In a systematic review that assessed 52 studies comparing methods ofdiagnosing OME by myringotomy and otoscopy, tympanometry, etc., the sensitivity of diagnosing OME with type B andtype C2 tympanograms was 93.8%, and the specificity was
61.8% [76]. The diagnostic accuracy of tympanometry improves when performed simultaneously with pneumatic otoscopy.
According to a study in which high-resolution computed
tomography (CT) and tympanometry were performed in 51
ears affected by OME, MEE was observed by CT in 94%
of the ears with type B tympanograms. Ears with type C2
tympanograms were divided into two groups based on thepresence/absence of MEE. No MEE was observed with type
A or type C1 tympanograms [81].
NoteBecause the external auditory canal cartilage of infants is
soft, it is impossible to accurately diagnose MEE using 226Hz tympanometry [82]. A study in newborn infants using
otomicroscopy and 226-Hz and 1000-Hz tympanometry reported that 1000-Hz tympanometry was particularly reliable
at and below 9 months of age; thus, 1000-Hz tympanometry[mNS;February 26, 2023;0:41]
15

was recommended in these patients [83]. In Japan, 226-Hz
tympanometry is commonly used, whereas 678-Hz and 1000Hz tympanometry are also used in newborn infants in Westerncountries.
In terms of multi-frequency tympanometry (MFT), refer to
Chapter 5, which addresses future prospects for improving
diagnostic techniques.
2.6. Is otoacoustic emission (OAE) useful for the diagnosisof hearing loss with OME?
OAE reflects the functions of the inner ear, especially outerhair cells, and it is therefore a useful tool for evaluating thedegree of inner ear damage and hearing loss.
2.6.1. Background
Evaluation of the level of hearing loss is important in determining the treatment strategy for infant OME. It is sometimes
difficult to evaluate the precise hearing level in infants andchildren. Therefore, an objective hearing test such as an auditory brain-stem response (ABR) and/or an auditory steadystate evoked response test is often needed.
2.6.2. Commentary
Evoked OAE, which is induced within the inner ear
via sound stimulation, is divided into two types. Transiently evoked otoacoustic emission (TEOAE) is evoked bya click (broad frequency range) or tone burst (brief duration
pure tone) stimulus. Distortion product otoacoustic emission(DPOAE) is evoked by a pair of primary tones (f1 and f2)

Fig. 6. Treatment algorithm for otitis media with effusion in children. For conservative treatment, please refer to the following: 3.CQ2: Antibiotics, 3.CQ3:
Other medication, 3.CQ4: Conservative treatment other than medications. Follow-up should be performed at least once every 3 months until the tympanic
cavity is aerated and the eardrum findings and hearing are normalized. Indications for adenoidectomy are described in 3.CQ9. Indications for unilateral otitis
media with effusion are described in 3.CQ10.

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with a particular intensity and ratio. OAE is a useful objective
hearing test that can be done noninvasively in a short time,even in children. However, there are several disadvantages
to OAE. For example, OAE cannot be detected in the caseof external auditory canal lesions, earwax plugs, retrocochlear
hearing loss, or hypertrophy hypoplasia of the cochlear nerve.
It should also be noted that OAE in the low tones is noisy
for neonates or infants.
Several reports have described the use of OAE as a screening tool. Yilimaz et al. compared the results of OAE tests
in 116 cases, discriminating between those with and without OME in patients ranging from 15 to 25 years in age.
They found that OAE could be used to detect irreversible
damage to the ME or cochlea caused by otitis media [84].
Another study, which used TEOAE as a screening tool in
116 school children, reported 100% sensitivity in diagnosing
hearing loss >30 dB and 90% sensitivity and 64% specificity in diagnosing hearing loss >25 dB [85]. Balatsouras
et al. evaluated TEOAE in the diagnosis of OME as comparedwith tympanometry in 38 children (76 ears) with bilateral otitis media and reported that TEOAE was absent in 51 ears
(67%) and diminished in the remaining 25 ears (33%) [86].
Thus, TEOAE was recommended as an objective diagnostic
tool for OME when used in conjunction with tympanometry[86,87]. By comparing the results of pure-tone audiometry
and TEOAE tests in young children with OME prior to andafter TS tube insertion, a high correlation was found between
tests; thus, OAE was considered the method of choice forhearing screening [88–90].
Note
In Japan, OAE is approved only for the evaluation of innerear function. Its use in OME children is recommended only
when inner ear damage is suspected.
2.7. Are findings regarding peripheral organs (paranasal
sinuses and epipharynx) helpful in understanding theclinical condition of OME?
To understand diseases that are considered related to OME
in children, findings regarding peripheral organs (paranasal sinuses and epipharynx) are helpful. In a clinical setting, thephysician asks a subject (or parent/guardian) regarding the patient’s nasal symptoms, the extent of mouth breathing, snoring and sleep apnea at nighttime, and seasonal or perennial
rhinitis symptoms. This is followed by observation of the patient’s nasal cavity, oral cavity, and pharynx. Further tests
should only be conducted after considering the balance between reasons for conducting the tests and invasiveness andcosts.
2.7.1. Background:
OME in children is often associated with rhinosinusitis,
allergic rhinitis, and adenoid hypertrophy. These diseases candirectly or indirectly contribute to the clinical condition of
OME.

2.7.2. Commentary:a) Rhinosinusitis
The complication rate of rhinosinusitis associated with
OME in children in Japan prior to the 21st century was reportedly 70-80% [91] and 25-60% outside Japan [92–94]. Several
factors affect how rhinosinusitis contributes to OME in children. In a bacteriological examination of 32 OME cases inchildren associated with chronic rhinosinusitis, 69% of bacteria taken from MEEs and aspirates taken from the maxillarysinus matched, suggesting that rhinosinusitis is the infection
source via the ET [95]. In pediatric patients with OME, it
has been shown that the mucociliary function of the nasal
cavity/pharyngeal orifice of the auditory tube is significantly
lower than that of healthy subjects, indicating that rhinosinusitis may give additive effects [96,97]. In addition, occlusion of the pharyngeal orifice of the auditory tube due topostnasal discharge and sniffing are also suspected as playing a role [98]. In terms of the efficacy of drugs used fortreating rhinosinusitis in children with OME, please refer to
Sections 3.2–3.4.
b) Allergic rhinitis
The complication rate of allergic rhinitis associated with
OME in children is reportedly 24-89% [99,100]. Some reports
indicate an epidemiologic link between OME in children
and allergic rhinitis, but other reports do not [45,101,102].
Clinical studies of nasal provocation tests using mites inperennial allergic rhinitis patients showed occlusion of the
ET in 55% of ears [103]. Both Th1-type and Th2-type
cytokines have been detected in MEEs of OME patients, but
IL-4 concentrations are significantly higher in OME patientswith allergic rhinitis than OME patients without allergic
rhinitis. This indicates that IL-4 concentration affects mucin
production in the ME cavity [104].
With respect to atopic factors underlying allergic rhinitis(i.e., patients have been sensitized to inhalant allergens), it has
been shown that the numbers of eosinophils, T cells, IL-4–
positive cells, and IL-5–positive cells invading the mucosa of
the pharyngeal orifice of the auditory tube are significantly
higher in atopic patients than non-atopic patients [105]. In
allergic rhinitis patients, mucosal edema, mucus production,and ciliary dyskinesia on the ET are thought to be caused byeither the allergens themselves inducing inflammation of themucosa of the ET via IgE or by cytokines and other mediators
produced on the nasal mucosa that affect the mucosa of theET [100]. For a discussion of the efficacy of allergic rhinitis
drugs in children with OME, please refer to Section 3.3.
c) Adenoid hypertrophy
Adenoids usually enlarge physiologically in early childhood, and most studies have failed to show any relationshipbetween OME in children and the size of the adenoids [106–109]. However, some recent reports showed a tendency oflarger adenoids in pediatric patients with OME than children
with healthy ears [110,111]. Most studies have shown that
almost the same bacteria and endotoxins are found in MEEs
and adenoids [112–116]. However, 16S rRNA phylogenetic

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analyses showed that the bacteria detected in MEEs and adenoids are different [117–119]. In children with OME, reports
indicate that collapse of the mucosal barrier on the adenoid
surface, biofilm formation, a decrease in normal flora on theepipharynx, and other factors may have a relationship with
OME [120–122]. No evidence indicating that adenoids compress the ET and inhibit its permeability was found in a comparison of ET function before and after adenoidectomy; therefore, adenoids are thought to affect the clinical condition of
OME as the source of infection/inflammation of the epipharynx [123]. For a discussion of adenoidectomy with regard tosurgical treatment, please refer to Section 3.9.
Current data indicate that diseases associated with peripheral organs are related to OME in children and can affectthe pathogenesis of OME. The clinical condition of OME
in children is complex, and there are large individual differences in terms of mechanism of onset, prolongation, relapse,
and intractability. Therefore, findings regarding peripheral organs are important for understanding the clinical condition of
OME in each case.
2.8. Are language development tests (articulation tests,
development tests) useful for determining the pathology of
OME?
There is a relationship between a child’s language development and hearing loss, cognition, and social development.
After a diagnosis of OME in a child, language development
tests are performed when delayed language development or
an articulation disorder is suspected.
2.8.1. BackgroundOME in children affects speech and language development,
intelligence, attention at school, activity at school, manual
skills, and social behavior. However, OME particularly affects
the speech and language development in young children up
to 47 months of age [124].
2.8.2. Commentary
A meta-analysis examining 11 papers published between
1996 and 2002 did not show any clear associations between
OME in preschool children and vocabulary, syntax, or speech
development, but the study did find negative correlations between OME and receptive and expressive language. Negative correlations between hearing loss due to OME in infancy and receptive and expressive language have also beenreported [125]. Majerus et al. assessed language development
at 8 years of age in 20 children with OME that had persisted
for at least 3 months by 3 years of age, comparing these children with 20 control children with no history of OME. They
reported that verbal short-term memory and new-word learning ability were not affected by OME based on assessment oflanguage skills at 8 years of age [126]. Another study that assessed word recognition thresholds categorized by age in children with and without OME reported an increase in thresholdof 4-5 dB in children with unilateral OME and 15 dB in children with bilateral OME. Specifically, OME affected the word

17

recognition threshold in children 31 months and 43 months ofage. OME that starts early and persists has a greater impact
on word recognition [127]. However, the authors of that study
also reported that OME had no clear impact on word recognition and no long-term impact in children 61 months of age
who had a type A tympanogram [127]. These reports showedthat although OME in children affects language development
in infancy, there are no differences in language developmentby the time the children reach school age.
Language development tests include the PictureVocabulary Test-Revised, National Rehabilitation Centerfor the Disabled’s Test for Language-Retarded Children,
the TK-style Language Development Diagnostic Test, Kyoto
Scale of Psychological Development 2001 Version, Enjoji
Scale for Infant Analytical Development Test, the TsumoriInage Infant Mental Development Test, and the Denver
Developmental Screening Test II. These tests are selectedbased on patient age and symptoms.
2.9. Is it useful to perform imaging studies to diagnose
OME?
The onset and prognosis of OME is related to the development of mastoid cells. Imaging of the temporal bone is thus
useful for estimating the development of mastoid cells.
2.9.1. Background
Development of the temporal bone is reportedly related
to susceptibility and prognosis of OME. The status of ME
ventilation is also related to the development of mastoid cells.
The prognosis of OME is related to the degree of mastoid cell
development. Imaging of the temporal bone is thus useful for
estimating the severity and prognosis of OME.
2.9.2. Commentary
Aoki et al. (1989) reported that a child with good development of mastoid cells was unlikely to suffer from OME but
could easily heal even if the child did develop OME [128]. In
addition, Ando (1992) and Takahashi (1986) reported that theincidence of inflammatory disease of the ear and the prognosis of ear disease were correlated with the development of
mastoid cells [129,130].
Takahashi (1998, 2017) reported that ears with good gas
exchange function have significantly better development of
mastoid cells [131,132]. Therefore, it is useful to check thedevelopment of mastoid cells in imaging studies to assess
the pathology of OME and its prognosis in children. Several
methods are useful for diagnostic imaging, such as simple Xray, CT, and magnetic resonance imaging [133]. Considering
the influence of exposure on children, radiological imaging
techniques such as CT should be limited to the minimum
necessary [134]. A patient with hearing loss presumably attributed to a pathogenesis other than OME (i.e., congenitalcholesteatoma and ossicular malformation) would be a candidate for CT. In simple X-ray exams, the Shüller position iscommonly used to assess the development of mastoid cells.

