December 17, 2021

Over-the-Counter (OTC) Hearing Aids

Last month, the U.S. Food and Drug Administration (FDA) proposed a rule permitting the sale of a new category of Over-the-Counter (OTC) hearing aids that could be sold directly to consumers without an exam. While unregulated OTC hearing aids may work as intended, there is a risk that the devices could be defective or completely inadequate for the treatment of hearing loss. Advertisements for these new OTC hearing aids have already targeted consumers even though there are currently no OTC hearing aids that have received FDA approval.

Whenever individuals are going to make a “big purchase” they tend to think it over and do research. This must also apply to hearing aids, especially as it is part of your physical and mental health.

Companies that sell over-the-counter hearing devices are not held to the same standards as the licensed professionals who provide these devices. They are also not required to inform consumers of the risks associated with their products. While consumers may be tempted to purchase these unregulated products because of their low prices, the ultimate price you pay may be further hearing loss.

Hearing aids are not a “one size fits all” product. In fact, they need to be custom programmed and fine-tuned to an individual’s hearing loss. The OTC hearing aids can create further hearing loss by being inappropriately fit to the user.

Medical device companies are required to register and list their devices with the FDA, though this registration only indicates that the company has provided information to the FDA; it does not indicate FDA approval, clearance, or authorization of the device. Unfortunately, this has not stopped some disreputable sellers of OTC hearing devices from falsely claiming that their products are “FDA-registered” or “FDA-cleared.” Since the devices are not approved or regulated by the FDA for their overall acoustic output or volume, the effects can be damaging to any remaining hearing the individual has left if it is set too loud.

If you are considering buying a hearing aid, take the following recommendations into account:

  • Beware of misleading claims. Over-the-counter hearing aids are only meant to treat mild to moderate hearing loss and may not be able to treat severe hearing loss. Avoid purchasing OTC hearing aids that claim to treat severe hearing loss or hearing loss in children.
  • Have your hearing evaluated by a medical professional. While online hearing tests may be convenient, they may fail to detect serious hearing loss, or the underlying causes of your hearing loss that may need medical management.
  • Know your rights. Under state law, if you are unhappy with your hearing aids you are allowed to return them within 30 days of receipt. The seller must provide you with a written statement with this information.

If you believe you or a loved one may need help hearing, seek a licensed medical professional for a complete hearing evaluation to determine the status and nature of the hearing loss and whether it can be corrected with medical intervention or hearing aids.


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