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Unintended consequences of over-the-counter hearing aids

I have almost 98% hearing loss in both ears. For over 30 years, I’ve spent thousands of dollars on hearing aids partially offset by insurance. This week, the FDA finalized over-the-counter (OTC) hearing aids that can be sold without a prescription to people with mild to moderate hearing loss. OTC hearing aids will be available as soon as October.

For the past two years, analysts have been predicting that when OTC hearing aids finally arrive, they will revolutionize the U.S. market, making the devices cheaper and available without a medical prescription or testing obtained under the circumstances. But while this new business model means manufacturers can sell directly to consumers, it could have unintended consequences for me or other deaf people with more than moderate hearing loss.

According to the National Institute on Deafness and Other Communication Disorders, approximately 13% of the US population (30 million people) is 12 years of age or older with hearing loss, as determined by standard hearing tests. About 28.8 million U.S. adults could benefit from wearing hearing aids, but choose not to wear them for reasons of cost, accessibility, stigma and preference.

This is not a new question. In the 1930s, doctors recognized deafness as a public health concern and worked with deaf and hard of hearing organizations to advocate for regular hearing tests and hearing aid prescriptions. As the hearing aid industry improves the technical specifications of its products, hearing aid dealers use direct sales and storefront displays to attract resistant consumers. Consumers can choose from a variety of models and features, even for their specific type of hearing loss. However, rising maintenance costs, rising prices for powerful new models, and insurance restrictions prevent many people from buying hearing aids. Even today, hearing aids are still not covered by health insurance.

But that trend has changed. In 2017, Congress passed the FDA Reauthorization Act (FDARA), which created a class of OTC hearing aids for adults with mild or moderate hearing loss. Under the guidelines set out in October 2021, OTC hearing aids can be purchased from any seller over the counter for about $600 per pair, rather than the average cost of $5,000 to over $14,000 per pair (including accessories and follow-up service) . Once OTC hearing aids hit the market, they will provide consumers with cheaper, more accessible and technologically advanced options to improve hearing. But despite these improvements, the marketing and acceptance of these OTC hearing aids may ultimately reinforce stereotypes that continue to stigmatize the deaf community.

One problem is Consumers may become frustrated with their hearing aids if not further personalised fitting Worsening hearing loss – OTC hearing aids may exacerbate this problem as they will have preset or limited settings. Some startups are trying to solve this problem by offering smartphone apps associated with their OTC prototypes to approximate the audiologist’s experience. However, as audiologists say, consumers cannot properly self-diagnose their own hearing assessment without proper hearing testing in a controlled environment such as a soundproof room.

The most pressing question is how OTC hearing aids have come to market. Advertisements and press releases emphasize that untreated hearing loss can be serious: In addition to physical stress, it is often associated with dementia, depression and social isolation. These campaigns are primarily aimed at older adults with fixed incomes, reinforcing stereotypes of hearing loss and aging. Additionally, advertisements for these OTC hearing aids suggest they will be “invisible,” thus reducing the stigma or embarrassment of being deaf. This marketing tactic pushes deaf people into a binary: either they are “hearing passers-by” or they are part of a deaf culture that communicates primarily using sign language. However, both groups are expected to receive “curative” medical and technological options. However, not all deaf people – including myself – want to be “healed” and would rather accept their deafness as a sphere of auditory experience and identity.



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