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What Otolaryngologists Need to Know About OTC Hearing Aids

The prevalence of hearing loss nearly doubles with every decade of life, such that nearly two-thirds of adults 70 years of age or older have hearing loss (Arch Intern Med. 2011;171:1851–1852). However, fewer than one in five hearing-impaired adults report hearing aid use (Arch Intern Med. 2012;172:292–293). This disparity recently prompted numerous national organizations, including the Institute of Medicine, National Academies of Sciences, and President’s Council of Advisors on Science and Technology, to call for a change in Food and Drug Administration (FDA) hearing aid policy, which has remained mostly untouched since its introduction in 1977. As a result, Congress signed the Over-the-Counter (OTC) Hearing Aid Act into law on August 18, 2017.


Current State of Hearing Aids

At this time, no devices are technically permitted to treat hearing loss other than hearing aids. However, personal sound amplification products (PSAPs), over-the-counter amplification devices designated by the FDA for “normal” hearing individuals, are often indirectly marketed to offer the same benefits as hearing aids. Although many PSAPs are of relatively poor quality, a recent study found that select PSAPs demonstrated improvements in speech understanding in noise comparable to traditional hearing aids for individuals with mild to moderate hearing loss (JAMA. 2017;318:89–90). Such PSAPs may mirror future OTC hearing aids.

FDA policy specifies that hearing aids sold in the U.S. require medical clearance by a physician, not limited to the otolaryngologist. However, many patients still purchase hearing aids without medical clearance by signing a waiver declining medical evaluation. In the U.S., hearing aids are most commonly sold by audiologists, who provide comprehensive aural rehabilitation and treatment. In addition, hearing aids can be sold by hearing instrument specialists, also known as hearing aid dispensers. Hearing instrument specialists are licensed by states, requiring as little as a brief apprenticeship after high school (J Am Board Fam Med. 2016;29:394–403). Online retailers frequently sell hearing aids directly to the consumer because interstate commerce is not regulated by state law.

Most insurers, including Medicare, cover diagnostic services, such as audiograms, with a referral from a licensed physician but do not cover most hearing treatment or rehabilitative services, including hearing aids. The average price of a pair of traditional hearing aids is approximately $5,000, putting them out of financial reach for many Americans.

What’s Changing?

By August 18, 2020, the FDA will release a draft of regulation surrounding OTC hearing aids, opening it up to public comment. It is not yet known when the OTC hearing aid regulations will be finalized by the FDA. Based on the original wording of the bill, OTC hearing aids will be:

  • The “same fundamental scientific technology” as standard hearing aids but without the involvement of a hearing health professional.
  • Available to adults (18 years of age or older).
  • Customized or “fit” based on self-assessment and personal preference.
  • Purchased in person, by mail, or online.

OTC hearing aids are intended for those with mild to moderate hearing loss. However, a study comparing subjectively reported hearing loss to audiometry found that approximately 30% of adults misclassify their hearing, most often underestimating their degree of hearing loss (Ear Hear. 2015;36:164–167). There is reasonable concern that patients with severe hearing loss may obtain minimal benefit from OTC hearing aids and not seek a higher level of hearing rehabilitation. Alternatively, there is a potential to eliminate many of the poor quality PSAPs, which mislead hearing-impaired adults into thinking their hearing loss is being optimally treated.

There is also concern that patients may overlook treatable or even insidious causes of hearing loss. The American Academy of Otolaryngology–Head and Neck Surgery outlines 10 red flags of hearing loss that warrant specialist evaluation. These include:

  • Pain;
  • Sudden onset of hearing loss;
  • Dizziness;
  • Deformity of the ear;
  • Unremitting tinnitus;
  • Ear drainage;
  • Asymmetric hearing loss;
  • Conductive hearing loss; and
  • Complex history (e.g., ear infections, noise exposure, autoimmune disorder, ototoxic medication use, otosclerosis).

It is important that we emphasize these red flags to the lay population and even advocate that these be included on OTC hearing aid packaging.

—Dr. Contrera is with Johns Hopkins School of Medicine in Baltimore, Dr. Moberly is with The Ohio State University Wexner Medical Center in Columbus, and Dr. Babu is with the Michigan Ear Institute

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