Statement of Principles concerning otosclerosis (Balance of Probabilities) (No. 24 of 2025)

This instrument is a Statement of Principles (SoP) concerning otosclerosis and death from otosclerosis, made by the Repatriation Medical Authority under subsection 196B(3) of the Veterans' Entitlements Act 1986 (VEA) (s 3). It commences on 25 March 2025 (s 2) and repeals the prior Statement of Principles concerning otosclerosis (No. 62 of 2016) (s 4). The instrument applies to claims that fall within the statutory claims pathways in the VEA and the Military Rehabilitation and Compensation Act 2004 (MRCA), specifically claims to which s 120B of the VEA or s 339 of the MRCA applies (s 5).

Mechanically, the SoP does three things. First, it defines the medical condition to which it applies: otosclerosis is defined as a disorder of the ear characterised by abnormal bone remodelling of the otic capsule with clinical consequences (s 7(2)). Familial otosclerosis is explicitly excluded (s 7(2)(b)). Second, it sets the standard of proof and evidentiary basis: the Authority states that, on the sound medical‑scientific evidence available, it is more probable than not that otosclerosis and death from otosclerosis can be related to relevant service (s 8). Third, it lists the factors that must exist for a connection to service to be established on the balance of probabilities: at least one factor must be present, and the only enumerated factor is "inability to obtain appropriate clinical management for otosclerosis before clinical worsening" (s 9(1)).

The SoP specifies how the listed factor relates to service: the factor in s 9(1) is confined to material contribution to, or aggravation of, pre‑existing otosclerosis where the condition was suffered or contracted before or during relevant service but did not arise out of that service (s 10(2)). The instrument also links factors which refer to other injuries or diseases to the Statements of Principles for those conditions (s 11). The SoP includes definitional material in Schedule 1, including the meaning of otic capsule, relevant service categories, and terminal events relevant to deaths (Schedule 1).

The core legal-concept architecture of this Statement of Principles is compact and rests on a few interlocking elements: the statutory authority, the medical definition, the standard of proof, the discrete causal factors, and the relationship rules that constrain how factors may be applied in claims.

Statutory authority and scope: the Authority made the instrument under s 196B(3) of the VEA (s 3) and expressly applies it to claims governed by s 120B of the VEA and s 339 of the MRCA (s 5). The instrument repeals the previous otosclerosis SoP (s 4) and comes into force on 25 March 2025 (s 2).

Medical definition: otosclerosis is given a specific clinical meaning for the instrument, not merely the ICD‑10‑AM label. The statutory definition is "a disorder of the ear characterised by abnormal bone remodelling of the otic capsule which can progress towards the stapes resulting in conductive hearing loss, or less commonly towards the cochlea resulting in sensorineural hearing loss" (s 7(2)(a)). Multifactorial presentations such as mixed hearing loss are acknowledged in note form (s 7(2) Note 2). Familial otosclerosis is excluded from the statutory meaning (s 7(2)(b)). The Schedule defines "otic capsule" to include the cochlea, vestibule and semicircular canals (Schedule 1).

Reference to clinical coding: the SoP notes that otosclerosis attracts ICD‑10‑AM code H80 but clarifies that, for the purposes of this instrument, the meaning is as given in s 7(2) (s 7(3)). The instrument also specifies the edition and effective date of ICD‑10‑AM relied upon (s 7(5)).

Standard of proof and medical‑scientific basis: the Authority states its view that, on the balance of probabilities, otosclerosis and death from otosclerosis can be related to relevant service based on the available sound medical‑scientific evidence (s 8). That is the statutory threshold for the SoP to exist and to be applied in claims.

Causal factors: the SoP contains a single enumerated factor that must exist to establish a connection to service: inability to obtain appropriate clinical management for otosclerosis before clinical worsening (s 9(1)). The instrument frames the relationship to service for that factor: it applies only to material contribution to, or aggravation of, otosclerosis when the condition pre‑existed or was contracted before or during relevant service but did not arise out of it (s 10(2)). This limits the factor’s application to worsening or exacerbation scenarios rather than new onset due to service.

