Coates Hearing Clinic, P.A.

OTC Hearing Aids

On July 9, 2021, President Joe Biden signed a comprehensive Executive Order that addresses a section on the long-anticipated rules for classifying over-the-counter (OTC) hearing aids. The President specifically directed the US Department of Health and Human Services “to consider issuing proposed rules within 120 days for allowing hearing aids to be sold over the counter.”

Proposed OTC Guidelines

As of October 20, 2021, the Food and Drug Administration (FDA) officially proposed guidelines to establish a new category of over-the-counter hearing aids. When finalized, the rule would allow hearing aids within this category to be sold directly to consumers in stores or online.

Though we are cautiously optimistic about the proposed legislation, many state attorneys general across the United States have released statements of caution, warning of possible scams and sub-par performance of these devices. These statements urge those with hearing loss to seek out professional testing before purchasing one of these devices.

Here is the link to the statement from North Carolina’s Attorney General, Josh Stein. 

Basis for Providing Hearings Aids Without a Prescription

According to the National Institute on Deafness and Other Communication Disorders, hearing loss significantly affects the quality of life for tens of millions of adults in the United States and contributes to high healthcare costs. Untreated hearing loss can lead to isolation, and it has been associated with serious conditions such as depression, anxiety, low self-esteem, dementia, reduced mobility, and falls. Yet only one in four adults who could benefit from hearing aids has ever used them. Making hearing health care more accessible and affordable is a public health priority, especially as the number of older adults in the U.S. continues to grow.

Leading experts in science, technology, and hearing health care have been working with researchers, health professionals, and consumers to find safe and effective ways to improve access to hearing health care for adults. They suggested changing some regulations that studies showed were barriers to adults getting the hearing help they need. They also recommended that the FDA create guidelines and quality standards for OTC hearing aids.

ASHA Collaborates With The FDA

The American Speech-Language-Hearing Association (ASHA) appreciates the President’s attention to these long-overdue rules. ASHA has worked in collaboration with allied stakeholders and developed a series of evidence-based recommendations for the FDA to consider that ensure the safety, effectiveness, and proper marketing of OTC hearing aids. They have also emphasized the importance of an audiologist in hearing health care.

Know the Facts

  • Hearing aids are medical devices that are already regulated by the FDA.
  • OTC hearing aids will be newly regulated devices for adults with perceived mild to moderate hearing loss.
  • Studies have shown that adults underestimate their hearing loss when undertaking a self-assessment, so proper testing is a necessary first step.
  • Hearing screenings that are available online are not a substitute for an audiological exam. Among other things, these online screenings do not test bone conduction, use masking, test word recognition, or evaluate the same number of frequencies as our audiologists test. 
  • OTC hearing aids offer an affordable option to many more people. Having an affordable option should make hearing aid use more widespread.
  • A person with moderate to profound hearing loss needs to seek the services of a hearing health professional, such as an audiologist.
  • While an OTC hearing aid may offer some improvement, professionally fit hearing aids would be so much better as they are prescribed to meet a patient’s needs and hearing loss.
  • OTC hearing aids are not programmed to the wearer’s specific hearing loss. It is unknown at this point if this could result in long-term negative outcomes.
  • An audiologist is 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.
  • An audiologist can screen for other hearing-related issues such as asymmetry, which could indicate a serious underlying medical issue.
    One size OTC hearing aid does not fit all.
  • The American Speech-Language-Hearing Association (ASHA) considers a consultation with an audiologist as a critical component of ensuring good hearing health and consumer protection.

Coates Hearing Clinic

In anticipation of this upcoming release, Dr. Kathleen Coates and Dr. Tessa Merrill of Coates Hearing Clinic, wanted to emphasize the importance of seeing an audiologist to evaluate, diagnose, and treat hearing loss. This new class of OTC devices may be prescribed to patients who have only a mild hearing loss.

Hearing Evaluations

If you suspect you may have a hearing loss and would benefit from hearing aids, our audiologists at Coates Hearing Clinic will be glad to conduct a thorough hearing evaluation for you to assess your needs. If hearing aids are recommended for your specific hearing loss, our audiologists are trained to fit the devices for your ear and specific needs with state-of-the-art technology at their fingertips. Hearing loss treatment is a process, and our audiologists will guide you every step of the way.

Hearing Aids

There are many types of hearing aids today, and the style or device depends on your lifestyle, budget, and hearing loss needs. There are in-the-ear styles as well as behind-the-ear styles. In addition to selecting the right style of device, it’s also important to consider what features would be most beneficial to you. From directional microphones to waterproof options, there are numerous varieties to meet everyone’s personal needs. Today’s hearing aids are equipped with Bluetooth connectivity to work with wireless technology like a cell phone or television.

Hearing aids are available in many different sizes and styles, thanks to advancements in digital technology and miniaturization of the internal components. Many of today’s hearing aids are considered sleek, compact, and innovative – offering solutions to a wide range of hearing aid users. When selecting a style of hearing aid, the following should be considered:

  • The type/degree of the hearing loss
  • Power requirements
  • Manual dexterity and visual abilities
  • Budget
  • Cosmetics and aesthetics
  • Anatomical and medical considerations
  • Lifestyle requirement

Hearing Aid Costs

Our hearing aids range in cost from $950 to $6,500. The cost depends on many factors, including whether or not you need one or two hearing aids, your type and degree of hearing loss, your lifestyle, and many other things as determined by your audiologist.

If you feel your financial circumstances preclude you from affording to purchase hearing aids, talk to us. There are many options available to help patients cover the cost of hearing aids. In fact, many people have hearing aid benefits as part of their insurance, so they might end up paying little or nothing out-of-pocket. There are also some state programs to help with hearing aid needs.

Coates Hearing Clinic is in-network with a state program that provides one hearing aid for adult patients who qualify. Additionally, we offer deferred interest payment plans, such as 12 months, same as cash plans, and there is also our non-profit, Matthew 11:15 in Smithfield. We’re committed to ensuring that any patient motivated to start treatment gets help, even if cost is a concern.

Coates Hearing Clinic in Smithfield, NC

Coates Hearing Clinic supports ASHA steadfastly in its commitment to advocating for policies that support a robust hearing health care delivery system and safe, effective, and affordable technology. We also agree that a consultation with an audiologist is critical to ensuring good hearing health and consumer protection. Our sincere hope is that the upcoming OTC legislation will allow more people to gain access to treatment.

If you are interested in a hearing evaluation, our compassionate team of audiologists at Coates Hearing Clinic is here to support your need for better hearing health. Call us at (919) 351-8100 to schedule an appointment.

If an OTC-type hearing aid is all you need, our audiologists will prescribe that for you. We are not in the business of up-selling to technology that the patient doesn’t need (unlike many of the chain hearing aid sellers). We exist to provide our patients with the highest level of audiological care available anywhere, not just to sell hearing aids. Our sincere wish is that no one would need hearing aids at all and that our patients’ perceived deficit is due to a simple issue like wax in the ears. But, when hearing aids or other treatment is necessary, you can trust that we will find the most cost-effective way for you to get the help you need.

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