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Chapter 3. Treatment algorithm and CQs for OME inchildrenFig. 6 presents a clinical management algorithm recommended for OME in children without risk of intractability
and sequelae. The algorithm was created by integrating evidence obtained from systematic reviews and the expert opinion of the Guideline Committee. The algorithm should therefore be applied in clinical practice in consideration of theunique circumstances of each individual patient. Clinicians
should not adhere to the algorithm in treating patients that
do not show improvement with the treatments recommended
herein or to patients with sequelae such as adhesive otitis
media or cholesteatoma formation. These are described separately (3.11. Supplemental CQs).
In addition, the treatment of OME in children with DS
and cleft palate, who are at high risk for pediatric OME, isdescribed separately in Chapter 4.
3.1. CQ1: How long is the appropriate period to monitor
OME?
3.1.1. Recommendation (refer to Fig. 6)
Watchful waiting for 3 months from the date of effusion
onset or from the date of diagnosis is recommended for managing a child with OME who is not at risk for pathologicalchanges in the TM.
[Recommendation Strength: Strong Recommendation,
Evidence quality: A]
The clinician has an option to continue close monitoringof patients in which OME is prolonged >3 months, specifically in cases without hearing impairment or any pathologicalchanges (i.e., adhesions or retractions) in the TM.
[Recommendation Strength: Recommendation, Evidence
quality: B]
3.1.2. BackgroundIf a child with OME does not show spontaneous resolution within 3 months after onset, the chances of spontaneous
resolution will be lower.
3.1.3. Aggregate evidence quality• Benefits for patients: Potential to avoid undergoing unnecessary medication in cases with presumably spontaneous remission.
• Risks, harms for children: Pain, discomfort, and needfor physical restraint during the physical examinations,
including inspection of TM and earwax removal. Timeconsuming medical economic burden for attending hospitals.
• Benefits–harms assessment: Benefits exceed harms ifpatients undergo careful follow-up.
• Patient preference: Adequate informed consent is requisite.
• Exclusions: None.
3.1.4. Commentary
Although persistent asymptomatic MEE after the resolutionof acute inflammatory responses is common, approximately

75 to 95% of the residual OME after an AOM episode resolves spontaneously by 3 months [5,75]. Meta-analyses addressing the spontaneous regression of OME in pediatric patients reported that 25% of newly detected OME in children
resolved by 3 months. However, longer spontaneous resolution after 6 to 12 months was observed in only 30%, with
only marginal benefits if observed longer [5,6]. Namely, children in whom OME does not show spontaneous resolution in
3 months after onset would not show spontaneous recovery.
Based on these results, watchful waiting is recommended fora child with OME at 3 months after onset [6].
Ventilation tube (VT) treatment of OME improves hearing
for approximately 6-9 months compared with no VT. The difference decreases gradually with time as hearing improves in
the untreated ear, but the long-term effect on hearing status
has yet to be determined [51,73,135]. Among children with
OME prolonged for more than 3 months, many will not show
marked hearing loss of >30 dB or pathological changes in
the TM. In terms of the balance between benefits and harms
attributed to interventions, the clinician has an option to continue careful monitoring of these patients.
3.2. CQ2: are antibacterial agents effective for treatingOME?
3.2.1. Recommendation (Fig. 7)
The use of antibacterial agents for treating OME in children is not recommended. As an exception, macrolide treatment (long-term, low-dose clarithromycin) is a therapeutic option in children with OME associated with rhinosinusitis.
[Recommendation degree: Recommendation, Level of evidence: B]
In cases without bacterial infection of the surrounding organs, administration of antibacterial agents for OME in children is not recommended because the risks outweigh the benefits.
[Recommendation degree: Recommendation, Level of evidence: B]
3.2.2. Background
The rate of bacterial detection in MEE from children with
OME is high [136]; therefore, antibacterial agents can be effective in the short-term. In addition, antibacterial agents are
effective for bacterial infection of the surrounding organs.
This includes rhinosinusitis; as this condition is a precipitating factor for OME in children, its treatment can result in
OME resolution. However, the use of antibacterial agents may
cause adverse effects and increase the risk of development ofbacterial resistance.
3.2.3. Aggregate evidence quality• Benefits for children: Appropriately selected antibacterial agents for bacterial infections of peripheral organs
may be useful in the treatment of OME in children.
• Risks and harms for children: Antibacterial treatment
may lead to gastrointestinal symptoms, particularly diarrhea. All antimicrobials can lead to the developmentof drug resistance in bacteria.

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Fig. 7. Treatment algorithm for prescribing antibacterial agents for otitis media with effusion in children.

• Benefits–harms assessment: The benefits outweigh theharms if the choice of antibacterial agent is adapted tothe type of bacteria causing the infection.
• Patient preferences: Patients must be fully informed,
and consent must be obtained.
• Exceptions: Do not use antibacterial agents to which
the patient is allergic.
3.2.4. Commentary
Cure rates of 65.6% and 16.1% were reported for 55
patients (96 ears) treated with a low-dose macrolide (clarithromycin: CAM) and 19 patients (31 ears) treated withusual-dose cephem antibiotics (control group), respectively.
The efficacy was significantly higher in the low-dose CAM
treatment group, especially in patients with sinusitis [137]. It
was also reported that treatment with low-dose CAM (at theusual dose for one cycle) plus an inhaled nasal steroid for 812 weeks was effective in 88.7-95.2% of children with OME
when treated within 3 months after infection, and this approach provided significant improvement compared with children receiving an inhaled nasal steroid alone (50.9–60.3%)[138]. In addition, administration of low-dose CAM plus aninhaled nasal steroid for 8 weeks was effective in 72.1% ofchildren with OME when treated more than 3 months after infection. However, the number of cases was small (26cases in this study); thus, further investigation is required.
Another study showed that macrolide treatment was only minimally effective in children aged 2 years or younger and inpatients with associated adenoid vegetation [137]. Given thedecreasing susceptibility of Streptococcus pneumoniae andHaemophilus influenzae to macrolide antibiotics in Japan, thewidespread use of these agents in cases in which they are
anticipated to be minimally effective should be avoided.
Antibacterial agents other than low-dose CAM have shortterm efficacy (2–8 weeks) for OME in children, but theirlong-term efficacy is unproven. Given the possibility of adverse effects (such as cutaneous drug eruption, vomiting, anddiarrhea), microbial substitution of resident flora in the nasopharynx, increasingly resistant bacteria, and a poor costeffectiveness ratio, the use of antibacterial agents is not recommended [75].
In an analysis of two systematic reviews, Williamson concluded that the risks of antibacterial agents for OME outweighthe benefits; thus, they should not be recommended [139]. A
Cochrane review of 3,027 cases from 23 articles compared

the clearance rate of MEE at 2-3 months after treatment between patients treated with or without antibacterial agents andconcluded that use of antibacterial agents should not be recommended [140,141].
Antibacterial agents should be used for the treatment of
AOM in children with OME in accordance with the "Clinical Practice Guidelines for the Diagnosis and Managementof Acute Otitis Media (AOM) in children in Japan – 2018
update [21,22]." The present Guidelines is not intended toprevent reasonable treatment for complicating bacterial infections of other surrounding organs. In children with upper respiratory inflammation or rhinosinusitis, OME often develops,
worsens, or becomes prolonged. In such cases, antibacterial
agents should be considered, but their widespread use should
be avoided.
Note: Japanese Health Insurance does not allow antibiotic treatment for OME. Our Guideline states that antibiotic treatment is indicated for bacterial infections of
the surrounding organs.

3.3. CQ3. Are drug therapies other than antibacterial
agents effective for the treatment of OME?
3.3.1. Recommendationa) Carbocysteine
Carbocysteine is recommended as a treatment option.
[Recommendation Strength: Strong recommendation, Evidence quality: A]b) Corticosteroids
Oral corticosteroids have short- but not long-term efficacy
for the treatment of OME in children but are not recommended because the risks outweigh the benefits.
[Recommendation Strength: Strong negative recommendation, Evidence quality: A]
On the other hand, inhaled nasal corticosteroids are associated with a low risk of adverse events and have recently
been shown to be effective.
[Recommendation Strength: Recommendation, Evidence
quality: B]

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20c) Antihistamines
Second-generation antihistamines for treating OME in children should be considered a treatment option in patients withallergic rhinitis. The efficacy of first-generation antihistamines
for the treatment of OME in children has not been demonstrated, and they are thus not recommended because the risks
outweigh the benefits.
[Recommendation Strength: Recommendation, Evidence
quality: B]
3.3.2. Background
Carbocysteine is the only oral medicine currently approvedin Japan for treating OME in children, and it is expected to beeffective for inflammatory lesions of the surrounding organs.
Rhinosinusitis, allergic rhinitis, and chronically inflamed adenoids are considered precipitating factors for OME in children
and have been implicated in its pathophysiology. The present
Guidelines are not intended to prevent the treatment of complicating lesions in the surrounding organs.
3.3.3. Aggregate evidence quality• Benefits for children: Improvement of inflammatory lesions in the surrounding organs, which may improve
OME. Patients do not receive unnecessary antibacterial
treatment. Patients may benefit from a reduction in adverse effects such as gastrointestinal symptoms (mainly
diarrhea) and a reduction in the likelihood of drugresistant bacteria developing.
• Risks and harms for children: Adverse effects of individual drugs. Stress for parents and children (e.g., timeconsuming, reluctance to take medication), and costs(e.g., drug costs) associated with taking medication.
• Benefits–harms assessment: The benefits outweigh theharms if a drug therapy is chosen that has minimal
harmful adverse effects and reduces inflammatory lesions in the surrounding organs.
• Patient preferences: Patients must be fully informed,
and consent must be obtained.
• Exceptions: Do not use agents to which the patient isallergic.
3.3.4. Commentarya) Carbocysteine
Based on a systematic review (meta-analysis of 7 articles)of controlled clinical studies of carbocysteine, Moore et al.
reported an improvement rate of 35% with administration ofcarbocysteine for 1–3 months, compared with 17% improvement in control groups. Adverse effects are unlikely to occur,and therefore, carbocysteine is recommended for treatment
of OME in children [142]. It was shown that mucociliary
function in the nasal cavity and pharyngeal orifice of the ET
was significantly deteriorated in children with OME comparedwith healthy children, and carbocysteine may be associatedwith improvement of mucociliary function. Data also showedthat carbocysteine is effective for treating adult chronic rhinosinusitis, and the agent is commonly used for this purpose
in Japan [143,144].

To summarize, carbocysteine is a treatment option during
the follow-up period for children with OME and rhinosinusitis.
b) Corticosteroids and antihistamines
A Cochrane systematic review on the efficacy of drug treatment for OME in children using oral or inhaled nasal steroids
or first-generation antihistamines has been published [145].
This review showed that oral corticosteroids in combination
with antibacterial agents led to a quicker resolution of MEE(7-28 days) compared with antibacterial agents alone but did
not improve auditory acuity. There is no evidence that oral
steroids alone or inhaled nasal steroids are effective in resolving MEE and improving auditory acuity. Long-term useof oral steroids may increase the risk of systemic side effects,
and therefore, the risks outweigh the benefits, and these agentsare thus not recommended for treatment of OME in children,which has other treatment options and does not require immediate care.
In contrast, inhaled nasal steroids have a low risk of adverse events and have recently been shown to be effectivein clearing effusions and improving hearing [146–148]. Efficacy in adenoid hyperplasia has also been shown, and inhalednasal steroids are reportedly effective in allergic rhinitis andadenoid hyperplasia cases rather than in OME itself [149].
In Japan, however, inhaled nasal steroids are not currently
covered by health insurance for treating OME in children.
There is no evidence of benefit from treatment with firstgeneration antihistamines, either alone or in combination withdecongestants, in the short- or long-term, for resolution of
MEE or improvement of auditory acuity. In addition, 10% of
patients receiving antihistamines experience adverse effects.
Therefore, they are not recommended because the risks outweigh the benefits [149–152].
Given that allergic rhinitis and allergic reactions may havea negative impact on OME in children, oral second-generation
antihistamines or inhaled nasal steroids should be administered to treat allergic rhinitis.
c) Other medications
In terms of Kanpo medicine, there is no established evidence available for OME treatment. However, because theconditions of OME are thought to be caused by water poisoning, diuretic prescriptions are mainly used. Saireito (anherbal medicine) has a diuretic effect and is thus used fortreatment of edema. Saireito also has anti-inflammatory andanti-allergic effects, and it is reportedly effective in the treatment of OME [153].
3.4. CQ4: Are conservative therapies effective for thetreatment of OME?
3.4.1. Recommendationa) Local treatment
Although there is insufficient evidence as to whether local
treatment of the paranasal sinus or ME inflation procedure on