Death from otosclerosis: death is included where otosclerosis contributed to a terminal event or condition; "terminal event" is defined in Schedule 1 with examples such as pneumonia, respiratory failure, cardiac arrest and cessation of brain function (s 7(4) and Schedule 1).

Primary affected persons are veterans, serving members and claimants who seek entitlements under either the Veterans' Entitlements Act 1986 or the Military Rehabilitation and Compensation Act 2004 where otosclerosis or death from otosclerosis is alleged to be connected to relevant service (s 5). The SoP is designed to be applied by decision‑makers in determining claims under s 120B of the VEA or s 339 of the MRCA (s 5). The source does not itself create new entitlements; it provides the evidentiary and causation framework for deciding whether an existing claim satisfies the statutory causation tests used in those Acts.

Relevant service categories are defined in the Schedule and therefore shape who may be affected: relevant service means eligible war service (other than operational service) under the VEA, defence service (other than hazardous service and British nuclear test defence service) under the VEA, or peacetime service under the MRCA (Schedule 1). That definition constrains the cohort whose service may be the basis for a claim invoking this SoP.

Medical practitioners and medical assessors who provide evidence in support of claims will be affected in the sense that their reports should address the statutory elements: the clinical features that meet the definition of otosclerosis as given (s 7(2)) and the temporal and causal links required by s 9 and s 10. The SoP explicitly excludes familial otosclerosis (s 7(2)(b)); claimants with that diagnosis are outside the instrument’s scope.

Decision‑makers within the Department, the Repatriation Commission, Military Rehabilitation and Compensation Commission or other adjudicative bodies that apply the VEA and MRCA will use this instrument as a determinative source of medical causation guidance: the SoP sets a prescriptive factor list and relationship rules (s 9-s 11) that feed into statutory causation assessments.

Survivors and dependants who seek death benefits under the VEA or MRCA will be affected where death from otosclerosis is alleged. The SoP treats death from otosclerosis as inclusive of death from terminal events that were contributed to by otosclerosis, with terminal events listed in the Schedule (s 7(4); Schedule 1).

Insurers, legal advisers, and medical‑legal experts who prepare or respond to claims will need to align evidence-gathering and argument to the SoP’s particular construction: demonstrate the enumerated factor(s), situate otosclerosis relative to the timing of service, and, where appropriate, link to other Statements of Principles for co‑morbid or causally related conditions (s 11). The instrument’s repeal of the prior 2016 SoP (s 4) means practitioners must apply the new text for claims arising after commencement (s 2).

The Statement of Principles is regulatory guidance used for claim adjudication; it does not impose statutory duties on private parties in the way a compliance law does, nor does it create standalone civil rights. Its operative content affects decision‑making under the VEA and MRCA by identifying the medical definition of otosclerosis, the qualifying factor(s) for establishing connection to service, and the conditions for applying those factors.

Right to have a claim assessed with this SoP: claimants whose claims fall under s 120B of the VEA or s 339 of the MRCA are entitled to have otosclerosis causation assessed having regard to this SoP once it applies (s 5). The Authority’s statement that it is "more probable than not" that otosclerosis can be related to relevant service (s 8) is the evidentiary basis that underpins application of the SoP as the medical‑scientific framework in claim assessments.

Duty on decision‑makers to apply the SoP: while the instrument does not use prescriptive language such as a statutory duty, it is made under s 196B(3) of the VEA (s 3) and therefore functions as the statutory Statement of Principles to be used in determining causal connection in the statutory claims processes. That means decision‑makers applying s 120B VEA or s 339 MRCA must have regard to this SoP as it frames the nexus between otosclerosis and relevant service (s 5, s 8).

