Hearing aids come to the pharmacy

OTCs Today

Mary Warner

On August 16, 2022, FDA finalized a historic rule enabling OTC access to hearing aids. The rule establishes a new category of OTC hearing aids and will allow patients with hearing loss to purchase hearing aids directly from stores or online retailers without the need for a medical exam, prescription, or visit to an audiologist.

Congress passed bipartisan legislation requiring FDA to create the new category of OTC hearing aids in 2017, but it was not fully implemented until now.

FDA estimates that close to 30 million adults in the U.S. could benefit from hearing aid use. The new rule, which takes effect on October 17, 2022, is expected to significantly lower the costs of hearing aids for adults with perceived mild to moderate hearing impairment by stimulating competition and facilitating the sales of hearing aids in traditional neighborhood stores.

Hearing aids 101

While hearing aids improve hearing by making sounds louder, they’re generally unable to restore hearing to normal levels or quality the way glasses can restore vision to 20/20. They’re classified as either air conduction or bone conduction hearing aids, depending on how they work.

Air conduction hearing aids are the most common. They bring amplified sound into the ear canal, then through the eardrum and the 3 tiny bones in the middle ear to the inner ear, where it’s processed and sent to the brain. In contrast, a bone conduction hearing aid transfers sound by bone vibration directly to the cochlea, bypassing the outer and the middle ear and is useful for conductive and mixed hearing losses. It requires a surgical implant along with an external processor.

There are several types of air-conduction hearing aids: behind-the-ear aids (the largest of the available types), receiver-in-the-canal aids, in-the-ear aids, and in-the-canal aids (the smallest and least visible type). Each has pros and cons, and the type of hearing aid chosen depends on several factors, including the type and severity of hearing loss, lifestyle, and manual dexterity. In addition, features such as directional microphones, telecoils (which enable the hearing aid to pick up sound directly from compatible phones or sound systems in public places), noise reduction, rechargeable batteries, and wireless connectivity are not available for every type of hearing aid.

Hearing aids vs. personal sound amplification products

Hearing aids are not the only option for sound amplification. Personal sound amplification products (PSAPs) are also available. But these are not alternatives to hearing aids: they’re intended for people with normal hearing to amplify sounds in certain situations, such as in noisy restaurants, crowded public places, or birdwatching. Although manufacturers of PSAPs may advertise them as “hearing aids,” they are not medical devices and not regulated by FDA.

Concurrent with issuing the final rule on OTC hearing aids, FDA also issued final guidance, Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products, to clarify the differences between these devices. Manufacturers that claim a product improves hearing loss/impaired hearing would be subject to the regulatory requirements applicable to devices, including the specific requirements applicable to hearing aids.

The new rule

Only air-conduction hearing aids intended for adults with perceived mild to moderate hearing impairment are covered under the new rule.

Hearing aids that do not meet these requirements for the OTC category, such as those intended for treatment of severe hearing impairment or for patients younger than age 18, will remain prescription devices.

The final rule incorporates several changes from the
proposed rule, including lowering the maximum sound to reduce the risk to hearing from over-amplification of sound, revising the insertion depth limit in the ear canal, requiring that all OTC hearing aids have a user-adjustable volume control, and simplifying the device labeling to ensure it is easily understood. The final rule also includes performance specifications and device design requirements specific to OTC hearing aids. Patients could see OTC hearing aids available in pharmacies as soon as mid-October when the rule takes effect.

Pharmacists are in a good position to help patients with hearing loss determine the best way to improve their hearing. Berenbrok and colleagues published a commentary in JAPhA on August 23, 2022, expanding on the opportunity for collaboration between pharmacists and audiologists.

What to tell your patients

Advise patients that while aging and chronic exposure to loud noises are the most common causes of hearing loss, a buildup of ear wax or an ear infection can also be the cause, so it’s important to rule out other causes before trying a hearing aid. Hearing aids are not “one-size-fits-all,” and patients should be advised that they may need to try several types before finding a hearing aid that is both effective and comfortable. It may be helpful to visit an audiologist for advice on treating their specific type of hearing loss. Finally, if a patient’s hearing loss is progressing or they have associated symptoms like dizziness, ear pain, or drainage from the ear canal, they should see an otolaryngologist for further evaluation. ■