Over-The-Counter hearing aids (OTC) is a new category of instruments that will be available to adults. The conception of this product began five years ago due to public health concern for individuals with hearing loss.

The National Academies of Sciences, Engineering and Medicine

A report in 2016 by The National Academies of Sciences, Engineering and Medicine addressed hearing aid accessibility and affordability for adults with hearing loss. The report additionally noted hearing loss is a significant public health concern and adults should have alternative means of obtaining hearing aids.

The committee recommended that the US Food and Drug Administration (FDA) remove the regulation requiring adults to have a medical evaluation or sign an evaluation waiver to purchase a hearing aid, and recommends a new category of over-the-counter, wearable hearing devices, separate from hearing aids, that could assist adults with mild to moderate hearing loss.

Food and Drug Administration Reauthorization Act of 2017

The movement then expanded in 2017 with the Food and Drug Administration Reauthorization Act of 2017 (FDARA). This legislation included the Over-The-Counter Hearing Aid Act. The act would provide increased accessibility and affordability for adults with a perceived mild to moderate hearing loss, without seeing a hearing healthcare provider.

Additionally, FDARA required the FDA to create and regulate a new category of OTC hearing aids. This regulation would ensure the same high standard of safety, consumer labeling and manufacturing protection as other medical devices. This regulation was to be completed in three years with a final ruling 180 days after the public closing period. This 2020 deadline was delayed due to Covid-19.

President Biden’s Executive Oder

On July 9, 2021, President Biden signed an Executive Order (EO) aimed at improving competition and updating anti-trust guidance in a wide range of sectors, one of which was health care. Hearing aids were identified as one of the health care areas in which limited competition impacts cost and access.

The EO notes that the FDA has yet to issue rules for the OTC hearing aids. To advance this, the President directed the FDA to consider issuing proposed rules within 120 days for OTC hearing aids.

Hearing Aids and Personal Sound Amplifier Products

Hearing Aids are a Class 1 or Class 2 medical device available from licensed hearing healthcare providers. Hearing aids are regulated by the U.S. Food and Drug Administration (FDA) for the manufacturing and distribution of the devices to ensure they are safe and effective for individuals who wear them.

Personal Sound Amplifier Products (PSAPs) are basic amplifiers. These products are usually used by individuals who need some extra volume for certain situations, such has hunting or bird watching. PSAPs are not intended to treat hearing loss, therefore they are not regulated under the Food, Drug, and Cosmetic Act and there is no regulatory classification, product code or definition for these products. However, the FDA does regulate PSAPs under certain provisions of the Radiation Control for Health and Safety Act of 1968, covering electronic products such as sound amplification equipment that emits sonic vibrations.

PSAPs have been used by individuals with hearing loss for a number of years. These devices are advertised in magazines and in recent years online and television. Because they increase sound over a broad frequency range, individuals find them useful for watching television, but often too noisy for situations with background noise. Also, the earpieces are standard sizes, individuals may find they are not always comfortable to wear.

OTC Consensus Statement Published by AAA, ADA, HIS, ASHA

On August 14, 2018, Regulatory Recommendation for OTC Hearing aids: Safety and Effectiveness was developed by a working group of the above four organizations, which represent the major hearing healthcare professionals. The recommendations were endorsed by the Hearing Industry Association. Summary of the recommendations include that the devices be called “Self-Fit OTC Hearing Devices”. The devices are intended for a mild-moderate degree hearing loss between 26-55 dB with 26 dB of gain and maximum output of 110 SPL. The recommendation included the devices should include volume control and clear easy to understand outside and inside labeling and include safety and efficacy of use.

FDA Publishes Proposed Rules for OTC Hearing Aids

On October 20, 2021 the FDA published the proposed rules for a new category of over-the-counter hearing aids in a 114-page document, “Medical Devices: Ear, Nose, and Throat Devices: Establishing Over-the-Counter Hearing Aids” is published in the Federal Register. The ruling creates two categories of hearing aids. “OTC hearing aids” and “prescription hearing aids”. The OTC hearing aids would be sold directly to the consumers in stores or online without a medical examination. The prescription hearing aids and OTC hearing aids will be fitted by licensed hearing professionals. The ruling would include, but not be limited to, manufacturing electroacoustic requirements, packaging and labeling, returns and conditions for sale.

The proposed ruling closely follows the recommendation made by previous committees, for adults with a perceived mild-moderate degree hearing loss, except the area involving the maximum output level of the device. The OTC Consensus Statement recommended a maximum output of 110 dB SPL. However, the ruling followed the recommendation by the Consumer Technology Association (CTA) to allow output up to 120 dB SPL. With this increased output, it is possible the device may be used by an individual with a more severe hearing loss, which is a greater hearing loss than that originally proposed. The ruling does emphasis the OTC hearing aids are for adults over 18 and outside labeling would recommend the individual consider a consultation with a hearing healthcare professional. Red Flag conditions would be included on the label. These are symptoms which recommend a medical consultation. Example of red flags include onset of ringing in the ear, pain, ear drainage, unknown vertigo or dizziness.

Below is the link to view and submit comments on the proposed rules:

https://www.federalregister.gov/documents/2021/10/20/2021-22473/medical-devices-ear-nose-and-throat-devices-establishing-over-the-counter-hearing-aids

Finalization of the Regulations

There is a 90-day comment period which is open for online or written comment until January 18, 2022. The FDA then reviews the comments and makes changes to the proposed ruling, usually a 180-day period. When it is finalized, the rule is effective 60 days after publication in the Federal Register. Assuming there are no barriers to the typical timeline, the final rules would take effect on or around September 2022.

Closing Comments

Americans will benefit from OTC hearing aids, as it is estimated over 30 million Americans experience hearing loss. While there has been great improvements and affordable options in hearing aid technology, only about 20% of adults use hearing aids. Untreated hearing loss is linked to social isolation and depression, and research studies reveal a strong connection of hearing loss and cognitive decline. It is anticipated this new category of hearing aid will improve the quality of life for Americans, and better support them in enjoying social interactions with family and friends.

Ann DePaolo Wietsma, Au.D., CCC-A, FAAA

Dr. DePaolo Wietsma is an audiologist and owner of The Audiology Offices, LLC. The practice provides hearing healthcare to children and adults in the Northern Neck and Middle Peninsula area of Virginia, with locations in Kilmarnock, Gloucester and Warsaw.