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an outpatient basis at an ENT department is effective for treatment of OME in children, these treatments may be performed
during the monitoring period prior to surgical treatment.
[Recommendation Strength: Option, Evidence quality: C]b) Autoinflation
Autoinflation using a balloon more than 3 times a day isrecommended as a treatment option.
[Recommendation Strength: Recommendation, Evidence
quality: B]
3.4.2. BackgroundME inflation is a treatment procedure for low pressurein the ME due to ET dysfunction. Local treatment of theparanasal sinus can treat rhinosinusitis, which is a precipitating factor for OME in children, and it is thus expected
to lead to OME resolution. However, this has not yet been
demonstrated.
3.4.3. Aggregate evidence quality• Benefits for children: Improvement of clinical symptoms such as hearing loss and aural fullness.
• Risks and harms for children: The procedure may
induce AOM during upper respiratory tract infection.
Local procedures (other than autoinflation) are associated with social and economic disadvantages of hospital
visits. ET ventilation (catheterization) can result in TM
perforation and affect the surrounding organs (epistaxis,
emphysema, etc.).
• Benefits–harms assessment: The benefits outweigh theharms if guidance is given, (e.g., do not perform theprocedure during the infection).
• Patient preferences: Adequate explanation and consent
for the procedure is required.
• Exceptions: none.
3.4.4. Commentary
Etiologies of OME in children include ET dysfunction andinflammation of surrounding organs. Low pressure at the tympanum can be resolved by opening the ET, but it recurs after
treatment. Therefore, the treatment should be performed frequently to increase its effectiveness. It was shown that selftreatment by opening the ET is not effective at a frequencyof 1-2 times per day, but it is effective if done 3 times per
day [154–156]. A systematic review found no evidence of theefficacy of tympanograms or pure-tone audiometry alone but
significant benefit when they are combined. It is thus reasonable to consider its use during the follow-up period due to its
cost and low risk of adverse effects (harm) [157,158]. RCTs
have also reported its efficacy [159].
Therefore, opening the ET may be planned both as autoinflation and as an outpatient treatment at an ENT department.
It has also been reported that recurrences can be reduced after repeating autoinflation [160], and thus, the treatment may
be indicated for recurrences. If performing this treatment at
an ENT department can ensure the resolution of low pressure, even in the short-term, this may prevent adhesion of the
TM. In addition, observation of the TM before and after such21

outpatient treatment may help in the evaluation of disease
conditions (e.g., by observing whether the TM is adhesive orjust in contact). Complications associated with autoinflation
with nasal balloon inflation include AOM, injury of the TM,
and mucosal damage. It should be suggested that this treatment be avoided in cases of upper respiratory tract infection
because AOM occurs frequently in this context.
Recently, the efficacy of balloon Eustachian tuboplasty wasreported in adults with ET stenosis. Although it is reportedly
effective in children [161], it is not indicated for children in
Japan, and there are no reports of long-term outcomes.
3.5. CQ5: Is myringotomy effective for the treatment of
OME?
3.5.1. Recommendation
Myringotomy is recommended for the diagnosis and determination of treatment protocol for OME in children. It iseffective for short-term prognosis, but it is not recommended
for the purpose of long-term treatment.
[Recommendation Strength: Option, Evidence quality: D]
3.5.2. Background
Myringotomy involves making a small incision or perforation in the TM using a myringotomy knife or laser. While theperforation remains patent, pressure between the ME cavity
and the atmosphere is equalized, and the MEE resolves [73].
Fluid can be suctioned from the ME cavity through this perforation, enabling rapid improvement in hearing even in theearly stages after OME onset. Therefore, myringotomy canbe recommended and performed without hesitation in cases
complicated by moderate or severe hearing loss.
3.5.3. Aggregate evidence quality• Benefits for children: Promotes rapid improvement ofclinical symptoms, such as hearing impairment and aural fullness.
• Risks and harms for children: Bleeding, pain and discomfort, and the need for physical restraint during theprocedure, and otorrhea and a risk of persistent perforation after the procedure, etc.
• Benefit–harms assessment: Benefits exceed harms inselected patients, based on symptoms and otoscopic
findings in short-term prognosis. Harms exceed benefits in repeated myringotomy for long-term treatment.
• Patient preferences: Appropriate informed consent isrequisite.
• Exceptions: Proper skills and equipment are essential;
clinicians should not implement this procedure otherwise.
3.5.4. Commentary
Myringotomy can provide immediate improvement in hearing impairment due to OME. In the present Guidelines, TS
tube insertion is recommended for children with OME for 3
months or longer duration after onset or detection (refer to
Section 3.6). However, for patients with hearing impairment
or other symptoms caused by OME that interfere with daily

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life or group life, such as school life, myringotomy should beconsidered for selection as a treatment method, as it provides
immediate effect during conservative treatment.
We reviewed three RCTs examining treatment with amyringotomy knife [162–164]. With regard to important clinical outcomes such as resolution of MEE and hearing improvement, the results of the three studies with myringotomy alone
using a myringotomy knife were less effective than those for
TS tube insertion. Reflecting similar interpretations of this evidence, myringotomy alone using a myringotomy knife is notrecommended as a therapeutic approach in OME treatment
guidelines outside Japan [7,16]. Another study [164] divided
cases of OME into untreated, myringotomy alone, and TS
tube insertion groups and reported that MEE was observed in
64%, 61%, and 17%, respectively, at 1 year. Although it was
concluded from these results that myringotomy alone has notherapeutic effect on long-term prognosis, there was no discussion regarding the short-term effects of myringotomy forchildren with OME.
In myringotomy using a myringotomy knife (incisional
myringotomy), the incision usually closes in a few days,
whereas in laser-assisted myringotomy, the incision remains
open for an average of 2 weeks [165,166]. A systematic review of laser-assisted myringotomy included 3 RCTs
[167–169] and 5 case control studies [170]. Yousaf et al.
reported that 89.7% and 53% of OME cases treated withlaser-assisted tympanostomy had continued hearing improvement after 30 days and 6 months, respectively. Conversely,
in cases with TS tube insersion, hearing improvement wasobserved in 91% and 79.5% of cases after 30 days and 6
months, respectively. Therefore, even for laser-assisted procedures, tympanostomy is considered less effecitive in treating
children with OME than TS tube insertion. In addition, they
conducted a comparsion between laser-assisted tympanostomy
and myringotomy with a myrintotomy knife, and the ratesof hearing improvement after 2 weeks, 4 weeks, 2 months,
and 6 months were 92%, 92%, 62%, and 54%, respectively,
for laser-assisted tympanostomy and 80%, 60%, 36%, and24%, respectively, for myringotomy knife treatment. According to these results, the authors concluded that laser-assisted
tympanostomy is more effetecive than myringostomy using amyringostomy knife [168].
Regarding complications, the perforation rate of laserassisted tympanostomy over 6 months is reportedly 0.8 to
1.9% [166,169], which is considerably lower than the perforation rate for TS tube insertion (2.2% for short-term tube
and 16.6% for long-term tube).
These findings show that myringotomy alone using amyringotomy knife for OME in children is unlikely to have
any long-term treatment effects on MEE or hearing and thatthe therapeutic effect of laser-assited tympanostomy is inferior to that of TS tube insertion but superior to that of knife
myringotomy alone. However, it should be noted that laserassisted tympanosotmy is not covered by national health insurance in Japan at present.
Myringotomy is ineffective for OME in children because
the incision closes quickly. However, it may be useful for diagnosis or determining the therapeutic approach. Rapidly ven-tilating the tympanic cavity may improve hearing; therefore,
myringotomy can be effective for diagnosing complicationsof ME lesions, such as ossicular malformations and congenital cholesteatoma, as well as sensorineural hearing loss. Furthermore, there are cases of OME in children in which thepatients and their guardians do not notice the hearing loss.
In such cases, myringotomy can enable awareness of hearing improvements within only a few days of surgery. For thepatients and their guardians, awareness of hearing loss canprovide motivation for subsequently undergoing appropriate
follow-up and treatment.
Myringotomy is an effective procedure that can be performed by an otolaryngologist under local anesthesia in an
outpatient clinic, and it is useful for diagnosis, determining
the therapeutic approach, and providing rapid improvement ofhearing loss in children with OME. However, myringotomy
is an invasive procedure for pediatric patients, and sufficient
explanation should be given to both the patients and theirguardians. Furthermore, myringotomy should be performed
under a microscope or other magnifying device for safety.
It is recommended that myringotomy be performed in theanterioinferior quadrant of the TM, where there is little impact on the ossicular chain. An aberrant course of the internal
carotid artery may, on rare occasions, be observed in the anterioinferior quadrant of the TM [171,172], and a high jugularbulb may be present in the ME [173,174]. These vascularanomalies are usually observed by pulsation of the vessels orvisibility of the vessels through the TM. However, it may bedifficult to identify these signs because of fluid in the ME ora child’s crying and vigorous movement. Therefore, carefulattention is required for myringotomy.
3.6. CQ6: What are surgical indications for TS tube
insertion?
3.6.1. Recommendation (refer to Fig. 6):
Clinicians should offer TS tube insertion for children withbilateral OME that has persisted for 3 months or more AND
as follows:
1. When pathological changes of the TM such as atelectasis
and TM adhesion are observed.
[Recommendation Strength: Strong Recommendation,
Evidence Quality: B]
2. When hearing difficulties with hearing loss (≥30 dB) of
the ear on better-hearing side are documented.
[Recommendation Strength: Recommendation, Evidence
Quality: B]
3. When clinical findings that may be caused by OME arerevealed, such as impaired academic performance, problems in behavior, vestibular symptoms, hypoactivity, ear
discomfort, and decrease in QOL. However, symptoms due
to developmental disorders are excluded.
[Recommendation Strength: Recommendation, Evidence
Quality: B]

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3.6.2. Background
Pediatric OME is a disease that can be expected to spontaneously resolve. However, once OME has persisted accompanied by hearing loss in both ears for a long period of time,
there is a risk of negative effects on child development. Moreover, serious pathological changes in the TM may cause adhesive otitis media or cholesteatoma.
3.6.3. Aggregate evidence quality• Benefits for children: Decrease in the negative effects
on child development associated with hearing loss. Decrease in the frequency of other otitis media (AOM,
adhesive otitis media, and cholesteatoma).
• Risks and harms for children: Pain, discomfort, andneed for physical restraint during the surgical procedure under local anesthesia to the TM. Potential risks ofgeneral anesthesia in cases of surgery performed undergeneral anesthesia. Otorrhea while tubes are in place,spontaneous drop of TS tube into the tympanic cavity,
and adverse events affecting the TM, including persistent perforations and tympanosclerosis after extrusion
or removal of tubes. Medical economic burden such as
surgical cost of TS tube insertion and outpatient fee after the insertion. Restrictions on swimming, the needfor earplugs, etc.
• Benefits–harms assessment: Benefits exceed harms because adverse consequences, including perforation of
the TM, can be reduced by choosing short-term TS
tubes.
• Surgical cost: TS tube insertion (K309).
• Patient preference: Adequate informed consent is requisite.
• Exclusions: Those with DS and cleft palate are excluded in this CQ; refer to Chapter 4.
3.6.4. Commentary
Regarding the effectiveness of TS tube insertion for OME
in children, three systematic reviews of RCTs have been reported [51,73,135]. The literature search did not find any new
RCTs on TS tube insertion after the most recent RCT by
Berkman, which was considered in the present systematic review.
Hellstrom et al. and Browning et al. qualitatively evaluatedthe results of their studies without conducting a meta-analysis[51,135]. In the RCTs examined in these systematic reviews,
the effectiveness of the following three treatments were compared among children with bilateral OME aged 1 to 12 years:
TS tube insertion, myringotomy, and/or medication with apolicy of performing TS tube insertion if necessary after 2-3
months or longer period of follow-up.
As for complications of TS tube insertion, Kay et al. conducted observational studies of OME in children and integrated the incidence of complications and sequelae in an RCT[175].
In this section, we make recommendations for this CQ bycomprehensively evaluating the evidence of the benefits andharms of TS tube insertion for OME in children, focusing on
the results of these systematic reviews and meta-analyses.

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23

3.6.1. Benefits of TS tube insertion
The benefits of TS tube insertion are decreasing MEE andnegative influences with OME such as hearing loss.
Hearing is the most important outcome of pediatric OME.
Browning et al. performed an RCT and meta-analysis inwhich children with OME were randomly assigned to twogroups, TS tube insertion and non-TS tube insertion. They
found that the mean hearing levels were 11.9 dB and 4.2 dB
better in TS tube insertion group children than in the non–surgically treated children at 3 and 6-9 months after surgery,respectively. However, the difference in mean hearing level
between the two groups at 12 and 18 months after surgery
was 0.41 dB and 0.02 dB, respectively, and no statisticallysignificant differences were found [135].
In addition, in a meta-analysis of three studies in which
random assignment was performed for each ear in bilateral
pediatric OME, TS tube insertion was found to improve hearing levels by 10.1 dB and 5.2 dB at 4-6 months and 7-12
months after surgery, respectively. However, the difference between the two groups at 24 months after surgery was only 2.1
dB, revealing no statistically significant difference [135]. Hellström et al. qualitatively integrated eight RCTs and reported
that TS tube insertion treatment of OME improved hearing
level until 9 months after surgery, but the effect graduallydiminished; thus, the long-term effect was unknown [51].
The effect of TS tube insertion on reducing MEE, whichis the exact pathophysiology of pediatric OME, has also been
examined. Browning et al. estimated the incidence of MEE
within 1 or 2 years after TS tube insertion by a meta-analysisof several studies [135]. In each study, the incidence of MEE
within 1 year after TS tube insertion in the TS tube insertion
group and in the myringotomy/medication group were 1736% and 48-70%, respectively [165,176,177]. These findings
showed that the TS tube insertion group was 32% less likely
to have MEE within 1 year than the myringotomy/medicationgroup [135]. Similarly, the proportion of periods during which
MEE was observed within 2 years after intervention in the
TS tube insertion group and in the myringotomy/medicationgroup were 30-35% and 40-51%, respectively [164,177,178],
and TS tube insertion therapy was 13% less likely to involve
MEE during the first two postoperative years than myringotomy/medication therapy [135].
Only one RCT has examined the incidence of AOM during the course of OME. The number of incidences of AOM
per year per patient within 3 years after TS tube insertion,
myringotomy, or non-surgery was 0.18, 0.58, and 0.38, respectively [162].
Three studies (average age of children: 1.6 to 3.3 years)
on speech perception and production were analyzed by systematic reviews [135]. Meta-analyses of these RCTs revealed no statistically significant differences in language or
speech development at 6-9 months after TS tube insertion[135,176,179,180]. Paradise et al. assessed speech, language,
and cognition at the age of 3 years, vocabulary, intelligence,and speech processing ability at the age of 6 years, and speech
development, speech processing ability, and understanding ofphoneme at the age of 9-11 years in children with bilateral pediatric OME, but no significant differences between

