OTC hearing aid advertising: FDA and FTC rules for audiology practices and sellers

Since October 17, 2022, adults with perceived mild to moderate hearing loss can buy an air-conduction hearing aid in a store or online without a prescription. The FDA created that over-the-counter category in a final rule published at 87 FR 50698, now codified at 21 CFR 800.30, and in the same rule moved the labeling for prescription hearing aids to 21 CFR 801.422. For an audiology practice or a hearing aid dispenser, the change opened a new product line and a new kind of competitor. It also brought a set of words and claims with legal weight: “OTC”, “hearing aid”, “FDA registered”, “clinically proven”, and anything that suggests a sound amplifier helps with hearing loss.

This guide reads the federal rules from the point of view of a practice that advertises hearing aids, whether it sells OTC devices, prescription devices or both. It covers which product category your ad describes, what the labeling rules mean for product pages, the line between a hearing aid and a personal sound amplification product, and how FTC advertising law applies to performance claims. For the wider plan, see our guides to audiology practice marketing, medical device marketing claims, ENT and allergy practice marketing and tinnitus clinic marketing. If a device you advertise is recalled or corrected, see marketing during a product recall. If you also remove earwax for hearing aid users, read our guide to earwax removal and microsuction clinic marketing.

The short version

• An OTC hearing aid is an air-conduction hearing aid for people 18 or older with perceived mild to moderate hearing impairment, sold without the involvement of a licensed person (21 CFR 800.30(b)). Any hearing aid that does not meet 800.30 is a prescription hearing aid.
• Sale of an OTC hearing aid to or for a person younger than 18 is prohibited (21 CFR 800.30(g)(1)). Ads for OTC devices should not target or show children as users.
• The outside package of an OTC device must carry the marks “OTC” and “hearing aid”, warnings, red flag conditions, advice that professional services are available and the manufacturer’s return policy (21 CFR 800.30(c)(1)). Product pages that sell the device are a good place to repeat that information.
• A product that is marketed as helping with hearing loss is a hearing aid in the eyes of the FDA, whatever the seller calls it. The FDA guidance lists claims that turn a sound amplifier into a device, including calling it an alternative to a hearing aid.
• Registration with the FDA does not mean approval. Under 21 CFR 807.39, implying official approval because of registration is misbranding, and the FDA OTC page warns that “FDA Registered” and “FDA Certified” may mislead.
• FTC law requires a reasonable basis for performance claims and at least the level of proof the ad claims. For health benefits, the FTC guidance says that generally means randomized, controlled human clinical testing.
• A licensed audiologist or dispenser may sell OTC hearing aids, and a practice that presents itself as a licensed dispenser stays subject to state rules even for OTC sales (21 CFR 800.30(h)(2)).

Two categories, one definition of hearing aid

Under 21 CFR 800.30(b), a hearing aid is any wearable device designed for, offered for the purpose of, or represented as aiding persons with, or compensating for, impaired hearing. The words “offered for the purpose of” and “represented as” matter for marketing: the category depends in part on what the seller says.

An OTC hearing aid, under the same paragraph, is an air-conduction hearing aid that does not require implantation or other surgery and is intended for a person age 18 or older to compensate for perceived mild to moderate hearing impairment. Through tools, tests or software, it lets the user control the device and customize it to their hearing needs. It may use wireless technology or include tests for self-assessment of hearing loss, and it is available without the supervision, prescription or other order, involvement or intervention of a licensed person, in person, by mail or online, as long as it meets the rest of 800.30. A prescription hearing aid is any hearing aid that is not an OTC hearing aid or does not meet 800.30, and its labeling is set by 21 CFR 801.422.

The FDA page OTC Hearing Aids: What You Should Know adds two points useful for patient education. OTC hearing aids are intended only for perceived mild to moderate hearing loss and not for severe or profound loss, because their maximum output is limited. And prescription hearing aids are available only through a licensed hearing health care professional who can program the device to the patient’s level of loss, and may be appropriate for all levels of loss and all ages depending on their indications. The output limit behind that statement is in 21 CFR 800.30(d): 111 dB SPL in general, or 117 dB SPL for a device with input-controlled compression activated.

For your ads, this means a claim about who a device is for has to fit its category. An OTC device ad aimed at people with severe loss, or at parents of a child with hearing loss, describes a use outside the OTC definition.

Who may sell OTC hearing aids, and what state law can still require

Under 21 CFR 800.30(h)(1), no state or local government may keep a requirement specifically related to hearing products that would restrict or interfere with the servicing, marketing, sale, dispensing, use, customer support or distribution of OTC hearing aids and that differs from the federal rule, including any requirement that a licensed person be involved before a consumer can get an OTC hearing aid.

Paragraph (h)(2) sets the professional side. Selling or marketing OTC hearing aids does not by itself require a special license. A licensed person may service, market, sell, dispense, provide customer support for or distribute OTC hearing aids. Selling OTC hearing aids does not exempt anyone from state professional or establishment requirements consistent with the rule. And a person who represents as any other defined professional or establishment, or as a state licensed dispenser, stays subject to state and local requirements even when they only deal in OTC hearing aids.

