Over-the-counter hearing aids are a great idea - but only if they’re safe: Martha Woodruff

January 5, 2022


The Build Back Better spending bill would, as currently written, provide Medicare coverage for hearing aids for the first time. Some might find it incomprehensible that Medicare hasn’t provided this coverage before now, given that about half of all Americans over 60 have some degree of hearing loss.


There is no guarantee, of course, that this controversial legislation is going to come to fruition, but there is another effort underway to make hearing aids more accessible and affordable. The U.S. Food and Drug Administration has issued proposed regulations that would allow hearing aids to be sold over-the-counter to adults with mild-to-moderate hearing loss without involvement from trained hearing care professionals.


This is a welcome step, particularly for seniors of modest financial means, to providing increased access and making hearing aids more affordable. However, serious questions must be asked as to whether consumers would be at risk of experiencing increased hearing loss as a result of using an over-the-counter (OTC) hearing aid governed by these rules.


The problem concerns maximum decibel (dB) levels. The FDA’s proposal, quite frankly, is written for consumers who listen to music on earbuds for short periods of time while they run or sit at the coffee shop. This proposal is not adequately crafted to ensure safety for those with hearing loss who will wear hearing aids for many hours in a day.


The FDA is proposing an output limit of 115 to 120 dB for OTC hearing aids. This is simply too high for sustained use by people who are struggling with mild or moderate hearing loss. In fact, the National Institute for Occupational Safety and Health recommended a standard in 1998 that workers not be exposed to 120 dB of sound for as long as nine seconds.


Any good accomplished by making hearing aids more accessible will be wiped out if those devices damage the hearing of users.


The FDA is justifying this proposal, with comments open through Jan. 18, by saying that OTC hearing-aid users will have 28 seconds to either reduce the volume or remove the device to avoid further damage. This approach is problematic because it disregards the fact that many users of OTC hearing aids will be seniors who have not consulted a hearing-care professional and know what constitutes a safe and acceptable sound volume. Also, many older Americans may be afflicted with other adverse health conditions that carry dexterity or cognitive challenges which would make it virtually impossible to act within half a minute to avoid further damage.


The FDA needs to provide that safety, instead of placing the burden on seniors to protect themselves against increased hearing loss.


The solution is simple. Four national associations representing hearing-care professionals have agreed that there should be an upper sound output limit of 110 dB, not 120 dB, to ensure OTC hearing aids are safe and effective. These associations have also said there should be a limit on gain, the level of amplification applied to incoming sounds, which hasn’t been set by the FDA. The hearing-care associations, as well as notable ear surgeons and ear, nose and throat doctors, have said this is needed to provide reasonable assurances of safety and effectiveness, as required by Congress.


Maybe Congress will act to expand Medicare coverage to include hearing aids, but in the meantime, OTC hearing aids may be on store shelves as early as next year. Before that happens, though, steps must be taken to ensure these products don’t turn mild hearing impairments into severe hearing loss for people using OTC hearing aids.


Martha Woodruff is an advocate for older Ohioans and writes a newsletter for Fairhill Partners, which has served the Greater Cleveland community for over 78 years connecting people to opportunities for lifelong learning, intergenerational relationships, and successful aging.


See the original article on Cleveland.com.