Statement of Principles concerning otitis externa (Reasonable Hypothesis) (No. 25 of 2021)

This instrument is a Statement of Principles (SoP) concerning otitis externa (Reasonable Hypothesis) (No. 25 of 2021) made by the Repatriation Medical Authority under subsection 196B(2) of the Veterans' Entitlements Act 1986 (s 3). It commences on 25 January 2021 (s 2), and expressly repeals the earlier Statement of Principles concerning otitis externa No. 58 of 2012 (s 4). The SoP applies to claims that fall within section 120A of the VEA or section 338 of the Military Rehabilitation and Compensation Act 2004 (MRCA) (s 5).

Mechanically, the instrument performs three functions:

• It defines the medical entity to which it relates, otitis externa, as an infectious or non-infectious inflammation of the external auditory canal and lists sub‑types (acute diffuse, furunculosis, eczematous, malignant, acquired cholesteatoma of the external auditory canal, otomycosis) (s 7(2)). It states that while ICD‑10‑AM codes are associated (H60, H62.x), the statutory meaning for the SoP is the textual definition in s 7(2) (s 7(3)-(4)).

• It sets a causation threshold for the purposes of establishing a "reasonable hypothesis" linking otitis externa (or death from it) to relevant service by prescribing discrete, enumerated factors that must exist in relation to clinical onset or clinical worsening (s 9). These factors are temporal and content‑specific (for example, "participating in aquatic activities within the ten days before the clinical onset" (s 9(1)); "being exposed to hot and humid weather conditions on at least ten days within the 30 days before the clinical onset" (s 9(2)); and a list through s 9(27)).

• It frames how those factors must relate to service (s 10) and how to treat instances where a listed factor overlaps with an injury or disease covered by another SoP (s 11). The SoP also incorporates defined technical terms and thresholds in Schedule 1, for example, the precise definitions of "aquatic activities", "hot and humid weather conditions" and "immunocompromised state as specified".

The instrument explicitly includes death where otitis externa contributed to a terminal event (s 7(5)). It records the RMA's view that "sound medical‑scientific evidence" supports a relationship between otitis externa and relevant service (s 8), and then operationalises that view by prescribing the factors and definitions claim assessors must apply.

For decision‑makers and advisers, the practical effect is to narrow the question of whether a "reasonable hypothesis" exists to whether at least one of the enumerated factors, properly related to the person's relevant service, is shown according to the temporal and definitional constraints in the SoP (s 9, s 10, Schedule 1). The SoP does not itself award benefits or set entitlements, but it is a binding instrument for the purposes described in subsection 196B(2) of the VEA and so is applied in the claims adjudication process referenced in s 5.

This SoP is structured around a small set of core legal and medical concepts that determine causation for claims under the VEA and MRCA.

1. Otitis externa and death from otitis externa. The instrument defines otitis externa in statutory terms (s 7(2)): an inflammation of the external auditory canal, infectious or non‑infectious, and explicitly lists included clinical variants. It also extends coverage to death where otitis externa contributed to a terminal event or condition (s 7(5)). The instrument acknowledges ICD‑10‑AM coding but takes its meaning from the textual definition (s 7(3)-(4)).

2. Reasonable hypothesis standard. The SoP establishes what facts are required so that a "reasonable hypothesis" is raised that the condition is related to relevant service. Operationally, section 9 sets out the discrete factors which, if present and related to relevant service, suffice as the minimum evidence that a reasonable hypothesis exists.

3. Temporal nexus and clinical event markers. The instrument differentiates between clinical onset and clinical worsening. Many factors are tied to short, specific pre‑event windows , commonly ten days before clinical onset or clinical worsening, or within 30 days before onset/worsening (for example s 9(1), s 9(2), s 9(3), s 9(10)). For aggravation or material contribution, subsections 9(14)-9(27) apply only where the person's otitis externa was suffered or contracted before/during (but did not arise out of) the person's relevant service (s 10(2)). Thus the SoP separates new onset during service from aggravation of pre‑existing disease.

