Professional Scope of Practice, Governance, and Regulatory Alignment

Introduction and Purpose of this Statement

This Professional Statement sets out, in a transparent, precise, and verifiable manner, the scope of services, professional governance arrangements, regulatory position, and legal framework under which Isle Hear Care operates. Isle Hear Care is a healthcare service operating in the Isle of Man and is delivered by a Registered Nurse and Advanced Clinical Practitioner, regulated by the Nursing and Midwifery Council. This statement is intentionally published to facilitate scrutiny by professional peers, insurers, commissioners, manufacturers, regulators, and members of the public, including those who may seek to assess or challenge the legal and professional basis upon which services are provided.

Isle Hear Care does not present itself as, nor does it purport to be, an audiology service. The clinician delivering services is not registered as an audiologist and does not claim audiologist status. The service is lawfully delivered by a registered healthcare professional whose professional scope permits aural care and aural impression-taking where appropriate training, competence, governance, and indemnity arrangements are in place. This position is consistent with guidance issued by the British Society of Audiology, which recognises circumstances in which non-audiologists may undertake aural care and impression-taking, provided defined standards of competence, accountability, and governance are met (British Society of Audiology, 2022c).

This statement documents how Isle Hear Care aligns its operation with Isle of Man legislation, Nursing and Midwifery Council professional standards, and nationally recognised United Kingdom clinical guidance where such guidance is relevant and persuasive, notwithstanding that ear care services of this nature are not subject to statutory registration or inspection in the Isle of Man.

Jurisdictional Framework and Regulatory Position

Isle Hear Care operates exclusively within the jurisdiction of the Isle of Man and is governed by Isle of Man legislation. The service is not subject to regulation or inspection by United Kingdom healthcare regulators, and no such regulatory status is implied. The clinician delivering services is professionally regulated by the Nursing and Midwifery Council, a statutory regulator/governing body; and remains accountable to the NMC Code of Practice irrespective of the geographical location of practice (Nursing and Midwifery Council, 2018).

Written confirmation has been received from the Registration and Inspection Team, Department of Health and Social Care, Isle of Man Government, confirming that the services provided by Isle Hear Care, as fully described and disclosed, do not require registration or inspection under current Isle of Man regulatory frameworks. This confirmation was issued in November 2025 following direct enquiry and consideration of the scope of services provided.

Written confirmation has also been received from the Customs and Immigration Division, Isle of Man Government, confirming that Isle Hear Care is not required to register for Value Added Tax at the time of assessment, based on the nature and scale of the business activity disclosed. This confirmation was issued in November 2025. Isle Hear Care acknowledges its ongoing responsibility to monitor turnover and comply with VAT legislation should circumstances change.

At the time of writing this statement, Isle Hear Care is expected to commence operation as a sole trader. It is anticipated that the business may, in due course, transition to operating as a limited company or under an umbrella limited company arrangement. Any such incorporation would be undertaken in accordance with the Companies Act 1931 (Isle of Man) and/or the Companies Act 2006 (Isle of Man), as applicable. Regardless of legal form, Isle Hear Care operates in compliance with Isle of Man business law, financial accountability requirements, and statutory obligations (Isle of Man Government, 1931; Isle of Man Government, 2006).

Professional Regulation and Accountability

The clinician delivering services at Isle Hear Care is a Registered Nurse and is qualified as an Advanced Clinical Practitioner, regulated by the Nursing and Midwifery Council. Professional conduct is governed by the NMC Code: Professional Standards of Practice and Behaviour for Nurses, Midwives and Nursing Associates (Nursing and Midwifery Council, 2018), which establishes enforceable standards relating to safety, consent, record-keeping, accountability, professionalism, and ethical conduct.

The clinician is qualified, regulated, and professionally accountable for advanced clinical activities, including diagnosis and prescribing, within their Advanced Clinical Practitioner scope of practice. However, diagnosis and prescribing are deliberately excluded from the service remit of Isle Hear Care. This exclusion reflects service-specific governance decisions, professional indemnity arrangements, and explicit risk-management measures intended to limit medico-legal and litigation exposure arising from activities that fall outside the defined scope of the business. The clinician may provide clinical explanation, advice, or guidance on a case-by-case basis where appropriate, provided such activity remains proportionate, within competence, and consistent with the service boundaries described in this statement.

Advanced Practice Framework

The Advanced Practice Framework, published by Health Education England, applies to the clinician delivering services and does not constitute a regulatory framework for Isle Hear Care as a business entity (Health Education England, 2017). Regulation, fitness to practise, and disciplinary oversight rest solely with the clinician’s governing body, the Nursing and Midwifery Council.

