In 2017, in a rare moment of bipartisanship, the U.S. Congress passed legislation mandating the U.S. Food and Drug Administration (FDA) to approve a new type of hearing aid that could be sold over the counter (OTC). For five years, the FDA worked on specifications and details like how deep the hearing aid could go into the ear, how loud it could be, and what materials it could be made of. In August of 2022, the new class of OTC hearing aid was pronounced safe, effective, and affordable for people ages 18 and older with “perceived” mild to moderate hearing loss.

In the past, if you needed a hearing aid, you would probably go to your primary care doctor, who would send you to an ear, nose, and throat specialist. You would get a complete exam and a hearing test to find the cause of your hearing loss. If you needed hearing aids, you would be sent to an audiologist or hearing-aid specialist to have a custom fitting for hearing aids to match your hearing loss. The average cost would be about $4,600. Now, you can order a set of hearing aids online or buy them at the drug store for $250 to $1,000.

Severity of hearing loss

There are several things to think about: How do you know if your hearing loss is mild to moderate? How do you know if the type of hearing loss you have needs a hearing aid? Could it be a sign of a problem that needs treatment? Could it be correctable? Without an ear exam and a hearing test called an audiogram, you are flying blind. According to the FDA, if your hearing loss is beyond moderate, you fit into the old category of needing an exam and a prescription for a hearing aid.

Judging the severity of your hearing loss without a hearing test is possible. According to The National Institute on Deafness, you may have mild to moderate hearing loss if:

  • Someone talking to you sounds muffled.
  • You have more trouble hearing speech when you are not looking at the speaker, in a noisy area, or on the phone.
  • You must turn up the volume on the TV.
  • You frequently must ask people to repeat or talk more slowly.

If you have severe hearing loss, you are unable to understand any speech when a person is talking; it just sounds like noise.

Types of hearing loss

On the other hand, knowing the cause of your hearing loss without an exam and an audiogram is not possible. The most common type of hearing loss in older adults is nerve loss due to age, called sensorineural hearing loss or presbycusis. This type affects both ears, and the only treatment is a hearing aid for both ears. However, a hearing aid may not be the best option for the other common type of hearing loss, called conductive hearing loss.

Conductive hearing loss means that your hearing nerves may be fine, but sound is not reaching them. There could be many causes, and most are correctable without a hearing aid. The simplest example is impacted wax. Other common causes are bony growths in the middle ear, a hole in the eardrum, fluid in the middle-ear space, or a middle-ear infection. The type of hearing test you can do online or by a phone app cannot tell the difference between sensorineural and conductive hearing loss. 

In addition to conductive hearing loss, some hearing loss symptoms may be a red flag for a disorder that needs treatment. The FDA says if you have any of these red flags, you should see a doctor before buying an OTC hearing aid:

  • hearing loss that starts suddenly
  • hearing loss in only one ear
  • hearing loss that comes and goes
  • hearing loss with ringing (tinnitus), pain, discharge, or pain
  • hearing loss after trauma.

FDA thought process

The FDA recognizes that there are some risks associated with OTC hearing aids, but they decided the benefit of getting hearing aids into more ears outweighs those risks.

About one-third of Americans between ages 56 and 74 and half of Americans over age 75 have hearing loss. Due mainly to cost, only 20 percent of these people are using a hearing aid. Untreated hearing loss has been linked to a higher risk of dementia, isolation, depression, and even heart disease and diabetes. OTC hearing aids could benefit most people with hearing loss because most hearing loss is the mild to moderate sensorineural type.

The FDA still believes a medical exam by a licensed physician, preferably an ENT specialist, is advisable before trying OTC hearing aids, but if you do not want to see a doctor or get an audiogram, the FDA does not intend to enforce the requirement.

OTC hearing aids may increase competition and innovation. For many years, the hearing aid market has been controlled by a small group of companies that own thousands of audiology clinics. They have been controlling pricing and development.

The bottom line on the new OTC hearing aids, following the FDA’s logic, is that if you have mild to moderate sensorineural hearing loss confirmed by a licensed physician, an OTC hearing aid could be a good bargain for you.

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