4. Enumerated environmental, traumatic and medical factors. Section 9 enumerates factors grouped by exposure type (aquatic activities s 9(1) and s 9(14)), climatic exposure (hot and humid weather s 9(2) and s 9(15)), medical interventions and trauma (radiation s 9(3), trauma s 9(4) and s 9(17), foreign object s 9(5) and s 9(18), extrinsic aural device s 9(6) and s 9(19)), structural/anatomic predispositions (narrowing or obstruction s 9(7) and s 9(20)), skin and infectious disease comorbidities (s 9(8), s 9(9), s 9(21), s 9(22)), ear disease comorbidity (chronic suppurative otitis media s 9(10) and s 9(23)), systemic risk states (diabetes mellitus s 9(11) and s 9(24), immunocompromised state s 9(12) and s 9(25)), and treatment‑linked fungal disease (otomycosis factors s 9(13) and s 9(26)). There is also a catch‑all factor for "inability to obtain appropriate clinical management" (s 9(27)).

5. Precise definitional thresholds in the Schedule. The Schedule provides technical thresholds and examples that the SoP requires assessors to apply: "aquatic activities" includes both submersion and retention of water in the ear canal and gives examples such as swimming, diving and trekking through watercourses; "hot and humid weather conditions" is defined as ambient humidity exceeding 40 per cent and maximum temperature exceeding 30 degrees Celsius; "extrinsic aural device" is defined and exemplified (ear buds, hearing aids, headphones, stethoscopes); "immunocompromised state as specified" lists states and circumstances (immunosuppressive drugs, malignancy, chronic renal failure, HIV, severe malnutrition, transplantation) with further definition of chronic renal failure and immunosuppressive drug (Schedule 1, Definitions).

This SoP affects three principal groups directly and several secondary actors indirectly.

Primary directly affected groups

1. Veterans, serving members and claimants. By its terms (s 5), the SoP applies to claims falling under s 120A of the VEA or s 338 of the MRCA. Schedule 1 defines "relevant service" broadly to capture operational, peacekeeping, hazardous and British nuclear test defence service under the VEA, and warlike and non‑warlike service under the MRCA. Any person lodging a claim that relies on otitis externa (or death contributed to by otitis externa) as being related to relevant service will be assessed against this SoP.

2. Claim adjudicators and decision‑makers. Departmental officers, case managers, medical referees, and the decision bodies that apply the VEA and MRCA will use the SoP as a statutory benchmark to determine whether a reasonable hypothesis exists that links otitis externa to service. Section 3 records the statutory authority of the RMA to make the instrument, and s 9 prescribes the minimum factors.

3. Clinicians providing evidence. Treating physicians, ENT specialists and other clinicians will be required to report and document the clinical onset/worsening date, comorbidities and exposures listed in s 9, and to give opinions that can be matched against the SoP factors. The Schedule’s precise definitions (for example the temperature/humidity threshold for "hot and humid weather conditions", or the cumulative hours for use of extrinsic aural devices) will guide the clinical evidence that is necessary.

Secondary affected groups

4. Legal representatives and advocates. Lawyers and advocates preparing claims must frame factual material to show one or more of the listed factors within the temporal windows, and that those factors are linked to relevant service under Schedule 1 definitions.

5. Government budgets and administrators. While the SoP itself is an evidentiary instrument, its application can influence the number and quality of successful claims. The instrument therefore affects the fiscal exposure of the Veterans' Entitlements scheme through its causal threshold, although the SoP does not itself appropriate funds or set entitlements.

6. Service planners, occupational health and operational commanders. The enumerated exposures,particularly aquatic activities, hot and humid exposure, use of extrinsic aural devices, and exposure to blast or surgical procedures,are operational realities. The SoP can influence what evidence service personnel are advised to record (for example, records of water immersion, ear protection use, or local environmental conditions) because those records will be material to claims.

This SoP does not itself create novel statutory duties to third parties or confer direct entitlements; rather, it prescribes a binding evidentiary framework to be used in adjudication of claims under the VEA and MRCA. Nevertheless, it imposes practical duties and recognises claimant rights in several concrete ways.

Duties on decision‑makers and administrators

• Apply the SoP as the operative statement of factors that must exist to raise a reasonable hypothesis. Section 9 sets out the minimum factors and s 10 requires that any such factor must be related to the person’s relevant service. The SoP therefore imposes a duty on adjudicators to check for at least one enumerated factor, assess its temporal proximity to clinical onset/worsening, and then link that factor to relevant service.

• Where a listed factor refers to another Statement of Principles, the other SoP's factors apply according to that SoP "as in force from time to time" (s 11). Decision‑makers must therefore identify cross‑references and apply those other SoPs.

