Michael McGrath (Cork South Central, Fianna Fail)
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947. To ask the Minister for Health his plans to introduce regulations to oversee the provision of hearing aids; and if he will make a statement on the matter. [19789/17]

Simon Harris (Wicklow, Fine Gael)
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The HSE advises that hearing aids supplied in the public audiology service conform to the highest international standards and are procured using an international procurement process. The HSE Integrated Audiology Programme set up a working group of key stakeholders in 2015, with the aim of assessing the standards that were applied to the fitting of medical devices (i.e. hearing aids) within Ireland. The group has drawn on various good practices that are applied across Audiology and Hearing Aid Audiology and are currently in the final stages of producing a best practice guide to ensure a code of practice for the profession (both public and private) for use within Ireland.

The sale of medical devices, including hearing aids, within the European Union is regulated by EU legislation. All medical devices placed on the market undergo a conformity assessment to confirm that they meet specified safety and performance requirements. Once a medical device is CE marked and is not subject to prescription control it may be sold on the EU market without restriction.There are new distributor requirements that will come into effect with the application of the new EU medical devices regulations which will broaden the scope of the current regulatory framework to address obligations of all economic operators.

The profession of audiologist is not included in the 14 professions currently designated under the Health and Social Care Professionals Act 2005. The Act provides that the Minister for Health may, following a consultation process and with the approval of the Houses of the Oireachtas, make regulations designating a health or social care profession not already designated if the Minister considers it in the public interest to do so and if certain specified criteria have been met.

My Department is proposing, towards the end of this year or early next year, when all registration boards have been established, to ask CORU - the Health and Social Care Professionals Council to undertake a risk assessment, in terms of public protection, of the principal health and social care professions seeking designation under the Act and to make recommendations concerning options for their possible future regulation. The question of designating the professions of audiologist will be considered as part of that process.