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What’s Wrong with OTC Hearing Aids?

Are OTC hearing aids a boon or a boondoggle? Who will adjust them? Will they be too complicated? How well will they work for older people?

A few weeks ago we asked “Could You Benefit from Over-The-Counter Hearing Aids?” We pointed out that roughly 30 million Americans have hearing problems but only about 20% use hearing aids. The cost is often a big obstacle. Such devices can range from $4,000 to $6,0000 and some cost far more. OTC hearing aids seem like a good answer, but many readers pushed back. What are the downsides to the FDA’s new ruling?

The Move to Self Care!

We have been enthusiastic supporters of the self-care movement. Decades ago we supported Dr. Tom Ferguson in his revolutionary journal called Medical Self Care. We were founding members of the Society for Participatory Medicine. We firmly believe that people deserve access to all the tools they can get to improve their health.

The Modern Pharmacy Offers Lots of Tools:

There was a time, not that long ago, when drug stores mostly sold over-the-counter remedies and prescription medicines. Today, the modern pharmacy offers an amazing array of self-help tools that allow people to both diagnose and treat a wide range of conditions.

There are rapid COVID tests that can tell people within 15 minutes if they have contracted the SARS-CoV-2 virus. There are pregnancy tests, sophisticated blood glucose kits to monitor diabetes and blood pressure devices that allow patients with hypertension to track progress.

At one time, such technology was restricted to health professionals. But people appreciate the power that such tools provide.

OTC Hearing Aids:

The latest evolution in self-care is also designed to save consumers thousands of dollars. On August 16, 2022, the Food and Drug Administration issued a final rule to facilitate access to hearing aids. No longer will people with mild to moderate hearing loss have to make an appointment with an otolaryngologist (ear, nose and throat doctor) or an audiologist to acquire a hearing aid.

What did you say?” is a frequent question people with hearing loss often ask of friends and family, who may sometimes become annoyed repeating themselves over and over. Arguments over the ideal volume of the TV or car radio can create conflict within a family.

Advertisements for hearing aids have long promised to solve such problems. But standard hearing aids are pricey. And they are not covered by Medicare or most traditional insurance plans.

A sizable part of the expense goes to the audiologist or hearing clinic. They test a patient’s hearing in a special sound-proof booth. They make recommendations about devices and help adjust hearing aids to maximize sound quality. If there are problems, the audiologist is available to help solve them.

After five years of debate, the FDA is now permitting the sale of non-prescription hearing aids. They will likely be available in many pharmacies and stores as well as online by the middle of October.

Several companies have already begun marketing personal sound amplification devices. These cannot be sold as hearing aids, but they also do not require the intervention of an audiologist. Some of them are less visible than Bluetooth mobile phone earpieces.

Potential Problems with OTC Hearing AIDS:

The new OTC hearing aids are likely to be even more sophisticated than the existing non-prescription products. One of the challenges, though, will be selecting the most appropriate device from a range of options.

There are already a wide variety of OTC hearing assist products on the market, ranging in price from under $100 to more sophisticated options that may cost close to $1,000. And that’s before the FDA’s new rule about OTC hearing aids goes into effect.

Many people will opt for inexpensive “hearing aids” that may be poorly made and hard to operate. They could give up in disappointment and assume that OTC hearing aids are rip offs.

Some older folks, unfamiliar with high-tech Bluetooth connections with a cell phone, may find some over-the-counter hearing aids too complicated to set up on their own. Without an audiologist to help, they too may give up.

Readers Share Their Concerns About OTC Hearing Aids:

David offers this caution:

“Insurance mostly bought my current hearing aids ($2600) almost 4 years ago. It took 8 visits to get the programming just right. Who’s going to do that with an OTC hearing aid?

“I take them in for cleaning every 3 months – no charge. They’ve been repaired twice at no charge. Now that they’re out of warranty repairs will cost a flat $100.

“I don’t see how a $99 or $199 pair of hearing aids can match that. If you have mild hearing loss and can’t afford Costco, then they’re probably better than nothing.”

Lyle shares this perspective:

“I’ve been wearing hearing aids for 14 years with ‘profound’ hearing loss in one ear. The pair I now have were $5000, down from $7000 for the previous model, and includes a 4-year full warranty and service – they are top-of-the-line aids, which my ENT told me I needed.

“I live in Texas and play golf 4 times a week – the perspiration and sunscreen wreck the aids and the internals have to be replaced about twice a year – all covered by warranty. I don’t know if the makers of OTC hearing aids will provide service like that. However, when the warranty expires on my current aids, I’m going to check them out.

“With that said, I would only give the aid performance about 2 out of 5 stars. They are good in quiet places like churches but are terrible in restaurants regardless of what “filters” are programmed into them (they still amplify all sounds). My biggest issue is in normal conversation, I still find myself asking people to repeat themselves way too often. While I can ‘hear’ them, I can’t understand what they say – soft voices are the most difficult.”

Luna suggests that we get over our reluctance to use hearing aids:

“Aside from the absurdity that insurance doesn’t cover hearing aids, (much like our teeth and eyes are excluded though all systems influence each other), I wonder why there would be a stigma attached to wearing hearing aids? Hopefully, as hearing aids become more widely available, it will simply be the same as wearing glasses, shoe inserts, or using mobility aids.”

Deni wants to know why hearing aids are not covered by insurance:

“I think it’s a political cop-out and a money-making scheme. What should happen is that all insurance companies should be forced to cover hearing aids and eyeglasses. These are things people need to have to function in life. The neediest people will still not be able to buy them if the choice is between rent or hearing aids.”

Marty believes that most people will need help adjusting their hearing aids:

“Many, if not most, people will need a good audiologist to program their hearing aids for their particular hearing loss. Otherwise, the purchase of OTC hearing aids will result in frustration and wasted money. I am not an audiologist, but I know from experience how important it is to have hearing aids programmed correctly, and this requires an attentive audiologist and more than one appointment. Unlike OTC reading glasses, OTC hearing aids would be significantly more wasted money.”

The Good News:

Experts expect many companies to take this opportunity to expand the market and develop new technology. Young people (under 18) and those with severe hearing loss will still need prescription devices.

Why is this regulatory change so important? Hearing loss can have devastating effects on people’s health. The social isolation it can produce may contribute to loneliness, depression and even cognitive decline among older people.

Accessing affordable hearing aids will enable millions of Americans to engage in social activities again. It may also stimulate the development of newer and more effective electronic devices.

What Do You Think?

Clearly, there is a lot of controversy surrounding hearing aids. We would love to read your thoughts in the comment section below. Have you ever used hearing aids? How well did/do they work for you? Do you think that OTC hearing aids are a good idea?

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About the Author
Joe Graedon is a pharmacologist who has dedicated his career to making drug information understandable to consumers. His best-selling book, The People’s Pharmacy, was published in 1976 and led to a syndicated newspaper column, syndicated public radio show and web site. In 2006, Long Island University awarded him an honorary doctorate as “one of the country's leading drug experts for the consumer.”.
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