FDA Creates Over-the-Counter Hearing Aids for Adults With Mild to Moderate Hearing Loss (2022)

Table of Contents

1. What the FDA Did on August 17, 2022
2. Who Can Buy an OTC Hearing Aid
3. What Counts as an OTC Hearing Aid
4. What the Box Has to Say
5. Hearing Aids Versus Sound Amplifiers
6. The October 2022 Letter to State Officials
7. The Numbers the FDA Gave
8. What the Rule Does Not Do
9. Dates and Legal Status as of October 18, 2026
10. How It Fits Other FDA Nonprescription Actions
11. Primary Documents
12. Key Research Papers
13. Connections
14. Featured Videos

1. What the FDA Did on August 17, 2022

The FDA published the final rule “Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the-Counter Hearing Aids” in the Federal Register, the U.S. government’s daily publication of rules and official notices, on August 17, 2022 (87 FR 50698, Docket No. FDA-2021-N-0555). The rule runs 65 pages and amends four parts of the FDA’s regulations (21 CFR parts 800, 801, 808 and 874). The government’s regulatory agenda lists it as “Economically Significant.”

The rule’s summary says the FDA is “establishing a regulatory category for over-the-counter (OTC) hearing aids” and making related changes to the way hearing aids are regulated. In its own words, the rule does five things:

• defines OTC hearing aids and sets the requirements that apply to them;
• amends existing rules so they are consistent with the new OTC category;
• repeals the “conditions for sale” that had applied to hearing aids;
• amends the existing labeling requirements for hearing aids;
• updates the rules on state applications for exemption from federal preemption that become obsolete once the hearing-aid requirements change.

The stated aim is to provide “reasonable assurance of safety and effectiveness for these devices as well as foster access to, and innovation in, hearing aid technology, thereby protecting and promoting the public health.” Federal preemption means that a federal requirement takes the place of a different state requirement on the same subject; the old exemption decisions let certain state hearing-aid rules stand alongside the federal ones.

The rule took effect on October 17, 2022. It followed a proposed rule of the same title published on October 20, 2021 (86 FR 58150), on which public comments were accepted until January 18, 2022. A Federal Register docket is the public file for an action, where the documents and public comments are kept on regulations.gov.

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2. Who Can Buy an OTC Hearing Aid

The FDA consumer page “OTC Hearing Aids: What You Should Know” states that the new category is for “adults 18 years of age and older with perceived mild to moderate hearing loss.” Such a buyer, it says, can purchase an OTC hearing aid “in a store or online without seeing an ear-nose-throat (ENT) doctor, or a licensed hearing health care professional (audiologist).” “Perceived” means the buyer’s own sense of the hearing loss; no hearing test is required.

The FDA’s Hearing Aids page sums up the conditions for sale of the new category in a comparison table:

• the purchaser must be 18 years or older;
• no medical exam;
• no prescription;
• no fitting by an audiologist;
• no need for a licensed seller.

The consumer page adds that OTC hearing aids can also be bought from a hearing health care professional (an audiologist or hearing aid dispenser), who can perform a hearing test and hearing aid evaluation, and that a person can request those evaluation records and buy the hearing aid elsewhere.

The FDA describes two limits. OTC hearing aids are “NOT for the treatment of severe or profound hearing loss,” because they “are limited in their maximum output and may not be adequate to treat more severe hearing losses”; for a suspected severe or profound loss, the page points to a licensed hearing health care professional. And people younger than 18 need prescription hearing aids; for them the FDA page refers to a doctor, preferably an ENT, because the condition “needs specialized care.”

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3. What Counts as an OTC Hearing Aid

The FDA consumer page defines a hearing aid as “a medical device that is intended to help with hearing loss and is worn behind or within the ear canal,” and states that the FDA regulates all hearing aids. According to the page, OTC hearing aids:

• are air-conduction hearing aids that do not require implantation or other surgery. They bring amplified sound into the ear canal; the sound then moves through the eardrum and the three tiny bones of the middle ear to the inner ear, where it is processed and sent to the brain;
• are intended for people 18 and older with perceived mild to moderate hearing loss;
• let users control the device settings and customize the device to their hearing needs “through tools, tests, or software”;
• may use wireless technology or include tests for self-assessment of hearing loss;
• are available “without the supervision, involvement, or prescription of a licensed health care professional.”

