OTC Hearing Aids Are Coming!

On August 16, 2022 the U.S. Food and Drug Administration (FDA) released its Final Rule for the sale of Over-the-Counter (OTC) hearing aids. Affordable hearing help has been an issue for some time and many feel that FDA-regulated OTC hearing aids are long overdue.

Chances are that these devices could be available online and in retail and drug stores by mid-October. At the very least, we must get ready for the media onslaught and marketing Blitz.

In its Final Rule, FDA states: “In creating a regulatory category for OTC hearing aids and amending existing rules, we intend to provide reasonable assurance of safety and effectiveness for these devices as well as foster access to, and innovation in, hearing aid technology, thereby protecting and promoting the public health.”

Hopefully, this defined “regulatory category” will clear at least some of the confusion concerning the myriad of “hearing” instruments that are NOT meant to treat hearing loss.

OTC hearing aid decisions! A lot is left to the consumer

OTC hearing aids are air-conduction aids that conform to specific FDA regulations. They are meant for people 18 years of age and older who have a perceived mild to moderate hearing loss. The user controls the device and customizes it to his/her/their hearing needs and preferences. Hearing tests, ear inspections or professional consults are not required to purchase OTC hearing aids.

Although these hearing aids will be a lot less expensive, they will still cost many hundreds of dollars a pair. And so, the decision to purchase these devices still carries financial considerations, at least for many.

Are OTC hearing aids appropriate to help my hearing? This is a very good question and the final decision is left up to the customer. How much do hearing issues interfere with life?

The perception of a mild to moderate hearing loss is reason enough to be a candidate for OTC hearing help. Might it be wax? How can one tell without an ear inspection? And so, the buyer decides.  

But what is a mild to moderate hearing loss? Are there symptoms?  FDA says that common hearing loss symptoms will be listed on the label. Whatever they will be, check them out.

We know that as soon as people lose hearing, sounds become duller and understanding speech-in-noise becomes an increasing struggle. With a mild loss, sounds in the range of 26 to 40 decibels are difficult to hear. This can include sounds such as whispers or buzzing flies or a running refrigerator.

A moderate hearing loss covers the range of 41 to 55 decibels. Now, consistent attempts to read lips and turning everything up louder become tell-tale signs. It is hard to hear a regular clothes washer, which puts out between 50 and 55 dBs.   

Consider seeing an audiologist when hearing challenges make you feel excluded from conversations that proceed at normal talking levels. Thinking that everybody mumbles or not being bothered anymore by the noise of the vacuum cleaner are signs that OTC hearing aids may no longer be appropriate.

Read the fine print!

OTC hearing aids put the user in charge of tuning the instruments. FDA will require the package label to include information on the type of control platform and electronics that are needed in order to access, control and manipulate the devices. This is when the buyers must make sure that the aids work with their available technology, such as smartphones, computers etc. Just in case, study the Return Policy!

In the end…

The wait will soon be over. OTC hearing aids will become an everyday sight in stores. What will they look like? One would hope that their constant presence will reduce the bias and stigma against hearing loss and hearing help. As they blend in with other pieces of technology, will they become normal, mainstream? Hopefully, people will dare to check them out and maybe get the help they need. Now that would be a good thing!   


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