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the early treatment group and late-treatment groups were observed [177,181,182]. Hall et al. tracked children in Maw’s
RCT for a longer period, and they reported that language
development at the age of 4.5 years was better in the TS
tube insertion group than in the non-surgery group, with an
adjusted odds ratio of 3.45, but there was no statistically significant difference between the two groups in language development test results at the age of 8 years [183].
The effect of TS tube insertion on behavioral development
was evaluated in two RCTs. Wilks et al. evaluated pediatricOME using behavioral checklists and found that the proportion of children with behavioral problems was significantly
lower in the TS tube insertion group (30%) than the non-TS
tube insertion group (47%) at 9 months after surgery, but nodifference between the two groups was observed at 18 months[184]. In the other RCT, children with OME were evaluated
via a behavioral checklist at the age of 3, 6, and 9-11 years,
and again, there was no difference between the TS tube insertion group and non-TS tube insertion group [177,181,182].
The QOL of children with OME was analyzed in Rovers’
RCT using the TNO-AZL Infant Quality of Life, a comprehensive QOL scale for children aged 1-4 years. There wasno statistically significant difference in QOL in children with
OME aged 1 to 2 years at 6 and 12 months after TS tube
insertion between the TS tube insertion and non-TS tube insertion groups [185].
3.6.2. Harms of TS tube insertion
The risks and harm associated with TS tube insertion include various complications (otorrhea, granulation formation,
tympanosclerosis, pocket and cholesteatoma formation, persistent TM perforation, damage to the ossicular chain andinjury to the high jugular bulb, and accidental drop of theTS tube insertion into the tympanic cavity), pain, discomfort,
need for physical restraint during the surgical procedure underlocal anesthesia to the TM, potential risks of general anesthesia, and medical economic burden, such as surgical cost of
TS tube insertion and outpatient fees after surgery.
Knutsson et al. conducted an RCT including 800 ears andreported that infection was found more than once in 13.8%(infection occurring more than twice was observed in 3.1%),
and infection was less frequent in patients with silicon tubes[186].
Kay et al. conducted systematic reviews of short-term adverse events of TS tube insertion for OME based on 70 observational studies and 64 RCTs [175]. After TS tube insertion,transient otorrhea occurred in 16% of patients within 4 weeks
after surgery (26.1% after a longer period), whereas persistent otorrhea lasting for more than 3 months after surgery wasobserved in 3.8%, recurrent otorrhea in 7.4%, and otorrhea requiring TS tube insertion removal in 4.0% (long-term TS tube
insertion was used in 87% of cases).The incidence of adverse
events during TS tube insertion, except for otorrhea, were tube
occlusion (6.9%), granulations that did not require treatment(4.2%), granulation requiring treatment (gromets and/or granulation removal, 1.8%), early spontaneous extubation (3.9%),and spontaneous drop of the tube into the tympanic cavity(0.5%).

Pathological changes in the TM after tube removal included tympanosclerosis (31.7%), atrophy and retraction(24.6%), and retraction at the pars tensa (3.1%). Persistent
perforation of the TM after tube removal was found in 2.2%
and 16.6% of short-term and long-term TS tube insertions, respectively. In addition, cholesteatoma was observed in 0.8%
of short-term TS tube insertion cases and 1.4% of long-term
TS tube insertion cases [175]. For a discussion of the formation of cholesteatoma as a complication of TS tube insertion,refer to Section 3.7.
Kay et al. also estimated the relative risk of tympanicchanges after TS tube insertion in a meta-analysis [175]. The
relative risk of TM atrophy and retraction was 1.7 (n = 10
studies), and that of sclerosis of the TM was 3.5 (n = 13
studies) for the TS tube insertion group vs. the non-surgicalor myringotomy groups. As the lower limit of the 95% confidence interval was close to 1.0 for the outcome of TM atrophy and retraction, it is possible there was no substantial
difference. In a survey of 297 ears of 156 patients by Branco
et al., tympanosclerosis was observed in 35.7%, and the authors stated that this is more likely to occur in cases with more
frequent otitis media (p = .001) and otorrhea (p = .0029) andless likely in cases less than 12 months after TS tube insertion(p=.009) [187].
Two cohort studies observed hearing for more than 10
years after TS tube insertion. One was a birth cohort study,
which showed a tendency toward worse hearing of 5-10 dB
in patients with a history of TS tube insertion compared withthose without a history of TS tube insertion at the age of 18
years [188]. In another cohort study, 224 patients with OME
who underwent TS tube insertion on one side at an early age
and myringotomy on the other side showed no difference inhearing level between ears [189]. Thus, the long-term effectof TS tube insertion on hearing has not been conclusively
shown [135].
3.6.3. Decision regarding recommendations
In determining recommendations for indications of TS tube
insertion, not only the above-mentioned benefits and harms of
TS tube insertion, but also the characteristics of OME should
be considered. The Committee for the present 2022 Guideline
recommends watchful waiting for 3 months from the date ofeffusion onset or diagnosis of OME for managing a child with
OME, because the influence of pediatric OME on hearing usually ranges from none to moderate (refer to Section 2.4.), andthe disease sometimes spontaneously resolves. However, early
TS tube insertion is recommended in cases of bilateral OME
persisting for more than 3 months in the following cases: (1)when pathological changes of the TM occur, such as atelectasis and adhesions (refer to Section 1.20); (2) when a hearing
loss of ≥30 dB is documented in the better-hearing ear; and(3) in the presence of clinical findings that may be associatedwith hearing loss due to OME, such as decreased activity inschool.
This recommendation is based on the consideration that,
despite the possibility of spontaneous resolution of the disease, once OME has persisted in both ears for a long periodof time, there is a potential risk for negative effects associatedPlease cite this article as: H. Hidaka, M. Ito, R. Ikeda et al., Clinical practice guidelines for the diagnosis and management of otitis media with effusion(OME) in children in Japan – 2022 update, Auris Nasus Larynx, https:// doi.org/ 10.1016/ j.anl.2022.12.004

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25

Fig. 8. Types of tympanostomy tubes.

with hearing loss on child development in terms of learning, emotions, and communication ability, etc. Moreover, if
an irreversible change in the TM progresses to adhesive otitis
media or cholesteatoma occurs (refer to Section 3.11), treatment becomes more difficult, and patients may have permanent and irreversible hearing problems.
On the other hand, early TS tube insertion may also be recommended in cases with a hearing level between 25 and 30
dB bilaterally; in those with risk factors of prolonged OME,
such as poor development of mastoid cells; or in those showing a clinical finding that may be associated with hearing loss
due to OME, such as slowing of academic progress. However,
we do not consider that immediate TS tube insertion on all
children with OME is justified. This is because several reports
have demonstrated with high evidence levels that hearing improvement resulting from TS tube insertion is expected only
during 6 to 9 months after the procedure [135]. Harms suchas postoperative complications and sequelae must be considered more carefully. For a discussion of indications of TS
tube insertion in unilateral OME, refer to Section 3.10.
Although there is no evidence to provide quantitative criteria for pathological changes in the TM for which TS tube
insertion effectively prevents, abnormal TM findings relevant
to sequelae include the following (expert opinion good practice point): severe retraction in pars tensor or flaccida of theTM, destruction of the ossicles, and adhesive retraction of theTM [6,9].
In addition, TS tube insertion may be effective in preventing MEE and retraction of the TM and cholesteatoma
in cases when patients can overcome sniffing habit. This is
described in detail in the section regarding the etiology andpathophysiology of OME [43,192]. In any case, the decision
regarding whether to perform TS tube insertion should beshared with parents by comprehensively judging the degreeof hearing loss, symptoms other than hearing loss, TM findings, duration of disease, intentions of the patient and theirfamily, medical expenses required for treatment, etc.
 Appendix: Selection of tympanostomy tube.
There are two types of tympanostomy tube: short-termand long-term (Fig. 8). While tubes can remain in the TM

for varying lengths of time, the mean duration of short-term
tubes is 8-16 months, accompanying many cases of spontaneous extrusion and closure of the TM perforation, and therate of persistent perforation is approximately 2% [73,175].
Conversely, long-term tubes are intended to remain in the TM
for at least 15 months, with spontaneous extubation occurring
at a mean of 18-36 months, and many cases eventually require
removal [31,73]. Compared with short-term tubes, long-term
tubes are often associated with otorrhea and a high rate (17%)
of residual perforation [175].
As most RCTs examining the treatment effects of tube
insertion have focused on short-term tubes, the evidence suggests that short-term tubes should be the first choice for initial
TS tube insertion for OME in children not at risk of becoming refractory. As OME recurs after extubation in 20–50% ofcases, in which tube re-insertion is required within 3 years[162,164,193], recovery without sequelae can be achieved
with a single short-term tube insertion in 50-80% of cases.
Consideration should also be given to long-term tubes in cases
showing pathological changes such as atelectatic ear and adhesive otitis media, in which short-term tubes are susceptible
to premature extrusion. Even at the first surgery, long-term
tympanostomy tube can be considered for children with OME
that appears to be refractory [186].
For a discussion of indications of TS tube insertion incases involving atelectasis or adhesive otitis media, refer to
Section 3.11.

3.7. CQ7: How should physicians manage tympanostomy
tubes after surgery?
3.7.1. Recommendation
Early postoperative and routine follow-up (up to once every 4-6 months) is recommended to observe the postoperative condition of tympanostomy tubes and to evaluate hearing. Follow-up and evaluation of recurrence of OME and thenecessity for additional treatment (including re-insertion) is
required after a tympanostomy tube is extubated.
[Recommendation Strength: Strong Recommendation,
Evidence Quality: A]

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Table 8. Risk factors for developmental difficulties in children with OME (at-risk children; adapted fromRosenfeld et al. 2016).
Permanent hearing loss independent of OME
Suspected or confirmed speech and language delay or disorder
Autism spectrum disorder or other pervasive developmental disorders#)
Syndromes (e.g., Down’s) or craniofacial disorders that include cognitive, speech, or language delays
Blindness or uncorrectable visual impairment
Developmental delay#): A group of complex neurodevelopmental disorders characterized by repetitive and characteristic patternsof behavior and difficulties with social communication and interaction.

3.7.2. Background
After TS tube insertion, it is necessary to confirm the therapeutic effect and cure of OME, as well as manage any complications and sequelae of TS tube insertion.
3.7.3. Aggregate evidence quality• Benefits for children: Decreased negative effects associated with hearing loss on development. Reduced frequency of complications due to TS tube insertion.
• Risks and harms to children: Medical, economic, andphysical burdens, time constraints for follow-up visits
to doctor’s office after TS tube insertion.
• Benefits–harms assessment: When performing appropriate postoperative management, benefits exceed
harms.
• Patient preference: Appropriate informed consent isrequisite.
• Exclusions: None.
3.7.4. Commentary
It is difficult to establish a uniform standard follow-up program after TS tube insertion because the local medical situation and the disease condition in each case can vary. Considering these issues, the Guideline Committee recommends
early postoperative and routine follow-up (up to once every
4-6 months) to observe the postoperative condition of the tympanostomy tube and to evaluate hearing. Children and theirguardians should be advised to undergo re-examination whenproblems occur, such as recurrence of OME after natural removal of the TS tube insertion or otorrhea due to infection.
After the tympanostomy tube is extubated, further follow-up
is necessary to check for recurrence of OME and to assess
the necessity for additional treatment (re-TS tube insertion).
Within 1-3 months after extubation, the condition of the TM
and presence or absence of MEE should be checked, and a
final evaluation should be made to ensure that OME is cured
with no need for re-insertion 6 to 12 months after extubation.
If a child with OME has another disease causing hearing
loss, TS tube insertion may not sufficiently improve hearing(refer to Table 8 in Section 3.10). Therefore, improvement inhearing should be confirmed early after surgery, and anothercause of hearing loss should be examined if improvement ofhearing loss is poor. During follow-up, in case the tympanostomy tube becomes invisible, hearing loss is suspected, orcomplications of TS tube insertion are observed, consultation
with a more-advanced medical institution should be considered.

Complications of TS tube insertion include obstruction of
the tube, recurrent/protracted otorrhea resistant to conservative treatment, granulation formation, enlargement of the perforation, and dropping of the tube into the tympanic cavity[9,141,194].
Complications after removal of a tympanostomy tube include tympanosclerosis, persistent perforation, atrophy or retraction of the TM, and cholesteatoma formation (refer toAppendix 2, Kay et al., 2001). In particular, when TM perforation remains, it may cause hearing loss depending on thesize of the perforation, and even small perforations can lead to
infection in the tympanic cavity. In cases of TM perforationor pathological changes requiring surgery or cholesteatoma
formation, consultation with a higher medical institution may
also be required. Refer also to Section 3.6–8. for a discussionof complications and sequelae of TS tube insertion.
 Appendix 1: Guidance on bathing and swimming after
TS tube insertion.
The use of earplugs when swimming after TS tube insertion is not always recommended. Carbonell et al. analyzed
the results of two RCTs and nine cohort studies and reported
that use of earplugs during swimming as well as prophylactic
use of antibacterial ear drops after swimming did not reduce
the risk of AOM [195]. Goldstein et al. performed an RCT in
which 201 children with OME who received bilateral TS tube
insertion were randomly assigned to with or without earplugs
groups during bathing or swimming. They reported that theincidence of otorrhea was significantly reduced in the "withearplugs" group [196]. However, the effectiveness of earplugs
is limited, and the frequency of otorrhea is reduced from 56%
to 47% by constant wearing of earplugs, indicating that 2.8
years continuous use of earplugs is necessary to prevent even
only one episode of otorrhea [9,196].
To avoid excessively restricting the activity of the patient,continual use of earplugs should not be recommended. Patients should be instructed to avoid swimming in lakes andoceans (where the chance of infection is higher), diving deepin swimming pools, or submerging themselves in bathtubs.
Conversely, specifically in cases in which these situations cannot be avoided or in cases in which a child has repeated otorrhea or complains of otalgia or otorrhea during swimming,
they should be instructed to use earplugs.
 Appendix 2: Cholesteatoma formation as a complicationof TS tube insertion.