• Use Schedule 1 definitions. The Schedule provides technical thresholds and examples that are part of the instrument (s 6 directs that terms defined in Schedule 1 have the meaning given). Decision‑makers have a duty to interpret factors in accordance with those definitions,e.g., "hot and humid weather conditions" is ambient humidity over 40 per cent and maximum temperature over 30 degrees Celsius (Schedule 1).

Claimant rights and procedural implications

• Right to be assessed against a settled medical template. Claimants have the right to have their otitis externa claims considered under the terms of this SoP where the relevant statutory claim provisions apply (s 5). That gives claimants predictable criteria (temporal windows and defined exposures) that can be relied upon in assembling evidence.

• Right to rely on cross‑SoP content where relevant. If an enumerated factor invokes another disease covered by a separate SoP, claimants may rely on that SoP's factors (s 11) and thus can present evidence under either instrument as appropriate.

Practical duties on claimants and clinicians

• Claimants are required to present or enable production of records that show the existence of one or more factors and their relation to relevant service. For example, to satisfy s 9(1) a claimant must show participation in aquatic activities within ten days before clinical onset. To satisfy s 9(6) a claimant must show occlusion with an extrinsic aural device for a cumulative period of at least eight hours within the seven days before onset.

The instrument is an evidentiary Statement of Principles; it does not create criminal offences, civil penalties, or enforcement sanctions in itself. Its legal effect is procedural and determinative within the veterans' compensation claims process rather than punitive.

Scope and legal force

• Authority and operation. The RMA made the SoP under subsection 196B(2) of the VEA (s 3). SoPs made under that provision are statutory instruments used to guide the determination of whether a disease or injury can be related to service for the purposes of veterans' entitlements. The SoP therefore has force in administrative decision‑making under the VEA and MRCA but it does not itself impose standalone statutory penalties.

• Enforcement mechanism. Enforcement in the sense of "application" is carried out by those charged with adjudicating claims under the VEA or MRCA. The instrument prescribes factors decision‑makers must consider; failure by an administrator to apply the SoP when it is applicable could be reviewed by internal review mechanisms, merits review bodies or judicial review processes under the broader statutory framework. The SoP itself does not describe those mechanisms , it only prescribes the criteria to be applied (s 5, s 9).

No penal sanctions in the SoP

• The text contains no fines, imprisonment, or other penal sanctions. It does not create obligations for employers or third parties enforceable by penalty. It contains no enforcement provisions that empower inspectors or compliance officers to act beyond the normal claim adjudication functions under the VEA/MRCA.

Implications for decision‑makers

• Administrative compliance risk. While there are no criminal or civil penalties in the SoP, administrative errors in applying the instrument might result in internal reviews, reversal on merits review, or judicial review of decisions in the statutory schemes that reference the SoP. The instrument itself is silent on appeals or penalties, so enforcement of consistent application occurs through the broader VEA/MRCA procedures that give claimants review rights.

Evidentiary and procedural consequences

• The principal "consequence" of the SoP in practice is evidentiary: presence of at least one of the enumerated factors, properly related to relevant service, meets the minimum threshold to raise a reasonable hypothesis linking the condition to service (s 9, s 10). That evidentiary consequence affects a claimant’s eligibility pathway for entitlements, and therefore indirectly affects administrative payments and obligations under the VEA/MRCA.

The SoP is a statutory instrument made under the Veterans' Entitlements Act 1986 (s 3) and designed to be used in claims processes governed by the VEA and the Military Rehabilitation and Compensation Act 2004 (MRCA) (s 5). The instrument is therefore embedded within a broader legal framework and expressly cross‑references other Statements of Principles where overlap occurs.

Interaction with the VEA and MRCA

• Applicability to claims. Section 5 states the instrument applies to a claim to which section 120A of the VEA or section 338 of the MRCA applies. The SoP is therefore an instrument used in interpreting causation within the statutory claims procedures set by those Acts. It does not amend or replace the substantive provisions of the VEA or MRCA; it operates as a medical‑scientific statement that informs whether the causal link requirement within those statutes is satisfied.

• Relevant service definitions. Schedule 1 defines "relevant service" by reference to VEA categories (operational service, peacekeeping service, hazardous service, British nuclear test defence service) and MRCA categories (warlike service, non‑warlike service). The SoP directs decision‑makers to apply those statutory categories when deciding whether the enumerated factors are related to the person's service.

