Audiology and hearing aid practice marketing: FDA and FTC rules

Since October 2022, adults with perceived mild to moderate hearing loss can buy hearing aids in a store or online without seeing anyone. For audiology and hearing aid practices, that changed the competition and the questions patients ask. It also changed what a practice needs to get right in its marketing: which device category it is talking about, what a hearing test is, and what the device can honestly be said to do.

This guide covers the federal rules behind those questions, using the regulation and agency pages themselves. If you sell hearing aids without a prescription, read our guide to OTC hearing aid advertising rules. Wax removal services are covered in our guide to earwax removal and microsuction clinic marketing. Balance clinics have their own guide; see vertigo and balance clinic marketing.

The FDA over-the-counter hearing aid rule in brief

The FDA established the OTC hearing aid category in a final rule published in the Federal Register on August 17, 2022, effective October 17, 2022. The requirements are in 21 CFR 800.30.

The regulation defines an OTC hearing aid as an air-conduction hearing aid that does not require implantation or surgery, is intended for a person age 18 or older to compensate for perceived mild to moderate hearing impairment, lets the user control and customize it, and is available over the counter without the supervision, prescription or other order, involvement or intervention of a licensed person. Sale to or for a person younger than 18 is prohibited (800.30(g)(1)).

The FDA explains that a prescription hearing aid is any hearing aid that is not an OTC hearing aid, and that prescription hearing aids are available only through a licensed hearing health care professional. FDA’s comparison table lists prescription hearing aids as intended for people of any age and any degree of hearing loss, including severe.

The FDA also distinguishes personal sound amplification products. Its table describes them as intended for people with normal hearing to amplify sounds in certain environments. They are not hearing aids, so a practice should not present them as a treatment for hearing loss.

Say which category you mean

The most common marketing problem after the rule is blurred categories. A few rules of thumb that follow from the definitions:

• When you advertise hearing aids for children, or for severe hearing loss, you are talking about prescription hearing aids. OTC devices are defined for adults with perceived mild to moderate loss.
• If you sell or fit OTC devices, describe them as OTC hearing aids and do not imply that a professional fitting is required to buy one. The regulation defines them as available without a licensed person’s involvement.
• If you offer professional services around OTC devices, such as a hearing evaluation or help with setup, describe those as optional services with their own price.
• Do not describe an amplifier or a sound app as a hearing aid unless it is one.

21 CFR 800.30(h) also addresses state law. It preempts state or local requirements specifically related to hearing products that would restrict the marketing or sale of OTC hearing aids in ways that differ from the federal rule. It also says that representing yourself as another defined professional, or as a state licensed dispenser, keeps you subject to applicable state and local requirements. Your licensing board is the place to confirm how your state applies this.

Device claims and the FTC

The FTC shares jurisdiction with the FDA over the marketing of devices and other health-related products, and its Health Products Compliance Guidance says claims about health benefits must be supported by competent and reliable scientific evidence. For hearing aids, the claims to look at closely are the ones that go beyond the device’s labeling:

• Claims that a device restores or cures hearing, or stops hearing loss from progressing.
• Claims about health benefits beyond hearing, unless you have the evidence the FTC guidance describes.
• Claims that a device works for everyone, or comparisons to other brands you cannot support.
• “Invisible” or similar wording, unless it is literally accurate for how the device is worn.

Patient stories about hearing better are endorsements, and under 16 CFR 255.2(b) they are likely to be read as typical. Our guide to patient testimonials covers the FTC and HIPAA rules. Claims made in an ad by a manufacturer you carry are still your claims when you repeat them, so check them as your own.

Free hearing tests and other offers

Many practices advertise a free hearing test or a free trial. The FTC guide concerning use of the word “free” (16 CFR 251.1) says that when making free or similar offers, all the terms, conditions and obligations should be set forth clearly and conspicuously at the outset of the offer. If the free test is only a screening rather than a full diagnostic evaluation, say so. If a trial has a restocking or fitting fee, state it with the offer.

If you offer payment plans for devices, the Truth in Lending advertising rules apply to how you describe them. See advertising payment plans and patient financing.

Medicare and insurance: get the facts right

Medicare.gov states that Medicare does not cover hearing aids or exams for fitting hearing aids, and that some Medicare Advantage plans offer extra benefits that Original Medicare does not cover, such as hearing. Ads that say or imply “covered by Medicare” for hearing aids are likely to mislead. If you accept specific Medicare Advantage or commercial plans with hearing benefits, name the plans and tell people to check their own benefits.

Clinics that see patients for ringing in the ears face their own claim questions, such as cure and silence wording and how to describe sound generators. Our guide to tinnitus clinic marketing covers them.

Marketing to people with hearing loss

Your audience is more likely than most to rely on captions and text. Caption every video, publish transcripts for audio, and give people ways to contact you other than the phone, such as a booking form or text. The WCAG success criteria behind this are covered in our guide to website accessibility for medical practices.

Local search matters too: keep your Google Business Profile categories and services accurate, including which device categories and services you offer. See Google Business Profile for doctors.

How we help

We build audiology and hearing practice websites with clear device categories, accessible video and contact options, and claims checked against the rules above. We do not give legal advice. See our medical lead generation and healthcare SEO services, or the full list in our healthcare marketing rules guide.

Frequently asked questions

Sources

• 21 CFR 800.30: Over-the-counter hearing aid controls
• Federal Register: Establishing Over-the-Counter Hearing Aids (final rule, August 17, 2022, effective October 17, 2022)
• FDA: OTC Hearing Aids, What You Should Know
• FDA: Hearing Aids
• FTC: Health Products Compliance Guidance (December 2022)
• 16 CFR 251.1: Guide concerning use of the word “free”
• 16 CFR 255.2: Consumer endorsements
• Medicare.gov: Hearing aids coverage

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