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Over-the-counter hearing aids approved by FDA

By Kayan Tara

Posted October 17, 2022

Over-the-counter hearing aids without prescription approved for purchase by FDA

Audiologists and EMT physicians still recommend those struggling with hearing loss consult their physicians prior to purchasing over-the-counter hearing aids. (James Musallam)

The Food and Drug Administration (FDA) is allowing over-the-counter hearing aids to be sold for those with mild-to-moderate hearing loss.

Approved by the FDA in August, these hearing aids will save individuals thousands of dollars, and will be accessible directly from stores or online without a prescription, medical examination or audiologist fitting required.

Specialists emphasize that these over-the-counter hearing aids are only FDA-approved for mild-to-moderate hearing loss. Anyone with severe hearing loss, ear pain, drainage, a sudden hearing loss, or anyone under the age of 18 still needs to see a physician, according to Sarah Burgin, an EMT physician at Eskenazi Health and IU professor of otolaryngology.

“Those people absolutely still need to see a physician, even if what they ultimately end up getting is an over-the-counter hearing aid,” Burgin said. “The biggest benefit [to over-the-counter hearing aids] is access and cost. Paying for hearing aids is a major problem among my patients.”

While getting checked by an audiologist is the gold standard, the cost of the whole process, and purchasing hearing aids can be costly, according to Elizabeth Thompson, owner and audiologist at Hickory Audiology in Bloomington.

“[Even though] technology has gotten so much better and hearing aids are so much better than they used to be, we just haven't seen an increase in the adoption of hearing help,” Thompson said. “That stemmed this conversation about why does that occur? It either is because they don't have access to proper hearing health, or they can't afford it.”

Burhin and Thompson still recommend those struggling with hearing loss consult their physicians prior to purchasing over-the-counter hearing aids.