Interaction with other Statements of Principles

• Cross‑SoP application. Section 11 requires that where a factor in this SoP refers to an injury or disease covered by another SoP under subsection 196B(2) of the VEA, the factors in that other SoP apply according to its terms "as in force from time to time". This creates an inter‑instrument hierarchy: where overlap occurs, decision‑makers must consult the other SoP and apply its factors. The effect is to prevent inconsistent application where multiple SoPs relate to interconnected conditions.

Interaction with medical coding and classification

• ICD‑10‑AM. Section 7(3) states that while otitis externa attracts ICD‑10‑AM codes H60, H62.0-H62.4, the meaning of otitis externa for the SoP is the textual definition in s 7(2). Section 7(4) explains what is meant by a reference to an ICD‑10‑AM code (the particular ICD‑10‑AM edition and publisher). Decision‑makers should therefore prefer the SoP’s textual definition over reliance on diagnostic codes alone, but the SoP acknowledges the codes as a point of reference.

Interaction with clinical and regulatory standards

The instrument itself records only limited historical detail within its text. The relevant points present in the document are:

• New instrument designation and date. This is the Statement of Principles concerning otitis externa (Reasonable Hypothesis) (No. 25 of 2021), dated 24 December 2020, and it commences on 25 January 2021 (s 1, s 2).

• Repeal of prior instrument. Section 4 states that the previous Statement of Principles concerning otitis externa No. 58 of 2012 (Federal Register of Legislation No. F2012L01801) made under subsections 196B(2) and (8) of the VEA is repealed. That is the only explicit repeal or replacement recorded in this instrument.

• No other amendments recorded. The text contains no express amendments to other statutory provisions, no transitional provisions specifying treatment of claims in progress at commencement, and no savings clauses beyond the repeal. The absence of further amendment text means that the prior SoP is replaced as the operative instrument for all relevant claims from the commencement date; the instrument does not include explicit grandfathering language.

Implications for records and prior decisions

• Supersession. Because the 2012 SoP is expressly repealed, any determinations or practices that relied on that SoP must, from the commencement date, be made with reference to the No. 25 of 2021 SoP. The instrument does not itself restate how to treat claims made prior to commencement; normal administrative practice will determine whether earlier decisions continue to stand or are subject to re‑assessment in light of the new SoP.

• Version control and application "as in force from time to time". Section 11 contemplates other SoPs "as in force from time to time", which means decision‑makers should track the current versions of any cross‑referenced SoPs. The RMA periodically issues or updates SoPs; the instrument’s citation practice and its repeal provision make version management important for adjudicators.

What is not in the amendment history

• No record of consultation or explanatory memorandum is included in the text provided here. Section 8 states the RMA's view that sound medical‑scientific evidence exists to support the relationship, but the instrument does not reproduce the evidence base or an explanatory memorandum that would detail the RMA’s reasoning or compare the new instrument to the 2012 version.

The instrument itself contains no mention of litigation, judicial decisions, or case law. It does not cite prior tribunal or court rulings, nor does it record any determinations by judicial bodies that influenced its content. The text is limited to the RMA’s statutory determinations and definitions.

What the SoP records

• No cases or disputes are named. The instrument provides the RMA’s medical‑scientific view and the enumerated factors; it does not narrate or summarise any litigation history.

What this absence means for practitioners

• Independent check advisable. Because the SoP does not summarise any litigation, practitioners who need to advise on how the SoP will be interpreted in contested appeals or judicial review proceedings should search the tribunal and court databases for decisions that reference Statements of Principles generally or this SoP in particular since its commencement. Reviewing merits review decisions and judicial decisions will indicate how tribunals and courts treat the SoP’s factors and the application of the "reasonable hypothesis" standard.

• Potential for future litigation. Any administrative instrument that changes evidentiary thresholds can generate disputes about its proper application. Common points of dispute that have arisen under SoPs historically (inferred from the structure of this instrument) include: whether the documented facts satisfy a particular enumerated factor within the precise temporal window; whether Schedule 1 definitions apply; whether cross‑SoP interaction was correctly handled under s 11; and whether the required relationship to relevant service (s 10) is met. Such issues are fertile ground for appeals under the VEA/MRCA processes and, potentially, judicial review if the decision‑making process is alleged to be legally flawed.

How to proceed for case law research

• Check tribunal decisions under the VEA and MRCA. Review merits review bodies (for example the Administrative Appeals Tribunal where applicable) and any Federal Court or Federal Circuit Court decisions that consider how SoPs are applied, particularly concerning otitis externa or ENT conditions.

• Track RMA publications and explanatory material. The RMA often publishes explanatory material or medical evidence summaries that support SoPs; those may be referenced in later decisions and can inform how tribunals treat the instrument.

