Guest Post | Are OTC hearing aids for everyone with hearing loss?

Exclusively written for the Official ReSound Blog

By Dr. Amy Sarow, Michigan Ear Institute   

In August, the U.S. Food and Drug Administration (FDA) announced an approved regulation that will pave the way for over-the-counter (OTC) hearing aids in October.

The idea behind the recent FDA ruling approving over-the-counter (OTC) hearing aids comes from a good place. In the United States 15 percent of the adult population (37.5 million) report some degree of hearing difficulty[1] and worldwide the WHO reports that 1.5 billion people suffer from hearing loss[2]. Despite the large number of people affected, only about 14 percent actually use amplification[3].

Unfortunately, access to hearing healthcare is limited, primarily due to two culprits: cost and stigma. The cost of a pair of hearing aids is a major investment for most households. Additionally, some are thwarted from pursuing hearing devices due to the social stigma associated with hearing loss and visible hearing aids. One study found that 40 percent of adults with hearing loss avoid hearing aids due to stigma[4]. At face value, OTC hearing aids aim to reduce the barrier to entry for these two contributing factors.

[1] Lin FR, Niparko JK, Ferrucci L.  Hearing loss prevalence in the United States. [Letter] Arch Intern Med. 2011 Nov 14; 171(20): 1851-1852.


[3] Chien  W, Lin  FR.  Prevalence of hearing aid use among older adults in the United States.  Arch Intern Med. 2012;172(3):292-293.

[4] Kochkin S. Marke Trak VII: Obstacles to adult non-user adoption of hearing aids. Hear Jour. 2007;60(4):24-51.

Kochkin S. MarkeTrak V: “Why my hearing aids are in the drawer”: the consumers’ perspective. Hear Jour. 2000;53(2):34.

Mental and Social Well Being

The Covid pandemic certainly has had an impact on mental health – and for good reason. It can be really hard on us mentally and emotionally when we feel isolated and disconnected. We are social creatures and need social interaction to feel connected and fulfilled. For many with hearing loss, this type of social isolation is an unfortunate result of hearing difficulty. Hearing impairment is associated with increased risk of depression, most notably among adults aged 18 to 69[5].

Hearing Loss Can Have a Big Impact on Healthcare Costs and Income

Hearing loss can be costly for both patients as well as the healthcare system. According to a recent study, those with untreated hearing loss will have an additional $22,434 in healthcare costs over ten years than patients with normal hearing.[6] Misunderstandings in patient-provider interactions can lead to increased healthcare costs or misunderstandings regarding medication instructions, for example.

Not only that, but hearing loss can also impact salary. Imagine missing out on important points during meetings with clients, small talk with colleagues, and other important aspects of daily work. Estimates speculate that employees lose as much as $30,000 per year in annual salary with an untreated hearing loss[7]. Meaning that untreated hearing loss can cause someone to both miss out on earning potential and cost more money in health expenses.

[5] Li, C.-M., Zhang, X., Hoffman, H. J., Cotch, M. F., Themann, C. L., & Wilson, M. R. (2014). Hearing impairment associated with depression in US adults, National Health and Nutrition Examination Survey 2005-2010. JAMA Otolaryngology–Head & Neck Surgery, 140(4), 293.

[6] Reed et al (2019). Trends in Healthcare cost and utilization associated with untreated hearing loss over 10 years. JAMA Otolaryngology-Head & Neck Surgery. 145(1), 27 – 34.

[7] Kochkin, S. (2010). Marketrak VIII: The efficacy of hearing aids in achieving compensation equity in the Workplace. The Hearing Journal, 63(10), 19–24.

The good news is that for many people with hearing loss, treatment can make a big difference in overall health and wellbeing – and even financial health.

However, can OTC hearing aids provide enough benefit to see these health improvement outcomes?

Hearing care professionals ensure you get the right hearing instrument

The major selling point of over-the-counter hearing aids is that they will be available at a lower price than traditional hearing aids. The reason for this being individuals will not need to pay for a professional fitting or diagnosis. These devices would be for sale at local pharmacies and stores or for purchase online. Sounds promising, right?

The downside to this is that over-the-counter hearing aids may not be as effective in treating hearing loss as traditional hearing aids, especially for those with advanced stages of hearing loss. This is because they will not be custom programmed or fit to a person’s specific hearing needs by a trained hearing care professional. In one study, about 55% of individuals were able to successfully self-fit their hearing devices[8]. Those who are more tech savvy may have an easier time with this. However, for many people, hearing loss has developed gradually over a period of time, making it difficult to tell what needs to be amplified to provide the intended benefit.

Further, one attractive feature with current hearing aid technology is Bluetooth connectivity. However, patients typically need assistance to pair the devices with their phones as well as the app on their phone. An OTC hearing aid will not involve a professional fitting appointment, so there is always a question of who will assist these patients? Pharmacists are already swamped with their regular duties; will they be able to stop what they’re doing and troubleshoot the devices and phones? It is hard to imagine a busy pharmacist dropping everything to help with a hearing aid.

[8] Convery, E., Keidser, G., Seeto, M., & McLelland, M. (2017). Evaluation of the self-fitting process with a commercially available hearing aid. Journal of the American Academy of Audiology, 28(02), 109–118.

Additionally, some of what goes into a hearing aid fitting also includes instruction on how to insert, remove, and clean the hearing aids as well as proper selection of a type of hearing aid and size of the portion that goes into the ear canal. Some individuals may have no trouble reading this information in a booklet, but other people would really benefit from having personal instruction and someone to answer their questions.

For some people, having a professional eye on your ear is also helpful. For example, to monitor for earwax build-up, ear canal irritation, or other concerns that may need to be addressed.

Although a hearing test will technically not be required for OTC devices, they are unlikely to provide benefit if hearing loss is greater than a mild to moderate hearing loss.

However, how does someone know if they have a mild to moderate hearing loss? The best place to start is with a professionally administered hearing test that can give good information about whether a hearing device option will provide benefit. For those with Medicare, these tests are covered with a physician referral. Some will wish to purchase the devices without a hearing test, but they will run the risk of wasting time and effort on devices that cannot provide adequate benefit.

Bottom Line

Will OTC hearing aids provide benefit? For some the answer is yes. However, a hearing test will still be important to know if these devices will work for the purchaser, and they may still need help from a professional to provide the intended benefit. In any case, OTC hearing aids offer a chance to start the hearing care discussion for many. And that’s a good thing. 

Author bio:
Dr. Amy Sarow obtained her Doctor of Audiology at the University of Iowa. She spent her 4th year residency at the Mayo Clinic School of Health Sciences in Jacksonville, Florida. She currently resides in Michigan and works as a full time clinical audiologist. You can follow her blog at 

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