Everything You Need to Know About Over-The-Counter (OTC) Hearing Aids

For the past eight years there has been conversations and recommendations from different organizations about the introduction of over-the-counter hearing aids. Not much headway has been made until 2022 when there were several changes happening pretty quickly.

What is the Over-The-Counter (OTC) Hearing Aid Rule?

The new OTC Hearing Aid Rule will define two (2) types of hearing aids:

1. Over-the-counter hearing aid: “an air-conduction device that does not require implantation or other surgical intervention, and is intended for use by a person age 18 or older to compensate for perceived mild to moderate hearing impairment.” It is able to be controlled and customized by the user to suit their hearing needs. The device may include the capabilities to allow the user to test their own hearing loss. It does not require the supervision, prescription, or involvement of any kind of a licensed person. It can be purchased by mail, in-person, or online.

1. Prescription hearing aid: A hearing aid that is not an OTC hearing aid because it does not meet the requirements for the OTC category (i.e. it is intended for someone with a severe hearing loss or someone under 18 years old).

The standards set by the FDA on OTC Hearing Aids

OTC purchasers will most likely be purchasing OTC hearing aids without professional advice. Therefore, stricter standards for OTC hearing aids were established by the FDA (ANSI/CTA-2051:2017). Some of the standards that go above and beyond the previously established hearing aid standards (ANSI/ASA s3.22) are:

• Input and output distortion limits
• Noise level limits
• A wide frequency bandwidth
• Slow latency
• A smooth frequency response

These standards essentially have to do with sound quality. They will help to ensure that the OTC hearing aids are going to provide good sound quality to the user, increasing audibility and hopefully better hearing.

Two of the big discussions about the standards of OTC hearing aids had to do with output limits and gain limits. These have more to do with protecting the user:

Output limit: There is an output limit set by the FDA final rule when it comes to OTC hearing aids. The output of an auditory device is the maximum amount of sound pressure level (i.e. sound volume) that can come out of the device. This limit is intended to protect the user of the device as not to cause further damage (i.e. noise-induced hearing loss) from wearing the device. The output limit for a device with activated compression is 117 dB SPL and 111 dB SPL without activated compression.

Gain limit: There was no gain limit set by the FDA for OTC hearing aids. Gain is the amount of amplification a device has. There are different gain levels set for different frequencies and different inputs (soft, medium, loud) and how much gain is in a hearing aid should be dependent on the person’s hearing loss. Reducing the amount of gain a device is capable of producing would mean reducing the audibility of soft sounds for a user, as the soft sounds need the most amount of amplification to be heard.

Some other requirements for OTC hearing aids include:

• A user-adjustable volume control is required.
• The device can not go closer than 10mm from the tympanic membrane (eardrum).
• The user must be able to control and customize the device themselves using tools, tests, and software.
• The material must be “atraumatic”.
• The design must enable a good physical fit.
• A OTC hearing aids that was used must be reprocessed for the next user before sale.
• The device must be clearly identified as an OTC hearing aid intended for use by persons 18 and over with a mild to moderate hearing loss.
• Labeling should include specifications of age, medical warnings, usage conditions and the benefits of seeking professional help.

What is difference between OTC and prescription hearing aids?

There is not a lot of difference between OTC hearing aids and prescription hearing aids, technically. The difference between OTC and prescription hearing aids is in the intended use and the labeling.

OTC hearing aids are intended for adults 18 and over with a perceived mild to moderate hearing loss.

All OTC hearing aids should be customizable by the user. Prescription hearing aids must be “fit” by a licensed professional (i.e audiologist or hearing aid dispenser).

There are also labeling requirements of OTC hearing aids both inside the box and outside the box that are different from prescription hearing aid labeling. This is essentially due to the fact that a consumer purchasing an OTC hearing aid is not required to seek the advice of a licensed professional before purchasing. The language of the labeling for OTC hearing aids therefore must be easy for a consumer to understand.

What is the difference between OTC and hearing amplifiers (PSAPs)?

Personal sound amplification products (PSAPs) have been available for sale or “over-the-counter” for years. Although OTC hearing aids and PSAPs will likely look similar, there is going to be a big difference between an over-the-counter hearing aid and a PSAP. Along with the release of the FDAs Final rule on hearing aids, they also issued the final guidance, Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products (PSAPs).

First of all, PSAPs are not intended for people with hearing loss. They are intended to enhance someone’s hearing in specific situations, such as when bird watching or listening to a lecture. The FDA’s final guidance on PSAPs states “they are not devices as defined in the FD&C Act”.

Secondly, PSAPs are not regulated by the FDA. Manufacturers are not required to register these products with the FDA. This means there are no standards or technological specifications that are followed when it comes to a PSAP. The only thing PSAP manufacturers are required to report to the FDA are radiation exposures. If you haven’t already, check out my post about the difference between hearing amplifiers and hearing aids here.

My advice with a PSAP is to proceed with caution. PSAPs often look like hearing aids and the marketing can be very misleading. With the introduction of OTC hearing aids, manufacturers must adhere to very specific and rigorous regulations and requirements of their device (510(k)). It would be easy for a manufacturer to not obtain 510(k) clearance and just continue to sell their PSAP without needing to meet those requirements. Since OTC hearing aids are now an option, there really is no reason someone with hearing loss should choose a PSAP.

Here is a timeline of the progress of over-the-counter (OTC) hearing aids:

What Dr. Hearing Loss thinks about over-the-counter hearing aids

The purpose of the creation of OTC hearing aids was to lower the cost and make hearing aids more accessible to Americans. I hope it does. There are way too many people with hearing loss who are not wearing hearing aids.

The cost for a pair of hearing aids from an audiologist is around $2000-$7000. I suspect there will be a large range of costs for OTC hearing aids as well, but anticipate a pair to run between $500-$1500. The more expensive OTC hearing aids will likely incorporate some convenient features like rechargeability and/or bluetooth streaming.

Based on my experience working with hearing aid patients for the past 12+ years, I think that 50% of people with mild to moderate hearing loss will not only benefit, but thrive with OTC hearing aids. These are going to be people who are comfortable with technology and are a little more tech-savvy. The other 50% of people with mild to moderate hearing loss who are a lot less tech-savvy, are going to have a hard time with OTC hearing aids and may still need the support of an audiologist. However, as people become more and more comfortable with technology, the number of people comfortable with OTC hearing aids will go up.

OTC hearing aids are not intended for children or anyone with more than a moderate hearing loss. Because they are going to be sold over-the-counter, it is up to the consumer (or parent) to follow this recommendation as anyone can order an OTC hearing aid online or pick one up at the drug store.

I strongly advise the following people to proceed with seeing an audiologist and obtaining a prescription hearing aid:

• Anyone under the age of 18. Parents, please do not put OTC hearing aids on your child. Most insurances will cover the cost of hearing aids for children.

• Anyone with more than a moderate hearing loss. If you have had a hearing test and it was confirmed that you have a moderately-severe, severe or even profound hearing loss, seek professional help with your hearing.

• Anyone who tried OTC hearing aids and does not like them or benefit from them. Do not give up on hearing aids if OTC hearing aids don’t work out for you. There are so many benefits to wearing hearing aids and a professional can help you be successful with hearing aids.

• Anyone with a cognitive impairment, regardless of age.

• Anyone with a suspected medical issue causing their hearing loss.

I’m here to help you make an informed decision in regards to OTC hearing aids. If you have any questions please contact me.