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Cholesteatoma may arise from the retracted fragile partor edge of the perforation of the TM as a complicationof TS tube insertion [50]. On average, the incidence ofcholesteatoma after TS tube insertion is approximately 1%
and less than 1% in cases attributed to ET dysfunction[50,175]. Golz et al. retrospectively examined 2,829 pediatricOME patients (5,575 ears) who received TS tube insertionand reported that the incidence of cholesteatoma occurring in
the ME side of the normal TM or at the margin of the TM
perforation was 1.1% (62 ears). The authors commented thatthe incidence was significantly higher in children in whom TS
tube insertion was performed under 5 years of age, as wellas in those who received three or more TS tube insertions in
the past [197].
In a large cohort study by Spilsbury et al., cholesteatoma
developed in 460 of 45,980 children with a history of at least
one TS tube insertion. It is reported that the cholesteatoma
was diagnosed on average 3.8 years after the last TS tube insertion. In addition, analyses of risk factors for cholesteatoma
revealed that the risk of cholesteatoma formation increases
with the number of TS tube insertions in children with OME(without cleft palate). For example, children who had four
TS tube insertions had 5.6 times greater risk of cholesteatoma
than those who had only one TS tube insertion. Children who
have received TS tube insertion several times thus need to befollowed more carefully. On the other hand, although the incidence of cholesteatoma in children with cleft palate is ashigh as 4.3%, an increase in the number of TS tube insertions does not lead to an increase in the hazard ratio, and ET
dysfunction may be more involved than TS tube insertion inthese cases [69].
3.8. CQ8: How long should a tympanostomy tube beinserted?
3.8.1. Recommendation
In cases of OME in children not at risk of becoming refractory, the standard duration of TS tube insertion shouldbe about 2 years. Tube removal should also be considered inpatients with otorrhea resistant to conservative treatment orwith severe inflammatory changes (granulation) at the tube
insertion site.
[Recommendation Strength: Recommendation, Evidence
Quality: C]
3.8.2. BackgroundFor children with OME, a longer period of tube therapy isdesirable; however, long-term TS tube insertion also increases
the risk of sequelae.
3.8.3. Aggregate evidence quality• Benefits for children: Intentional extubation at the appropriate time reduces the incidence of OME recurrence
as well as complications due to TS tube insertion.
• Risks and harms for children: In case of recurrenceof OME after extubation, risks, harms, and burdens will
increase with re-TS tube insertion (refer to Section 3.6).

[mNS;February 26, 2023;0:41]
27• Benefits–harms assessment: Extubation at the appropriate time reduces adverse events, and thus, benefits
exceed harms.
• Patient preference: Appropriate informed consent isrequisite.
• Exclusions: Those with history of multiple TS tube insertion, DS, and cleft palate are excluded in this CQ.
3.8.4. Commentary
Tympanostomy tubes are classified as short-term (8-18months) or long-term (15 months or longer) [31]. It is known
that long-term tubes have a higher incidence of otorrhea andpersistent perforation of the TM than short-term tubes [175].
If otorrhea or granulation formation is observed during thefollow-up period after TS tube insertion, removal of the tube
may be necessary if it is not improved by conservative treatment (refer to Section 3 CQ6–7 for a discussion of complications due to tube type and frequency of sequelae).
While it has been pointed out that cure of OME is related
to the period of tube therapy, the appropriate period necessary for the cure of OME remains unclear. A histopathologicalstudy of the temporal bone of children with OME suggested 6
months or more [198], and other studies suggested 12 months
or more [199], 13 months or more [200], 12 to 18 months[201], 18 months or more [202,203], 18 to 24 months [204],
19 months or more [205], or 19 to 36 months [206]. As many
short-term tympanostomy tubes are spontaneously extubated
10 to 18 months after insertion, it may not be necessary to intentionally remove the tube considering the minimum required
period. On the other hand, there are individual differences in
the amount of time the tube stays in position, and it may be
more important to consider removal of the tube if it stays inposition for more than 2 years. If a long-term tube tends tostay in the TM for 2-3 years or even longer, tube removal
also should be considered in such cases. It has been reported
that the incidence of persistent perforation of the TM, which
is a complication of TS tube insertion, is 3% when the tube
is removed less than within 3 years after insertion, but therisk increases to 15% when the tube stays in for more than
3 years [207].
3.9. CQ9: Are adenoidectomy and tonsillectomy effective forOME?
3.9.1. Recommendation (Fig. 9)a) Adenoidectomy
If adenoid hyperplasia is present, adenoidectomy is effective in the treatment of OME. However, it is a more invasive
procedure and should be performed with the following considerations in mind:
1 In the absence of a clear indication for adenoidectomy
in upper airway disease, it is not recommended as theinitial surgery for OME in patients under 4 years ofage.
[Recommendation Strength: No recommendation), Evidence Quality: A]

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Fig. 9. Treatment algorithm for planning adenoidectomy.


1 Adenoidectomy combined with TS tube insertion is expected to reduce the recurrence rate of OME in patientsabove 4 years of age. The combination of adenoidectomy and TS tube insertion may be considered.
[Recommendation Strength: Strong recommendation, Evidence Quality: A]


1 At the time of reoperation for recurrent cases of ventilation tube dislodgement after the initial surgery, adenoidectomy should be performed if the absence of cleft
palate has been confirmed.
[Recommendation Strength: Recommendation, Evidence
Quality: B]b) Tonsillectomy
Tonsillectomy should not be performed for the treatment
of OME in children.
[Recommendation Strength: There is sufficient evidenceof no benefit), Evidence Quality: A]
3.9.2. Background
Adenoids contribute to clinical status in OME in children(refer to Section 2.7), and adenoidectomy is performed astreatment for OME in children in clinical practice.
3.9.3. Aggregate evidence quality• Benefits for children: Prevention of OME recurrencein patients above 4 years old.
• Risks and harms for children: Risks associated withthe use of general anesthesia, intraoperative bleeding, postoperative pain and bleeding, and hyper-nasal
speech.
• Benefits–harms assessment: The benefits outweigh theharms in recurrent cases and in children above 4 yearsof age.
• Socioeconomic disadvantages: Hospitalization for several days, surgery under general anesthesia.
• Surgical cost: Adenoidectomy (K370).
• Patient preference: Adequate explanation and consent
are required.
• Exceptions for patients under 4 years of age: Consider adenoidectomy in cases of upper airway involvement caused by adenoids (e.g., pharyngotonsillitis, severe nasal obstruction, and obstructive sleep apnea). It
is essential to have the necessary skills and equipment
to perform the surgery safely.

3.9.4. Commentarya). Adenoidectomy
Two systematic reviews have been reported investigating
the effects of adenoidectomy for OME in children [73,208].
Among them, van den Aardweg et al. also reviewed recurrent AOM in addition to OME. After publication of thesereports, the results of the Trial of Alternative Regimens in
Glue Ear Treatment (TARGET) study, a large-scale RCT regarding OME, were released [209]. Berkman et al.’s review[73] comprised a qualitative evaluation of the TARGET study
and the seven OME studies included in the review by van
den Aardweg and colleagues. According to these three studies, this Guideline’s recommendations have been developed
based on the eight RCTs (patient age range, 2 years 1 month– 14 years).
The effects of adenoidectomy on OME in children were
evaluated based mainly on the following outcomes: rate of
OME improvement, duration of MEE, and degree of hearing
improvement.
A meta-analysis of three RCTs by van den Aardweg et al.
revealed that the rates of OEM improvement with adenoidectomy were 22% and 29% at 6 and 12 months, respectively,
compared to those of watchful waiting [208]. These results
indicate that adenoidectomy for OME in children improves
MEE to some degree. However, in three RCTs that comparedadenoidectomy and watchful waiting, hearing tests at 6 and12 months showed no significant difference between the two
approaches [163,190,209].
Four RCTs have evaluated the additional benefits of adenoidectomy as an adjunct to TS tube insertion. An RCT by
Roydhouse et al. found no significant difference in the mean
rates of effusion recurrence between adenoidectomy TS plus
tube insertion and TS tube insertion alone at 12 (18% vs.
23%, respectively) or 24 (15% vs. 18%, respectively) months[73,210]. Another study comparing adenoidectomy plus TS
tube insertion and TS tube insertion alone found that the proportions of examination days on which MEE was observed
over the 2-year follow-up were 26%±21% and 36%±24%(mean ± SD), respectively, showing a significantly better outcome with adenoidectomy combined with TS tube insertion(p=0.0101) [178]. Furthermore, rates of repeated surgery during the 2-year follow-up were significantly lower for adenoidectomy plus TS tube insertion (14%) than for TS tube
insertion alone (28%; p = 0.007). Casselbrant et al. comparedadenoidectomy plus TS tube insertion and TS tube insertion
alone and found no significant difference in the proportion

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of patients who developed MEE during the 36 months after
surgery (20.6% vs. 18.6%) [211].
The TARGET study compared the treatment effects of
adenoidectomy plus TS tube insertion and TS tube insertion
alone on hearing [191]. No significant difference in hearing
TARGET was observed up to 6 months, possibly because offunctioning tympanostomy tube. Conversely, at 12-24 months,
hearing with combination adenoidectomy was better at 4.2 dB(p < 0.001) than with TS tube insertion alone. The TARGET
study also investigated the proportion of patients who underwent repeat surgery. Comparison of adenoidectomy plus TS
tube insertion and TS tube insertion alone revealed that, withhearing loss of 25 dB as the criterion for repeat surgery, theproportions of repeat surgery did not differ significantly between the approaches at 6 months. However, in the second
year after surgery, the chance of repeat surgery was approximately 3 times higher (relative risk, 2.7) with TS tube insertion alone compared with combination adenoidectomy (35%
vs. 13%), respectively [191].
Boonacker et al. performed a meta-analysis of 10 RCTs
with or without adenoidectomy in cases of OME and recurrent otitis media (1,761 patients under 12 years of age).
In patients aged ≥4 years affected by OME, the prevalenceof treatment failure at 12 months (i.e., persistent OME) was
51% in the group that underwent adenoidectomy and 70%
in the group without adenoidectomy. Moreover, additional
surgery was required in 2.2% of patients in the adenoidectomy group and 18.8% of patients in the group without adenoidectomy. On the other hand, in patients under 4 yearsof age, fluid retention after 12 months was 23.4% in the
adenoidectomy group and 9.7% in the other group. There
was no significant difference in the effect between the twogroups [212].
In a systematic review and meta-analysis by Mikals et al.
[213] that included 15 studies, the recurrence rate was 17.2%
when adenoidectomy was combined with TS tube insertionand 31.8% when the surgery was limited to TS tube insertion . In patients above 4 years of age, the recurrence rate
for the two groups was 16.8% and 35.5%, respectively. There
was no apparent benefit for patients under 4 years of age,with recurrence rates of 19.2% vs. 16.8% [213]. According
to the international consensus on the management of OME
summarized at the International Federation of Otorhinolaryngological Societies Annual Congress in 2017, the indication
for TS tube insertion plus adenoidectomy was only for patients above 4 years of age and for those with obstructive
disease of the upper airway [15]. In a large prospective study
conducted in Taiwan using the National Health Insurance Research Database, the rate of repeated TS tube insertion was
5.1% when adenoidectomy plus TS tube insertion was performed and 9% when TS tube insertion alone was performed(p = 0.002). When the age range was divided into subgroups(0-2, 2-4, 4-6, and 6-9 years), the decrease in the recurrence
rate with combined adenoidectomy and TS tube insertion
was found to be especially pronounced in patients above 4
years of age (p = 0.02 at age 4-6 years, p < 0.001 at age
6-9 years) [214].