Within the category, the FDA page describes two kinds of device: “legacy” (traditional) and wireless hearing aids with basic features such as volume control and preset programs, and self-fitting hearing aids, with or without wireless features, that offer greater customization through hearing tests, software and smartphone apps.

The rule also redraws the line for every other hearing aid. In the FDA’s words, “A prescription hearing aid is any hearing aid that is not an OTC hearing aid.” Prescription hearing aids are available only through a licensed hearing health care professional, and, the page says, “may be appropriate for all levels of hearing loss and for all ages based on the indications for use.” The 2021 proposal had explained that the change “would more clearly define prescription hearing aids” but “would not change the classification of existing device types.”

The FDA’s economic analysis of the rule refers to OTC requirements “such as output limits”; the specific limits are set in the rule text, which is not reproduced here.

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4. What the Box Has to Say

The FDA consumer page states that the OTC hearing aid regulation “requires important information to be displayed on the outside package labeling for consumers to review before buying.” The required items are:

1. Warnings and information about hearing health, made up of:
   • a warning against use in people younger than 18;
   • symptoms that suggest perceived mild to moderate hearing loss — the FDA’s examples are trouble hearing speech in noisy places, finding it hard to follow speech in groups, trouble hearing on the phone, listening that makes a person tired, and needing to turn up the TV or radio so that other people complain it is too loud;
   • information on when professional help may be needed, for example not hearing speech even in a quiet room, or not hearing loud sounds such as music, power tools or engines well;
   • a “WARNING: When to See a Doctor” list of “red flag” conditions: an ear with a birth defect or unusual shape, or one injured or deformed in an accident; blood, pus or fluid coming from the ear in the past 6 months; ear pain or discomfort; a lot of ear wax or something possibly in the ear; strong dizziness or a spinning or swaying feeling (vertigo); hearing that changed suddenly in the past 6 months; hearing that gets worse and then better again; worse hearing in one ear; and ringing or buzzing in only one ear;
   • contact information where the full labeling, including the user instructional brochure, can be found online or requested on paper;
   • the manufacturer’s return policy, or a statement that there is none.
2. Whether the device is used or rebuilt.
3. The words “OTC” and “hearing aid” displayed prominently.
4. The type and number of batteries, and whether they are included.
5. Whether a mobile phone or remote-control device is needed to control the hearing aid.

The same page notes that claims such as “FDA Registered” or “FDA Certified” and the use of an FDA logo on OTC hearing-aid packaging “may be misleading,” and that “the FDA’s OTC hearing aid regulations do not require manufacturers to provide a warranty.”

For problems after purchase, the FDA page lists the agency’s MedWatch reporting form and the phone line 1-800-FDA-1088. The adverse events it gives as examples include skin irritation of the ear canal or outer ear, injury from the device (such as cuts, scratches or burns from an overheated battery), pieces of the device lodged in the ear canal, and a sudden increase in the severity of hearing loss during use.

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5. Hearing Aids Versus Sound Amplifiers

On the same day as the rule, the FDA announced a final guidance titled “Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products” (87 FR 50568, August 17, 2022, Docket No. FDA-2020-D-1380). A guidance document describes how the FDA reads and applies the law; it does not itself create new legal requirements.

The Federal Register notice says the guidance describes hearing aids, personal sound amplification products (PSAPs), their intended uses and the regulatory requirements that apply to each. It explains that the FDA Reauthorization Act of 2017 (FDARA) directed the FDA to update and finalize a draft of this guidance issued on November 7, 2013; the final guidance “fulfills this FDARA requirement” and supersedes the earlier version dated February 25, 2009.

