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What Are Over-the-Counter Hearing Aids?

In response to demands from several government agencies to increase the affordability and accessibility of hearing aids in the United States, the Food and Drug Administration (FDA) Reauthorization Act was signed into law in 2017. This act includes language that urges the FDA to develop a set of regulations for over-the-counter (OTC) hearing aids.

As the FDA implements these regulations (these regulations are NOT out yet), it is likely that you’ll begin seeing OTC hearing aids advertised in your local big box stores, online, and via mail. OTC hearing aids look similar to hearing aids that are available at an audiologist’s office however they differ in a few very important ways.

OTC hearing aids:

  • Are approved for use by adults older than the age of 18 only
  • Are for adults with mild to moderate hearing levels only
  • Can be customized by the user for their hearing needs and may include self-assessments of hearing
  • Are available over-the-counter, without a prescription, supervision, or involvement of a licensed hearing healthcare professional, such as an audiologist

Both FDA regulations as well as position statements from the American Academy of Audiology maintain the strong position that OTC hearing aids are not approved for use in children younger than age 18.

What Is a Pediatric Audiologist?

Why Does My Child Need an Audiologist to Get Hearing Aids?

Hearing aids are only as good as the professional programming them. An accomplished pediatric audiologist is a crucial resource for families of children with hearing loss. Selecting an OTC hearing aid for your child is not only against FDA regulations and Academy recommendations, but it also means that your child will not be able to benefit from the comprehensive care a pediatric audiologist can provide.

Children with hearing loss have a unique set of needs that require the skilled care of a pediatric audiologist. Pediatric audiologists are masters or doctorate level hearing healthcare professionals, licensed in audiology, who have undergone extensive training to diagnose and treat hearing and balance disorders in children younger than the age of 18.

If you have concerns for your child’s hearing, perhaps due to speech and language delays, frequent ear infections, or because they have not passed a hearing screening, the first step is to have a diagnostic hearing test completed by an audiologist. An audiologist can help determine the degree and type of hearing loss. They are also knowledgeable to understand when to involve other healthcare professionals, such as ear, nose, and throat (ENT) physicians, when results suggest that medical care is necessary.

If hearing loss is diagnosed and hearing aids are recommended, a pediatric audiologist is an important member of your child’s care team. Pediatric audiologists are specially trained to help select hearing aid technology that is appropriate and safe for your child’s unique hearing levels, age, and stage of development. They also use the most current, evidence-based methods to program hearing aids on little ears.

Research indicates that hearing aids that are not custom-programmed to children’s unique hearing and age-based needs may lead to delays in language growth. Children with well-programmed hearing aids are more likely to have language similar to their normal hearing peers and be ready to enter school. Pediatric audiologists use specialized equipment to ensure that the volume of the child’s hearing aids will not be too loud, is appropriate for their hearing levels and age, and provides access to important speech sounds the child will use to develop spoken language.

Lastly, pediatric audiologists are experienced with working not just with the child with hearing loss, but with the entire family. Pediatric audiologists can help make referrals to other agencies, such as early intervention, to make sure that your child doesn’t fall behind on their developmental milestones and is ready to learn alongside their peers. Pediatric audiologists also routinely work with the child’s educational team, to ensure they have access to high quality speech at school through a teacher microphone system that connects with conventional pediatric hearing aids. They are also available to help give guidance and support to your family through the challenges and triumphs that come along with raising a child with hearing loss.

Why Aren’t Over-the-Counter Hearing Aids Advised for Pediatric Use?

Specifically, OTC hearing aids are very risky and not approved for use in children because:

  • They may be self-programmed by the child or a parent to be too loud, risking damage to the child’s remaining hearing
  • They may be self-programmed by the child or a parent to be too quiet. Hearing aids that are too quiet may mean that the child doesn’t have opportunities to hear important speech sounds, which can negatively impact their spoken speech and language development, educational success, and social interactions with peers and family. In addition, hearing aids that are too quiet may prevent children from being aware of what is happening around them, which could put them in unsafe or dangerous situations.
  • They may not include important safety features for pediatric use, such as a tamperproof battery door. Hearing aid batteries are toxic, if swallowed. Leaving a small child unattended with a hearing aid that does not feature a tamperproof battery door poses a significant health and safety risk.

Using an OTC hearing aid on a child introduces significant safety concerns for the child. OTC hearing aids can contribute to delays in language learning, school readiness, and social-emotional development. Seeking care from a pediatric audiologist helps ensure that your child is properly diagnosed, treated, and supported throughout their hearing loss journey.

What Are the Financial Considerations of Over-the-Counter Hearing Aids?

For many families the cost of hearing aids can be overwhelming, and the affordability of OTC hearing aids may seem attractive. However, using an OTC hearing aid is not an appropriate solution and there are funding options a pediatric audiologist can discuss with you and your family. Many state Medicaid plans include coverage for hearing aids, especially for the pediatric population. Additionally, many states now have legislation that mandates private insurance companies provide some coverage towards hearing aids for pediatric patients. Lastly, there are often other funding agencies to which families can apply to see if they qualify for scholarships or hearing aids. A pediatric audiologist can help your family determine what avenue for funding is best for your child and family. While seemingly more affordable, using an OTC hearing aid is not an appropriate substitute for evidence-based treatment options for your child.

What Do I Do if My Child Needs Hearing Aids?

If you think your child may have a hearing loss and may need hearing aids, a pediatric audiologist can help navigate these concerns. To find a pediatric audiologist in your area, visit the Academy’s Find an Audiologist Directory and search by the pediatric specialty.

Find an Audiologist link


Educational Audiology Association Position Statement: Over the Counter Hearing Aids

Outcomes of Children with Hearing Loss Parent Handout

Outcomes of Children with Hearing Loss Presentations

Outcomes of Children with Hearing Loss Publications


FDA Reauthorization Act of 2017 (FDARA) | FDA

Tomblin, J. B., Harrison, M., Ambrose, S. E., Oleson, J., Moeller, MP. (2015) Language outcomes in young children with mild to severe hearing loss. Ear and Hearing, 36(Suppl. 1), 76S-91S.Children of Nebraska Hearing Aid Act « District 40 News and Information

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