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How to get more hearing aid patients: a plan for practices

A hand on a ringing desk phone at an audiology and ENT practice front desk

Prescription hearing aids, fitted by audiology and ENT practices, are mostly paid for by the patient, and since October 2022 adults can also buy over-the-counter (OTC) hearing aids in stores and online. How you describe the service shapes who books and what they expect. This guide is for practice owners, patient coordinators and front desk teams: what FDA, the National Institute on Deafness and Other Communication Disorders (NIDCD) and MedlinePlus say about prescription and OTC hearing aids, which claims to avoid, and how to turn requests into well-informed hearing evaluations.

  1. SearchAn adult looks for care near them.
  2. Your pageWhat you treat, who sees them, one way to book.
  3. Call or formThey call or send a request.
  4. Front deskBooks the visit and never guesses a cause.
  5. Clinical teamThe clinician decides the plan.
How a new patient request reaches your practice.

1. Know what prescription hearing aids are and are not

FDA’s page OTC Hearing Aids: What You Should Know explains that FDA created the OTC category for “adults 18 years of age and older with perceived mild to moderate hearing loss”. Under 21 CFR 800.30, an OTC hearing aid is sold “without the supervision, prescription, or other order, involvement, or intervention of a licensed person”. The same FDA page says “A prescription hearing aid is any hearing aid that is not an OTC hearing aid” and that “Prescription hearing aids are only available through a licensed hearing health care professional who can program the device to your unique level of hearing loss.” In short:

  • OTC hearing aids: adults 18 and older with perceived mild to moderate hearing loss, no medical exam, prescription or fitting by an audiologist needed. FDA says they are “NOT for the treatment of severe or profound hearing loss.”
  • Prescription hearing aids: FDA says these “may be appropriate for all levels of hearing loss and for all ages based on the indications for use.” People younger than 18 need a prescription.
  • Personal sound amplification products (PSAPs) are not hearing aids. FDA’s hearing aids page says they are “intended for consumers with normal hearing” and “are not medical devices like hearing aids”.

NIDCD’s OTC hearing aids page says OTC devices “are not meant for children or for adults who have more severe hearing loss or significant difficulty hearing.” It tells people who have trouble hearing conversations in quiet settings, or trouble hearing loud sounds, to consult a hearing health professional. MedlinePlus, on hearing aids, says “You may need prescription hearing aids or other devices if you have significant or complicated hearing loss.” Do not run down OTC hearing aids; explain the difference and offer an evaluation. FDA also notes practices can sell OTC hearing aids, and that patients “can request your hearing evaluation records from your hearing health care professional and may buy your hearing aid elsewhere.” Have a clear process for records requests.

FDA’s OTC page also says “The FDA regulates all hearing aids to ensure safety and effectiveness for consumers.” That is not the same as approval. Under 21 CFR 874.3300 a standard air-conduction hearing aid is “Class I (general controls)” and exempt from premarket notification, and wireless air-conduction hearing aids (874.3305) are Class II and also exempt. So do not say “FDA-approved” or “FDA-cleared” unless that model’s own FDA record says so (see FDA approved or FDA cleared?). FDA’s OTC page warns that statements such as “FDA Registered” and “FDA Certified”, or an FDA logo on OTC packaging, “may be misleading”. In the 2022 final rule, FDA wrote “FDA does not endorse particular devices and representations of such in labeling can be false or misleading.” Call the device what it is: a prescription hearing aid or an OTC hearing aid.

2. Keep claims in line with the risk and labeling information

FDA’s benefits and limitations page says “Hearing aids do NOT restore normal hearing” and “Hearing aids can amplify all sounds, including background noise, that you may not want to hear.” NIDCD’s hearing aids page says “A hearing aid will not restore your normal hearing.”

21 CFR 800.30 requires OTC hearing aid packages to show “Red flag” conditions. FDA’s OTC page shows that wording under “WARNING: When to See a Doctor”: “If you have any of the problems listed below, please see a doctor, preferably an ear-nose-throat doctor (an ENT).” This is FDA’s red flag list for OTC package labeling:

  • “Your ear has a birth defect or an unusual shape.”
  • “Your ear was injured or deformed in an accident.”
  • “You saw blood, pus, or fluid coming out of your ear in the past 6 months”
  • “Your ear feels painful or uncomfortable”
  • “You have a lot of ear wax, or you think something could be in your ear”
  • “You get really dizzy or have a feeling of spinning or swaying (called vertigo)”
  • “Your hearing changed suddenly in the past 6 months”
  • “Your hearing changes: it gets worse then gets better again”
  • “You have worse hearing in one ear”
  • “You hear ringing or buzzing in only one ear”

For prescription hearing aids, 21 CFR 801.422 requires red flag conditions on the outside package and, in the user brochure, “Red flag” conditions, addressed to dispensers. Ask your clinicians for the brochure of each model you fit, and keep staff wording to what it says. Do not invent a risk list or say a hearing aid has no side effects.

Avoid “invisible”, “restore normal hearing”, “hear like you used to”, “cure hearing loss”, “guaranteed results”, “FDA-approved”, “FDA Registered” and “FDA Certified”. NIDCD describes the smallest style as “nearly hidden in the ear canal”; style depends on the hearing loss, so do not promise one. Do not use a “free hearing test” as bait for a sale. Better: “the audiologist will test your hearing and explain which options fit your hearing loss and daily needs”.

