OTC hearing aid

The Food and Drug Administration’s recent rule has expanded access to hearing aids by creating a new category of hearing aids: over-the-counter (OTC) hearing aids. They can be purchased by consumers in retail stores and online and do not require a physician or audiologist visit before purchase. Although involvement of an audiologist is not required, people interested in OTC hearing aids may have many questions that could be answered by a professional. The Melosound offers guidance in helping you decide whether an OTC hearing aid is right for you and how to choose one.

What are OTC hearing aids?

OTC hearing aids were implemented to help assist adults with a perceived mild-to-moderate degree of hearing loss and who may not need hearing assistance in every listening situation. An OTC hearing aid may help enhance speech and provide improvements in communication for people who are able to hear well generally but experience occasional difficulty hearing.

Devices traditionally known as hearing aids that are purchased through an audiologist are now labeled by the FDA as “prescription hearing aids.” OTC hearing aids have limited loudness output and features compared with prescription hearing aids. Both categories of devices share some of the same features, however the amount of customization, functions, and computer processing varies greatly between them. The variety, quality and functions of OTC hearing aids changes weekly as new OTC hearing aids enter the market.

What should I consider when choosing an OTC hearing aid?

There are some things to consider when choosing a hearing device. The OTC hearing aid market is direct to consumer — meaning you are both the consumer and the patient. Some prescription hearing aid manufacturers also make OTC devices with involvements from an audiologist. Consider the following items when researching your OTC hearing aid options:

Durability and Cost

· Is there a trial period with option to return the device?

· How much does it cost? Is that for one device or for a pair?

· Can I use my health insurance or HSA/FSA to purchase an OTC hearing aid?

· Is there a warranty that covers losing the OTC hearing aid?

· Can I get the device repaired if it stops working?

· What if it doesn’t fit in my ear?

· Is it waterproof?

Ease of Use and Function

· Do I need to have a smartphone to use the OTC hearing aid?

· Do I need to install an app on my phone to tune the device?

· Does it work with both iPhone and Android phones?

· Is the device rechargeable or does it require weekly battery changing?

· Is the OTC hearing aid Bluetooth compatible where I can stream my phone calls and music?

· Can I enter a hearing test in order to tune the OTC device to better match my hearing needs?

· Is there online support or a telehealth option?


Melosound specializes in developing OTC hearing aids, which can help more people with hearing loss afford OTC hearing aids and make our lives better!

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