For an audiology practice, the practical reading is that your license comes with you into the OTC aisle. When your site says “licensed audiologist” next to an OTC product, your state rules for audiologists still apply to that sale. The FDA page also notes that consumers can buy OTC hearing aids from a hearing health care professional, who can perform a hearing test and hearing aid evaluation, and that consumers can request their hearing evaluation records and buy a hearing aid elsewhere.

Labeling rules that shape your product pages

The 800.30 labeling duties fall on the device and its manufacturer or distributor, but a practice that sells online is showing the patient that information before the sale. Under 800.30(c)(1)(i), the outside package must carry a warning against use in people younger than 18, symptoms suggesting perceived mild to moderate hearing loss, advice that professional services are available, “red flag” conditions, contact information and the manufacturer’s return policy. Under (c)(1)(iii), the principal display panel must bear the marks “OTC” and “hearing aid” as prominently as the statement of identity. The package must also say whether a mobile device or other control platform is required and how it connects (c)(1)(v), and give battery type and number and whether batteries are included (c)(1)(iv).

The FDA page sets out the red flag list in plain words, including an ear with a birth defect or unusual shape, fluid or blood from the ear in the past 6 months, pain or discomfort, dizziness or vertigo, hearing that changed suddenly in the past 6 months, worse hearing in one ear, and ringing or buzzing in only one ear. It tells consumers with those signs to see a doctor, preferably an ear, nose and throat doctor.

Inside the package, 800.30(c)(2) requires a user instructional brochure, and the manufacturer or distributor must make an electronic version available for download without site or customer registration and without requiring purchase. If clinical or nonclinical studies were done by or for the manufacturer to support performance, the brochure must include a summary of them (c)(2)(xiii). A product page can link to that brochure instead of rewriting it.

For software sold apart from the device, 800.30(c)(5)(i) requires that before first use or before payment details are collected, the user sees compatibility requirements and any fees or payments after first use, such as subscriptions or add-on features, with what each covers. If you sell or recommend a hearing app, check that its fee terms appear where the rule puts them.

Two points from the FDA page are worth adding to your own pages. The OTC rule does not require manufacturers to provide a warranty, so state the return or trial terms that actually apply to the device you sell. And the FDA suggests consumers allow time to test a device in different listening environments, which is a reason to state the length of any return window clearly. If you do offer a written warranty, see our guide to warranty rules for health devices and products.

Sound amplifiers: claims that make them hearing aids

Personal sound amplification products, or PSAPs, are a separate product type. The FDA guidance Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products (August 2022) says PSAPs are not intended to compensate for hearing impairment; they are intended to accentuate sounds in specific listening environments for listeners without hearing impairment. Because of that intended use, they are not devices under the FD&C Act, though they are electronic products subject to radiation control rules. The guidance gives hunting, bird watching and lectures with a distant speaker as examples of PSAP use.

The FDA decides which category a product is in by intended use, and 21 CFR 801.4 says intended use is the objective intent of those responsible for the labeling, shown by labeling claims, advertising matter and oral or written statements. The guidance says that explicitly or implicitly claiming that a product addresses, mitigates or improves hearing loss would be an intent to treat or mitigate disease, and lists examples of claims that would generally make the product a device:

• suggestions that the product is for users with certain types or severity of hearing loss;
• suggestions that it is for situations associated with and indicative of hearing loss;
• suggestions that it is an alternative to a hearing aid, such as a less expensive alternative, or marketing it to consumers who may have hearing loss and are not yet ready to buy hearing aids;
• information given to the user to tune the product to their hearing loss, such as hearing thresholds or a fitting formula.

If your practice sells or recommends a sound amplifier, its ad and product page should describe listening situations for people without hearing loss and nothing more. An ad that says “a budget alternative to hearing aids” or “for people who are not ready for hearing aids” fits the guidance’s own examples of claims that make it a hearing aid, and a product sold that way would then have to meet the hearing aid rules.

FDA registration is not FDA approval

Under 21 CFR 807.39, registering a device establishment or holding a registration number does not denote approval of the establishment or its products, and any representation that creates an impression of official approval because of registration is misleading and is misbranding. The FDA OTC page says statements such as “FDA Registered” and “FDA Certified”, and use of an FDA logo on OTC hearing aid package labeling, may be misleading.

Hearing aid ads use regulatory words as trust signals. Before you write any of them, ask the manufacturer what the device actually has. A device may be exempt from premarket notification, cleared through a 510(k), or granted marketing authorization, and each of these is a different thing. Use the term that matches the document you have in hand, link to the FDA database entry if one exists, and leave out any FDA logo.

FTC rules for performance claims

The FTC Act applies to hearing aid ads alongside the FDA rules. Under 15 USC 45(a)(1), unfair or deceptive acts or practices in or affecting commerce are unlawful, and 15 USC 52 prohibits disseminating any false advertisement to induce the purchase of devices. The FTC Health Products Compliance Guidance (December 2022) explains how the agency reads health claims, and three parts of it map onto hearing aid copy.

