Pittsburgh Audiology & Hearing Aid Center, Inc.

Over the Counter Hearing Aids

Over the counter hearing aids have been in the news lately with bi-partisan Over the Counter Hearing Aid act getting signed in to law. The new law directs the Food and Drug Administration (FDA) to regulate the sale of hearing devices that can be sold off the shelf without the assistance of an audiologist. The FDA has 3 years to complete its rule making process. The goal of the legislation is to make hearing aids more accessible as more than 50 million people in the US have hearing loss, yet 80% goes untreated. Cost is not the only barrier, as a majority are unaware of their loss or are in denial that they have a loss.

What is an Over the Counter Hearing Aid?

PSAP-Ad-Sample-256x300.pngFirst off,  OTC hearing devices are available today, they are known as Personal Sound Amplification Products or PSAPs. Perhaps you’ve seen ads on late night TV or offers for low priced “hearing devices” available online. These devices are currently not regulated nor can they be called a hearing aid. Prices are very low, ranging from $15 -$300 or more a piece. They are amplifiers that simply make all sounds louder, where a hearing aid can be programmed by a professional (like us) to meet the unique hearing loss of the patient. If you have 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. It will only make it more difficult to hear what a person is trying to say, especially if other noise is present. Since the rule making is left up to the FDA and the process is only just beginning, we have no idea what will be considered as an OTC hearing device. Any changes in classifications and new products are years away from being available for purchase.

OTC Hearing Aids Increase Accessibility

We are in favor of anything that will help the 34 million people in the US that live with untreated hearing loss. Untreated hearing loss can lead to social isolation, broken relationships, decreased earning power, and even cognitive decline.  Like the above image shows, devices are available today. Proponents of the new OTC hearing aid legislation believe this will help people with  mild hearing loss to get some help as they may be put off by the investment in quality devices. The worlds’ leading manufacturers are aware of the price barriers for some and have developed affordable options that give budget conscious consumers hearing aids that are truly programmable and have many of the noise reduction capabilities of higher end hearing aids. Learn about affordable hearing aid options here.

What you won’t get with OTC Hearing Aids

  1. A hearing exam from a professional audiologist. By self treating, the patient won’t know the true degree of their hearing loss or if there are other medical issues that need to be addressed.
  2. Follow-up Care. Part of the treatment process is rehabilitation. Rarely is it a one and done process. Patients require counseling and adjustments over the life of the hearing aid. Hearing loss for most patients is a gradual process until the point where the seek treatment. Hearing these sounds again is not easy and training is needed. Hearing changes over time, especially as we age. Without regular hearing tests, a device may not be programmed to get the maximum hearing benefit.
  3. Proper fit. 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 are one of a few practices that uses Real Ear Hearing Aid Verification to make sure your hearing aids are giving you the maximum benefit that you need.
  4. 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.
  5. Programability. Today’s hearing aids can be programmed and readjusted to meet your daily lifestyle or changes in your hearing. OTC devices are closed systems with a few basic settings. You can’t bring them to a professional to make necessary adjustments to fine tune the device.

Effectiveness of OTC Hearing Devices

Researchers at the University of Indiana published a study of more than 150 adults between the ages of 55 and 79. Some were given fully programmable hearing aids and service from an 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 conclusion was that both groups benefitted from hearing aids. The OTC group however was less satisfied and less likely to purchase the devices at the end of the 6-week trial period. The OTC group was given an option to continue with a 4-week period with the assistance of an audiologist. At the end of the study, those OTC patients reported a significantly higher satisfaction level. The conclusion: patients fared far better when their devices were properly programmed by an audiologist. You can read about the study at the AARP website.

Can PSAPs Help Your Hearing?

Consumer Reports 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 conclusion: 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 decades of treating hearing loss, being unable to discern conversations in noisy settings is one the biggest drivers to seek treatment. While that might not be a concern 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 determine what device will give you the benefit you are seeking. Read the full article on PSAP’s here.

You get What you Pay For

It’s valuable advice we received 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 General Motors. The Cadillac is considerably more in price because it has more space, a more powerful engine, a high end sound system, heated and cooled seats, etc. If you are six adults traveling through 8 inches of snow, you can’t get the job done with a Chevy Spark. Hearing aids are the same way…not all devices will get the job done. That’s where an audiologist comes in. 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. 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 legislators. Since hearing loss is associated with aging and noise exposure, there is a huge number of potential patients as the tail end of baby boomers are now well in to their fifties. Seeing this potential 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 have helped to gain credibility by getting their devices “regulated” by the FDA.  Whether or not this legislation 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 for any new drug. This lobbying will be baked in to the prices of OTC hearing aids. Check out this opinion column published in The Hill.


There is certainly a lot of information floating around for consumers to digest about over the counter hearing aids. To sum up:

  • People with mild hearing loss will benefit from trying good quality hearing devices
  • It is important to get a professional hearing evaluation (remember most insurances and Medicare Part B cover your exam if you are cost conscious)
  • There are limitations to performance in an OTC setting
  • It will be several years before we know what the FDA guidelines and rules will be.

The best thing to do if you suspect you have a hearing loss is to call us for an evaluation. From there you can decide what is the best path to address your hearing. It’s hard to fix a problem if you don’t fully understand the problem.