Over the Counter (OTC) Hearing Devices

In recent years, consumers have increasingly taken charge of their health and options for medical treatment, which includes bypassing traditional routes of care. We now have the ability to purchase glasses, contacts, invisalign-type braces, even colonoscopy screenings, online. Sound devices are no exception. Although not true hearing aids, to date there are at least 120 devices available as OTC (over the counter), DTC (direct to consumer), or PSAPS (personal sound amplification products). However, anything sold over the counter (Walmart, CVS, Best Buy, etc) or online (Eargo, Nano, Bose) are not regulated by the FDA and cannot be sold as hearing aids. These devices are not interchangeable with hearing aids, and according to the FDA they are not allowed to state that they will compensate for or treat hearing loss. The typical cost of these devices ranges from $10 -->$2500, which is considerably less than the average traditional hearing aid cost.


Additionally, hearing tests are not always required to purchase these devices; instead, you may take a quick screening test on your computer or phone. Most of these devices provide general amplification with little to no noise reduction, so that hearing in background noise may still be difficult. Some do offer phone apps that allow the consumer to adjust the aids, or allow for direct streaming to your phone. Any service is provided via phone calls or mailing them back to the company, and - as of now - no local audiologist or hearing aid dispenser can maintain, repair, or adjust these devices.


In contrast, traditional hearing aids are obtained through audiologists or hearing instrument specialists after a hearing exam (which must be performed within the previous 6 months), and medical clearance by a physician to rule out a medically treatable hearing loss (which is rare). They are then programmed based on your specific hearing loss at specific frequencies, after counseling and a determination of what your needs and hearing goals are. The average cost for a pair of aids is $5000 (with many priced lower, some priced higher), includes office visits for maintenance, cleanings, adjustments, and will last an average of 5-7 years before they need to be replaced. The cost of hearing aids is not often covered by insurance, and we are acutely aware that the average cost of hearing aids is not within reach for many consumers. Additionally, more consumers are demanding quality for fewer dollars and more transparency with what they purchase.


OTC, DTC, and PSAPs are best suited to those with mild to moderate hearing loss and for those who a medically treatable hearing loss has been ruled out. If you cannot hear or understand someone speaking at a normal volume in the same room, these devices are not made for you, despite what they may say.


Reading glasses are perfect for reading books, restaurant menus or small print on medicine bottles, but when that no longer works, people then go to the eye doctor. People don’t blame the glasses when they can no longer see well, but people DO blame hearing devices when they don’t hear well. It’s very important that if you or a family member purchases an OTC, DTC, or PSAP, and find they are still unable to hear well, that they then seek the guidance of an audiologist or dispenser to determine why and what can be done to help.


There is an average of 28 million people with hearing loss, and we fit approximately 2 million with traditional devices - that leaves a lot of people who need help and don’t get it, undoubtedly price is one of the reasons why they don’t or can’t. Therefore, OTC/DTC/PSAPs are not, in my opinion, a bad thing as long as they are used properly and for the right type of hearing loss. More importantly, if this is the only type of device that a person can afford, and they are able to hear general conversation and TV again, and they are able to participate in functions they had been missing, then we as hearing professionals should be happy. What we do caution against is that if you find this type of device does NOT work, please do not lump all hearing devices - especially traditionally fit hearing aids - into the same category. Additional care or counseling, or properly fit hearing aids may be what is needed. Our office offers different types of pricing from the traditional all-included model to a lower price/pay as needed option, and we are almost always able to find a solution that works for everyone.











Jen Schumacherr, AuD, F-AAA

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