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Over-the-Counter Hearing Aids: What Does This Mean for Your Family?

3 min read
Clarke Audiologist cleaning a hearing aid
Christine Kelley, AuD, audiologist at the Clarke Hearing Center in Northampton, MA.

October is Audiology Awareness Month, and this year we’re following an interesting development from the FDA.  

On August 16, 2022, the Food and Drug Administration approved over-the-counter (OTC) sales of certain hearing aids for people 18 years of age and older with perceived mild to moderate hearing loss.  

It’s critical to note up front that hearing aids for individuals under 18 will still require them to work with a hearing healthcare provider. It’s essential that children who are deaf or hard of hearing, like those served by Clarke, continue to receive audiology care to ensure appropriate access to sound and optimized auditory experiences in their homes and learning environments. Clarke recommends that children and individuals under the age of 18 see an audiologist to appropriately identify their type and degree of hearing loss, as well as receive recommendations for the best hearing technology for their individual diagnosis. This is especially important for children establishing neurological pathways, learning to listen and building spoken language skills. 

But this new ruling represents a big shift for consumers over the age of 18, increasing access to a technology that is essential for many—and can also be expensive. If enacted effectively, this change will enable many adults with perceived hearing loss, limited budgets and/or access to medical care to find effective solutions to make life more engaging and vibrant.  

This update also brings important considerations. Notably, adult consumers can potentially bypass the assessments of audiologists, the experts we turn to at Clarke to make access to sound possible for individuals of all ages. 

Here are a few considerations as we move toward the availability of OTC hearing aids:  

Over-the-counter products are intended to assist adults with mild or moderate hearing loss. While there may be questionnaires and online surveys to guide the selection process, a licensed audiologist can confirm if hearing loss is mild, moderate or severe. The American Speech-Language-Hearing Association (ASHA) reports, Studies have shown that adults tend to underestimate their hearing loss when undertaking a self-assessment. Audiologists are trained to assess medically treatable causes of hearing loss and to ensure that any technology used to assist with hearing loss is appropriate or safely customized for each individual patient. Hearing loss is different in every person!” 

Audiologists test for hearing loss across different frequencies. In most cases, hearing loss occurs within specific frequencies and hearing assistive technology is selected and programmed accordingly for each individual. Hearing aids purchased over the counter may not address what is needed at each frequency, which can lead to over/under amplification at different frequencies. Hearing aids that are not fitted appropriately can have multiple effects, ranging from poor sound quality to the user not wearing them at all due to discomfort—and potentially even damaging any residual hearing that the user still has.   

The FDA’s rule increases access to hearing technology that is helpful for many Americans, and shopping online or at a local retailer is convenient. Before browsing for OTC products, consider what information may be missing. An appointment with an audiologist, though an additional step, may be helpful and comes with many benefits, including:

Hearing aids, amplifiers and OTC hearing devices are small. It is not uncommon for these items to get lost or broken.  A lost or damaged device can mean complete replacement of the device. Audiologists who dispense hearing aids typically provide services to get hearing aids cleaned and repaired as needed, and they often have loaner hearing aids available. Be sure to double-check what—if any—warranty and/or repair services are included with the purchase of an OTC device. 

Hearing assistive technology can be a major expense. We hope the FDA’s measures enable more adults with hearing loss to access the support they need to participate fully and confidently in their communities—at work, at home and with their loved ones.

Clarke encourages adults who are able to, to seek the guidance of an audiologist before purchasing hearing assistive technology. We’re here to help. If you are in western Massachusetts, call 413.341.0040 to reach the Clarke Hearing Center or feel free to contact us at from anywhere with questions.  


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