The framework does, however, inform the clinician’s professional conduct across four pillars. The clinical practice pillar supports safe assessment, otoscopic examination, clinical reasoning, and procedural competence in aural care. The leadership and management pillar informs governance, audit, and risk management within the service environment. The education pillar underpins continuing professional development and maintenance of competence specific to ear care and impression-taking. The research pillar supports evidence-based practice, critical appraisal of guidance, and integration of recognised standards into clinical decision-making. Application of this framework relates exclusively to the clinician.

Scope of Services and Explicit Exclusions

Isle Hear Care provides otoscopic examination, ear cleaning interventions including microsuction, irrigation, and manual cerumen removal, and aural impressions for custom-made devices. Services are delivered only where the clinician has completed recognised training, maintains competence, and holds appropriate professional indemnity.

Isle Hear Care does not provide audiological diagnostic services, including hearing assessment, audiometry, tympanometry, or formal diagnosis of hearing loss. The service does not replace assessment or management provided by audiology, otolaryngology, or other specialist services.

Consent and Capacity

Informed consent is fundamental to all services provided by Isle Hear Care and is obtained in accordance with Isle of Man legislation, professional standards, and ethical principles. Capacity is recognised as decision-specific and time-specific and is assessed proportionately for each intervention in accordance with the Mental Capacity Act 2018 (Isle of Man Government, 2018a).

All procedures are preceded by otoscopic examination to confirm that it is clinically safe to proceed. Verbal consent is obtained prior to otoscopy in all clients. For clients aged sixteen years and above, verbal consent is sufficient for otoscopy and aural impressions, while written consent is required for ear cleaning interventions due to the increased procedural risk and the need for auditable documentation.

Where a client lacks capacity, or where there is uncertainty regarding capacity, procedures are deferred unless it is clearly in the client’s best interests to proceed and lawful authority exists, such as parental responsibility under the Children and Young Persons Act 2001 (Isle of Man Government, 2001) or decision-making authority conferred by the Mental Capacity Act 2018 (Isle of Man Government, 2018a), including welfare powers of attorney or court-appointed decision-makers.

Children and Young People

Children and young people may access services provided by Isle Hear Care where the child is able to tolerate the procedure, no contraindications are present, and appropriate written consent has been obtained from a parent or legal guardian. The child’s views, understanding, and willingness to proceed are actively considered, and the child retains the right to refuse or withdraw assent at any point.

Consent for children and young people is obtained in accordance with the Children and Young Persons Act 2001 (Isle of Man Government, 2001). Written parental or guardian consent is required for otoscopy, ear cleaning, and aural impressions involving minors. Communication and engagement are adapted to the child’s level of understanding while ensuring that lawful authority for consent is maintained.

Infection Prevention and Control

Isle Hear Care maintains infection prevention and control arrangements consistent with Isle of Man statutory obligations. In addition, relevant United Kingdom guidance and best-practice recommendations are applied as reinforcement to strengthen safety standards without displacing local legislative requirements.

Single-use products are disposed of immediately following use and replaced for each client. Reusable instruments are cleaned using detergent or alcohol wipes and, when necessary, sterilised using Milton solution, in accordance with manufacturer instructions and procedural requirements. Hand hygiene, environmental cleaning, and appropriate use of personal protective equipment are integral to service delivery. These arrangements support compliance with the Health and Safety at Work Act 1975 (Isle of Man Government, 1975).

Clinical Governance, Risk Management, and Referral

Clinical governance within Isle Hear Care integrates professional standards, statutory obligations, and internal quality assurance processes. Each client encounter includes assessment of clinical risk, contraindications, procedural tolerance, and capacity. Where risk exceeds the clinician’s verified competence or safe practice cannot be assured, procedures are deferred.

Isle Hear Care does not initiate referrals to General Practitioners or other healthcare professionals on behalf of clients, except in emergency or exceptional circumstances where immediate escalation is required to protect health or safety. Where appropriate, a written letter may be offered to the client to support onward care. This approach supports client autonomy by ensuring individuals retain responsibility and control over their own engagement with healthcare services.

Record Keeping, Information Governance, and Data Protection

Clinical and business records within Isle Hear Care are managed predominantly in electronic format using Google Workspace. Records include clinical notes, consent documentation, correspondence, and governance records. Where handwritten notes or wet-ink signatures are used, including consent forms, these are scanned or photographed and securely incorporated into the electronic client record.

Isle Hear Care is registered with the Isle of Man Information Commissioner, the independent statutory authority responsible for overseeing compliance with data protection and information rights legislation in the Isle of Man. Registration demonstrates accountability as a data controller and confirms lawful processing of personal data in accordance with statutory requirements.

