OTC Hearing Aids, Safe and Effective for Everyone?

By Dr. Noël Crosby, Au.D.

In August of last year, the FDA announced guidelines to approve a new class of hearing aid that is available for adults with mild to moderate hearing loss. These over-the-counter hearing devices became available in the US in October. OTC hearing aids are now appearing in stores and through on-line retailers without the need for a medical exam, prescription, or fitting from a hearing aid provider.

Who are OTC hearing aids for?
Over the counter hearing aids are for adults (18 years or older) with mild to moderate hearing loss, but in my experience, only those with mild hearing loss are appropriate candidates.

They may be an option for those who:
• Hear muffled sounds.
• Have trouble hearing in a noisy area or on the phone.
• Repeatedly have to ask others to repeat what they’ve said.
• Must turn up the volume on the tv or radio to a level that is uncomfortable for others.

It is always better to have an otoscopic inspection to rule out wax problems and a hearing exam prior to purchasing any hearing devices. If your hearing concerns are more than mild and also include trouble hearing loud speech and loud sounds, such as a car, you should seek professional help. Moderate to severe hearing loss should be evaluated and treated by a hearing health professional to determine what type of device is best for you.

What can OTC hearing aids provide for me?

OTC hearing aids provide:
• Amplification for mild-to-moderate hearing loss only.
• A maximum OSPL90 output level of 111 dB sound pressure level (SPL) at any frequency or 117 dB if the device offers a way to safeguard hearing from the amount of input sound.1
• The same fundamental technology as prescription air conduction hearing aid with not as many options for adjustment.
• Ability for the user to control the volume of the devices.
• The ability to self-fit and self-assess using apps. The person must have some type of smart phone for this and not all smart phones work the same.
• Wireless technology (some, not all).

Why are OTC hearing aids being made available?
In the US, hearing loss affects millions of adults. It contributes to high health care costs. When left untreated, hearing loss can lead to isolation which can then contribute to depression, anxiety, dementia, reduced mobility, and even falls.

So, why is it that only an estimated 1 in 4 adults who need a hearing device has even used one? We don’t have all the answers, but making hearing health care more affordable and accessible is important as the elderly population of the US continues to grow. Experts in science, technology, and hearing health have worked for the last 5 years with researchers to find safe and effective ways to improve access to hearing health care. Their suggestions of changing some of the FDA guidelines and quality standards for OTC hearing aids has made these new options available to adults who may not have otherwise had access to help.

What are some of the risks of OTC hearing aids?
Since these hearing aids are so new to the market, there are still some potential problems that may need to be addressed. Additionally, not getting a regular check up from a hearing health professional can be dangerous in that problems and medical conditions can be missed.

Some of these problems could include:
• Risk of improper treatment of hearing loss
• Risk of not being diagnosed with a serious health problem that has contributed to hearing loss
• Instant-fit devices could open the market to poor-quality devices from “unscrupulous” manufacturers
• Repair or replacement would be the responsibility of the consumer. Some prescription hearing aids can be purchased for close to the same cost, but  will come with a 3 year warranty and loss and damage coverage. Know your options first!

Buyer Beware!!!! Many hearing devices that are being marketed as OTC Hearing Aids are nothing more than cheap amplifiers. Please do your research and choose wisely If you decide to go this route without the guidance of a hearing professional.

The importance of regular hearing examinations
A regular hearing checkup conducted by a hearing health professional will allow the provider to:
• Identify whether you have earwax that needs to be removed.
• Diagnose medical conditions. Some hearing loss is due to underlying medical problems such as diabetes or high blood pressure. Often, hearing loss can be corrected by treating the medical condition that is causing the loss.
• Identify potential problems. An annual hearing test can track changes over time and help your hearing specialist track the rate of hearing loss. It can help the patient to know if there are hidden dangers, such as noise-induced hearing loss or other medical concerns.
• When hearing problems are left untreated,  there is a risk of cognitive decline. Once hearing is  significantly lost, patients can fall into depression  from the feelings of isolation that can accompany living in a world with reduced or no sound at all.
• Begin treatment. As mentioned above, treating even minor hearing loss can prevent it from getting worse. A hearing professional can help manage this loss even if you initially choose over the counter hearing aids for treatment.

If you feel that you or someone you love has hearing loss, make an appointment to see an audiologist to have it confirmed. It may be something as simple as removing excess earwax. However, if it is more serious, an audiologist can help you find a solution that is right for you.

Call Today to make your appointment:
941-474-8393

References:
1. Over-the-counter (OTC) hearing aids – what are they? Hearing
Tracker. Available at: https://www.hearingtracker.com/over-
the-counter-hearing-aids