Should the government regulate hearing aids as consumer electronic products?

As a pharmacy technician, I watched countless individuals speak with a pharmacist about how different drug therapies work, and what they should know before taking any pharmaceuticals.

But I also have a hearing loss, and as a patient myself, I am struck by how confusing it is for consumers to find the right treatment.

Hearing loss is a medical condition that affects nearly one-third of adults between 65 and 75, and half of those 75 and older. But only about 30 percent of those who could benefit from hearing aids have ever tried them. This is a troubling statistic.

Two years ago, Congress passed the Over-the-Counter-Hearing-Aid Act of 2017 that mandates the Food and Drug Administration (FDA) create a new category of hearing aids for mild-to-moderate hearing losses. This law was designed to increase consumer access by making hearing solutions available over-the-counter without the guidance of a licensed professional.

The FDA is determining how to regulate this new category of consumer products and how to expand access to hearing devices, while fulfilling its Congressional mandate to ensure they are safe, effective, and used correctly.

Currently, there are two main categories of products designed to amplify in-ear sounds.

Hearing aids are medical devices intended to correct hearing loss and are already regulated by the FDA.  Currently, hearing aids are dispensed only after a hearing care professional performs testing to determine the level and type of hearing loss. If appropriate as treatment, a device is then recommended, and programmed to the precise needs of the individual hearing experience.

Personal sound amplification products or PSAPs, on the other hand, are designed to increase environmental sounds for non-hearing-impaired consumers and are not regulated as medical devices. PSAPs amplify all nearby sounds, which is useful for certain specific activities, such as detecting animal sounds in the wild.

The FDA has acknowledged that PSAPs are not a replacement for hearing aids, as the characteristics that make for a good PSAP are very different than those in a hearing aid designed to correct a medical condition.

While the FDA has not yet revealed specifications for the new OTC category of hearing aids, actions by the agency last fall related to the marketing of ‘self-fitting’ hearing aids suggest it may be leaning toward regulating the OTC hearing aids based on a “consumer electronics” standard and not on a standard for medical devices.

If OTC hearing aids are regulated as consumer electronics products, these devices will be allowed to produce a maximum output of 120 decibels. This is as loud as a live rock concert or aircraft at take-off. This can be dangerous – not only could it increase the consumer’s hearing loss, but it could induce pain and ear injury.

This is neither safe nor effective.

Both the World Health Organization and the U.S. Center for Disease Control recommendations state that sounds as high as 120 decibels can be safely listened to for only seconds per day. Consistently, hearing care professionals have made recommendations more in line with safe and effective standards for medical devices that include a maximum output at 110 decibels and a limit on the gain (or amplification) that the devices can produce.

Over-the-counter hearing aids could benefit many people who suffer from mild to moderate hearing loss. Making them accessible through popular retail outlets is a good idea that promotes consumer choice. But the FDA has the responsibility to ensure consumers are protected against misuse of products designed for a different purpose entirely.

Shari A. Hicks is a pharmacy technician.

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