First, net impression. The guidance says marketers must identify all express and implied claims an ad conveys to consumers acting reasonably, and consider the ad as a whole, including the text, product name and images. A product name, a photo of a person hearing clearly in a crowded restaurant, or a headline about “crystal clear hearing” can each carry a claim about performance that needs support.

Second, substantiation. The guidance says claims about the health benefits or safety of health-related products require competent and reliable scientific evidence, and that as a general matter this will need to be randomized, controlled human clinical testing. It also says marketers must have at least the level of support they claim to have: an ad that says “clinically proven” claims a specific level of proof, and the evidence has to match that claim.

Third, words a reader takes literally. Terms such as “invisible”, “no one will know” or “hear like you did at 30” can read as objective claims about the device or about the result, and the net impression test applies to them like any other words in the ad. Ask the manufacturer for the support behind any claim you repeat, keep it in your files, and describe what the evidence shows in plain words rather than repeating the slogan.

Questions to ask the manufacturer before you advertise a device

• Is this device an OTC hearing aid under 21 CFR 800.30, a prescription hearing aid under 801.422, or a sound amplifier? What document shows it?
• What is the regulatory status: exempt, 510(k) cleared or another pathway? Is there an FDA database entry we can link to?
• Where is the electronic user instructional brochure, and does it include a summary of any performance studies?
• What evidence supports each claim on the box and in the marketing kit, such as clarity, speech in noise, battery life or comfort?
• What return policy and warranty apply, and for how long?
• Does the device need a smartphone or app, and are there fees after first use?

Use and avoid

• Use: the device category in plain words: “OTC hearing aid for adults 18 and older with perceived mild to moderate hearing loss.”
• Use: a line that says when to see a professional, with the red flag conditions, on OTC product pages.
• Use: the exact return window and warranty terms that apply to the device you sell.
• Use: the regulatory term that matches the document you have, such as “FDA 510(k) cleared”, with a link to the FDA entry.
• Use: a summary of what the manufacturer’s study measured, if you cite it at all.
• Avoid: “FDA registered”, “FDA certified” or an FDA logo as a sign of quality.
• Avoid: calling a sound amplifier a cheaper alternative to hearing aids, or marketing it to people with hearing loss.
• Avoid: “clinically proven” without studies that match that claim.
• Avoid: OTC ads that show or target children, or that speak to severe or profound loss.
• Avoid: promises about results, such as hearing “perfectly” or “like new”.

An illustration

This example is invented. [Practice name], an audiology practice in [city], adds a line of OTC hearing aids to its online store and plans a search ad and a product page. The draft headline reads “FDA registered OTC hearing aids, clinically proven clarity, the affordable alternative.”

The owner checks the draft against the rules. They remove “FDA registered” and ask the manufacturer for the device’s regulatory status, which turns out to be a 510(k) clearance, and they link to the FDA entry. They drop “clinically proven clarity” because the manufacturer’s brochure summary describes one study of speech in noise, and they describe that study in a sentence instead. The page now says the device is for adults 18 and older with perceived mild to moderate hearing loss, lists the red flag conditions, states the [number]-day return window and links to the brochure. A short note says that a hearing test is available at the practice for people who want one, without making it a condition of purchase. The owner asks counsel how the state rules for audiologists apply to OTC sales made under the practice’s name.

Checklist

• List each hearing device you advertise and record its category: OTC, prescription or sound amplifier.
• Keep the manufacturer’s regulatory documents and the electronic brochure link for each device.
• Remove “FDA registered”, “FDA certified” and FDA logos from ads, pages and print.
• Match each performance claim to evidence on file, and drop or rewrite claims you cannot support.
• Check sound amplifier copy for any reference to hearing loss or to hearing aids.
• Add the age limit, the mild to moderate scope and the red flag conditions to OTC product pages.
• State return, trial and warranty terms as they apply to each device.
• Exclude minors from OTC ad targeting and imagery.
• Have a health care attorney review your pages against your state audiology and dispenser rules.

How we help

We build websites, local and organic search, Google Ads and lead generation and an AI front desk for independent practices. For an audiology practice, that means product and service pages, ads and booking flows that name the device category, state who it is for and when to see a professional, and keep regulatory words to what the documents show. Our tools are built with HIPAA in mind. We confirm in writing what a BAA covers before any patient information flows through a tool, and if it is not covered, we do not route patient information through it. We are not a healthcare provider and we do not give legal or medical advice. Read our guide to healthcare marketing rules for the wider picture.

Sources

• 21 CFR 800.30: Over-the-counter hearing aid controls
• 21 CFR 801.422: Prescription hearing aid labeling
• 21 CFR 801.4: Meaning of intended uses
• 21 CFR 807.39: Misbranding by reference to establishment registration
• Federal Register: Establishing Over-the-Counter Hearing Aids, 87 FR 50698 (August 17, 2022)
• FDA: Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products (August 2022)
• FDA: OTC Hearing Aids: What You Should Know
• FTC: Health Products Compliance Guidance (December 2022)
• 15 USC 45: Unfair methods of competition unlawful
• 15 USC 52: Dissemination of false advertisements

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