The FDA’s Hearing Aids page draws the distinction plainly. Hearing aids are intended for people who have hearing loss. PSAPs are intended for consumers with normal hearing, to make sounds louder in certain settings, “such as during recreational activities like birdwatching or hunting.” PSAPs are electronic products regulated under the FDA’s Electronic Product Radiation Control Program, “but they are not medical devices like hearing aids.” The page’s table summarizes the three groups:

• OTC hearing aids: medical device and electronic product; people 18 and older with perceived mild to moderate hearing loss; sold without exam, prescription, fitting or licensed seller.
• Prescription hearing aids (any hearing aid that does not meet the OTC requirements): medical device and electronic product; people of any age, including under 18, with any degree of hearing loss, including severe; prescription needed, and in some states purchase from a licensed seller.
• PSAPs: electronic product only; people of any age with normal hearing; no applicable FDA conditions for sale.

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6. The October 2022 Letter to State Officials

On October 13, 2022, four days before the rule took effect, the director of the FDA’s Center for Devices and Radiological Health sent a “Dear State Official” letter because, it said, “there may be some confusion” about the final rule. The letter restates three technical changes the rule makes:

• it repeals the conditions for sale for hearing aids in 21 CFR § 801.421;
• it defines non-OTC hearing aids as prescription devices, subject to 21 CFR § 801.109, rather than as “restricted devices”;
• it adds updated labeling requirements for prescription hearing aids in a new 21 CFR § 801.422.

The letter then clarifies that the final rule:

• “Does not change the necessary qualifications of who may provide hearing healthcare with prescription hearing aids, including the recommendation, selection, fitting, and dispensing of these devices”;
• does not require an additional professional, and “does not in any way require a physician’s involvement prior to fitting these devices”;
• “Does not require an examination of any kind to obtain a prescription hearing aid.”

It explains that a state can authorize many kinds of practitioners to order a prescription device, that a licensed audiologist, for example, would not need to consult a physician under the rule, and that the document used to obtain a prescription hearing aid “need not be called a ‘prescription’ under State law.” Citing a 2016 National Academies of Sciences, Engineering, and Medicine report, the letter notes that “medically treatable causes of hearing loss are relatively rare,” while certain circumstances, such as the red-flag conditions in the required labeling, may warrant a physician’s involvement in individual cases. Its conclusion: the rule “does not, and is not intended to, create barriers to accessing hearing aids, including prescription devices.”

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7. The Numbers the FDA Gave

The FDA consumer page states that “Close to 30 million adults living in the U.S. have some degree of hearing loss,” and that “only about one-fifth of those who could benefit from a hearing aid seek intervention.” The page also states the FDA’s view that using hearing aids “may reduce the frequency or severity of cognitive decline, depression, and other health problems in adults,” with added benefits that “can include improved social participation and a better quality of life.” The research on hearing aids and cognitive decline is listed in the Key Research Papers below.

The FDA’s regulatory impact analysis, the economic assessment published with the rule, estimates:

• Consumer benefits of between $6 million and $147 million per year, with a mean of $63 million per year, in the form of cost savings for people with perceived mild to moderate hearing impairment who want lower-cost hearing aids “not bundled with professional services” but could not buy them before because of state regulations or because they do not shop online.
• Costs to manufacturers of between $1 million and $2 million per year (mean $1 million), for changing the labeling of existing hearing aids, reading the rule and revising internal procedures.
• Net benefits of between $5 million and $145 million per year, with a mean of $62 million.

The analysis also names effects it could not put a number on: some people who already bought hearing aids online might find that devices meeting the OTC requirements, such as the output limits, do not suit them and would then need prescription devices with professional input — a cost in services, set against the benefit of addressing health risks that professional care is meant to catch. Others might wait for a preferred model to become available as a prescription device or be redesigned to meet the OTC requirements.

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8. What the Rule Does Not Do

• It does not cover children. People younger than 18 need prescription hearing aids, and the OTC box must carry a warning against use under 18.
• It does not cover severe or profound hearing loss. OTC devices are limited in maximum output; more severe losses remain the territory of prescription hearing aids.
• It does not turn sound amplifiers into hearing aids. PSAPs remain electronic products for people with normal hearing, not medical devices.
• It does not require a warranty or set prices. The FDA page states the regulations do not require a warranty; the box must state the return policy, or that there is none.
• It does not change who may dispense prescription hearing aids. According to the October 2022 letter, the qualifications for providing prescription hearing aids are unchanged, no physician is required, and no examination of any kind is required to obtain one.
• It does not change the classification of existing device types, as the 2021 proposal stated.

