Over-the-counter (Otc) Hearing Aids

Dear Patients of Eye Consultants of Atlanta,

Many of you are requesting our professional opinion regarding the recent over-the-counter (OTC) hearing aid rule, and what it means for you or a loved one. We have been following the progression of this ruling closely since 2017. As audiologists who are passionate about helping people improve their hearing, we have supported any legislation that improves the access and affordability of audiology services and products. We value your trust and would like to offer further insight on this ruling.

In 2017, the Food and Drug Administration (FDA) released its proposal to allow certain hearing aids to be sold over-the-counter (OTC) without a prescription or a hearing evaluation. The purpose of the bill was to increase access and lower the costs of receiving hearing aid technology. On August 17, 2022, the FDA released its final language of approval.

Audiologists and hearing aid dealers have prescribed and professionally fit hearing aids (Class I & occasionally Class II FDA Medical Device) for years based on lifestyle, cognition, hearing evaluations, and many other factors. While this will continue, the new FDA language will now include hearing aids to be sold over the counter. The hearing devices will be available on October 17, 2022 when the rule takes effect.

The language that was written and approved by the FDA includes:

  • Over-the-counter hearing aids are meant for individuals who perceive they have mild to moderate hearing loss.
  • No hearing evaluation is required.
  • The consumer must be 18 years of age or older.
  • Over-the-counter hearing aids can be sold outside of a medical office.
  • Consumers must have symmetrical hearing loss (see an audiologist for asymmetrical hearing loss).
  • Not recommended for those who have a sudden change in hearing (see an audiologist).
  • Not recommended for those who have tinnitus, a ringing or roaring noise (see an audiologist).
  • Not recommended for those who have a history of chemotherapy and/or have had radiation to the head or neck (see an audiologist).
  • Not recommended for those who have active drainage in one or both ears (see an audiologist or otolaryngologist).
  • Not recommended for those who have ear pain or discomfort (see an audiologist).
  • Not recommended for those who have episodes of vertigo, severe dizziness (see an audiologist).

An OTC device may be a viable option for patients who meet the listed requirements and do not have medical conditions that require monitoring. However, without a thorough audiological evaluation, medical conditions may be overlooked and not monitored appropriately. We encourage you to start your hearing journey with an audiologist to find out what level of care your hearing problem requires.

A common analogy that can be used to understand OTC hearing aids is over-the-counter reading glasses compared to an eyeglass prescription. While a low cost pair of reading glasses picked up at your local drug store may assist you in reading a restaurant menu, it will not be able to treat your full range of visual needs. Many vision patients require an ophthalmologist to manage their treatment plan due to an underlying medical diagnosis, similar to many hearing patients who require an audiologist to manage their treatment plan.

The best way to find out if you are a candidate for an OTC hearing aid is to see an audiologist. We are here to professionally evaluate your hearing and communication difficulties. It is our job to work with patients to find appropriate solutions to reduce listening fatigue, decrease communication issues, and enhance your quality of life. We believe the most effective treatment option is a hearing aid that is accessible and affordable to the patient.

The Hearing Center of Eye Consultants of Atlanta welcomes patients regardless of whether they have purchased a hearing device in-house or elsewhere. We understand consumers are faced with a variety of different hearing aid options. By using evidence-based clinical practices and state-of-the-art equipment, our providers can accurately test the effectiveness of a patient’s hearing device. This is extremely important because a patient with hearing loss doesn’t know what they are not hearing. If you have a hearing aid or an OTC device, we encourage you to schedule an evaluation to ensure your device is providing you with the most benefit.


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