29

Thus, adenoidectomy combined use with TS tube insertion has additional benefits, particularly with regard to reducing the need for tube re-insertion. However, adenoidectomy
is more invasive than TS tube insertion and associated withincreased risks of complications of anesthetic, intra- and postoperative hemorrhage (0.2-0.6%), [191,215], and other problems. Therefore, since the harmful effects outweigh the benefits, it is not recommended as an initial procedure. A total of
50-80% of pediatric patients with OME recover with just one
TS tube insertion [164,194]; therefore, exposing all patientsto the risks of adenoidectomy as an initial procedure should
not be recommended.
Specifically, in patients above 4 years of age, performance of adenoidectomy in combination with TS tube insertion should be considered at the time of recurrence, as
it is expected to reduce the recurrence rate. In Japan, mostadenoidectomies are performed under general anesthesia andrequire several days of hospitalization. Adequate explanations
and consent are required.
In principle, adenoidectomy may be indicated for adenoid vegetation in the case of upper airway lesions (including pharyngotonsillitis, choanal atresia, and obstructive sleep
apnea syndrome) caused by the adenoids. Adenoidectomy is
not recommended in patients with cleft palate due to the riskof velopharyngeal insufficiency [216]. Preoperative evaluation
for concomitant conditions, including submucous cleft palate,should be performed.
b) Tonsillectomy
Many studies have reported a lack of efficacy of tonsillectomy for OME in children. An RCT by Maw et al. included
103 patients aged between 2 and 11 years (mean age: 5.25
years). The healing rate of OME 6 weeks after surgery was
16% for the group that only underwent TS tube insertion,
39% for the group that underwent TS tube insertion plus
adenoidectomy, and 59% for the group that underwent TS
tube insertion plus adenoidectomy plus tonsillectomy. These
rates at 1 year after surgery were as follows: 26%, 72%, and62%, respectively. Adenoidectomy (p < 0.001), adenoidectomy and palatine tonsillectomy (p < 0.01), and adenoidectomy and tonsillectomy (p < 0.01) were more effective thanTS tube insertion alone in curing otitis media. Whereas adenoidectomy and tonsillectomy (p < 0.01) were effective, noadditive effect from the addition of tonsillectomy comparedwith adenoidectomy alone was observed [217].
The risk of postoperative hemorrhage of approximately 4%[215] means that tonsillectomy should not be recommended
for the treatment of OME in children. Similar recommendations are found in treatment guidelines for OME in children
outside Japan [6].
3.10. CQ10: Is the tympanostomy tube effective forunilateral OME?
3.10.1. Recommendation
Similar to the case of bilateral OME (3.CQ6), clinicians
may consider TS tube insertion for children with unilateral
OME complicated with pathological changes of the TM (refer

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to Table 6). Conversely, watchful waiting with monitoring of
the bilateral hearing level is recommended in cases without
such pathological changes.
[Recommendation strength: Recommendation, Evidence
Quality: C]
Exceptions include children who are more susceptible todeveloping sequelae involving speech and language (at-riskchildren), and clinicians should offer more proactive management than for otherwise healthy children. Children sufferingfrom unilateral OME should receive personalized medical carewith monitoring of hearing on the contralateral side.
[Recommendation strength: Recommendation, Evidence
Quality: C]
3.10.2. BackgroundChildren with unilateral OME would experience lesssevere impact on language development than those with bilateral OME. Clinical recommendation should depend on presence or absence of pathological changes in the TM. Specifically, clinicians should follow up patients carefully, avoiding
the overlooking of non-evident pathologies, including congenital cholesteatoma.
3.10.3. Aggregate evidence quality• Benefits for children: As long as there is minimal effecton language development, patients can avoid undergoing
unnecessary interventions.
• Risks and harms for children: Pain, discomfort, and needfor physical restraint during the surgical procedure underlocal anesthesia to the TM. Potential risks of general anesthesia in cases of surgery performed under general anesthesia. Otorrhea while tubes are in place, accidental dropof tympanostomy tube into the tympanic cavity, and adverse events affecting the TM, including persistent perforations and tympanosclerosis after extrusion or removalof tubes. Medical economic burden such as surgical costof TS tube insertion and outpatient fees after TS tube insertion. Restrictions on swimming, the need for earplugs,
etc.
• Benefits-harms assessment: Benefits exceed the harms
as long as patients undergo watchful waiting and hearing
evaluation in a careful and deliberate manner.
• Surgical cost: TS tube insertion (K309).
• Patient preference: None.
• Exclusion: In cases presumably involving cholesteatoma,including congenital cholesteatoma.
3.10.4. Commentarya) Unilateral OME complicated with pathological changes
in the TM
As in the case of bilateral OME, TS tube insertion is atreatment strategy used in the following pathological cases:
severe retraction pocket predisposed from the segmental atrophic area and/or atelectatic TM because ME cholesteatoma
and adhesive otitis media are serious sequelae of these pathological conditions [218].

b) Unilateral OME without pathological changes in the TM
As long as normal hearing on the contralateral side can beretrained, children would be less adversely affected in theirlanguage development. TS tube insertion would not be recommended in such cases with minimal hearing disorder without pathological changes in the TM, and watchful waiting
should be recommended. The US Clinical Practice Guideline
updated in 2016 recommended regular follow-up to evaluatehearing status on the healthy side and careful examinationof the TM to identify any abnormalities, as mentioned above[6,9,13]. Again, the incidence of underlying intractable otologic pathophysiologies should be monitored, such as congenital cholesteatoma and ET dysfunction [219].
Conversely, even in cases of unilateral OME, insertion ofa tympanostomy tube to resolve effusion and facilitate better assessment of hearing status may be appropriate on an
individual basis for children who are disproportionately affected by MEE. Specifically, clinicians should determine if achild with OME is at increased potential risk and/or showing signs of speech, language, or learning problems due toMEE. Children who are at risk for developmental difficulties
would likely be disproportionately affected by hearing problems from OME sequelae as compared with otherwise healthy
children. The US Clinical Practice Guideline updated in 2016
defined these children collectively as “At-risk Children”, particularly for speech and language disorders, imbalance, developmental delays, and being less task oriented and less capableof independent classroom work [9,13].
In cases of hearing loss on the contralateral side to the ear
with OME, interventions including TS tube insertion would
contribute to normalization of language development. Specifically, children with blindness or uncorrectable visual impairment depend on hearing more than their normal-vision counterparts. Even if OME is encountered on the unilateral side,these children are further susceptible to OME sequelae, including difficulties with speech perception in noise, soundlocalization in the environment, and impairment of activities
requiring balance [6,9,13,75].
Children with autism spectrum disorder and other pervasive developmental disorders are also included in the “At
Risk Children” category, as shown in Table 8. By evaluating hearing impairment and characteristics associated withpoorer QOL attributed to OM [220], clinicians should plan
individual treatment strategies, including insertion of a tympanostomy tube. Finally, patients with DS and cleft palate are
discussed in Chapter 4.
3.11. Supplemental CQ: how are children with OME
complicated with adhesive otitis media clinically assessed
and managed?
3.11.1. Recommendation
Tympanoplasty can be recommended as an option for patients whose TM exhibits atrophy and adhesions, complicatedwith otorrhea and/or hearing loss, and cases progressing tocholesteatoma.
[Recommendation strength: Recommendation, Evidence
Quality: X]

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3.11.3. Aggregate evidence quality• Benefits for children: Surgical intervention could relieve otologic symptoms, including hearing loss and otorrhea, and also prevent the lesion from progressing tocholesteatoma.
• Risks and harms for children: Risks of general anesthesia, bleeding during or after surgery, postoperative pain,
risks and costs associated with general tympanoplasty.
• Cost of surgical procedures: Tympanoplasty with intact
chain preservation (K319-1) or with reconstruction of ossicular chain (K319-2).
• Benefits-harms assessment: Benefits exceed the harms inselected patients, based on symptoms and clinical course,
after sufficient evaluation of individual patients.
• Patient preference: Appropriate informed consent is requisite.
• Exclusion: Skills and equipment are essential; if not, clinicians should not carry out this procedure.

3.11.2. Background
Adhesive otitis media is a condition in which an atrophic or
retracted TM is fixed by adhesions to the promontrium and/or
may be fixed to other ME structures, including ossicles. These
conditions are usually attributed to long-term suffering from
otitis media and functional or structural disorders of the ET.
Negative ME pressure is induced by clearance of ME fluid,
impairment of the ventilation and pressure regulatory systemof the ET and ME, and/or habitual sniffing.
Specifically, gas exchange functions of the ME deteriorate
in ears with poor mastoid pneumatization or loss of aerationin the ME. The above-mentioned negative ME pressure isthus persistent and may develop to retraction of the TM. To
prevent these progressions from atelectatic TM to the adhesive
otitis media, insertion of the ventilation tube with induction of
aeration of the mastoid is important to keep the pathologicalcondition in the earliest stage and prevent sequelae [132].
In addition to tubal stenosis, many cases involve dysfunction of the ET, including patulous ET and habitual sniffing
associated with closing failure of the ET. Clinicians should
ask about the patient’s habit of sniffing in order to correct
ear discomfort due to patulous ET and should evaluate tubal
functions as far as possible.
Adhesive otitis media often accompanies hearing loss.
However, factors that can predict the progression of hearing loss of this disease have not yet been revealed. Borgstein[221] revised the classification of TM retraction and adhesion
by Sade´& Beroco [222] and proposed a new classification
for ME atelectasis in children. This system would be usefulin that it follows the natural progression of the disease andwould therefore be more practical in determining therapeuticstrategies at each stage (Fig. 10) [221]. However, consensus
has not yet been established in terms of the timing, stage ofprogression, and management strategies by surgical interventions.

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3.11.4. Commentary
3.11.1. Pathogenesis
Among pathological changes of the TM, atelectatic TM
refers to a reduction in volume of the ME space, and it isassociated with medial displacement of the TM toward thepromontory; it can be fixed or mobile. Long-term OME progressively induces atrophic TM, accompanied by loss of tension and elasticity attributed to a loss of the organized collagenous layer that maintains the tension of the intrinsic layers of the TM [222–224]. Long-lasting negative ME pressure
also contributes to the progression, and the atrophic TM adheres to the promontrium and/or the incudostapedial complex[224]. Without MEE, patients with atelectatic TM tend tohave less-severe hearing loss, but progression to the adhesive
otitis media is regarded as a serious change and should be
carefully monitored in those patients.
In the atelectatic TM, retraction of the TM can be released
by applying positive pressure to the ME cavity. Conversely,in adhesive otitis media, the TM is partially or totally fixedby adhesions to the ME structures. To differentiate these twopathological conditions, it is useful to examine the mobility of the atelectatic TM by applying the Valsalva maneuver, tympanic inflation, and/or pneumatic otoscope (refer to
Section 2.3). Some atelectatic TM without MEE or adhesions
shows Ad-type tympanograms. Conversely, partial or total adhesion to the ME structures sometimes presents a type witha biphasic peak or type B, respectively.
Among these refractory cases, clinicians may encounterpatients whose case is complicated by not only tubal stenosis but also functional disorders of the ET, including patulous ET causing habitual nasal sniffing. By correctly diagnosing the patient’s tubal pathophysiology and offering
appropriate interventions, clinicians can achieve dramatic
curative effects [37–39,41,43,225]. Evaluating tubal functions using tubal function tests is thus recommended inthese intractable cases [42,132,226]. Practically, tubal function tests are not applicable to infants. We thus recommend a questionnaire, given the risk of habitual nasal
sniffing.
Finally, ME cholesteatoma is the most serious sequelaof OME. In ears with OME complicated by severe retracted TM, medialization of the TM sometimes predisposes to focal retraction pockets in the pars flaccida andevolves into acquired cholesteatoma (refer to Section 2.19.).
Conversely, adhesive changes affecting the posterosuperior quadrant of the pars tensa progress to pars tensacholesteatoma [224].
3.11.2. Treatment
In cases complicated by pathological conditions of surrounding organs, such as rhinosinusitis and allergic rhinitis,
clinicians should provide therapy to these structures. Again,in cases involving habitual sniffing associated with closing
failure of the ET, clinicians should explain its harmful effects
and advise patients to refrain from sniffing habitually (refer to Section 2.7., 3.CQ2–4). In refractory patients resistant
to conservative treatment, clinicians can offer tympanoplasty

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Fig. 10. Alternative classification by Borgenstein et al. (2007), categorized according to the severity of retraction and/or adhesion of the pars flaccida.
Comparison with the Sade system is also shown.

tube insertion. Specifically, in the case of atelectatic TM, clinicians should choose the most suitable tube according to theseverity of atelectasis and/or history of ventilation tube insertion (refer to Section 3. CQ6, Fig. 3).
Specifically for cases lacking enough space for ventilation tube insertion, some reports alternatively advocate thesubannular tube (SAT) method [227–229]. In this method, after the tympanomeatal flap is elevated, a T-tube is inserted
through the bony external auditory canal wall to the ME
sub-annularly, leaving the TM intact. Without invasive procedures affecting the TM, this method has an advantage interms of avoiding postoperative sequelae such as myringosclerosis or persistent perforation (refer to Section 1.20., 3.CQ7).
Again, patients whose case is complicated by thinned TM
attributed to atelectasis and/or patients who have undergone
repeated insertion of a tympanic ventilation tube are reportedly candidates for the SAT method [230]. However, pediatric patients undergoing these procedures need generalanesthesia [231].
Several reports have recommended tympanoplasty in patients with adhesive otitis media because of potential riskof progression to cholesteatoma and possible negative effects
on the ossicular chain [58,60–63]. Specifically, adhesive otitis media in pediatric patients is usually a less-severe condition than in adolescents, involving a higher prevalence ofpartial adhesion rather than total adhesion. Several reports
have thus advocated earlier surgical interventions to prevent
progression toward higher pathological stages of the adhesive TM [64,232–234]. On the other hand, we have not yet
reached conclusions whether such earlier surgical interventions could improve long-term prognosis or prevent development of cholesteatoma [58]. In planning for the indications
and timing of surgical interventions, radiological imaging, including CT, should be considered to evaluate development

and pneumatization of mastoid air cells with favorable gas
exchange functions (refer to Section 2.9.) [132,235]. With regard to CT, imaging should be kept to the minimum necessary[134].
Chapter 4. Management of OME in patients with Down
Syndrome (DS) or cleft palate
4.1. Management of OME in children with DS
4.1.1. Prevalence of hearing impairment
DS is caused by 21 trisomy, and it is one of the most frequent congenital aberrations (1:700 live births) [236]. There
are approximately 2200 DS births per year in Japan according
to recent surveillance [237]. This syndrome is characterized
by several abnormalities of external and visceral malformations, and results in mental and physical retardation. In theotolaryngological field, anomalies such as hearing loss, stenosis of the external ear canal, and cleft lip and palate are frequently associated with this syndrome.
Various degrees of hearing loss are noted in 39–78% ofchildren with DS. Most of the children show conductive hearing loss caused by OME. The prevalence of sensorineural
hearing loss is higher in children with DS than those without
DS, and the prevalence increases with age in children with
DS. According to the results of a recent newborn hearing
screening test in the United States, the rate of “refer” was
26.2% in babies with DS, much higher than those without
DS [238]. Approximately half of the children who receive
a “pass” in newborn screening tests later show conductive
hearing loss associated with OME and undergo TS tube insertion [238]. Iino et al. reported that 54% of children aged 3
months to 13 years showed moderate or severe hearing loss
[239]. Kreicher et al. studied hearing acuity in 1,760 ears

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of children with DS using pure-tone audiometry and showed
mild hearing loss in approximately 30%, whereas moderate
or greater loss was observed in <20%. The hearing loss was
mostly conductive hearing loss and improved with age. In
contrast, the hearing level of children with mixed hearing loss
or sensorineural hearing loss tended to deteriorate with age[240].
To summarize, the rate of “refer” in newborn hearing
screening tests in babies with DS is approximately 25% andsignificantly higher than in healthy babies. Half of children
with DS will later show mild to moderate hearing loss, andmost of them appear to have conductive hearing loss associated with OME.

