Hearing Gain?
An audiologist must have a doctoral degree, complete 9 months of clinical experience and be well-versed in a wide variety of medical, clinical, and social topics in order to pass the certification exam necessary to hang out a shingle. That said, many audiologists not only diagnose hearing problems but also provide corrective ‘appliances’ commonly known as hearing aids. These little items, which are only covered by expensive insurance policies, can range from a few hundred dollars to a few thousand dollars, and given that they are essentially mobile devices, they need battery changes regularly, with many batteries costing over $25. Some audiologists replace batteries for only the cost of the battery, while others charge rates almost as high as an office visit.
As with any consumer product there are those that take advantage of consumers, and in the case of hearing aids, the market is oriented toward an older crowd, many of whom have fixed incomes or limited financial resources. Experiences with elderly family members being charged outrageous fees for ‘fittings’, ‘adjustments’, and repairs are quite common, all of which are added to the initial price of the devices. Long gone are the days of hearing aids that sat in your breast pocket and were connected to a device that was the size of a pack of Lucky’s, but rather than prices going down as electronics miniaturization made modern hearing aids smaller than wireless earbuds, prices remained high because you could not buy hearing aids from anyone other than an audiologist or associated vendor.
In October, the FDA issued a proposal to allow millions of US citizens access to low-cost hearing aid technology by creating definitions for a category of OTC hearing aids, repealing the ‘conditions of sale’ that had previously limited access, and amending the existing labeling requirements for these devices, essentially granting public access to such non-prescription hearing aids. The ruling, which has yet to be finalized, would not remove the classification of prescription hearing aids but would add a category that would allow access without an examination by an audiologist or require a prescription. The FDA is asking for public comments by 1/18/22.
Over 30m people in the US are affected by some sort of hearing loss yet only 20% of that population seek ‘intervention’. When queried the typical hesitancy comes from high cost, the stigma associated with being seen as old or debilitated, and the cost relative to the benefits received, and while there will still be the “I hear what I want to hear”, and the “…Yes dear..” crowd that will still reject the idea, the cost of such devices will likely become a competitive battleground, benefitting consumers. The FDA will have to maintain a careful eye over OTC products, which will still be under their purview, but we expect a wide variety of prices and options to become available once the rule is approved and in this case the FDA rules preempt any state regulations that differ from or add to the new FDA rules.
While audiologists might lobby to have the potential rules eliminated, it is certainly time to eliminate the high cost of hearing aids for those unwilling or unable to spend thousands to regain their ability to engage socially or just hear the birds chirping in the AM. Once the field of OTC hearing aids is opened, R&D in new product development and new technology will become financially viable given the potential market and remotely controllable hearing aids, based on a smartphone app, would be relatively simple to operate and allow the user to gain as much control over the timbre and tone of what they hear, as they would like. They can still turn it off when the grandkids start screaming or when the wife starts nagging, but at least they can listen to “When the Swallows Come Back to Capistrano” or “Pennsylvania 6-5000” on the old Victrola.
As with any consumer product there are those that take advantage of consumers, and in the case of hearing aids, the market is oriented toward an older crowd, many of whom have fixed incomes or limited financial resources. Experiences with elderly family members being charged outrageous fees for ‘fittings’, ‘adjustments’, and repairs are quite common, all of which are added to the initial price of the devices. Long gone are the days of hearing aids that sat in your breast pocket and were connected to a device that was the size of a pack of Lucky’s, but rather than prices going down as electronics miniaturization made modern hearing aids smaller than wireless earbuds, prices remained high because you could not buy hearing aids from anyone other than an audiologist or associated vendor.
In October, the FDA issued a proposal to allow millions of US citizens access to low-cost hearing aid technology by creating definitions for a category of OTC hearing aids, repealing the ‘conditions of sale’ that had previously limited access, and amending the existing labeling requirements for these devices, essentially granting public access to such non-prescription hearing aids. The ruling, which has yet to be finalized, would not remove the classification of prescription hearing aids but would add a category that would allow access without an examination by an audiologist or require a prescription. The FDA is asking for public comments by 1/18/22.
Over 30m people in the US are affected by some sort of hearing loss yet only 20% of that population seek ‘intervention’. When queried the typical hesitancy comes from high cost, the stigma associated with being seen as old or debilitated, and the cost relative to the benefits received, and while there will still be the “I hear what I want to hear”, and the “…Yes dear..” crowd that will still reject the idea, the cost of such devices will likely become a competitive battleground, benefitting consumers. The FDA will have to maintain a careful eye over OTC products, which will still be under their purview, but we expect a wide variety of prices and options to become available once the rule is approved and in this case the FDA rules preempt any state regulations that differ from or add to the new FDA rules.
While audiologists might lobby to have the potential rules eliminated, it is certainly time to eliminate the high cost of hearing aids for those unwilling or unable to spend thousands to regain their ability to engage socially or just hear the birds chirping in the AM. Once the field of OTC hearing aids is opened, R&D in new product development and new technology will become financially viable given the potential market and remotely controllable hearing aids, based on a smartphone app, would be relatively simple to operate and allow the user to gain as much control over the timbre and tone of what they hear, as they would like. They can still turn it off when the grandkids start screaming or when the wife starts nagging, but at least they can listen to “When the Swallows Come Back to Capistrano” or “Pennsylvania 6-5000” on the old Victrola.
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