Opinion: FDA’s new hearing rules help some, but leave others behind


Editor’s note: Sara Novic is a deaf writer and author of “True Biz,” “Girl at War” and “America is Immigrants.” The opinions expressed in this comment are his own. See more opinion articles on CNN.



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This week, the US Food and Drug Administration (FDA) finalized a rule change that would create a class of over-the-counter hearing aids that can be purchased without a prescription or fitting from an audiologist. The change came after a years-long wait — Congress passed a bipartisan bill on the issue in 2017 — news that was hailed as a huge relief to the millions of deaf and hard-of-hearing Americans who often encounter these expensive medical devices. reach

For those who are experienced with hearing aids like me, this change is more complicated. The FDA’s recent changes help some, but they also present potential risks for consumers and highlight major gaps in care for many who need it most.

Notably, while the coverage of the new rules is splashed with pictures of cute babies in hearing aids, they only apply to hearing aids for adults with mild to moderate hearing loss. However, this move makes hearing aids available to a subset of the population who need them, and I’m happy to know that this decision will help those people.

But as a deaf person, I’m wary that the FDA and our elected officials who voted on related legislation more than five years ago may see it as a box to check off a to-do list and forget about it. the rest of us who do not support this change. People like me who need higher powered devices will still be forced to pay out of pocket. No children will benefit from the new category of aid.

Our society tends to support the disabled in surface-level ways, innovating narrow solutions, continuing to shy away from systemic moves that would make things better for everyone. Hearing loss is a very common disability, with one in eight Americans over the age of 12 having some form of hearing loss. At the age of 75, this number rises to almost half of the population. But according to a survey by the American Speech and Hearing Association, only 20% of people with hearing loss who need treatment receive it, with most waiting more than 10 years after diagnosis to be fitted with aids.

In the US, barriers to hearing aid access are numerous. Hearing aids are not covered by Medicare or most private insurers, and state Medicaid coverage varies. Without coverage, a single aid could cost up to $5,000 depending on the technology, which includes hearing aid fitting referrals, tests, prescriptions and bills for multiple doctor visits for follow-up care.

In rural and low-income areas, access to audiologists or ENT (ear, nose, and throat) doctors is often limited, forcing patients to endure long trips or long waits to be seen. It is therefore understandable that many people are unable or unwilling to treat it.

Some have compared the creation of a prescription hearing aid class to buying a pair of reading glasses at a drugstore, but the comparison is ultimately wrong. As with many vision problems, there are different types of hearing loss, and most require more nuance than just making something louder. “Normal” human hearing requires the simultaneous function of the outer, middle, and inner ears, as well as the auditory nerves that carry this information to the brain and the brain’s processing centers themselves. A doctor’s evaluation is valuable in determining the source of an individual’s hearing problem.

Hearing aids best serve those with sensorineural hearing loss, the death of hair cells in the inner ear. This is the main cause of hearing loss, especially among the elderly, but it is not the only type, and only tests by an audiologist would be able to distinguish it. People who need treatment for other types of hearing loss can not only find their hearing aids unhelpful, but can also damage their cochlear cells by listening at high volumes for long periods of time.

Also, even for those with sensorineural hearing loss, a hearing aid is not the only solution. A person’s loss is seldom the same at all frequencies; most elderly people, for example, hear lower sounds better than higher ones. When an audiologist fits a person with hearing aids, the doctor programs the aids at each frequency level according to the patient’s unique needs. Many hearing aids also have programs for use in different settings, such as watching TV and another for a noisy restaurant, that change sound levels and reduce background noise to suit individual hearing levels.

Supporters of the FDA changes say increased competition among hearing aid manufacturers will spur technological innovation, including increased self-adjustment capabilities, but in the meantime, new hearing aid users are likely to feel pain from sounds that are too loud at certain frequencies, or would continue to struggle in situations with a lot of background noise. This may lead to reduced willingness to adopt the technology in the long term, even as overall access generally increases.

Finally, there is the issue of stigma. While wearing glasses is generally understood to be part of a standard variation of human experience and appearance, and sometimes even considered fashionable, hearing aid users are often stigmatized by a wide range of abilities and ageism. Even with increased availability, I expect that it will take an active and conscious way to dispel these negative stereotypes before we see meaningful use in hearing aid use.

The positives surrounding the hearing aid guideline changes hold great promise for the future, but do not provide specific support for those in need. Certainly, adults with mild sensorineural hearing loss, for whom first aid was too expensive, will be better for the changes. As for all the optimism we invest in the free market, only time will tell in terms of lowering prices due to innovation and competition. Ultimately, these changes feel like a Band-Aid on the bullet wound that is America’s health care system. Instead of equitable access to care for all, we see and hope to celebrate the fragmentation of certain measures.

And I celebrate with those that a bandage can stop the bleeding. I also hope that they and everyone else will continue to stand with deaf and hard of hearing Americans and advocate for access to hearing technology for all who need it.