Evidence duties for claimants and medical advisers: to satisfy the SoP’s requirements, evidence must show that the condition meets the medical definition in s 7(2), and that at least one factor listed in s 9 exists. The single listed factor is inability to obtain appropriate clinical management for otosclerosis before clinical worsening (s 9(1)). The SoP places temporal and causal limits on how that factor operates: s 10(2) restricts it to scenarios where otosclerosis was suffered or contracted before or during (but did not arise out of) relevant service and where the factor materially contributed to or aggravated the condition.

Interaction with other Statements of Principles: where a factor refers to an injury or disease covered by another SoP, the terms of that other SoP apply (s 11). The practical consequence is a duty on claimants and advisers to identify and present relevant cross‑condition evidence in accordance with the referenced SoP’s terms.

No new enforcement or penalty provisions: the SoP does not create new criminal, civil or administrative penalties or obligations in itself; its role is evidentiary and determinative in adjudicating claims under existing statutory mechanisms (see s 3 and s 5). Rights to compensation or other entitlements still depend on meeting the statutory tests in the VEA or MRCA, with this SoP supplying the medical causation framework.

The Statement of Principles contains no penalty provisions and does not itself create offences, fines, or direct enforcement mechanisms. The instrument is made under s 196B(3) of the VEA (s 3) and functions as guidance for the statutory decision‑making processes in the VEA and MRCA; enforcement and remedies remain those provided by those Acts and their administrative procedures (s 5). The source text includes no sections that prescribe penalties, compliance notices, or enforcement pathways.

Operational enforcement therefore rests indirectly with the administrative and statutory mechanisms of the VEA and MRCA. Decisions about entitlement, compensation, or rehabilitation under s 120B of the VEA or s 339 of the MRCA will be made by the relevant decision‑maker applying the SoP as part of the evidence base (s 5). Any sanction, repayment, or adverse findings in relation to claims would arise under those Acts’ provisions and the broader administrative review and merits/review pathways available under the legislation or general administrative law, none of which are set out in this instrument.

There is no administrative compliance regime in the SoP that requires regulated entities to keep records, report incidents, or obtain approvals. The instrument does not allocate coercive regulatory powers to the Repatriation Medical Authority beyond its power to determine Statements of Principles (s 3). It also contains no express offences for false statements, record‑keeping failures, or non‑compliance with medical treatment directives.

Because the SoP defines a medical condition and lists causation factors for adjudication purposes, potential consequences for claimants derive from the legal effect of a decision that accepts or rejects a causal connection under the VEA/MRCA. Those consequences (entitlement to benefits, denial, or reassessment) flow from the primary Acts, not from the SoP itself. The SoP does not prescribe procedural timelines, evidentiary standards beyond the single factor list, or appeal rights , those procedural elements remain within the VEA/MRCA framework.

This Statement of Principles is an instrument made under the VEA and is intended to operate within the statutory architecture of the Veterans' Entitlements Act 1986 and the Military Rehabilitation and Compensation Act 2004. The instrument explicitly states its basis in subsection 196B(3) of the VEA (s 3) and its application to claims under s 120B of the VEA and s 339 of the MRCA (s 5). Accordingly, the SoP is not freestanding; it is designed to be applied by decision‑makers operating under those Acts as the medical‑scientific framework for causation.

Reference to other Statements of Principles: s 11 provides a mechanism for cross‑instrument application. If a factor in this SoP refers to an injury or disease that is the subject of another SoP made under s 196B(3) of the VEA, then the factors contained in that other SoP "apply in accordance with the terms of that Statement of Principles as in force from time to time" (s 11). This creates a hierarchical or networked interaction: where co‑morbid or causally related conditions are involved, adjudicators must consult and apply the contemporary versions of those other SoPs.

Clinical coding and external classification systems: the SoP refers to ICD‑10‑AM code H80 for otosclerosis but clarifies that, in applying the SoP, the statutory meaning provided in s 7(2) controls (s 7(3)). The instrument also specifies the edition and effective date of ICD‑10‑AM being cited (s 7(5)). This establishes that clinical coding may be a secondary reference whereas the SoP’s statutory definition governs legal determinations.

