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FDA clears path for OTC hearing aids, which could be on store shelves as early as October 2022


Do you have hearing loss but feel like the cost is holding you back from getting hearing aids? You’re not alone: The price is a barrier for many, which is why Congress passed the Over-the-Counter Hearing Aid Act of 2017 to authorize over-the-counter hearing aids for adults with mild-to-moderate hearing loss.

On Aug. 16, 2022, the FDA announced their long-awaited OTC hearing aid guidance that now means hearing aids will be sold directly to consumers in stores or online without a medical exam or a fitting by an audiologist. The goal is to increase competition in the hearing aid market and ultimately make them more affordable.
*According to the American Speech-Language-Hearing Association, if you have any of the following health conditions a prescription hearing aid fit by a licensed audiologist or hearing instrument specialist will work better for you:

• Unilateral (one-sided hearing loss)
• Sudden recent hearing loss
• Ringing, roaring or beeping in one or both ears
• Take or have taken medication known to cause hearing loss
• Have a history of chemotherapy or radiation in head/neck area
• Have constant pain in ears
• Have frequent dizziness


Am I a candidate for an OTC hearing aid?


If you have mild hearing loss and are holding back because of the cost of hearing aids, OTC hearing aids will be low-cost and will give you a taste of the advantages of better hearing.

An OTC hearing aid will help you if you notice hearing issues only now and again—usually, in noisy places, groups or when you can’t see who is talking.

Often your family and friends will notice your hearing loss first. They might complain that they need to repeat themselves, you don’t hear them shouting from the other room, or you turn the TV volume up high.
Who is not a candidate for an OTC hearing aid?
If you have trouble hearing conversations even in quiet settings or miss loud sounds like cars honking when you drive or announcements in public buildings, your hearing loss is more severe than OTC hearing aids are designed to address, notes the National Institutes of Health.

You need to see a doctor quickly if you have a sudden hearing loss, sudden plunge in your hearing (even if it improves), a big difference between one ear and the other, or tinnitus (ringing) in only one ear. These are possible signs of a medical problem. After it is evaluated and treated, you will know what kind of hearing aid will help you.

If you have mild hearing loss and are holding back because of the cost of hearing aids, OTC hearing aids will be low-cost and will give you a taste of the advantages of better hearing.

 

An OTC hearing aid will help you if you notice hearing issues only now and again—usually, in noisy places, groups or when you can’t see who is talking.

 

Often your family and friends will notice your hearing loss first. They might complain that they need to repeat themselves, you don’t hear them shouting from the other room, or you turn the TV volume up high.

If you have trouble hearing conversations even in quiet settings or miss loud sounds like cars honking when you drive or announcements in public buildings, your hearing loss is more severe than OTC hearing aids are designed to address, notes the National Institutes of Health.

You need to see a doctor quickly if

you have a sudden hearing loss, sudden plunge in your hearing (even if it improves), a big difference between one ear and the other, or tinnitus (ringing) in only one ear. These are possible signs of a medical problem. After it is evaluated and treated, you will know what kind of hearing aid will help you.

A recent study showed that “premium” prescription hearing aids have the highest user satisfaction. This preference stemmed from factors related to comfort, specifically how the hearing aids processed background noise and how well the study participants could hear speech in a group setting. Because of the cost of the technology to develop these features, OTC hearing aids are unlikely to be as sophisticat

If you’ve browsed online shopping sites, you’ve likely come across hearing aids that cost little more than a meal at a fancy restaurant. Be warned that these are likely not true hearing aids, but are “hearing amplifiers,” also known as PSAPs, and they are not intended for use by people with hearing loss, which the FDA plans to address.


Original Source:

https://www.healthyhearing.com/report/53233-Otc-hearing-aids-over-the-counter-devices