Statement of Principles concerning OTITIS MEDIA (Balance of Probabilities) (No. 63 of 2022) The Repatriation Medical Authority determines the following Statement of Principles under subsection 196B(3) of the Veterans' Entitlements Act 1986. Dated 24 June 2022 The Common Seal of the Repatriation Medical Authority was affixed to this instrument at the direction of: Professor Terence Campbell AM Chairperson Contents 1 Name 2 Commencement 3 Authority 4 Repeal 5 Application 6 Definitions 7 Kind of injury, disease or death to which this Statement of Principles relates 8 Basis for determining the factors 9 Factors that must exist 10 Relationship to service 11 Factors referring to an injury or disease covered by another Statement of Principles Schedule 1 - Dictionary 1 Definitions 1 Name This is the Statement of Principles concerning otitis media (Balance of Probabilities) (No. 63 of 2022). 2 Commencement This instrument commences on 25 July 2022 3 Authority This instrument is made under subsection 196B(3) of the Veterans' Entitlements Act 1986. 4 Repeal The Statement of Principles concerning otitis media No. 52 of 2014 (Federal Register of Legislation No. F2014L00484) made under subsections 196B(3) and (8) of the VEA is repealed. 5 Application This instrument applies to a claim to which section 120B of the VEA or section 339 of the Military Rehabilitation and Compensation Act 2004 applies. 6 Definitions The terms defined in the Schedule 1 - Dictionary have the meaning given when used in this instrument. 7 Kind of injury, disease or death to which this Statement of Principles relates (1) This Statement of Principles is about otitis media and death from otitis media. Meaning of otitis media (2) For the purposes of this Statement of Principles, otitis media: (a) means an infective or inflammatory process within the middle ear; and (b) excludes cholesteatoma and isolated perforation of the tympanic membrane. (3) While otitis media attracts ICD‑10‑AM code H65, H66, or H67 in applying this Statement of Principles the meaning of otitis media is that given in subsection (2). (4) For subsection (3), a reference to an ICD-10-AM code is a reference to the code assigned to a particular kind of injury or disease in The International Statistical Classification of Diseases and Related Health Problems, Tenth Revision, Australian Modification (ICD-10-AM), Tenth Edition, effective date of 1 July 2017, copyrighted by the Independent Hospital Pricing Authority, ISBN 978-1-76007-296-4. Death from otitis media (5) For the purposes of this Statement of Principles, otitis media, in relation to a person, includes death from a terminal event or condition that was contributed to by the person's otitis media. Note: terminal event is defined in the Schedule 1 – Dictionary. 8 Basis for determining the factors On the sound medical‑scientific evidence available, the Repatriation Medical Authority is of the view that it is more probable than not that otitis media and death from otitis media can be related to relevant service rendered by veterans or members of the Forces under the VEA, or members under the MRCA. Note: MRCA, relevant service and VEA are defined in the Schedule 1 – Dictionary. 9 Factors that must exist At least one of the following factors must exist before it can be said that, on the balance of probabilities, otitis media or death from otitis media is connected with the circumstances of a person's relevant service: (1) having an upper respiratory tract infection within the 14 days before the clinical onset of otitis media; (2) having partial or complete obstruction of the Eustachian tube of the affected side within the 7 days before the clinical onset of otitis media; Note: Obstruction of the Eustachian tube usually involves symptoms of Eustachian tube dysfunction and negative pressure in the middle ear. Symptoms of Eustachian tube dysfunction include aural fullness, a feeling of pressure or being clogged, pain, popping and crackling in the ears. Signs include a serous middle ear effusion and retraction of the tympanic membrane. (3) having allergic rhinitis or sinusitis within the 7 days before the clinical onset of otitis media; (4) having a space-occupying mass within the nasopharynx at the time of the clinical onset of otitis media; Note: Examples of a space-occupying mass within the nasopharynx include malignant neoplasm of the nasopharynx, lymphoma, benign neoplasm of the nasopharynx such as pleomorphic adenoma and oncocytoma, and nasopharyngeal cyst such as an oncocytic cyst. (5) undergoing a course of therapeutic radiation for cancer, where the head or upper neck was in the field of radiation, before the clinical onset of otitis media; Note: Radiotherapy given to the nasopharynx or adjacent areas for cancer may include either or both Eustachian tubes in the field of radiation. This may result in otitis media in the ear contralateral to the side of the cancer. (6) having an acute rupture of the tympanic membrane of the affected side within the 3 months before the clinical onset of otitis media; Note: Circumstances in which an acute rupture of the tympanic membrane can occur include intrusion of a foreign body such as an implement, stick or projectile into the tympanic cavity and surgical procedures involving the tympanic membrane. (7) having chronic perforation of the tympanic membrane of the affected side before the clinical onset of otitis media; Note: Chronic perforation may be the result of previous otitis media. Chronic perforation includes tympanostomy tubes ("grommets"), usually inserted for acute recurrent otitis media or chronic otitis media. (8) having an episode of otitic barotrauma involving the affected ear within the 7 days before the