Over The Counter Hearing Aids

You may have seen over the counter hearing aids have been in the news recently. Congress passed the bi-partisan Over the Counter Hearing Aid which the President signed in to law. The new law orders the Food and Drug Administration (FDA) to regulate the sale of hearing devices that can be sold off the shelf without the help of an audiologist. The FDA has three years to write the rules regulating OTC hearing aids. The goal of the law is to make hearing aids more accessible to all people. Currently more than 50 million people in the US have hearing loss, and 80% goes untreated. There are many reasons for so many going untreated.

  • A majority are unaware of they have a hearing loss
  • Denial that they have a loss.
  • Insurance doesn’t often cover hearing aids
  • Misperceptions about price of hearing aids and treatment

What is an Over the Counter Hearing Aid?

OTC hearing devices are available today, they are known as Personal Sound Amplification Products or PSAPs and they are not regulated. You may have seen ads on late night TV or online offers for low priced “hearing devices.” Because these devices are currently not regulated and claims can’t be substantiated, they cannot be called a hearing aid. Prices are very low, ranging from $15 -$400 each. They are merely sound amplifiers that simply make all sounds louder. An actual hearing aid (like we provide) can be programmed by a professional (like us) to meet the unique hearing loss of the patient. For a high frequency hearing loss (like the pitch of a woman or child’s voice) it makes no sense to make the lower frequencies louder too. That will only make it more difficult to hear what a person is saying, especially when other noise is present. From our experience, most patients want help hearing in situations where there  is background noise.

The rule making process is left up to the FDA and is only just starting. We have no idea what will be designated as an OTC hearing device. Any changes in classifications and new products are years away from being available for purchase.

OTC Hearing Aids Will Increase Accessibility

We strongly support anything that will make it easier for the 34 million people in the US that have an untreated hearing loss. Untreated hearing loss often leads to social isolation, strained relationships, lower income, and even cognitive decline. Backers of the new OTC hearing aid law believe this new market will help people with mild hearing loss get help with easier access to devices. The worlds’ leading manufacturers are aware of price concerns for some and have developed affordable options that give budget conscious consumers high quality hearing aids that are truly programmable and have many of the noise reduction capabilities of higher end hearing aids.

What you won’t get with OTC Hearing Aids

A hearing exam from a professional audiologist. By self-diagnosing, a patient won’t know the true nature of their hearing loss or if there are other medical issues that need to be addressed.

Follow-up Care. Part of the treatment for hearing loss is rehabilitation. Rarely does a patient automatically adjust to sounds being re-introduced. Patients need counseling and adjustments over the lifetime of the hearing aid. Hearing these sounds again is not easy and training is needed. Hearing also changes over time, especially as we age. Without regular hearing tests, a device may not be programmed to get the maximum hearing benefit.

Proper fitting. A hearing aid is only as good as the professional that fits your device. Your hearing is as unique as your finger print. No two ear lobes are the same and your loss is at varying frequencies. We utilize Real Ear Hearing Aid Verification to make sure your hearing aids are giving you the maximum benefit that you need.

Custom Fit. The anatomy of the ear varies greatly. A device that fits your brother may not fit you. We provide a wide variety of styles that can be customized to your ear lobe and canal for a more comfortable fit and better performance.

Custom Programming. Your audiologist will program your hearing aids to meet your specific range of loss and to meet your daily lifestyle. OTC devices are closed systems with a few basic settings. You won’t be able to bring them to us to make necessary adjustments to meet your specific hearing loss.

Effectiveness of OTC Hearing Devices

University researchers conducted a study of more than 150 hearing impaired adults between the ages of 55 and 79. Some were given fully programmable hearing aids and service from a professional audiologist. Others received the same device, but out of the box as they would in a OTC scenario. The study group was monitored for six weeks. The study concluded that both groups benefitted from the digital hearing aids. The over-the-counter group however was less satisfied and not likely to purchase the devices at the end of the 6-week trial period. This group was given an option to continue with a 4-week period under the assistance of an audiologist. At the end of the study, these patients reported a significantly higher satisfaction level. The conclusion: patients fared far better when their devices were properly programmed by an audiologist. Read about the Indiana University study at the AARP website.

Can PSAPs Help Your Hearing?

Consumer Reports magazine tested a variety of Personal Sound Amplifiers to see if they can help people hear better. They tested four devices ranging in price from $20-$350. Their recommendation: avoid the low-end devices altogether. Their test subjects saw some gain with the higher-end PSAPs, however reported difficulty discerning conversations with noise present like in a restaurant. In our years of treating hearing loss, difficulty understanding conversations in noisy settings is one of the main reasons people seek treatment. While that might not be an issue for some older patients that live a quiet lifestyle, most people will be severely disappointed with the performance of these devices. Consumer Reports also recommends that it is still best to have a professional hearing test first and then decide what device will give you the benefit you need. Read the full CR article on PSAP’s here.

You get What You Pay For

Most of us got that advice from our parents. Something that has more features and higher quality will generally cost more. A Cadillac Escalade and Chevy Spark are both cars made by GM. The Cadillac is considerably more in price because it has more space, a more powerful engine, a high-end stereo system, heated and cooled seats, etc. If you are six adults traveling to the mountains, you can’t get the job done with a Chevy Spark. Hearing aids are the same way…not all hearing devices will get the job done. That’s where an audiologist is helpful. Without first knowing the degree of hearing loss, it is difficult to get the right level of performance. Keep in mind, the OTC legislation is directed at helping people with a mild hearing loss. Most people with are past a mild a loss when they get to the point where they are motivated to get treatment. An OTC device will likely underperform and lead to disappointment. The USA Today recently published a story about over the counter hearing aids which you can find here.

What is Driving the OTC legislation?

Like many people, we’re a bit skeptical about the motives of our legislators. Since hearing loss is associated with aging and noise exposure, there is a huge number of potential patients from baby boomers. Seeing this huge market, companies are looking to cash in without the enormous research and development that the leading hearing aid manufacturers like ReSound and Oticon have incurred. These amplifier companies hope to gain credibility by getting their devices “regulated” by the FDA.  Whether this law will improve the lives of millions of Americans is to be seen, as the devil will be in the details that the FDA creates. As companies that develop drugs knows there is an extreme cost burden of seeking FDA approval. This compliance will be baked in to the prices of OTC hearing aids. Read more in this opinion column published in The Hill.


There is plenty of information floating around for consumers about over the counter hearing aids. To summarize:

  • People with mild hearing loss will benefit from using good quality hearing devices
  • A professional hearing evaluation from a trained audiologist is key to successful outcomes (remember most insurances and Medicare Part B cover your exam if you are cost conscious)
  • There are limitations to performance with OTC self treatment
  •  It will be several years before the FDA guidelines and rules are, finalized. Be leery of ads promoting these new devices today.

The best thing to do if you suspect you have a hearing loss is to call us to schedule an evaluation. From there you can decide what is the best treatment to address your hearing. Waiting is seldom the best treatment.

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