In 2017, Congress enacted the Over-the-Counter Hearing Aid Act, requiring FDA to create a category for certain hearing aids intended for use by adults (18 and over) with mild to moderate hearing loss and available without the supervision, prescription, or other order, involvement, or intervention of a licensed hearing professional to customers through in-person transactions, by mail, or online.
On August 17, 2022, the final OTC rule issued by the FDA was published in the Federal Register. The final rule establishes a category for over-the-counter hearing aids and updates requirements for prescription hearing aids. The rule can be found here. The effective date of the final rule is October 17, 2022, 60 days after publication in the Federal Register.
The FDA created the medical device category of prescription hearing aids, which includes those hearing aids that are not OTC hearing aids. They may be appropriate for the treatment of mild, moderate, moderately severe, severe, and profound hearing loss, and remain available through a licensed hearing professional. Hearing professionals provide assistance and expertise throughout the treatment process, including performing an initial hearing assessment, assembling/customizing the device for a proper fit, inserting the hearing aid correctly into the ear, and adjusting the gain, output, and other features.
OTC hearing aids are also classified as medical devices and do not require the assistance of a hearing professional. They are distinguishable from Personal Sound Amplification Devices (PSAPs) or earbuds which are wearable electronic products that are not intended to compensate for impaired hearing, but rather intended for non-hearing-impaired consumers to amplify sounds in certain environments.
The introduction of new hearing devices and additional pathways for purchase will allow for increased access to hearing care options and help meet the needs of certain consumers who are ready, willing, and able to address their hearing loss. Hearing loss is unique to each individual and, in support of best practice, it is best to see a hearing professional to understand your individual hearing loss prior to making a purchase, whether OTC or prescription.
Hearing plays a crucial role in healthy living and healthy aging. A growing body of research links untreated hearing loss to multiple dimensions of mental and physical health, including a higher risk of depression, dementia, social isolation, falls leading to hospitalization, and more.1
The final rule was published in the Federal Register on August 17, 2022, and takes effect on October 17, 2022. OTC devices may be sold online, by mail, and in an array of brick-and-mortar locations, such as pharmacies, retail stores, and, perhaps, in hearing professionals’ offices.
Hearing loss is a medical condition. Hearing aids are medical devices. Choosing a hearing aid is an important decision best made with the advice and counsel of a licensed hearing professional.
Hearing loss can be caused by aging, extended exposure to loud noises, an underlying medical condition, medical treatment, or even earwax. The cause and type of each hearing loss is unique and seeing a licensed hearing professional, such as an ENT physician, audiologist, or hearing instrument specialist, can help you fully understand the nature of your hearing loss. These hearing professionals can also ensure your treatment provides customized sound quality that best benefits your unique hearing needs.
On average, prescription hearing aids purchased through a hearing professional range from $1,000 to $4,000. The total price includes the cost of the hearing aids (whether it be basic, mid-level, or advanced technology), the professional fitting, follow-up treatment, maintenance, troubleshooting visits, and sometimes batteries for the lifespan of the hearing aid(s).
Because over-the-counter (OTC) hearing aids do not require the service of a hearing professional, this will impact the overall price of the devices. Providing options at a wider range of price points will allow adults with mild to moderate hearing loss access a broader range of treatment options.
While traditional Medicare does cover certain hearing services, such as diagnostic hearing, balance exams, and/or cochlear implantation for individuals who meet specific selection criteria, that coverage does not extend to hearing evaluations for the purpose of obtaining a hearing aid, nor does it cover hearing aids or services related to the fitting or servicing of hearing aids. Multiple legislative proposals to expand Medicare to cover hearing aids and related services have been introduced, but none have advanced.
Under Part C Medicare Advantage (MA), approximately 97% of enrollees have access to some hearing health benefits and, of that, 95% of MA enrollees are in plans that provide access to both hearing exams and hearing aids.3 Some programs also provide an OTC allowance for select items at no additional cost.
According to MarkeTrak 2022, just over half of hearing aid owners had some assistance covering the cost of their hearing aids through Medicare Advantage, private insurance, Veterans Administration, Medicaid, union, or other.
Several states currently require that health benefit plans cover hearing aids for children. Some states are also moving to require minimum insurance coverage for adults with hearing loss, including Arkansas, Connecticut, Illinois, New Hampshire, Rhode Island, Maine, and Vermont.
Some insurers and Medicare Advantage plans provide an OTC allowance to purchase non-prescription, health, and wellness items. Check with your individual plan to see what benefits are available to you.