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 currently available hearing aids?

What does over the counter hearing aids mean?

Over the Counter hearing aids are a new class of hearing devices. Different from a 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 both the devices with the hearing professional’s service. Over the counter hearing aids are affordable due to the removal of the hearing professional’s needed time and expertise.
  • One size fits most: Over the counter hearing aids are designed for the end user to be able to open the box and use the product right away. This is done 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. The 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 these products. Patients still can purchase an over the counter device after going to a certified hearing professional for a hearing exam.

Weaknesses of

Over the Counter Hearing Aids

  • Unknown hearing loss or issues: Much like eyesight, hearing loss comes in a variety of types and challenges. Hearing loss comes in different types including sensorineural, conductive, and mixed hearing loss; each can have different treatment needs and frequencies impacted. The lack of a physical ear examination leads to other unnoticed potential issues that can show similar hearing loss symptoms such as eardrum damage or simply wax buildup.
  • One size fit most: Over the Counter hearing aids are much like generic reading glasses. They are one size fits most with limited customization for comfort. These devices will help if you need a mild correction but will not be specifically designed to your exact needs. Your ears are unique and what you might find comfortable might not be comfortable to the next patient.
  • Lack of service: Over the Counter Hearing aids come with little to know professional service or help. 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 and more stay unanswered.

How is it different from traditional prescription hearing aids?

Traditional prescription hearing aids are specifically customized to the needs and comfort of you, the patient. A licensed hearing professional takes you through a series of physical exams and audio tests to understand your specific hearing needs. Your provider will adjust different frequencies of the device to match your specific hearing loss needs. The hearing aid can be physically molded to your ear for added comfort and better sound quality. The result is 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 licensed hearing professional support. At Audibel, we believe that everyone should experience the joy of hearing. That is why we are offering annual exams and trouble shooting appointments to all hearing aid wearers. Regardless of where you purchased or what manufacturer, we can help ensure you are hearing to the best of your ability.

What levels of loss are treatable with which type of device?

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 (Try ours here) however they are not perfect medical tests. The only way to get an accurate reading of hearing loss is to go to a licensed hearing professional. Both an audiogram and a physical examination are required to get an accurate result.

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.

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