Message from the Editor-in-Chief
Definition of a Hearing Aid
Whether we are dealing with high-tech hearing aid terminology where band means something different than filter, or lower-tech phrases such as hearing impaired and hard of hearing, definitions can be quite important. In this issue of CanadianAudiology.ca, Gael Hannan tackles the hard of hearing vs. hearing impaired issue — a label that has controversy associated with it since I was a student back in the 1970s. In our cover feature article, Karen MacIver-Lux, following the recommendation of a 2019 position paper, uses the term “children who are deaf or hard of hearing” to encompass those with congenital or acquired hearing loss, whether unilateral or bilateral, ranging from mild to profound, including conductive, sensorineural, auditory neuropathy spectrum disorder, and mixed losses…” Sometimes the exact definition is just a word and sometimes, it can be quite meaningful.
In Canada we never have had a definition of “hearing aid” and this differs for our American colleagues south of the border. The FDA in the United States has defined several categories of hearing aids, one of them being “over the counter” or OTC hearing aids. This has never been an issue in Canada- for hearing aids to be marketed via the various provincial funding schemas and programs administered by third-party funders, they must meet certain criteria: Class II Medical Licence from Health Canada, including certain labelling requirements, service requirements, a statement (but not evidence) of safety, and a federal distribution license if manufactured outside of Canada.
So far, a hearing aid marketed by a well-known hearing aid manufacturer has the same definition as an OTC hearing aid. Indeed, Health Canada has recently approved several devices of what our American colleagues would call an OTC hearing aid. But other elements importantly include the patient target population and provincial policies.
OTC hearing aids are only “approved” for adults and those who suspect they have only mild to moderate hearing loss. The level of hearing loss does not need to be measured or verified – just the consumers’ subjective opinion. In contrast, “hearing aids” can be marketed for any age group and any degree of hearing loss, as long as a hearing health care professional verifies the hearing loss.
In the United States a single device may be marketed as a hearing aid for sale to the general population through the hearing health care route, and then perhaps with a different name or form factor shell type, as an OTC hearing aid for adults with only a mild to moderate hearing loss- they could be the identical device, just different markets.
Canada does not have a definition of a hearing aid, other than that such a product meets all criteria of a Health Canada Medical Class II license, a distribution license if manufactured outside of Canada, and is approved provincially for sale via the professional hearing health care route.
I would suggest that a definition of hearing aid not be a structural one; a single hearing aid may be marketed as either a hearing aid or an OTC device by any one manufacturer. In a blind-folded “taste-test” for adults with a mild to moderate hearing loss, someone may not be able to discern a difference in a quiet environment. To arrive at a “definition”, the difference would include a “value added” part made up of (1) individual assessment, (2) counselling, (3) aural rehabilitation by a hearing health care professional, and (4) verification that the hearing aid was both optimal and does not generate sound levels that may contribute to further hearing deterioration.
As such, I suggest that the products that we recommend and dispense to our patients with the “value added” services and measures, be called hearing aids. If they don’t, I would suggest that they be called devices. The difference would then be a functional one about how it is delivered to the client, rather than any structural or physical difference.
The Canadian Academy of Audiology has recently come out with a Position Paper, which not only discusses OTC “devices” but also all other sound-amplifying products such as off-the-shelf personal sound amplifying products (or PSAPs) and even consumer earphones- all of which can potentially cause deterioration in hearing acuity. Among many of the Position Paper’s recommendations, the term “device” is associated with all sound-amplifying products, whether they do not have a federal licensing approval such as consumer earphones or a federal licensing approval such as OTC devices.
The phrase “hearing aids” implies that the product has a Medical Class II license approval AND are value-added in the sense that they are provided to the consumer on an individual basis along with an assessment, counselling, aural rehabilitation by a hearing health care professional and verification that the hearing aid was both optimal and does not generate sound levels that may contribute to further hearing deterioration.
The perspectives in this Editorial are those of the Editor in Chief and are not necessarily representative of those of the Canadian Academy of Audiology.