In Québec, approximately 864 000 people, or 10% of the population, have permanent hearing loss that can lead to hearing disabilities (OMS, 2021b), making it one of the most widespread physical impairments. Approximately 32% of people 65 years of age and over have sufficiently significant hearing loss to interfere with their daily activities. As of the age of 75, the incidence of hearing loss increases to 47% (ASHA, n.d.). Current trends show that this prevalence rate is increasing, and it is estimated that one person in four will have a degree of hearing loss by 2050 (OMS, 2021a). Hearing aids are one of the main methods to compensate for hearing loss, but are only used by 20% of adults affected (Chien, 2013). A number of factors explain this underuse, including, in particular, the high cost of these devices (Blustein, 2022).

Since 2017, the OOAQ has been expressing its concern about the very high cost of hearing aids in Québec. Consequently, the OOAQ welcomed the new legislation published on August 17, 2022 by the Food and Drug Administration (FDA) in the United States creating a category of over-the-counter hearing aids (FDA, 2022). These medical devices, subject to regulation to ensure their quality and safety, can be purchased directly from stores or online retailers, without requiring a prior assessment or prescription from a hearing health professional in the United States.


Hearing aids

Hearing aids are medical devices that amplify the sounds in the environment. They can be adapted to almost every degree of deafness and can be used by people of all ages. These devices are adjusted individually, both physically and in terms of amplification, in order to optimize the user’s comfort and hearing. In Québec, hearing aids can only be acquired on recommendation from a physician or an audiologist.

New over-the-counter hearing aids in the United States

The new over-the-counter (OTC) hearing aids in the United States are only available to adults with mild to moderate perceived hearing loss. No prior hearing assessment or prescription is required. Consumers can have their hearing levels measured the first time they wear the device so that an automatic adjustment can be made. Several parameters are regulated, including the maximum volume emitted, and the product display must indicate situations in which the consumer should consult a health professional before purchase. These devices are not currently available in Canada.

Personal sound amplification products

It is also important to point out the existence of personal sound amplification products, designed for people with normal hearing to amplify sounds in certain environments. They are not regulated medical devices and are not designed for amplification in a context of deafness.


When someone suspects they have hearing loss, it takes an average of seven years before they ask for help (Statistics Canada, 2019). Over-the-counter hearing aids, which tend to be less expensive and more visible and accessible, could contribute to reducing this delay, leading to a decrease in the harmful long-term consequences of untreated deafness.

Untreated deafness can have multiple and very serious consequences for all ages: increased risk of dementia, cognitive fatigue, social isolation, reduced quality of life and activities, psychological distress, anxiety, impaired postural stability (which can increase the risk of falls), job loss, etc. Based on a meta-analysis to determine the costs of untreated hearing loss in Europe, experts estimate the cost in Canada to be $20 billion per year, or $11,800 per person living with untreated hearing loss (Shield, 2019).

This new range of products will also enable people experiencing hearing loss to compare prices, explore their options and take charge of managing their hearing health.

It is clear that these products do not respond to the needs of all adults with hearing loss, and will not be recommended for people presenting other auditory or vestibular symptoms that could require a medical examination and an assessment by an audiologist. However, considering the major limitations on access to hearing aids in Québec right now, this is a welcome advance.


This historic moment is an opportunity to review and improve the service delivery model for hearing amplification in Québec. Therefore, the OOAQ is of the opinion that:

  • over-the-counter hearing aids are a means of increasing the accessibility of hearing amplification for a greater number of people;
  • the absence of similar legislation in Canada leaves the door open to unsafe and ineffective technologies entering the market, with significant risks for Canadians with a perceived mild to moderate hearing loss.


The OOAQ is calling on the Canadian government to quickly legislate on over-the-counter hearing aids in Canada. Québec’s legislation should also be amended to enable over-the-counter sales of these products in the province.



Akbari, D. (2022). Why OTC Hearing Aids Will Help Many People, Including Audiologists.

American Speech-Language-Hearing Association. (s.d.). Hearing loss in Adults.

Blustein, J., Weinstein, B. E., & Chodosh, J. (2022). Over-the-counter hearing aids: What will it mean for older Americans?. Journal of the American Geriatrics Society70(7), 2115–2120.

Chien W, Lin FR. (2013). Prevalence of hearing aid use among older adults in the United States. Arch Intern Med.;172: 292-293.

Organisation mondiale de la santé. (2021a, March 2). WHO: 1 in 4 people projected to have hearing problems by 2050. [News release].

Organisation mondiale de la santé. (2021b, April 1). Deafness and hearing loss [Fact sheet].

Statistique Canada. (2019). Rapports sur la santé : Perte auditive non perçue chez les Canadiens de 40 à 79 ans.

United States Food and Drug Administration, Department of Health and Human Services. (2022). Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the-Counter Hearing Aids,, Document: 87 FR 50698

Shield B. (2019) Hearing loss–Numbers and costs. Evaluation of the social and economic costs of hearing impairment. Brussels, Belgium. Disponible sur :