Interaction with definitions of relevant service: Schedule 1 defines "relevant service" by reference to categories within the VEA and MRCA, distinguishing eligible war service, defence service, and peacetime service (Schedule 1). That definition determines whether the claimant's service falls within the scope of the VEA/MRCA claims processes that the SoP supports.

Death and terminal events: the SoP incorporates the Schedule’s definition of "terminal event" for death claims (s 7(4); Schedule 1). Where death from otosclerosis is alleged, decision‑makers must assess whether the terminal event (for example pneumonia, respiratory failure, cardiac arrest, circulatory failure, or cessation of brain function) was contributed to by the person’s otosclerosis (s 7(4); Schedule 1).

Repeal and replacement: the SoP expressly repeals the earlier otosclerosis SoP (No. 62 of 2016) (s 4). That repeal means any interplay with prior decisions that relied on the previous instrument must now be reconsidered under the new text for subsequent claims or reviews, subject to any transitional or savings rules found in the parent Acts (the instrument itself contains no transitional provisions) (s 4).

This instrument records one explicit amendment action: it repeals the earlier Statement of Principles concerning otosclerosis (Balance of Probabilities) (No. 62 of 2016) (Federal Register of Legislation No. F2016L01154) (s 4). The new instrument is titled "Statement of Principles concerning otosclerosis (Balance of Probabilities) (No. 24 of 2025)" and is dated 18 February 2025, with commencement on 25 March 2025 (front matter; s 2).

No other amendment or modification history is contained in the text supplied. The instrument does not include transitional provisions, savings clauses, or retrospective application language. The repeal clause (s 4) is categorical and unqualified: the prior SoP is repealed. The new instrument replaces the previous SoP as the operative Statement of Principles for otosclerosis for the purposes of determinations made under the relevant provisions of the VEA and MRCA (s 3, s 5).

Because the SoP is made under s 196B(3) of the VEA (s 3), future amendments would be effected by further determinations of the Repatriation Medical Authority under that subsection. The instrument itself, however, contains no internal schedule recording prior amendments, no amendment-by-reference provisions, and no savings arrangement preserving outcomes decided under the repealed SoP. Practitioners should therefore assume that, from the commencement date, the new text governs assessments unless and until it is itself amended or repealed by the Authority.

The Schedule provides definitions that are integral to interpretation; any amendment to the SoP that alters those definitions or the causal factors would materially change the application of the instrument. The text supplied does not show any such amendments beyond the wholesale replacement of the 2016 SoP with this 2025 instrument (s 4).

The instrument itself contains no record of litigation, cases, or judicial interpretation. The text supplies no references to judicial decisions, appeal outcomes, or challenges to either the 2016 SoP or the new 2025 SoP. There are no named cases cited in the instrument.

Accordingly, there is no litigation history contained within this source to guide interpretation. Any judicial treatment of Statements of Principles generally, or of otosclerosis SoPs specifically, would need to be sought in the judicial record and case law outside this instrument. The instrument does not reserve or refer matters to courts, nor does it specify how questions of law or fact arising under the SoP are to be litigated or appealed; those procedural aspects remain within the framework of the VEA and MRCA and the general administrative law and appellate routes those Acts provide, none of which are described in the SoP itself.

Because the SoP repeals the earlier 2016 instrument (s 4), any litigation that addressed the 2016 SoP would be part of the historical context but is not recorded here. This instrument contains only the operative text and definitions for the 2025 SoP.

Narrow factor list and single enumerated factor: the SoP lists only one factor under s 9(1): "inability to obtain appropriate clinical management for otosclerosis before clinical worsening". That narrow enumeration means that, for a medical causation connection to be established on the basis of this SoP, evidence must be marshalled to fit that specific factor. There are no alternative factors listed in this instrument that would support a finding on the balance of probabilities. Practitioners should note that the SoP’s causal gateway is confined to this single scenario (s 9(1)).

