FDA Regulation and OTC Hearing Aids

The slow pace of legislative procedure can hardly keep up with the rapidly advancing technology of today’s hearing aids. While hearing restoration technology used to be dominated by only a handful of manufacturers, the field of audiology has expanded greatly in just the past 10 years alone.

The traditional hearing aid market is on the brink of a major disruption as of this writing. Like most consumer products, what was released to the public initially as high-end, unique pieces of technology are being reworked by third-party brands who want to replicate these medical devices into consumer electronics at lower prices. Right now, several corporations and startup businesses are working to create generic, non-prescribed hearing aids to compete with the major manufacturers.

This is both good news and bad news if you have hearing loss. On the one hand, competition drives prices down for everyone, and it motivates researchers and designers to build better, smarter hearing aids. Attempts at deregulating hearing aids also suggest that the stigma against wearing them may finally be coming to an end, and that hearing preservation is now enough of a concern for many people that demand is creating a new supply chain.

On the other hand, self-diagnosis and treatment is a real risk ignored by these third-party manufacturers. If wearers believe they can purchase a hearing aid at their local drug store or supermarket without a prescription and receive all the same benefits as regulated medical-device hearing aids, then they’re severely underestimating the essential role hearing care professionals fill. Today’s hearing aids may come prepackaged with many automatic features, but they do not work the same way as eyeglasses. To keep them working effectively and safely, you need a proper diagnosis from a licensed professional, and regular visits for follow-up and maintenance. Hearing care professionals ensure you are fit properly. This can save you thousands of dollars in future medical costs you’re risking by self-diagnosing and choosing over-the-counter hearing aids that provide more amplification than you need and can result in further hearing damage.

What are PSAPs?

In today’s busy world, it can be hard to find time to take proper care of our health. Smartphones and other devices that measure our biometrics throughout the day have allowed us to automatically detect changes in our nutrition, blood pressure, and sleep patterns, making it easy to keep track of our progress and stay fit. As this trend continues, many people are beginning to feel skeptical about the traditional role of medical practitioners when it comes to their daily health, with some avoiding regular appointments altogether.

It’s no wonder then that so many new businesses have begun selling generic hearing care products that eliminate the consultation process entirely. Personal sound amplification products (PSAPs) are recreational consumer products designed to increase the volume of everyday activities and can be purchased online or in many retail stores. Mostly used by hunters or birdwatchers to detect subtle changes in their environment that might otherwise be missed, these products—often unregulated and not recommended by hearing professionals—have never been advertised as solutions for hearing loss until recently.

These devices are sometimes viewed as cheaper alternatives to the bundled packages offered by hearing care professionals, which include medical appointments, the hearing aids themselves, and any accessories. Ironically, the long-term damage that often results from self-care without an official diagnosis could cost you thousands in future health-related costs due to any further hearing you may lose. At the very least the devices may do little or nothing to actually improve your hearing, as they simply make everything sound equally louder (voices, background noise, your own voice)—much like the early iterations of medical device hearing aids.

To achieve even a fraction of the enhancement offered by modern, professional hearing aids, the cheapest PSAPs require hundreds or even thousands of dollars of additional bulky equipment, such as microphones, transmitters, and earpieces. In addition, most low-end PSAPs provide dangerously high amounts of low frequency gain, which can ruin your remaining hearing. High-end PSAPs can sometimes come close to the appropriate levels of amplification and directional functionality seen in regular hearing aids, but it is unlikely that these can be achieved without the maintenance and oversight of a hearing care professional.

Most people who purchase reading glasses over-the-counter will remove them in situations where they provide no added benefit. This is not the case with PSAPs, as it is likely that they will be left in all day if used as solutions to hearing loss.

Hearing aids and the FDA

As of this writing, a bill has passed both the House and Senate that will allow the FDA to approve the sale of over-the-counter hearing aids. Traditionally, a prescription from a hearing care professional following a hearing loss diagnosis was the only way to purchase a hearing aid. This regulation protects more than the pockets of the hearing care professionals and hearing aid manufacturers, as countless studies responding to this new legislation have found that hearing aid wearers regularly experience far better results when their devices are selected with the help of a licensed practitioner.

