If you are wondering when over-the-counter (OTC) hearing aids will be available to the public, you’re in luck. The FDA announced this month that OTC hearing aids will be available from October 16, 2022.
An estimated 48 million Americans suffer from mild-to-moderate hearing loss, and only 14% of these Americans own a hearing aid. Untreated hearing loss can impact an individual’s wellbeing and quality of life as it leads to social isolation and a decline in cognition. Hearing aids are the primary intervention for hearing difficulty—however, they are unaffordable for most Americans who could benefit from wearing them, especially because they aren’t typically fully covered by health insurance.
Recently, efforts to improve access to hearing aids have escalated. As part of the FDA Reauthorization Act of 2017, the US government took steps towards making over-the-counter (OTC) hearing aids available and instructed the FDA to institute legislation by August 2020. As a result of the COVID-19 pandemic, this was delayed.
In July 2021, following a bill that was sponsored by Senator Elizabeth Warren, President Biden issued an Executive Order in an effort to make these essential medical devices more easily accessible to individuals with mild to moderate hearing loss. As a result, the FDA has taken further steps to establish a new category of OTC hearing aids, making it possible for consumers to buy hearing aids over-the-counter in brick-and-mortar stores.
On August 16, 2022, the FDA issued a final rule to allow for the sale of over the counter hearing aids. These hearing aids are intended for individuals with mild to moderate hearing loss to easily attain affordable hearing aids without the requirement of exams, prescriptions, or audiologist fittings. This measure will take effect in mid-October, from when hearing aids will be in retail stores.
With over-the-counter hearing aids coming soon, there are plenty of questions about these new devices that can be sold directly to consumers. Let’s take a look at a few.
What are over-the-counter hearing aids?
Hearing aids purchased directly by consumers
One of the key benefits of OTC hearing aids is their accessibility. Consumers can purchase them directly from retailers (in-store or online).
Devices that feature the same technology as traditional hearing aids
Accessibility isn’t a trade-off for capability. OTC hearing aids utilize the same fundamental technology as traditional hearing aids. Modern features, like wireless technology or app functionality, may also be included.
Controllable and customizable
OTC hearing aids can be controlled by the user and may be customized to fit their specific needs. These OTC devices may include self-assessment tests to ensure the best possible functionality and user experience.
Regulated by the Food and Drug Administration
OTC hearing aids will be regulated by the FDA with clear labeling related to use, safety, and efficacy.
Who can wear over-the-counter hearing aids?
OTC hearing aids are designed to help adults with mild-to-moderate hearing loss. Adults with severe hearing loss and children under the age of 18 should not use OTC hearing aids.
Why are over-the-counter hearing aids so important?
As mentioned, OTC hearing aids are an accessible hearing solution, being that they don’t require a prior medical exam or consultation with a hearing professional. They will be easily purchasable in retail stores across the United States.
Over-the-counter hearing aids will likely be much more affordable than current, traditional hearing aid options, removing a significant barrier to those living with untreated hearing loss. One major reason for this is eliminating the need to pay for audiologist visits or other medical testing.
What hearing device options are available now?
Direct-to-consumer hearing aids
In line with the existing Medical Device Amendments (MDA) of 1976 and FDA requirements, affordable direct-to-consumer (DTC) hearing aids are currently available on the market. By signing a medical waiver, prescribed by the FDA, DTC hearing aids can be purchased online by persons older than 18 years and delivered ready-to-use (or can be fitted at home, if necessary). In some cases, the provider’s customer care team is able to provide remote support.
Personal Sound Amplification Products (PSAPs)
Personal sound amplification products (PSAPs) are not intended for people with hearing loss and are hearing devices that can be purchased directly (without consulting a medically trained professional. These devices have been developed for people without hearing loss to boost their ability to hear certain sounds in certain situations, for example, hunting or bird watching. PSAPs are not regulated as medical devices by the FDA.
In which instances should you first consult a hearing healthcare professional before buying OTC hearing aids?
If you experience any of the following conditions, you should first consult with a hearing healthcare professional before buying hearing aids over-the-counter.
- Visible deformity of the ear, either present since birth or from trauma.
- Fluid, pus or blood coming out of the ear in the past 6 months.
- Pain or discomfort in the ear.
- History of excessive ear wax or suspicion that something is in the ear canal.
- Episodes of vertigo (a sensation of spinning or swaying) or severe dizziness.
- Sudden, quickly worsening, or fluctuating hearing loss in the past 6 months.
- Hearing loss or ringing (tinnitus) only in one ear or a noticeable difference in hearing between ears.
What are the expected challenges of over-the-counter hearing aids?
Risk of improper treatment
While OTC hearing aids remove the need to see an audiologist, this does create the possibility that the user’s hearing loss will not be managed properly. One possible solution is to create a model that allows users to purchase OTC hearing aids with support from hearing care experts, to ensure the device is functioning effectively.
Lack of emotional support
Buying hearing aids over-the-counter can mean that a fitting is not provided to the user to meet their individual needs, which can create additional challenges. The traditional hearing aid fitting process involves complex tuning over time, during which the brain re-adapts to listening in the “normal” range. This process can be difficult to adjust to independently, and hearing professionals can offer emotional support and counseling to assist users through the adjustments. However, OTC hearing aid providers that offer support or expert care could help alleviate this.
What does Lexie Hearing offer?
Lexie Hearing offers the best of both worlds through the combination of the DTC hearing aid model with ongoing professional support and service as recommended by Lexie Experts. Lexie hearing aids are FDA-regulated and have been validated by experts in the hearing healthcare industry. Lexie hearing aids use smart technology so that wearers can take a hearing check or select from pre-programmed algorithms, depending on the model chosen, when their hearing aids are delivered and have their hearing aids programmed according to their unique hearing profile. The hearing aids also pair via Bluetooth with the Lexie app, so that wearers can control their hearing aids directly from the smartphone and directly contact Lexie hearing experts through voice or video call, at no additional cost.
hearX Group and its subsidiaries are not healthcare providers. The information contained herein is solely for informational purposes. It is not intended to be a substitute for professional medical advice and should not be relied upon as healthcare or medical advice and is provided with the understanding that neither the author nor the publisher is engaged in or has the intention of rendering any legal, business, or medical advice.
The views and opinions expressed are those of the author and do not necessarily reflect the official policy or position of hearX Group or any of its subsidiaries. Although efforts are made to ensure that information is accurate, hearX, including its subsidiaries, cannot guarantee that all the information provided is correct, complete or up to date.
You are advised to seek guidance from your doctor or other qualified health professional with any questions you may have regarding your health or a medical condition. Never disregard the advice of a medical professional, or delay in seeking medical advice or care because of the content published herein. If you choose to rely on any information provided by hearX Group or its subsidiaries, you do so entirely at your own risk.