For this reason, the Food and Drug Administration (FDA) announced draft recommendations for over-the-counter (OTC) hearing aids last year, in a first step toward providing Americans with more options for dealing with mild to moderate hearing loss.This is a complex and evolving topic, so let's start by answering some frequently asked questions about over-the-counter hearing aids.
According to the National Institute of Deafness and Communication Disorders, around 28.8 million adults in the United States could benefit from hearing aids. Still, only about one-third of them (or 30%) have taken steps to use them.
For this reason, the Food and Drug Administration (FDA) announced draft recommendations for over-the-counter (OTC) hearing aids last year, in a first step toward providing Americans with more options for dealing with mild to moderate hearing loss.
This is a complex and evolving topic, so let's start by answering some frequently asked questions about over-the-counter hearing aids.
To begin with, it's important to recognize that over-the-counter hearing aids aren't necessarily a new product category. They are, in reality, traditional hearing aids that have been chosen to be marketed directly to customers without a prescription or any medical approval.
This action is part of a bipartisan effort by the US Food and Drug Administration (FDA) to make hearing aids more accessible to those who might not otherwise be able to purchase them or seek care for their hearing loss. Adults 18 and older will be able to acquire OTC hearing aids online or in retail shops without a professional hearing test or fitting by a hearing care specialist once the rule is finalized.
The goal is to lower the cost of hearing aids while allowing those with mild to moderate hearing loss to improve their quality of life.
While we don’t have the final rules yet, OTC devices will likely be available to adults aged 18 and above with mild to moderate hearing loss. People with a more severe hearing loss or under 18 will still need to be evaluated and prescribed.
In general, over-the-counter hearing aids should be safe. Several paragraphs in the FDA's proposed rules focus on safety regulations, such as restricting their maximum volume output and requiring FDA approval for some types of self-fitting hearing aids.
However, some companies have already begun to promote their gadgets as over-the-counter (OTC) despite the lack of regulatory approval. Others refer to their hearing aids as "personal sound amplification products" and sell them as a way to treat hearing loss. This permits them to skirt FDA regulations and sell an unlawfully advertised and potentially dangerous product.
Consumers should be cautious about acquiring any hearing aid equipment sold over the counter before the FDA's rules are officially released as regulation.
OTC hearing aids can meet the initial needs of the many people with untreated mild hearing loss in the US population. New high-quality OTC solutions can demonstrate the life-changing advantages of hearing amplification and speech audibility for people who are just getting started in their hearing treatment journey.
That said, OTC hearing aids are not likely to replace the professional-fitted hearing aids that we currently provide at Silicon Valley Hearing any time soon. Hearing loss is a progressive medical condition, and we expect OTC hearing aid users to gravitate to more professionally fitted hearing aids as their hearing loss evolves.
In October 2021, the FDA formally proposed rules to establish the new OTC hearing aids category. Following that, groups such as the American Academy of Audiology, hearing-aid manufacturers, and advocates for persons with hearing loss had the opportunity to respond with comments during an open discussion period that ran until January of this year.
As of the writing of this article, the FDA is currently analyzing and assessing the recommendations made during that period.
According to most estimates, people will be able to acquire FDA-approved OTC devices by the middle of this year. This is when several manufacturers are likely to release their first OTC hearing devices under the new category.
At Silicon Valley Hearing, we believe that the best option for most people will be hearing aids from an Audiologist using industry best practices. For those with a mild-to-moderate hearing loss and unable to afford this option, over-the-counter devices may be an alternative to consider.
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