3. Answer first-call questions honestly

  • How much does it cost? Give a clear starting price per hearing aid or per pair for each level you offer, say what it includes (evaluation, fitting, follow-up adjustment visits, warranty, trial period) and whether the hearing evaluation is billed separately. NIDCD suggests patients ask “What is the total cost of the hearing aid?”
  • Does insurance pay? Do not promise coverage. NIDCD says “Hearing aids are generally not covered by health insurance companies, although some do.” Coverage varies by plan, so the practice checks each patient’s plan and explains what the patient may owe. FDA notes a doctor can give a referral “if your health plan requires a doctor’s referral for services.”
  • Should I just buy OTC hearing aids? “OTC hearing aids are made for adults with perceived mild to moderate hearing loss. A hearing evaluation shows the type and amount of your hearing loss, and the audiologist will tell you which options fit.”
  • Who does the evaluation? Give the audiologist’s or physician’s name and real credentials. Let callers check them with the state licensing board.

Leave screening to the clinical team. Your intake form can ask which ear or ears, how long the hearing loss has been noticed, current or past hearing aids, past ear problems or surgery, and medicines. Pass any report of sudden or quickly worsening hearing loss, ear pain, drainage from the ear, dizziness or vertigo, or hearing loss or ringing in only one ear to the clinical team promptly. For these and other ear problems NIDCD tells people to “please see a licensed physician promptly”. The audiologist or physician decides whether someone is a candidate and which hearing aid fits. Front desk staff only collect the answers. Use the new patient phone script for the rest of the call, and book the hearing evaluation, not a hearing aid sale, while the caller is on the line.

4. Plan the evaluation, fitting and follow-up course

FDA’s How to Get Hearing Aids page says that in the audiological exam the professional “will assess your ability to hear sounds and understand others with and without hearing aids, and to select and fit the hearing aids to your communication needs.” A medical exam can rule out causes of hearing loss “such as infection, injury or deformity, ear wax in the ear canal, and, in rare cases, tumors.” FDA also says “The FDA does not require a medical examination or hearing test for prescription hearing aids, but your State may require you to visit an audiologist or other licensed professional first.” Check your state’s rules.

Ask your clinicians for written notes on the course you offer: the evaluation, the fitting visit, follow-up adjustment visits, and when the trial period ends. Share them with callers early, so patients know it is a course, not a single visit. FDA says “Hearing aids usually entail an adjustment period that may take several months.” NIDCD tells patients to “Work with your audiologist until you are comfortable and satisfied.”

FDA lists adverse events to report, including ear canal or outer ear skin irritation, injury from the device, pieces of the device lodged in the ear canal, or “sudden increased severity in hearing loss with device use.” Make sure front desk staff route those calls to the clinical team the same day. Care and use depend on the model; the clinician and the user brochure give exact instructions.

5. Price, finance and follow up

  • Self-pay patients may be entitled to a good faith estimate; see the good faith estimate guide.
  • Before purchase, give the trial and return terms in writing: how long the trial or adjustment period is, how to return the hearing aids, how much is refunded, and any fees that are not refunded. FDA tells buyers to check “If any fees are nonrefundable if you return the hearing aids after a trial or adjustment period.” 21 CFR 801.422 requires prescription hearing aid packages to include a “Note about device trial options”. State law may set its own trial or return rules.
  • Put the full price, what is included and the warranty (length, what it covers, whether repairs are included) in writing too. Under 21 CFR 801.422 a hearing aid counts as used “if a user has worn it for any period of time”, outside a bona fide evaluation, and a used aid must be declared as used, so do not resell returned aids as new.
  • If you advertise a discount or a no-charge service, follow advertising prices and specials and say exactly what is included and what costs extra. Avoid deadline pressure on a purchase decision.
  • If you offer financing, follow the patient financing guide.
  • Follow up after the evaluation without pressure; see consultation to treatment. Track hearing aid requests separately, by new or replacement and by one or two ears, from request to evaluation to fitting to the end of the trial period.

Where MediLeadGen fits

MediLeadGen sends practices requests from people interested in cash-pay elective treatments. Each request goes to one practice only, with the person’s consent naming that practice, at a fixed price per delivered request.

See how it works for practices

Questions practices ask

How do we get more hearing aid patients?

Answer requests quickly, give clear prices and what they include, put trial and return terms in writing, be honest about insurance, introduce the audiologist or physician by real credentials, and book a hearing evaluation where the clinician decides whether a hearing aid fits and which one.

Can we call our hearing aids FDA-approved?

Not unless the model’s own FDA record says so. FDA regulates all hearing aids, but standard and wireless air-conduction hearing aids are exempt from premarket notification, and FDA warns that “FDA Registered” and “FDA Certified” claims may be misleading. Call it a prescription or OTC hearing aid.

Should we tell callers that OTC hearing aids do not work?

No. FDA made OTC hearing aids for adults with perceived mild to moderate hearing loss. Explain the difference honestly and offer a hearing evaluation, so the audiologist can tell the caller whether an OTC or a prescription hearing aid fits their hearing loss.

Does insurance cover hearing aids?

Coverage varies by plan. Check each patient’s plan, give the patient’s share in writing as an estimate, and do not promise coverage in ads or on the phone.

General information for practice teams, not legal or clinical advice. Check device labeling, FDA requirements, state rules and your advertising with counsel and your clinicians. Last reviewed October 2026.

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