Google Workspace is operated in compliance with the Data Protection Act 2018 (Isle of Man Government, 2018b) and incorporates technical and organisational safeguards, including multi-factor authentication, access controls, and audit logging. Data processing agreements are in place with relevant service providers, ensuring that any third-party processing of personal data occurs lawfully, securely, and in accordance with statutory obligations. Records are maintained in accordance with NMC standards for record-keeping, confidentiality, and data security (Nursing and Midwifery Council, 2018).

Product Provision and Commercial Arrangements

Isle Hear Care supplies custom ear moulds and custom hearing aid moulds through partner manufacturers operating to recognised quality and conformity standards, including CE and UKCA marking where applicable. The clinician’s role is limited to aural impression-taking and ensuring appropriate delivery of products within scope and competence. Isle Hear Care does not provide a hearing aid fitting service.

Manufacturing processes, production defects, and manufacturing quality control fall outside the scope of Isle Hear Care as a business. Reasonable support is provided to clients in liaising with manufacturers where concerns arise. Clients may also obtain aural impressions from Isle Hear Care and independently arrange manufacture of custom products through third-party providers of their choosing.

Professional Indemnity and Insurance

The clinician holds professional indemnity, medical malpractice, and public and products liability insurance, covering the services described in this statement. Insurance arrangements are maintained to support safe practice, risk management, and professional accountability.

Equality and Accessibility

Isle Hear Care operates in accordance with the Equality Act 2017 (Isle of Man Government, 2017), ensuring that services are delivered without unlawful discrimination and with reasonable consideration of accessibility, communication needs, and individual circumstances.

Complaints and Concerns

Concerns or complaints relating to services provided by Isle Hear Care are managed internally in accordance with professional standards and business governance arrangements. Where a client remains dissatisfied following internal review, external routes of redress may be pursued at the client’s discretion.

Use of National Guidance

Practice within Isle Hear Care is informed by guidance published by the British Society of Audiology, including guidance on ear wax removal, aural impressions, and professional competence (British Society of Audiology, 2022a–d). Guidance from the National Institute for Health and Care Excellence, including Hearing Loss in Adults: Assessment and Management (NG98), is applied as persuasive evidence to support safe and effective practice (National Institute for Health and Care Excellence, 2018). Use of United Kingdom guidance reflects the absence of equivalent Isle of Man–specific clinical guidance and does not imply United Kingdom regulatory oversight.

Non-Contractual Nature and Clinical Outcomes

This Professional Statement is published for transparency and informational purposes and does not, of itself, constitute a contract between Isle Hear Care and any client. While services are delivered with skill, care, and professional diligence, no guarantee is given regarding specific clinical outcomes. This reflects the inherent variability of clinical interventions and does not limit the clinician’s professional responsibilities or legal obligations.

References

British Society of Audiology (2022a) Practice Guidance on Aural Care (Ear Wax Removal). Reading: British Society of Audiology. Available at: https://www.thebsa.org.uk 

British Society of Audiology (2022b) Recommended Procedure for Taking an Aural Impression. Reading: British Society of Audiology. Available at: https://www.thebsa.org.uk

British Society of Audiology (2022c) Guidance on Competence, Scope, and Professional Responsibility. Reading: British Society of Audiology. Available at: https://www.thebsa.org.uk 

British Society of Audiology (2022d) Recommended Procedure for Ear Wax Removal Using Irrigation and Microsuction. Reading: British Society of Audiology. Available at: https://www.thebsa.org.uk

Health Education England (2017) Advanced Clinical Practice: Capability Framework. London: Health Education England.

Isle of Man Government (1931) Companies Act 1931. Douglas: Isle of Man Government.

Isle of Man Government (2006) Companies Act 2006. Douglas: Isle of Man Government.

Isle of Man Government (1975) Health and Safety at Work Act 1975. Douglas: Isle of Man Government.

Isle of Man Government (2001) Children and Young Persons Act 2001. Douglas: Isle of Man Government.

Isle of Man Government (2017) Equality Act 2017. Douglas: Isle of Man Government.

Isle of Man Government (2018a) Mental Capacity Act 2018. Douglas: Isle of Man Government.

Isle of Man Government (2018b) Data Protection Act 2018. Douglas: Isle of Man Government.

National Institute for Health and Care Excellence (2018) Hearing Loss in Adults: Assessment and Management (NG98). London: NICE.

Nursing and Midwifery Council (2018) The Code: Professional Standards of Practice and Behaviour for Nurses, Midwives and Nursing Associates. London: NMC.

Version 1.0

Published: Sunday 4th January 2026

Review date: January 2028

This Professional Statement is subject to periodic review and amendment at any time in response to changes in legislation, professional guidance, or service scope.