OTC Hearing Aids are not FDA approved

Have you heard about OTC hearing aids? They are not FDA approved, contain low-quality amplifiers, and are not appropriate for most of our patients’ lifestyle. Attorney General Ken Paxton even warns Texans in a recent press release. Learn more along with my take on this dire situation to the audiology industry: OTC Hearing Aids are not FDA-Approved

Oh come on, your scaremongering isn’t gonna work here, the writing is on the wall, the tide is turning, most people expect much more professionalism from you lot, but alas we have come to expect a lot less.

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Over the counter hearing devices like over the counter glasses have there purpose, for some but not all. They are great for the ones that can use them. I just hope the ones that need more will seek the extra help they need. I personally hold no hope of them helping my needs.

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Well said, Chuck! @cvkemp

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Maybe you should get yourself up to date? Reading this thread might help.

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Relative to OP, sounds like what blacksmiths must have once said about the Model-T.

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Curious how many read the article. It seems to be talking about a lot of the junk that’s currently available online.

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Don’t think that can officially qualify as OTC so a false whipping boy is being set up relative to what might come from more established OTC OEMs in the future. OTC is not really here yet.

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You may be correct as far as intent. Seems like FDA is trying to make “OTC” and “heaing aids” into technical terms when they also have meaning as lay terms. Communication is not their strong point.

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When people come in with OTC devices they want me to “fix” or repair them. Which usually is not possible. However, I actually do try and assist these patients. I do my best to provide a thorough cleaning of the device and replace any universal dome or piece I can. This often times is how I build a relationship with people and provide the service aspect which never came with the OTC device they purchased. My practice is about service and follow up care. As check ups/ fine tuning is key to success with hearing devices. So- yes for some people with financial/travel constraints etc… an OTC device may be better than nothing. Some providers won’t even touch any device they did not fit in their practice. In our rural setting of Denver City, Texas, people come first and personal relationship and education about options seems to go a long way.

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Any information regarding hearing aids from an indicted attorney general should be taken with a grain of salt.

Relative to the OP, CBS News has a recent upbeat piece on the current status of OTC HA’s. Certainly doesn’t sound like OTC devices are going to be the creatures from the Black Lagoon depicted down Texas way (where Lt. Gov. Dan Patrick a year ago called on older citizens to be prepared to die during the pandemic for the sake of keeping the U.S. economy running full tilt). Listen up: Cheaper, sleeker over-the-counter hearing aids may hit shelves next year - CBS News

When the FDA eventually does issue final rules, experts hope it will unleash competition among consumer electronics companies for a global market that some estimate should jump 40% to $11.6 billion by 2028. Currently, only a handful of specialty device makers dominate the hearing aid market.

Bose sells an $850 hearing design cleared by the FDA for direct-to-consumer online sales in five states, with plans to expand.

“These over-the-counter devices should cost $200 to $800. And they’ll be produced by companies like Bose, Samsung and maybe Apple,” said Dr. Justin Golub, an ear specialist at Columbia University Medical Center in New York. “These are the really innovative companies that always compete to drive costs down, constantly innovate and prove value. So we’re pretty excited about this.”

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