clinical onset of otitis media; Note: Otitic barotrauma is also known as otic barotrauma. (9) having tuberculosis or nontuberculous mycobacterial disease at the time of the clinical onset of otitis media; (10) having gastro-oesophageal reflux disease at the time of the clinical onset of otitis media; (11) having ascariasis or myiasis of the ear, nose or throat at the time of the clinical onset of otitis media; Note: Myiasis is an infestation of maggots. (12) having ANCA-associated vasculitis at the time of the clinical onset of otitis media; Note: ANCA (anti-neutrophil cytoplasmic antibody)-associated vasculitis refers to necrotizing vasculitis that primarily affects small and medium blood vessels and includes granulomatosis with polyangiitis, microscopic polyangiitis and eosinophilic granulomatosis with polyangiitis. (13) having an upper respiratory tract infection within the 14 days before the clinical worsening of otitis media; (14) having partial or complete obstruction of the Eustachian tube of the affected side within the 7 days before the clinical worsening of otitis media; Note: Obstruction of the Eustachian tube usually involves symptoms of Eustachian tube dysfunction and negative pressure in the middle ear. Symptoms of Eustachian tube dysfunction include aural fullness, a feeling of pressure or being clogged, pain, popping and crackling in the ears. Signs include a serous middle ear effusion and retraction of the tympanic membrane. (15) having allergic rhinitis or sinusitis within the 7 days before the clinical worsening of otitis media; (16) having a space-occupying mass within the nasopharynx at the time of the clinical worsening of otitis media; Note: Examples of a space-occupying mass within the nasopharynx include malignant neoplasm of the nasopharynx, lymphoma, benign neoplasm of the nasopharynx such as pleomorphic adenoma and oncocytoma, and nasopharyngeal cyst such as an oncocytic cyst. (17) undergoing a course of therapeutic radiation for cancer, where the head or upper neck was in the field of radiation, before the clinical worsening of otitis media; Note: Radiotherapy given to the nasopharynx or adjacent areas for cancer may include either or both Eustachian tubes in the field of radiation. This may result in otitis media in the ear contralateral to the side of the cancer. (18) having an acute rupture of the tympanic membrane of the affected side within the 3 months before the clinical worsening of otitis media; Note: Circumstances in which an acute rupture of the tympanic membrane can occur include intrusion of a foreign body such as an implement, stick or projectile into the tympanic cavity and surgical procedures involving the tympanic membrane. (19) having chronic perforation of the tympanic membrane of the affected side before the clinical worsening of otitis media; Note: Chronic perforation may be the result of previous otitis media. Chronic perforation includes tympanostomy tubes ("grommets"), usually inserted for acute recurrent otitis media or chronic otitis media. (20) having an episode of otitic barotrauma involving the affected ear within the 7 days before the clinical worsening of otitis media; Note: Otitic barotrauma is also known as otic barotrauma. (21) having tuberculosis or nontuberculous mycobacterial disease at the time of the clinical worsening of otitis media; (22) having gastro-oesophageal reflux disease at the time of the clinical worsening of otitis media; (23) having ascariasis or myiasis of the ear, nose or throat at the time of the clinical worsening of otitis media; Note: Myiasis is an infestation of maggots. (24) having ANCA-associated vasculitis at the time of the clinical worsening of otitis media; Note: ANCA (anti-neutrophil cytoplasmic antibody)-associated vasculitis refers to necrotizing vasculitis that primarily affects small and medium blood vessels and includes granulomatosis with polyangiitis, microscopic polyangiitis and eosinophilic granulomatosis with polyangiitis. (25) inability to obtain appropriate clinical management for otitis media. 10 Relationship to service (1) The existence in a person of any factor referred to in section 9, must be related to the relevant service rendered by the person. (2) The factors set out in subsections 9(13) to 9(25) apply only to material contribution to, or aggravation of, otitis media where the person's otitis media was suffered or contracted before or during (but did not arise out of) the person's relevant service. 11 Factors referring to an injury or disease covered by another Statement of Principles In this Statement of Principles: (1) if a factor referred to in section 9 applies in relation to a person; and (2) that factor refers to an injury or disease in respect of which a Statement of Principles has been determined under subsection 196B(3) of the VEA; then the factors in that Statement of Principles apply in accordance with the terms of that Statement of Principles as in force from time to time. Schedule 1 - Dictionary Note: See Section 6 1 Definitions In this instrument: MRCA means the Military Rehabilitation and Compensation Act 2004. otitis media—see subsection 7(2). relevant service means: (a) eligible war service (other than operational service) under the VEA; (b) defence service (other than hazardous service and British nuclear test defence service) under the VEA; or (c) peacetime service under the MRCA. Note: MRCA and VEA are also defined in the Schedule 1 - Dictionary. terminal event means the proximate or ultimate cause of death and includes the following: (a) pneumonia; (b) respiratory failure; (c) cardiac arrest; (d) circulatory failure; or (e) cessation of brain function. VEA means the Veterans' Entitlements Act 1986.