By Dennis Thompson Health Day Reporter
FRIDAY September 10, 2021
Until now, people with hearing loss typically had to fork out thousands of dollars for a device that could only be fitted by a professional audiologist.
No wonder only a quarter of the nearly 29 million American adults who could benefit from a hearing aid have actually tried one, according to the U.S. National Institutes of Health.
Less expensive, high-tech, over-the-counter hearing aids are being developed, and some have even entered the market through companies like speaker maker Bose.
But these newer, more affordable options exist in a medical gray area, as hearing experts and federal regulators grapple with issues with a class of devices that could be purchased without seeing a doctor for a hearing test.
A 2017 law requires the United States Food and Drug Administration to establish a class of over-the-counter hearing aids, along with the standards for them. The FDA missed its August 2020 deadline to propose these new rules, blaming the delay on the COVID-19 pandemic.
But consumers’ wait could end soon: President Joe Biden ordered the agency to complete its draft rules by November.
“We are waiting for the FDA to come up with guidelines that we believe should be released very soon, which would guide over-the-counter labeling and requirements,” said Angela Shoup, president of the American Academy of Audiology. “That would then determine what manufacturers would be able to move forward with.”
The FDA itself has muddied the waters by allowing companies like Bose to move forward with devices that appear to fit into this new, yet undefined midrange category.
In 2018, the FDA approved a Bose hearing aid for sale direct to consumers, based on clinical trial evidence showing that people themselves could fit it as well as a professional audiologist.
The Bose device costs $ 850, compared to $ 2,000 to $ 8,000 for the purchase and installation of a standard pair of hearing aids.
An Illinois company, Lexie Hearing, has started selling its own hearing aids for $ 799 direct to consumers online and through Walgreens pharmacies in five southern and western states.
These newer devices are intended to fill a significant gap in the hearing aid market, which now offers people two options: either go through the expensive process of getting a full-fledged hearing aid, or spend much less on one. gadget called a personal device. sound amplification product (PSAP).
PSAPs typically cost less than $ 500, and Amazon sells them for as little as $ 60. But experts warn you get what you pay for – PSAPs amplify all sound around you, but they don’t allow other adjustments to account for distortion or hearing loss at different heights.
“There’s not really a whole lot of customization other than maybe turning the volume up or down,” said Hope Lanter, chief audiologist at Hear.com, an online hearing aid retailer based in the Country. -Low. “An amplifier makes everything much louder. It doesn’t necessarily match the sound to the person’s hearing loss, but makes everything louder. When you do that, it can actually create more distortion or greater magnification of the sound. problem. “
Compared to PSAPs, both Bose and Lexie devices allow consumers to make adjustments on their own using a smartphone app, with specific volume and frequency options.
Part of the problem the FDA faces in making the rules is that hearing loss is much more subtle and difficult to discern than vision loss. These over-the-counter devices must be designed to help consumers primarily diagnose themselves, the experts said.
“Often times, hearing difficulties can be quite complex,” said Shoup. “For some listeners, we know that they can have a simple decrease in audibility for certain pitches of sound.”
For example, a person may have problems with high-pitched sounds.
“In this case, their experience may be that they feel like they can hear sounds very well but the speech is not very clear,” said Shoup. “They feel like people don’t speak very clearly, because they’re missing those high-pitched consonants.”
In that case, if they are able to adjust the sound device appropriately, they can do everything right, she said.
But the ear itself is only part of the problem, added Shoup.
The brain has its own process of interpreting signals from the ear, and some people with long-term hearing loss may need to retrain their brain to adapt to a hearing aid.
“Our brain pathways change and help support our ability to decode complex sounds such as speech, especially speech in background noise,” Shoup said. “In some cases, we have people who, even though the sound is amplified for them in areas of audibility where they have experienced hearing deficits, may still have some distortion or difficulty understanding voice signals.”
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In such cases, the person might need hearing rehabilitation and training to make the best use of their device, Shoup said.
Audiologists can help
There is another problem: we may not be the best judges of our own audience.
“The brain likes what it’s used to. Often times people put on an amplification device and then adjust it to be comfortable and sound normal, and to them looking normal is not hearing. all sounds available to them, ”Shoup said. noted. “It is difficult for them to know what kind of hearing difficulties will be helped by this over-the-counter device.”
Recognizing issues like these, the FDA recently said CBS MoneyWatch that he “worked diligently” to draft the new rules.
“The issuance of the proposed rule is a high priority for the FDA, and the agency is committed to ensuring that proper guardrails are in place to ensure that over-the-counter hearing aids will be a safe and secure option. effective for consumers, ”the FDA said in a statement. declaration.
Shoup and Lanter said their main concern is that a consumer will not get immediate relief from an over-the-counter device and will resign themselves to poor hearing rather than seeking a professional.
“If a person chooses to try an over-the-counter device, they should remember that if it doesn’t really seem to meet their needs, they could still benefit from the advice of an audiologist for diagnosis,” Shoup said. .
People might even want to take their over-the-counter device to an audiologist for adjustment, or talk to a professional ahead of time to see if such a device would be a reasonable alternative, Lanter said.
“The best case would be to have your hearing tested by a hearing care professional no matter what. Then you can see what the real results are,” she said. “It kind of clears the mystery around, is this the right direction for me to go or not?”
The US National Institutes of Health has more information on over-the-counter hearing aids.
SOURCES: Angela Shoup, PhD, president, American Academy of Audiology; Hope Lanter, AuD, Senior Audiologist, Hear.com, CBS Money Watch
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