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4.1.2. Prevalence of OME and its clinical course
The most frequent type of hearing loss in young children is
conductive deafness caused by OME. The incidence of OME
in DS is 40–70% according to several reports [239–241]. Approximately 60% of children with DS show MEE on unilateral or bilateral ears under an operating otomicroscope using apneumatic otoscope [239]. Morimoto et al. also reported that
43% of children with DS are diagnosed with OME [242]. The
prevalence of OME in DS is high in younger-aged children
and approximately 60% at the age of 6 years and 38% at
the age of 8 years [243]. Clinicians should be careful that inchildren with DS, the TM looks very dark, suggesting MEE;
however, this is sometimes due to the remnant of mesenchymal tissue of the ME [244].
OME gradually tends to resolve with age in healthy children. On the other hand, in children with DS, OME persists
for a long period of time despite conservative and surgicaltreatments. Less than 50% of children aged 2–12 years at thelast visit show resolution of MEE, despite medical treatment
lasting for more than 1 year. The same poor results were obtained in children with DS aged ≥10 years [239], and 24% ofchildren aged 7–18 years still had OME [245]. These results
clearly indicate that OME in DS is refractory otitis media.
The reasons of the high prevalence of OME in children
with DS are as follows: (1) frequent upper respiratory infections (90% of children with DS suffer from upper respiratory infections 4 times or more per year); (2) short skull
and narrow nasopharynx; (3) poorly pneumatized mastoid;and (4) extremely poor tubal function. Children with DS tend
to have infectious diseases because they have immunodeficiencies such as dysfunction of T- and B-lymphocytes anddysfunction of neutrophil chemotaxis. They also have a short
ET and tubal dysfunction. The latter may be caused by thecollapse of the ET resulting from a decrease in chondrocytes
in the cartilaginous portion of the tube. In addition, hypotonia of the tensor veli palatine muscle, which is responsible
for opening the ET, causes dysfunction of the tube.

in hearing [246]. In that study, it was suggested that late intervention using a TS tube failed to improve hearing. Shottet al. reported a high success rate for hearing improvement.
Ninety-three percent of the children with DS were judged tohave normal hearing 2 years after TS tube insertion when
they received the TS tube at the age of 2 years or younger.
The rate of resolution of OME was 3.6 times higher in DS
children who received TS tube insertion than in those who
did not [247]. On the other hand, DS children with a TS tube
who were followed for more than 3 years and assessed at theage of 7 years exhibited a significantly lower resolution rateof OME compared with healthy control children with a TS
tube. In addition, sequelae such as atelectasis, adhesion, andotorrhea from the tube were more frequently observed in DS
children than controls [248]. A study of OME in 57 children
with DS followed for 15 years showed that TS tube insertion
was performed in 88.8% of the cases, resulting in improved
hearing of normal to mild loss in 83.3%. However, 17% of
the cases had persistent TM perforation [249].
A study by Whiteman et al. showed significantly higher
verbal expression scores in DS youth treated with a TS tube
than in children without TS tube treatment. From these results, it is apparent that long-lasting hearing impairment affects language development in DS children [250].
To summarize, as OME in DS is very refractory and persistent, TS tube insertion is strongly indicated. TS tube insertion should be performed as early as possible to help withspeech development. However, if the TS tube is in place for along period, ME pathologies can appear as sequelae (refer to
3.CQ6–7). The indications for TS tube insertion in DS children are as the same as for those in healthy children (refer to
3.CQ6). Regarding hearing acuity, it is sometimes difficult toobtain accurate hearing levels by pediatric audiometry tests
such as COR (refer to Section 2.4–5). Repeated pediatric audiometry should be performed by skilled speech therapists,
and ABR is sometimes needed to judge the accuracy.
At the time of TS tube insertion, the external ear canal ofchildren with DS is extremely narrow, and it is relatively difficult to obtain patient adherence to treatment in the outpatientsetting. Therefore, TS tube insertion is usually done undergeneral anesthesia. Before surgery, it is necessary to checkfor complications such as congenital heart disease, pulmonary
hypertension, gastro-esophageal reflux, laryngeal stenosis, oratlantoaxial subluxation and then consult with pediatricians or
anesthesiologists about the operation. Informed consent fromcaregivers of the children is also necessary to ensure they areaware of potential complications such as otorrhea from thetube, tube re-insertion, and persistent perforation of the TM
after extubation. It has been reported that adenoidectomy is
not effective for the resolution of OME in children with DS[251].

4.1.3. Efficacy of insertion of TS tubes
There have been several reports concerning the efficacy
of insertion of TS tubes. Selikowitz et al. reported that inchildren with DS (6 years and older, mean age: 8.1 years)
who received a TS tube, 60% showed improvement in hearing, whereas 91% of healthy children showed improvement

4.1.4. Use of hearing aids
In the British NICE guidelines (refer to Section 1.4.), wearing a hearing aid is the first-line treatment for OME in children with DS, because early intervention is possible and there
are no complications [7,252]. There are no negative outcomes
associated with the use of a hearing aid. Therefore, physicians

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should not hesitate to recommend use of a hearing aid forchildren with DS. However, in children with DS, ingenuity isrequired to ensure the hearing aid remains in the ear or on
the auricle, because the external ear canal is extremely narrow,and the auricle cartilage is very thin and floppy. In addition,some children with DS refuse to wear a hearing aid with anear mold. It has been reported that only half of DS children
can wear hearing aids successfully [253]. Everyday training
with hearing aids results in active phonation and speech andincreased interest in sounds and people. Yamashita et al. reported that children who failed to wear hearing aids exhibitedsevere mental retardation. Their caregivers had the following
opinions [254]:“My child does not wear the hearing aid and takes it off
immediately.”“The efficacy of hearing aids is uncertain.”“There is a lot of stress for caregivers to force a child towear a hearing aid against his or her will.”“It is an economic burden to buy a hearing aid.”
Recent reports have described the use of bone-anchoredhearing aids (BAHAs) in children with DS who were unable
to use a hearing aid or undergo TS tube insertion [255]. The
children themselves and their caregivers were totally satisfied with BAHAs, although early complications involving thesoft tissue were seen in approximately half of the children.
BAHAs are thus an option for children with DS with hearing loss. In other reports, use of a sound field amplification
system (including an FM device) in school can selectively
amplify a teacher’s voice (improvement of signal/noise ratio),
resulting in better performance and good effects on speech
development in children with DS [256]. We anticipate further
advances to improve hearing loss in children with DS.
4.1.5. Guidelines for the management of OME in DS
1 Babies with DS are strongly recommended to have a
newborn hearing screening test to diagnose hearing impairment as early as possible.

2 Early diagnosis and intervention are necessary. The
main goal of the management of OME is to improve
hearing acuity and associated language and speech development.

3 TS tube insertion is one of the treatment options. TS
tube insertion is recommended as early as possible tohelp with speech development. However, if the TS tube
remains in place for a long period, ME pathologies candevelop as sequelae, such as persistent TM perforation
and adhesive otitis media after extubation.

4 Regular follow-up is mandatory. The assessment of otoscopic findings, hearing acuity, and speech development
should be done once every 3 or 4 months, with removalof earwax.
4.2. Management of OME in children with cleft palate
The prevalence of OME is very high in children with cleft
palate, and many of the cases are intractable. TM status andthe extent of hearing loss should be evaluated at approximately 1 year of age. Specifically, when TM status is ab-

normal or there is definite hearing loss, inserting a TS tube
and prescribing a hearing aid should be considered. Because
many cases are intractable, long-term follow-up is necessary.
4.2.1. Pathology
The tensor veli palatini muscle and the levator veli palatini muscle are involved in opening the ET, and their orientations are abnormal in children with cleft palate. Moreover,since the cartilage of the auditory tube is fragile and the auditory tube tends to remain open, there is impaired closure.
Once the pressure inside the tympanic cavity becomes negative because of sniffling, etc., it is impossible to eliminate
the negative pressure when swallowing. The developments ofthe mastoid air cells are suppressed in children with a cleft
palate in comparison with children without cleft palate, andtheir mastoid air cells are significantly smaller from 1 year ofage onward. The mastoid air cells develop as children grow,but even at 5 years of age, their area never catches up with
their area in children without a cleft palate. Moreover, evenwhen a TS tube has been inserted, their area is smaller thanin children without cleft palate [257]. The ME is ventilated
by gas exchange through the mucosa of the mastoid air cells
as well as the auditory tube. Not only is middle eaer ventilation in children with cleft palate impaired because of abnormal auditory tube morphology and function, their mastoid
air cells are smaller, and gas exchange is also poor. Because
these conditions result in greater susceptibility to OME, mostof the children have intractable OME. Therefore, long-term
follow-up is necessary.
4.2.2. Epidemiology
In a study of the incidence rate of OME, MEE was observed in 456 (71.9%) of 634 ears of Asian children with cleft
palate in whom myringotomy was performed at the same time
as palatoplasty [258]. Flynn et al. conducted a longitudinal
study extending from 1 year to 5 years of age to assess theincidence of OME in children with both unilateral cleft lip
and cleft palate and children without cleft palate. OME developed in 74.7% of the children with cleft palate and 19.4%
of children without cleft palate, and thus, it developed in significantly more children in the cleft palate group (p<0.001).
Even at 5 years of age, abnormal TM findings and abnormal tympanometry findings were observed in close to 90% of
the children with cleft palate. When followed up for an evenlonger time, the percentages with abnormal TM findings andhearing loss decreased as the children grew. However, evenat 16 years of age, abnormal findings were seen in the ME
of 19% of the subjects [259].
In a longitudinal study of 146 cleft palate and cleft lip
and palate cases from birth to 15 years of age, more casesof OME were observed in the latter group, and more ventilation tubes were placed. The cumulative incidence of OME
increased rapidly until the age of 2 to 4 years and then continued to increase at a lower rate until the age of 8 years andremained unchanged thereafter. At 15 years of age, 73% of
patients with cleft palate had a history of OME, and 44% of
patients had a history of at least one TS tube insertion. In

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patients with cleft lip and palate, 90% had a history of OME,
and 67% had a history of TS tube insertion [260].
On the other hand, Kwinter et al. examined 58 patients
under 15 years of age (mean age: 5.8 years) with submucosal
cleft palate. Sixteen of these patients presented chromosomal
abnormalities, including 7 cases of 22q11.2 deletion syndrome[261]. In their study, 30 patients (51.7%) had OME, 3 hadrecurrent otitis media, and 31 patients (47%) had a history ofat least one bilateral TS tube insertion.
In a report on patients under 7 years of age that compared
the incidence of OME in 111 ears from patients with cleft
palate, 65 ears from patients with submucosal cleft palate, and50 ears from patients with congenital nasopharyngeal atresia,
the incidence of OME was 69%, 62%, and 28%, respectively.
There was a significant difference in the prevalence rate between cases of cleft palate and congenital nasopharyngeal
atresia, but no obvious difference was noted between casesof cleft palate and submucosal cleft palate [262].The study
concluded that in children with cleft palate, observation of
the TM and otorhinolaryngological examinations should be
performed from birth and followed for an extended period oftime.
4.2.3. Diagnosis(1) Observation. Observation of the TM with a pneumatic
otoscope is useful at diagnosis. Otomicroscopes and otoscopes
are also used, but many children with a cleft palate have anarrow external auditory canal. Specifically, flexible electronic
scopes are suitable for observation of the TM in children witha narrow external auditory canal.
(2) Tympanometry (refer to Section 2.5). Tympanometry (Fig.
5) is useful for confirming MEE after observation with apneumatic otoscope. Chen et al. assessed 634 ears of cleft
palate patients by tympanometry. Of the 456 ears in which
myringotomy revealed a MEE, the tympanogram was type B
in 436 ears, type A in 11 cases, and type C in 9 cases [209].
The sensitivity of type B tympanograms was 0.956, andthe specificity was 0.596. When assessed according to monthof age, the results for specificity were 0.375 in 9-month-old
infants and 0.857 in infants 14 months of age and over [209].
Caution is required at diagnosis based on the results of tympanometry in infants up to 9 months of age. Examinations
at 678 Hz and 1000 Hz are performed on infants in Westerncountries [82,263].
(3) Hearing tests. Yang et al. performed tympanometry andrecorded TEOAEs and ABRs in 42 children 6 to 24 monthsof age with cleft palate [264]. The tympanogram was type A
in 30 ears, and the TEOAE results were poor in 5 ears (5.9%).
The ABR results showed moderate conductive hearing loss in
3 ears and moderate sensorineural hearing loss in 2 ears. The
TEOAE results were poor in all of the tympanogram type B
and type C cases.
The ABR thresholds were in the 30-95 decibel normal
hearing level (dBnHL) range in all of the cases, and the mean
threshold was 53.5 ± 13.6 dBnHL. The concordance rate between the TEOAE and ABR results was 80% [264].