Hearing aids are considered medical devices. While they may resemble some of the wearable tech products currently available on the market for entertainment or personal use, the function they provide is more than a luxury. In order to meet FDA standards, hearing aids must comply with the Quality System Regulation as outlined by the 21 C.F.R Part 820. This document provides information on how to design, manufacture, package, and label medical devices to guarantee their safety and effectiveness for wearers. Recalls, customer complaints, and product testing are also handled through this system. Generally, a hearing aid should not be programmed to exceed decibel levels of more than 132 dB, as this can cause further, permanent damage to the user’s hearing.

The current bill, which is backed by Massachusetts Senator Elizabeth Warren and Tennessee Representative Marsha Blackburn, would decrease the federal government’s ability to regulate products designed to treat hearing loss. Currently, it is not difficult to purchase low-cost PSAPs online or in stores, which raises questions about the effectiveness of this bill. While the bill advocates for increased consumer access to hearing aids, this is already the case for buyers. This regulation could muddy the distinction between a recreational PSAP and an actual hearing aid, which could lead to harm and confusion for wearers. Because of this risk, the approval of OTC devices could lead insurance providers to eliminate altogether their already-limited coverage of hearing aids.

Creating an OTC category for hearing aids will undoubtedly boost consumer interest in these devices. Audio engineering corporations that previously had little interest in the hearing aid market are now eager to profit from this new application for their digital technology. These companies, which have regularly put listeners in danger of hearing loss by allowing headphones and earbuds to exceed volume levels well beyond what is safe without clear warning notices, would now benefit from marketing a product that is designed to treat hearing loss. Their proposed solutions, some of which are already in development, are a mix between traditional earbuds and hearing aids known as hearables. Essentially, these corporations have slashed research and development costs by recycling the work of hearing aid manufacturers and advertising a one-size-fits-all solution that does not encourage regular consultations with a medical professional.

Making the right decision


West Virginia Representative David McKinley, who is profoundly deaf, speaks about his negative experience with self-diagnosis and treatment. In this session, he urges anyone with a hearing concern to consult a professional before making any decisions.


Did you know that even a professional hearing test is not enough to determine the severity of hearing loss? This means that no matter your illness or condition, self-diagnosis always comes at a risk. With hearing loss, there are far more contributing factors than age and noise exposure alone. The presence of hearing loss could indicate a separate—and potentially severe—condition unrelated to hearing. For this reason, nearly 4-5 percent of all those who visit a hearing care professional for an exam are referred to another doctor. Some of these “red flag” conditions that may go unnoticed during a self-diagnosis include:

  • Recent drainage or bleeding
  • Asymmetrical hearing loss
  • Acute or chronic dizziness
  • Excessive earwax buildup
  • Deformities or trauma of the ear
  • Co-morbidities indicating a serious general health concern (e.g., onset of heart disease or diabetes)

Even if your hearing loss is unrelated to other health factors, those with moderate to severe hearing loss stand a chance of programming their PSAPs or OTC hearing aids improperly. In most cases, this will lead to a less satisfying user experience, but more serious errors could actually worsen hearing in the long run.

None of this is to say that PSAPs or OTC hearing aids are entirely a scam and could never meet the needs of someone with mild hearing loss. In fact, a recent double-blind clinical trial performed by Indiana University found that self-selected hearing aids equally benefitted users. However, self-fitting did have one major reported flaw—only 55 percent of self-selectors said they would consider buying their new hearing aids. Among those who were fit by an audiologist, 80 percent said they would repurchase the same device.

This proves that allowing those with hearing loss to treat their condition without a hearing care professional involved would drastically limit their ability to enjoy the best hearing possible. While the current bill, which is expected to pass into law, would allow companies to advertise their products to those with mild to moderate hearing loss, it is likely that those on the moderate end will need regular adjustments and screenings to keep their hearing protected and their devices functioning effectively.

Regardless of your degree of hearing loss, a diagnosis from a hearing care professional is always recommended before making the decision to treat your hearing loss.

Don’t hide from hearing loss—speak to a hearing care professional today

Better hearing is not a luxury. Those with hearing loss should not feel the need to settle for lower-quality products. By making the responsible decision and selecting a hearing aid with the help of a hearing care professional, you are letting the world know that you recognize hearing loss is not something that can be solved with the push of a few buttons.