European Hearing Instrument Manufacturers Association
EHIMA
The Association is an international non-profit Association the main purpose of which is to represent, promote and defend the general common interest of hearing instrument manufacturers.
ID: 34590331316-73
Lobbying Activity
Response to Digital package – digital omnibus
14 Oct 2025
The European Hearing Instrument Manufacturers Association (EHIMA) welcomes the opportunity to contribute to the European Commissions stakeholder consultation on the Digital Omnibus Package. The Package presents an important opportunity to streamline existing legislation, eliminate redundancies, and ensure that the combined effect of digital regulations, including the AI Act, the Data Act, and relat-ed frameworks, supports rather than hinders innovation and growth. EHIMA therefore encourages the European Commission to pursue regulatory simplification, coherence, and proportionality, ensuring that Europes businesses can continue to thrive while contributing to the EUs strategic digital objectives. For a detailed overview of EHIMA's concerns and suggestions, please see the attached position paper.
Read full responseResponse to Targeted revision of the EU rules for medical devices and in vitro diagnostics
26 Sept 2025
As set out in our earlier submission, the European Hearing Instrument Manufacturers Association (EHIMA) welcomes the opportunity to contribute to the European Commissions stakeholder consultation on the revision of the Medical Device Regulation (MDR). EHIMA urges the European Commission to revise MDR implementation to ensure efficiency, consistency, and risk-based regulation. By addressing unnecessary bureaucratic hurdles, aligning Notified Body procedures, and creating structured escalation mechanisms, the EU can ensure a regulatory environment that fosters both patient safety and European industry competitiveness. For a detailed summary of suggested changes to the MDR, see the attached position paper by EHIMA.
Read full responseResponse to EU rules on medical devices and in vitro diagnostics - targeted evaluation
12 Mar 2025
The European Hearing Instrument Manufacturers Association (EHIMA) welcomes the opportunity to contribute to the European Commissions stakeholder consultation on the revision of the Medical Device Regulation (MDR). EHIMA urges the European Commission to revise MDR implementation to ensure efficiency, consistency, and risk-based regulation. By addressing unnecessary bureaucratic hurdles, aligning Notified Body procedures, and creating structured escalation mechanisms, the EU can ensure a regulatory environment that fosters both patient safety and European industry competitiveness. For a detailed summary of suggested changes to the MDR, see the attached position paper by EHIMA.
Read full responseResponse to A comprehensive approach to mental health
15 Feb 2023
The European Hearing Instrument Manufacturers Association (EHIMA) thanks the European Commission for the opportunity to contribute to the upcoming Comprehensive Approach to Mental Health, the EUs first-ever strategy on mental health and well-being. EHIMA unites the major companies developing and manufacturing more than 90% of the worlds hearing aids and implants. Our mission is to ensure that all people in need have the chance of hearing rehabilitation, critical for well-being and high quality of life at any age. Our members, in their line of work and as part of their collaboration with community professionals such as audiologists and hearing aid fitters, encounter issues surrounding mental health very frequently. Disability and physical/sensory impairment is a major risk factor behind poor mental health. According to Eurofound (1), people with disabilities rate their mental health a staggering 37% lower than people without disabilities (an average WHO score of 50, compared to 68). About 46% of people with disability are at acute risk of de-pression, compared to 16% of the non-disabled population. Hearing loss is a major cause of disability. According to the WHO (2), global prevalence is expected to rise from 466 million people in 2018 to 900 million by 2050. Age-induced hearing impairment (presbycusis, often beginning at age 50) is one of the most common medical conditions at advanced age. According to The Lancets Global Burden of Disease Study (3), in the EU, hearing loss is one of the top 20 causes of ill health, with about 34.4 million hard-of-hearing people. As such, there is a manifest link between hearing loss and poor mental health. Losing ones hearing can have severe psycho-social implications. Because one cannot participate in social activities as easily as before, hearing loss can cause loneliness and isolation. In fact, the impact of hearing loss on relationships with friends and family, the ability to go out and the chance to enjoy leisure activities, culture and entertainment are cited as the most immediate implications of hearing loss. This, in turn, means that people with hearing loss have an elevated risk of anxiety and depression. A decrease in cognitive abilities might also be attributed to untreated hearing loss. As the brain is missing the sensory input from the ears, hearing loss has been linked to dementia and Alzheimers. (4)(5)(6) As a result, assistive devices such as hearing instruments play a crucial role in addressing not just disability, but mental health as well. A comprehensive mental health strategy should consider the proxy effects of tackling mental health through its co-morbidities and disabilities. EHIMA calls on the European Commission to: Consider the impact of early screening and detection for hearing impairment and disability as a determinant of mental health; and important tools of mental illness prevention. Consider the role and value of access to assistive devices as a means of rehabilitation not just of disability and hearing impairment, but equally spilling over into mental health and well-being. Consider the disability/mental health nexus, and reflect the mental health needs of functionally and hearing-impaired persons. EHIMA looks forward to the launch of the Comprehensive Approach on Mental Health, and would be delighted to continue engaging on this topic. (1) Eurofound (2018), The social and employment situation of people with disabilities (2) WHO: Addressing the rising prevalence of hearing loss, 2018 (3) https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)30925-9/fulltext (4) Livingston et al.: Dementia prevention, intervention, and care: 2020 report of the Lancet Commis-sion, 2020 (5) Mosnier et al.: Long-term cognitive prognosis of profoundly deaf older adults after hearing rehabilitation using cochlear implants, 2018 (6) Amieva et al.: Death, Depression, Disability, and Dementia Associated With Self-reported Hearing Problems, 2018
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