Temporal and causation constraint on the factor’s application: s 10(2) restricts the s 9(1) factor to "material contribution to, or aggravation of, otosclerosis where the person's otosclerosis was suffered or contracted before or during (but did not arise out of) the person's relevant service." That excludes scenarios where the otosclerosis arose out of service, and confines the factor’s application to pre‑existing or contemporaneous conditions that were materially worsened by the inability to obtain management. The phrase "did not arise out of" places a clear limitation on the kind of causal narratives that will be enveloped by the factor.

Undefined operational language: key phrases such as "inability to obtain appropriate clinical management" and "clinical worsening" are not defined in the instrument. The Schedule defines other technical terms such as "otic capsule" and "terminal event", but does not define "appropriate clinical management" or "clinical worsening". That leaves room for interpretative discretion by decision‑makers and medical assessors as to what constitutes appropriate management and what level or type of worsening is required. Those interpretive choices will materially affect claim outcomes.

Familial otosclerosis excluded: s 7(2)(b) expressly excludes familial otosclerosis from the statutory meaning of otosclerosis for this SoP. Where a claimant’s diagnosis is familial, the SoP does not apply. Establishing familial versus non‑familial otosclerosis may therefore be determinative of whether this instrument is engaged.

ICD‑10‑AM code is secondary: while the instrument notes that otosclerosis attracts ICD‑10‑AM code H80, it also states that the meaning of otosclerosis for the SoP is that given in s 7(2) (s 7(3)). Relying solely on an ICD code without evidentiary alignment to the statutory clinical definition may be insufficient.

Death claims require contribution to a terminal event: for death to fall within the SoP, otosclerosis must have contributed to a "terminal event" as defined in Schedule 1 (s 7(4); Schedule 1). The Schedule lists examples (pneumonia, respiratory failure, cardiac arrest, circulatory failure, cessation of brain function), which suggests that a causal link between otosclerosis and such terminal events is required, not merely co‑existence.

What claimants must establish: to have a claim for otosclerosis or death from otosclerosis considered under this SoP, the claimant must first show they fall within an applicable claims pathway , a claim to which s 120B of the VEA or s 339 of the MRCA applies (s 5). They must then present medical evidence that the condition meets the statutory definition of otosclerosis (s 7(2)): evidence of abnormal bone remodelling of the otic capsule, and clinical consequences such as conductive or sensorineural hearing loss consistent with the definition. Familial otosclerosis is excluded (s 7(2)(b)), so clinicians’ notes and family history evidence should address whether a familial pattern exists.

Prove at least one listed factor: the SoP requires that "at least one of the following factor must exist" and enumerates a single factor (s 9(1)). To satisfy this instrument, evidence must demonstrate inability to obtain appropriate clinical management for otosclerosis before clinical worsening. This will require contemporaneous clinical records, referral histories, appointment scheduling evidence, documentation of service‑related constraints on access to care, and medical expert opinion linking the lack of management to clinically meaningful worsening of the otosclerosis.

Address timing and causal limits: because s 10(2) limits the factor to situations of material contribution or aggravation where otosclerosis was suffered or contracted before or during (but did not arise out of) relevant service, evidence needs to establish the timing of disease onset relative to service, and to exclude an "arising out of" causal chain. Medical records should show baseline status before or during service, objective progression (audiometry, imaging, operative notes), and a clear nexus between inability to access management and subsequent clinical deterioration. Expert medical opinion should address material contribution or aggravation specifically, not merely temporal association.

For death claims: if the claim relates to death from otosclerosis, establish that the otosclerosis contributed to a terminal event as defined in Schedule 1 (s 7(4); Schedule 1). Obtain cause of death documentation, coroner findings if relevant, and medical opinions tying the otosclerosis to the precipitating terminal event (for example pneumonia or respiratory failure) rather than merely listing co‑morbidities.

Where factors implicate other SoPs: if any element of the asserted chain of causation refers to another injury or disease that is the subject of a different Statement of Principles, identify that SoP and present evidence to satisfy its factors as well (s 11). Practically, that means compiling and coordinating medical evidence that addresses each relevant SoP’s requirements as in force at decision time.