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Flynn et al. performed inspections with an otomicroscope,
tympanometry, and hearing tests in 58 children with cleft
palate at 7, 10, 13, and 16 years of age and reported that
abnormal TM findings and hearing test results improved
as the children aged [265]. However, they reported no improvement with age in the 6000-Hz and 8000-Hz threshold values. They also reported differences according to cleft
type: the proportion of children who had abnormal TM findings was smaller among cases with cleft palate alone thanamong cases accompanied by cleft lip, and cases with bilateral cleft lip and cleft palate had the poorest hearing
at high-frequency thresholds [265]. It is desirable to perform regularly scheduled age-appropriate hearing tests, including newborn hearing screening, in children with a cleft
palate.
4.2.4. Treatment(1) Insertion of a TS tube (refer to 3.CQ6).
a) Indication. There is a report of TS tube insertion at
the same time as palatoplasty in almost every case [266], anda report of tube insertion in selected cases. Phua et al. conducted a comparative study of a group of 45 patients in which
they performed the customary treatment consisting of palatoplasty and routine simultaneous intubation and a select groupof 189 patients in which they performed tube insertion when
the following indications were fulfilled: “recurrent AOM, aclear 30-dB or more hearing loss, and a parent pointed out
hearing loss”. In the latter group, tube insertion according tothese indications was performed in 79 (41.8%) of 189 children with cleft palate. There were more cases of postoperative
recurrent AOM and abnormal TM findings in the customarygroup, and they reported that tube insertion should be performed in children with cleft palate who have recurrent otitis
media, clear hearing loss, etc., and not as a customary practice[267].
Szabo et al. considered the indications to be: “observationof ME effusion at the time of cheiloplasty, or bilateral conductive hearing loss of 25 dB or more that persists for 3 months
or more.” The subsequent analysis showed that tube insertion
had been performed at least once by 5 years of age in 98%of the patients and that it had been performed an average of
1.7 times [268]. Kobayashi et al. considered the indications
for tube insertion to be “when ME effusion persisting for 3
months or more, severe retraction of the TM, bilateral hearing loss of 30 dB or more, and language development delay
are observed.” They performed tube insertion by 5 years ofage in 38% of 108 children with cleft palate. Tube insertion
was particularly often necessary in cases with poor mastoid
air cell development at 1 year of age, and there were also
many cases with a poor course from 5 years of age onward[269].
In a systematic review of 18 papers, Ponduri et al. reported that there is insufficient evidence that routinely performing tube insertion early in cleft palate cases has any
long-term benefits in terms of auditory, conversational, linguistic, or psychosocial development [270]. Another recent
systematic review included 9 studies selected from 488 articles published between 1982 and 2013, and the rate of TS

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tube insertion for OME ranged from 38% to 53%, with a tendency to be performed more often in refractory cases. This
trend persisted for 1 to 9 years after TS tube insertion. TS
tube insertion had a positive effect on language development[271].
These results suggest that TS tube insertion is not necessary for every child with cleft palate. In cleft palate patients,
TS tube insertion is often performed at the same time as
palatoplasty around the age of 1 year to minimize the number of procedures requiring general anesthesia. Before palatoplasty, it is necessary to check the TM findings and the degreeof hearing loss.
b) Duration of tube insertion and complications. Tube insertion is not necessary in every child with a cleft palate.
However, some cases require two or more tube insertions,and in some cases, long-term tube insertion is necessary.
Ahn et al. reported that during a mean follow-up period of 4.9 years in 213 cases in which they performed
tube insertion during palatoplasty, there were 140 cases inwhich tube insertion was performed once and 73 cases
in which tube insertion had been performed 2 or moretimes [272].
Yamada et al. performed tube insertion at the same time
as palatoplasty at 1 year of age and assessed the tube insertion period in the 133 ears whose course they had followed
until ≥6 years of age. The mean tube insertion period was
22.3 months in the recurrent cases, 32.6 months in the caseswith a favorable course, and 43.9 months in the cases with apersistent TM perforation [273]. Long-term tube insertion for
approximately 30 months appears to be necessary in children
with cleft palate.
One study reported that by 18 years of age, cholesteatoma
was observed in 38 (4.4%) of 869 cases of cleft palate inwhich tube insertion had been performed one or more times;cholesteatoma developed in 556 (1.0%) of 56,080 cases without a cleft palate during the same period, and developmentof cholesteatoma was more common among the cleft palate
cases (p < 0.001) (refer to 3.CQ6, 3-11. Supplemental CQ)[274]. Regular otoscopic examination is thus necessary evenafter tube insertion.
(2) Palatoplasty. There have been few reports on the degree
to which palatoplasty directly contributes to improving OME.
When patients had reached 12 months of age, Klockars et al.
compared a group in which soft palate closure and tube insertion had been performed at 3-4 months of age with a group inwhich tube insertion alone had been performed at 3-4 monthsof age. They reported that the rates of recurrence of OME after tube extrusion and of tube occlusion were significantly
lower in the group in which the soft palate had been closed
early [275].
It is also possible that the incidence of postoperative OME
may differ depending on the specific palatoplasty techniqueemployed. In a recent systematic review of 7 studies thatexamined the number of postoperative TS tube insertion for
OME, it was found that the Sommerlad and Furlow methods
were associated with a lower incidence of OME and TS tube
insertion [276].

(3) Hearing aids. TS tube insertion is a common treatment
for hearing loss caused by OME. However, complications
such as ear discharge and permanent perforation of the TM
frequently occur. Therefore, some authors have recommended
the use of hearing aids [277,278]. The use of hearing aids is
associated with fewer complications than TS tube insertion.
4.2.5. Guidelines for the management of OME in cleft
palate
1 Early diagnosis of hearing loss using newborn hearing
screening tests.

2 If the result of a newborn hearing screening test is ‘refer’, a detailed hearing test should be performed as soon
as possible (refer to Section 2.4–6).

3 Prior to palatoplasty at around 1 year of age, observation of the TM and auditory evaluation should be
performed to determine the indication for TS tube insertion. (For the degree of hearing loss to be used as acriterion, refer to 3.CQ 6).

4 Cleft palate may require long-term or multiple TS tube
insertions. The risks of infection and permanent perforation of the TM are therefore increased. The use ofhearing aids should also be considered in future studies.

5 If the TM findings are abnormal, imaging studies shouldbe performed, but attempts should be made to minimize
radiation exposure.

6 Long-term follow-up is necessary.
Chapter 5. Supplementary note: future prospects for
improving diagnostic techniques
5.1. New screening tests for pediatric OMEThis chapter introduces promising new diagnostic techniques for ME transmission disorders: MFT, wide-band tympanometry (WBT), and optical coherence tomography (OCT).
Conventional 226-Hz tympanometry is a simple and minimally invasive testing method. It is especially useful for the
diagnosis of OME and evaluation of ME transmission disorders. This test is used widely by otolaryngologists as an
indispensable test. However, the test has a limitation: due tothe anatomical characteristics of the infant ear canal, the reliability of 226-Hz tympanometry in infants is reduced, andutilization of 1000-Hz tympanometry is recommended (refer
to Section 2.5). MFT can not only overcome this limitation,it also allows acquisition of a large amount of information.
It has been reported that high-frequency tympanograms aresuperior for evaluation of the ME in newborns [279]. Studies
on MFT were started as early as in the 1970s, and the usefulness of the test has been demonstrated. However, marketingof MFT has stalled due to not only the complexity of thedevice, but also the complexity of the analysis [279,280].
With the recent innovations and advances in computer processing speed, it has become easier to control and analyze
MFT data, allowing commercialization of the technique. OCT
is an unfamiliar term in the field of otolaryngology; however,
it is an indispensable device for retinal diagnosis in the field

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37

Fig. 11. Wideband tympanometry. A: Absorbance as a 3D pattern diagram in relation to frequency and pressure. B: Example of a wideband tympanogram.
Absorbance plotted as a function of frequency. Solid line: absorbance curve at tympanometric peak pressure; Dotted line: absorbance curve at ambient pressure.
Shaded regions and fine line: Pediatric normative data (age 3 to 11 years, 10th and 90th percentiles).

of ophthalmology, and it is expected to be applied in the fieldof otolaryngology in the future.
The clinical usefulness of OCT has been demonstrated in avariety of medical and surgical applications, including in thefields of gastroenterology, dermatology, cardiology, and oncology. OCT is a non-invasive, non-contact modality that uses
the light interference properties generated by near-infrared
light. OCT can produce three-dimensional tomographic images with high resolution. Therefore, there is no concern
about radiation exposure, and it can provide tomographic images of various organs of the human body. A system for
imaging cross-sections of the TM and diagnosing otitis mediausing OCT is currently under development.
5.2. WBT
Tympanometry using a single frequency (226 Hz) is an
essential tool for the diagnosis of ME disorders. However,the use of a single frequency makes it difficult to detect subtle changes in the physical mechanism of sound transmission
in the ME. WBT, a type of MFT, is used to diagnose ME
disorders. WBT sweeps external ear canal pressures and frequencies from low to high (4000-8000 Hz) (Fig. 11). Thismeasurement method allows testing over a wide range of frequencies, and it is affected to a lower degree by the external
ear canal space between the probe and the TM. MFT is reportedly useful not only for diagnosing ME disorders and dislocation or fixation of the ossicles but also for the diagnosisof labyrinthine diseases.
Of the types of MFT, WBT has been studied since the1990s. The test involves repeated use of a click stimulus overa wide frequency range (226 to 8000 Hz) delivered from aprobe placed at the external ear canal [281,282]. A microphone in the probe measures the reflected sound energy fromthe TM (reflected power) after the incident sound energy issent into the external ear canal. The ratio (absorbance) of thereflected power to the sound energy that finally passes to the
ME is then calculated. As the absorbance varies dependingon the frequency and the surrounding environment, the features of the sound response of the external ear and ME canbe imaged using the wide-band frequency. More specifically,
WBT measurements are sensitive to changes in the ME statuscaused by external and ME disorders [283].
 Comparison with conventional tympanometry and diagnostic accuracy
It is not possible to simply compare the diagnostic accuracy between MFT and tympanometry using a single frequency (226 Hz). However, for the diagnosis of OME, WBT
is reportedly superior to the conventional method in termsof sensitivity for differentiating effusion in the ME [284].
According to another study, WBT boasts a high diagnostic
rate when combined with examination of otoacoustic emissions [285]. Furthermore, due to the extremely large amountof information that can be obtained by WBT, various analysis methods can be used to identify pathological conditions,
including resonance frequency comparison and the use of averaged tympanogram data between certain frequencies.
 Future prospects
It has been reported that when OCT (described below) is
combined with MFT for observing the ME, differences inabsorbance can be seen depending on the viscosity of theaccumulated fluid and the amount of fluid [286].
5.3. OCT for otology applications
OCT is a non-invasive optical imaging modality that produces depth-resolved images. It is an optical imaging test thatenables high-resolution cross-sectional imaging of biologicaltissues and samples at clinically relevant depths [287,288].

Please cite this article as: H. Hidaka, M. Ito, R. Ikeda et al., Clinical practice guidelines for the diagnosis and management of otitis media with effusion(OME) in children in Japan – 2022 update, Auris Nasus Larynx, https:// doi.org/ 10.1016/ j.anl.2022.12.004

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38

Declaration of Competing Interest
The authors declare no conflict of interest.
Supplementary materials
Supplementary material associated with this article can befound, in the online version, at doi:10.1016/j.anl.2022.12.004.
References

Fig. 12. Optical coherence tomography for otology.

OME is defined as “otitis media that can lead to hearing
loss, characterized by the accumulation of exudate in the ME
cavity, without perforation of the TM and without acute inflammatory symptoms, such as ear pain and fever.” Therefore,
differential diagnosis from AOM is important. However, thedifferential diagnosis is difficult in some cases in which only
the findings of the TM are available. Improvement in thisniche is also desired from the viewpoint of proper use of antibacterial drugs. Application of OCT as a new differential
diagnosis method the in the field of otology has begun.
 Clinical application of OCT in the field of otology
ME OCT images were initially analyzed in animal studies
but have since progressed to clinical applications [288,289].
At present, studies on OCT imaging in the field of otology
are aimed at identifying pathologies of the TM and ME. Successive clinical studies on real-time OCT images of the TM
have been reported. In these studies, the thicknesses of thenormal TM and TMs in AOM and even chronic otitis media
were measured from tomographic images, and biofilm imagesof the back of the TMs and accumulation of exudate in the
ME were depicted (Fig. 12). These studies have concluded
that OCT can contribute to highly accurate diagnosis of otitis
media [290–294]. Moreover, it has been reported that OCT
enables evaluation of biofilms on both sides of the TM before
and after surgical intervention (TS tube insertion) [295].
 Future prospects
OCT for otology applications has great potential for future
development. Further advances are expected, such as development of an intraluminal OCT catheter for ET evaluation,a functional hand-held OCT otoscope with vibrometer, a surgical microscope integrated with OCT, and a micro-OCT forin vivo imaging [296]. Recent years have seen widespreaduse of OCT devices equipped with Doppler vibrometers forevaluating the mobility of the auditory ossicles. Thus, OCT isalso becoming useful for preoperative diagnosis of conductive
hearing loss, such as in cases of otosclerotic disease [297].
Financial disclosure
A portion of this study was supported by Funds from theJapan Otological Society.

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Please cite this article as: H. Hidaka, M. Ito, R. Ikeda et al., Clinical practice guidelines for the diagnosis and management of otitis media with effusion(OME) in children in Japan – 2022 update, Auris Nasus Larynx, https:// doi.org/ 10.1016/ j.anl.2022.12.004