F.D.A. Proposes Rule for Over-The-Counter (OTC) Hearing Devices Without a Prescription

by Dr. Nimet Adam

The proposed rule may make it easier for Americans with mild to moderate hearing impairments to get hearing devices. As Audiologists we are all about access to better hearing and hope that this rule will make talking about hearing loss more prevalent and mainstream. However, there are some concerns and the Academy of Audiology (AAA) and the American Speech and Hearing Association (ASHA) have highlighted these concerns as follows:

While OTC devices offer an affordable solution, the quality and technology is going to vary and will be left up to the consumer to navigate the onslaught of products that will hit the market. Cost will encompass a wide range and the way that these products are fit will be through no test, self-test, or sending a test in; this leaves a large margin for error.

Consumer research studies were initiated since 2017 in preparation for PSAP (Personal Sound Amplification Product) ruling and the recent OTC ruling. These studies indicate the following:

When consumers were asked to complete a self-test, various studies showed that up to 50% could not complete it accurately and underestimated the degree of hearing loss. In self-reported level of hearing loss patients that had a moderate hearing loss reported a mild loss and those with severe hearing loss perceived their loss to be mild or moderate. The hearing test results are the prescription to the appropriate selection and fitting of hearing devices and if half the consumers don’t’ get this part right, the fitting is going to be inadequate. Not to mention the fact that occluding wax could be a contributing factor for their poor hearing.

In one study, 40% of consumers chose to keep their hearing devices despite poor outcomes. This suggests that since a new hearing aid user has no frame of reference, they may be willing to put up with poor results/performance or live with the notion that something is better than nothing. This may keep them from seeking professional help and the benefit of a better hearing solution. Poor outcomes also lead to poor compliance. Eventually, when the consumer realizes they are not hearing as well as the want, they use the devices less and less and can eventually end up in the drawer.

Most Audiologists perform some form of verification testing to ensure that the patient is getting maximum benefit from their hearing devices. Tests such as Real Ear Measurement (REM) and functional gain as well as speech in noise tests, help to ensure not only that the proper device was selected but that it is delivering optimum hearing results. The consumer will forgo these important tests and will have to rely on their own subjective analysis. Volume should not be the only criteria, the consumer needs to pay attention to clarity and how well they hear in difficult listening situations.

In many Audiology practices, patients are seen regularly for a clean and check visit. The regular maintenance aspect of hearing aids is not often discussed but it is extremely important. Studies have shown, that hearing aids, like other electronic devices, fail often due to moisture, wax and debris, blocking the microphones or speaker. This can result in varying degrees of performance. Regular suctioning, dehumidifying and examination of the ears for wax are extremely important maintenance aspects of successful hearing aid use. This is something that is lacking with the OTC option. In addition, an annual hearing evaluation so the programming of the devices can be updated with any changes in hearing is recommended.

Proper insertion and counseling on appropriate use of the device may require some hands-on training. Studies show that between 35% to 58% of consumers did not insert the hearing device in their ear properly. This may lead to losing the device and insufficient benefit. In some cases, due to the shape of the ear or the degree of hearing loss, a custom ear mold is necessary, and this is not an option when ordering on-line.

While there are many concerns, there is also the hope that those going without help will now have a way to access affordable hearing devices. More media attention to the prevalence of hearing loss can hopefully address the stigma associated with it. Unlike glasses, hearing devices have a negative perception. It is our hope that this stigma will be reduced with more people reaching out to improve their hearing health and not look at it in a negative way but to improve their quality of life, communication and safety.

Hearing Partners of South Florida

Delray 561-638-6530          Boynton 561-736-6002          Jupiter 561-888-7260

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