The Food and Drug Administration (FDA) finalised regulations on Tuesday (August 16) allowing for over-the-counter (OTC) hearing aids to become more readily available in the US within the next couple of months.

These regulations are part of the FDA Reauthorization Act of 2017 which included creating a category of hearing aid that could be sold in retail. The FDA’s rule will take 60 days to come into effect, and manufacturers will have 240 days to make any needed adjustments.

A hearing aid is any device that assists a person suffering from hearing loss but differs from devices meant to amplify the hearing in regular people (i.e. personal sound amplification products). They can vary in terms of strength, position, and type of stimulation (electrical or vibrational) based on the needs of the person.

These products will only be for people with mild to moderate hearing loss and the FDA will also mandate that products have a lower maximum sound output and user-adjustable volume setting to reduce the risk of injury.

In addition to its new regulations on OTC hearing aids, the FDA also issued its final guidelines on personal sound amplification products (PSAPs). These consumer products, often sold online or through infomercials, have to be marketed as devices that can improve a person’s normal hearing and are not intended for those with hearing loss.

Ears, nose and throat (ENT) specialist Dr Guyan Channer spoke with Our Today and confirmed that although PSAPs to an extent have been used as ‘hearing aids’ as a cost-saving measure for some people, it is often inadequate because the needs of patients often vary and general use items like that in some cases could cause more harm than help.

While no statistical measurement has ever been done in Jamaica, generally, one-in-2,000 people suffer from hearing loss or hearing impairment. Any case where a person suffers from hearing loss to the extent that they experience impairment requires a hearing aid.

For advice/consultations, Channer can be contacted at [email protected]