Hearing loss in France affects about 10% of the population, namely over 6 million people haveto face hearing difficulties in daily life. Older adults (over 50 years old) are the most concerned– one third of this population – as hearing loss arises during the course of life (for 88% ofFrench people), through a natural and progressive phenomenon (presbycusis) or afterexposure to noise. In Europe, Japan and the United States, prevalence rates are comparableto those in France. The WHO estimates this burden of illness to currently concern more than5% of the global population, representing 360 billion people. Nowadays, hearing loss isconsidered as a major public health issue in the scientific literature and by international healthagencies.Not only is hearing loss apparent through direct functional limitations (understanding andcommunication difficulties), but hearing impairment is also associated with a higher frequencyof mental disorders, cognitive decline, falls and even mortality, independently of ageingeffects. Hearing loss could precipitate the elderly into dependency. Hearing aids (‘medicaldevices for individual use’) compensate, to a certain extent, for hearing impairment and,furthermore, ensure some individual rehabilitation: in 2015, more than 2 million French peopleowned hearing aids out of 3 million eligible people. This technical solution should be furtherencouraged, since 1 million French people declare a need for hearing aids but don’t get them.As a result, improving access to hearing aids represents a decisive issue, not only in terms offinancial accessibility and fairness, but also in terms of efficiency: hearing aid equipment ispresumed to reduce the significant implications of hearing loss on health state and healthcareexpenditure and, thus, improve the patient’s quality of life. Yet, the hearing aid sector in Francehas been long characterized by a wait-and-see public policy: the regulatory rules have beenfrozen for several decades, due to a lack of reliable information on the expected added valueof hearing aids (in economic terms of utility). This lack of information and stalled regulationshave resulted in several recent reports, released by the Court of Accounts (Cour des comptes)and the General Inspectorate for Social Affairs (Inspection générale des affaires sociales),which both underline the urgent need to re-examine the access rules to hearing aids and toprovide, at the same time an economic assessment of this equipment.The main obstacle to hearing aid access in France (financial barrier) concerns current financingrules, and particularly the public trade-offs that have led hearing aids to be classified in the‘low risk’ category and practically excluded from socialised health care. This classificationimplicitly indicates that the hearing aid is a luxury product whose medical added-value is verylow: in comparison to the trade-offs for drug classification, the hearing aid medical addedvalueranges between ‘low’ and ‘insufficient’, since its observed reimbursement rate is under15%. Yet, wide access to hearing aids (2/3 in terms of ‘real access’ of the eligible population)shows clearly that demand elasticity is low: they are a necessary item. In general, the publicchoice of coinsurance depends on the combination of ‘low risk’ and ‘commitment’. There isonly partial reimbursement in relation to ‘low risk’, or even totally exclusion from the socialhealth care basket when it does not depend on the collective responsibility and implies anindividual judgement on the trade-off consumption-price (in order to avoid over-consumptionor, in economics, the ‘moral hazard’ risk). Yet, not only is access significant despite the out-ofpocketpayment, but moreover its health consequences as well as its economic impact are6likely to be major. The cost to society of hearing aid renunciation, in terms of quality of life,expenditure and social inequalities is in total opposition to the objectives assigned to theFrench health system.Hearing loss: outline dataDisabling hearing loss prevalence is estimated today to range between 8.6% and 11.2% of theoverall French population. The analysis of hearing aid access shows that 30% to 35% of hearingimpaired people are equipped, namely 2 million out of 6 million people. This gap is reducedwhen considering people being equipped and people eligible for hearing aids: whatever theexpert assessments, survey data or empirical statements (monographs by country), only halfof hearing impaired people would be eligible for hearing aids, thus 3 million people in France.Thus, 65% of eligible French people are hearing aid owners whereas 35% of them remainunequipped.There are two main reasons which can explain this renunciation: a low public and privatecoverage (provision), and a lack of information. Indeed, the average price for one hearing aidcomes to 1,535 euros, and 3,070 euros for binaural equipment. But this expense is poorlycovered by the National Health Insurance (8%) and poorly reinsured by complementary healthinsurances (30%), leaving a high out-of-pocket payment for the adult insured (62%), namely950 euros per apparatus. The price for hearing aid equipment comprises both the device andthe hearing aid professional’s counselling and follow-up services.For the hearing aid owners, the equipment has an average duration of 5 to 6 years, duringwhich a qualified check-up is ensured by the hearing aid professional. The quality of theequipment as well as the quality of the follow-up should influence hearing aid efficiency, usersatisfaction and beneficial compliance. This hypothesis seems to be confirmed throughoutinternational comparisons: in countries where the access rate to hearing aids is higher, thesocial coverage is better for downmarket or middle market equipment. However, thesecountries don’t necessarily have greater rates of real HAs users (i.e. rates considering effectiveeligible people for hearing aids and effective wearing of hearing aids). Taken thus, Francewould present a real rate of use close to those of the United Kingdom, Germany and Norwayand starting from very different situations in terms of financial access to equipment. If thereis room for improvement in France regarding the need for hearing aid equipment – due tofinancial impediment - there is also room for growth in countries where hearing aids are(almost) freely delivered but where the compliance isn’t sufficiently performant. A review offinancial rules relating to hearing aids has to consider the compliance factors determining theeffective use of equipment and, thus, the level of satisfaction for hearing aid users.As concerns the payment schemes for hearing aid professionals, an economic analysis isnecessary, taking into account their incentive properties. In order to regulate the hearing aidsector and to design an incentive payment for hearing aids, a trade-off is necessary betweenthe objectives of expenditure control, health care quality and freedom of choice, in ahypothetic framework assuming a higher coverage of hearing aids. There are many toolsallowing us to realise the optimal trade-off for public financing, but a cautious approach isrequired regarding the issue of a possible decoupling of the device and the service. Thisdecoupling model brings up adverse effects which are similar to those of ‘cost-plus’ payment,7leading to increasing prices and putting patients’ compliance at stake, i.e. affecting thetherapeutic efficiency of hearing aids for some of them. At the same time that recourse toprospective payment systems is increasingly implemented for pricing in health systems, andas growing attention is paid to patients’ empowerment, this concept of divisibilitydevice/service falls within a backwards economic approach in terms of optimal incentives.International comparisons highlight the impact of coverage and health care organisation onhearing aid access, equipment renewal and patients’ compliance. They show also that Frenchprices for one hearing aid are very similar to those of other European countries.Health and economic consequences of hearing loss: impact studyInternational medical scientific literature as well as French survey data are profuse on theburden of illness topics and these start to provide evidence-based studies on the causalalleged connection between hearing loss and health state degradation. Disabling hearing loss(or moderate to total auditive functional limitations), by reducing the person’s communicationcapacities, rebounds significantly onto the whole dimensions of health state (mobility,autonomy, daily activities, pain/discomfort, anxiety/depression) through a succession of chainreactions, the main ones being social isolation, cognitive decline, suffering at work, mentaltroubles and falls. Hearing loss represents a major impairment which, by affecting more thansix million (often older) French people, not only has deleterious effects on quality of life butalso leads to additional health and social care expenditure for society as a whole.The scientific literature unambiguously reports the negative waterfall effects of hearing loss,but also shows the beneficial effects of hearing aid wearing: reduced mortality risk; improvedpsycho-social health state; and a normalising effect on cognitive decline risk. Publications alsopoint out that this favourable impact on mental health is appreciable starting from the first 3months of equipment. In the same perspective, some studies show the reliability and theefficiency of earlier screening for people at the end of their working lives, screening those whoare old enough to justify secondary prevention, but who are still young enough to benefit fromit since their hearing loss level is moderate to severe. Earlier screening appears to be a veryefficient strategy regarding cost and quality of life. It should be implemented over the courseof medical consultations, in the form of two short questions without additional costs to generalpractice.Starting from this literature and the survey data, two scenarios for economic assessment ofhearing loss are proposed. The first one gives rough estimates for intangible costs related toquality of life degradation in France. The aim is to assess the monetary value of lost healthyyears by valuing them in terms of the implicit price of human life. Based on realisticassumptions, this estimation draws an image of saved costs thanks to hearing aid equipmentor compliance, as well as the economic burden of hearing loss related to its prevalence:without equipment, this burden would amount to 23.4 billion euros. The real rate ofequipment (effective access and effective use of hearing aids) reduces this burden by 30%,whereas the target equipment rate (i.e. 50% of hearing impaired people related to actualcompliance) would lighten the burden by 40%.The second scenario relies on several assumptions in order to estimate, on the one hand,medical costs related to hearing loss without equipment and, on the other hand, averagescores of lost utility related to quality of life. Both dimensions are graduated according to8French hearing loss prevalence rates by age groups and by severity levels, then they areconnected with the rate of eligible people for hearing aids but who are not being equipped.For this specific population, we assume that a gain should be expected in quality of life and incost savings, if equipment were delivered for 6 years. Assessing these values allows us toroughly estimate a range for the incremental cost-utility ratio, expressing the cost to pay inorder to gain one additional healthy year for the period. Yet, through this simple simulation,the target strategy (i.e. equipment for eligible population not accessing hearing aids) wouldbe dominant, even taking into account the compliance rate that reduces quality of life gainsand costs savings: the overall cost of this additional equipment would be 1.5 billion euros, with48,000 QALYs gained and with cost savings worth 1.7 billion euros, namely a ICER of - 830euros/QALY. In other words, the target strategy of ‘all eligible people are equipped’ saves costsand provides an increased quality of life, and is thus the dominant strategy. This entire casestudy, which relies on acceptable assumptions, underlines the requirement for a substantialeconomic assessment that would corroborate these results, that is the highly efficient targetstrategy that ‘all eligible hearing impaired people are equipped’, since the annual overallexpenditure of the hearing aid sector comes close to 1 billion euros. However, it remains tosolve the touchy question of hearing aid financing likely to support access to them, andespecially the question of the relative financial contributions of payers, as seen in the firstsection of the report. Moreover, if the National Health Insurance could greatly increase itsfinancial role in hearing aid reimbursement, we would anticipate a bounce effect for peoplebeing equipped but having postponed hearing aid renewing. This effect would inevitablyincrease the budget impact of hearing aid access. That’s why an overall scenario has to be setup, through prospective cost-efficiency assessments, by collecting useful data in sequential orregular surveys based on the working and older population, in order to infer the differentialcost-utility ratio between strategies. This overall scenario would be completed by estimatingthe budget impact of hearing aid equipment depending on several coverage scenarios fromthe National Health Insurance’s point of view.Coming out of this overview, the health policy for secondary prevention, that could consist ofscreening and equipping hearing impaired people with hearing aids, is non-existent regardingpublic reimbursement. National Health Insurance, by covering only 8% of hearing aid price foradults, has almost excluded hearing loss from its management policy for health risk, leavingthe out-of-pocket payment to complementary insurance bodies and above all to patients. Infine, families, close relatives and the whole society bears the costs of this impairment, as wellas for the loss of autonomy since one third of the eligible population for hearing aids don’t getto them. Moreover, inequalities relating to the rights of those insured with complementaryhealth bodies, their revenue and ability to pay for equipment contribute to maintain thesesocial inequalities in health, by the renouncement effect. These statements would impose theneed for an urgent examination of the regulatory rules for the hearing aid sector in France, ata moment where ageing, and listening to amplified music among the young risks contributingto aggravated hearing loss prevalence in France.