This SoP contains several technical features and definitional constraints that can be pitfalls if not handled carefully in claims preparation and adjudication.

Temporal windows and event definition

• Short, specific time frames. Many factors require very short windows before clinical onset or clinical worsening: ten days (for aquatic activities, trauma, foreign object, radiation, and specific procedures) and 30 days (for chronic suppurative otitis media and otomycosis treatment history). Misstating or failing to document exact dates for clinical onset/worsening will defeat reliance on the factor. Practitioners must ensure that clinical notes record a clear date of onset or objective findings that can be dated.

• Clinical onset versus clinical worsening. The SoP distinguishes onset and worsening. Subsections 9(14)-9(27) apply only to material contribution/aggravation (s 10(2)) where the person’s otitis externa was suffered or contracted before or during (but did not arise out of) relevant service. That distinction can be decisive: factors intended to demonstrate aggravation do not apply to a new onset that arose out of service, and vice versa.

Strict definitional thresholds in Schedule 1

• Environmental thresholds are precise. "Hot and humid weather conditions" requires humidity exceeding 40 per cent and maximum temperature exceeding 30 degrees Celsius (Schedule 1). Adjudicators will need objective evidence that these thresholds were met on at least ten days in the 30‑day window. Anecdotal statements will be weak without supporting climate or operational environmental records.

• Cumulative time counts. Occlusion with an extrinsic aural device must be for a cumulative period of at least eight hours within seven days before onset/worsening (s 9(6), s 9(19), Schedule 1). Calculating cumulative usage across multiple days requires clear record‑keeping or contemporaneous logs.

Ambiguities and undefined terms

• "Inability to obtain appropriate clinical management" (s 9(27)) is undefined. The SoP provides no criteria for what constitutes "appropriate" clinical management or who determines the standard. This invites administrative discretion and potential disputes about the evidentiary standard required to prove inability to obtain care.

• Examples versus exhaustive lists. The Schedule gives examples for many definitions (for example, examples of aquatic activities and extrinsic aural devices). Examples are not exhaustive; claimants may rely on other activities or devices, but must connect them to the definition's core elements (e.g., water retention in the ear canal). Practitioners should avoid assuming examples are exhaustive.

For claimants, clinicians and administrators, compliance with this SoP means assembling and presenting evidence that aligns with the SoP’s enumerated factors, temporal windows and Schedule 1 definitions. Below is a practical checklist and recommended approaches tailored to the roles likely to interact with the SoP.

For claimants and their representatives

• Establish clinical onset and/or clinical worsening dates. Secure medical records that specifically document the date of first symptoms, clinical assessment, diagnostic findings, and any recorded episodes of worsening. Where onset is unclear, obtain treating clinician statements that specify a reasonable onset date based on history and objective findings.

• Match evidence to at least one listed factor. Identify which subsection of s 9 is relied upon and compile contemporaneous evidence for that factor within the stated temporal window (e.g., s 9(1) aquatic activities within ten days before onset). Examples of evidence: service logs, swim/diving records, training records, duty rosters, eyewitness statements, photographs, or electronic activity records.

• Document environmental exposures with objective data. Where relying on s 9(2) or s 9(15) (hot and humid weather conditions), collect meteorological records (station data, operational climate reports) showing ambient humidity and maximum temperature over the relevant 30‑day window, and evidence that the claimant was present at that location on the given dates.

• Provide treatment and procedure records. For factors that depend on procedures, foreign object insertion/removal, or therapeutic radiation (s 9(3), s 9(4), s 9(5), s 9(16), s 9(17), s 9(18)), provide operative notes, procedure reports, radiotherapy planning records, or nursing notes that specify dates and the anatomical site involved.

• Document device use. For occlusion with an extrinsic aural device (s 9(6), s 9(19)), provide logs, equipment issue records, training/work patterns showing cumulative daily wear times, hearing aid service records, or sworn statements verifying device usage and approximate durations.

• Record comorbidities precisely. Where relying on diabetes mellitus, chronic suppurative otitis media, immunocompromised states, or chronic renal failure (s 9(10)-s 9(12) and Schedule 1), secure clinical records that explicitly diagnose these states and, where relevant, lab values (e.g., GFR for chronic renal failure) and medication records identifying immunosuppressive agents by route of administration (note that inhaled/topical corticosteroids are excluded from "immunosuppressive drug" definition).