OTC Hearing Aids

FDA Approves Over-the-Counter (OTC) Hearing Aids

The US Food and Drug Administration (FDA) ruled on August 16, 2022, legalization of ‘Over-the-Counter’ or OTC hearing aids that will take effect within 60 days (estimated mid-October 2022). These products will be available online and in stores to customers without the need of a licensed hearing professional to test or fit the products. What does this mean for you, and how are these products different from hearing aids currently available today?

What does Over-the-Counter Hearing Aids Mean?

Over-the-Counter hearing aids are a new class of hearing devices. Different from traditional or prescription hearing aids, these hearing devices do not require a hearing test or licensed hearing professional to fit. Over-the-Counter hearing aids come with general settings with the ability to make small, limited adjustments, typically lumping low and high frequencies. There is also a mandatory volume control. These hearing aids are only designed to assist someone with mild to moderate self-perceived hearing loss.

Benefits of

Over-the-Counter Hearing Aids

  • Price Tag: Traditional hearing aids are seen as expensive because the cost includes the devices along with the service and expertise of the hearing professional.
  • One Size Fits Most: Over-the-Counter hearing aids are designed for the user to be able to open the box and use the product immediately. This is possible with a generic fit and removal of customizations. Most Over-the-Counter devices come with simple buttons and/or a smartphone app connection for customizations and volume control.
  • Combining Safety and Help: The FDA passed a law limiting the power and output of Over-the-Counter hearing aids for patient safety. These devices are beneficial for patients with mild to moderate self-perceived hearing loss. This means that a patient does not need a hearing test to purchase. Patients still can purchase an Over-the-Counter device after going to a certified hearing professional for a hearing exam.

Limitations of

Over-the-Counter Hearing Aids

  • Unknown Hearing Loss or Issues: Much like eyesight, hearing loss comes in a variety of types and pose different challenges. Hearing loss comes in a variety of types including sensorineural, conductive, and mixed hearing loss; each type of hearing loss impacts different frequencies and may require differing treatment methods. The lack of a physical ear examination may lead to other unnoticed potential issues that can show similar hearing loss symptoms such as ear drum damage or simple wax buildup.
  • One Size Fit Most: Over-the-Counter hearing aids are like generic reading glasses. They are one size fits most with limited customization for comfort. These devices may help if you need a mild correction but will not be specifically designed for your exact needs. Your ears are unique and what you might find comfortable may not be comfortable to the next patient.
  • Lack of Service: Over-the-Counter hearing aids come with little to no professional service or assistance. For the most part, it is a do-it-yourself solution. The lack of regular cleanings, verification, and monitoring of your specific hearing loss leaves room for doubt. Is this device truly helping me? How well does this adjustment fit my needs? Is there a bigger issue or wax build up? These questions plus more stay unanswered.

How is it Different from Traditional Prescription Hearing Aids?

Traditional prescription hearing aids are specifically customized for your needs and comfort.  A licensed hearing professional takes you through a series of physical exams and audio tests to understand your specific hearing needs. The hearing professional will help you determine which hearing aids are right for you and your lifestyle. They can adjust the devices frequencies to match your specific hearing loss needs. The hearing aid can be physically molded to your ear for added comfort resulting in the most natural sounding hearing solution possible.

What Services are Included with Over-the-Counter Hearing Aids?

Typically, Over-the-Counter hearing aids are self-fit with no assistance or support from a licensed hearing professional. At Echo Hearing & Audiology, we believe that everyone should experience the joy of hearing. That is why we are offering annual exams and troubleshooting appointments to all hearing aid wearers. Regardless of what manufacturer or where you purchased your hearing aids, we want to help ensure you are hearing to the best of your ability.

What Levels of Hearing Loss are Treatable with Over-the-Counter Hearing Aids?

The FDA limits Over-the-Counter hearing aids to mild-to-moderate self-identified hearing loss only. This is to protect patients from potential harm of over amplification which can result in permanent damage and significant hearing loss. Prescription hearing aids that are fit by a licensed hearing professional can work for all levels of hearing loss from mild to profound.

How will I know what my hearing loss is?

There are several online hearing tests available, and you can try ours here! However, they are not diagnostic medical tests. The only way to determine hearing loss or if you may need hearing aid solutions, is to schedule a hearing exam with a licensed hearing professional. Both an audiogram and a physical examination are required to determine hearing loss. 

Clinically, hearing loss falls into different degrees. Mild, moderate, severe, and profound are some of the most common degrees with variations in between. Your hearing loss degree depends on your ability to hear different pitches (frequencies) at different volumes (decibels dB). Hearing threshold of mild loss is 26-40 dB, moderate is 41-55 dB, severe is 71-90 dB and profound is over 91dB.

No matter what type of hearing aids you choose to try, our hearing aid specialist(s) can help ensure all your hearing healthcare needs are addressed over time as your hearing demands change. The first step would be to call or book your appointment online for a complimentary hearing screening.

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Karyn Flynn of Echo Hearing Systems and Audiology in Worthington, OH, is a rock star!! We have had so many roadblocks in our hearing aid journey. This wonderful doctor was so kind, professional and knowledgeable. The time she spent to learn all she could to offer the best solution is...

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Personable, professional and knowledgeable. Very pleasant experience. I have already referred 5 friends to them. I am very pleased with my hearing aids and my improved word recognition. Just purchased my 5th pair of hearing aids from Echo. 2019 - 2025

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The whole process from testing my hearing, fitting, and wearing them was absolutely wonderful. I was somewhat hesitant at first, Its the not knowing. Not knowing how they worked, how long it would take to receive them and if the testing was accurate. I have to say the testing was...

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