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9. Dates and Legal Status as of October 18, 2026

• February 25, 2009: the earlier guidance on hearing aids and PSAPs is dated (superseded in 2022).
• November 7, 2013: the FDA issues a draft update of that guidance.
• October 20, 2021: the FDA publishes the proposed OTC hearing-aid rule (86 FR 58150); comments are due January 18, 2022.
• August 17, 2022: the final rule (87 FR 50698) and the final hearing-aid and PSAP guidance (87 FR 50568) are published.
• October 13, 2022: the FDA’s device center writes to state officials about access to prescription hearing aids.
• October 17, 2022: the rule takes effect, and OTC hearing aids can be sold.
• May 3, 2023: the FDA publishes its consumer page “OTC Hearing Aids: What You Should Know,” with information for before and after buying.

Status as of October 18, 2026: final and in effect since October 17, 2022. A check of the Federal Register through October 18, 2026 found no FDA document amending, delaying or withdrawing the OTC hearing-aid rule. The later FDA documents found that mention hearing aids are routine notices, such as information-collection notices under the Paperwork Reduction Act and updates to the list of recognized technical standards; none changes the rule.

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10. How It Fits Other FDA Nonprescription Actions

The OTC hearing-aid rule created a new category of medical device that adults can buy without a professional’s involvement. In the years that followed, the FDA took other steps that moved products from prescription-only to nonprescription sale, each reported on its own page:

• the first over-the-counter naloxone nasal spray (2023);
• the first nonprescription daily birth control pill (2023);
• the first over-the-counter continuous glucose monitor (2024).

Among the 2022 actions, the December 2022 emergency contraceptive label update also concerns a product sold without a prescription. The full list of the year’s actions is on the FDA Actions of 2022 hub.

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11. Primary Documents

1. Food and Drug Administration, HHS (2022). Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the-Counter Hearing Aids. Final rule. Federal Register 87 FR 50698, August 17, 2022; effective October 17, 2022. Docket No. FDA-2021-N-0555; RIN 0910-AI21 — FR Doc. 2022-17230
2. Food and Drug Administration, HHS (2022). Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products; Guidance for Industry and Food and Drug Administration Staff; Availability. Notification of availability. Federal Register 87 FR 50568, August 17, 2022. Docket No. FDA-2020-D-1380 — FR Doc. 2022-17231
3. Food and Drug Administration, HHS (2021). Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the-Counter Hearing Aids. Proposed rule. Federal Register 86 FR 58150, October 20, 2021. Docket No. FDA-2021-N-0555 — FR Doc. 2021-22473
4. U.S. Food and Drug Administration. OTC Hearing Aids: What You Should Know. Consumer page, content current as of May 3, 2023 — fda.gov OTC hearing aids page
5. U.S. Food and Drug Administration. Hearing Aids. Program page with the comparison of OTC hearing aids, prescription hearing aids and PSAPs, content current as of May 3, 2023 — fda.gov Hearing Aids page
6. U.S. Food and Drug Administration, Center for Devices and Radiological Health. Letter to State Officials about access to prescription hearing aids, October 13, 2022 — fda.gov letter (PDF)
7. U.S. Food and Drug Administration. Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the-Counter Hearing Aids (Final Rule): Regulatory Impact Analysis. Content current as of August 17, 2022 — fda.gov regulatory impact analysis
8. Public docket FDA-2021-N-0555 — regulations.gov FDA-2021-N-0555

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Key Research Papers

1. Goman AM, Lin FR (2016). Prevalence of Hearing Loss by Severity in the United States. American Journal of Public Health 106(10):1820-1822 — PubMed PMID: 27552261
2. Chien W, Lin FR (2012). Prevalence of hearing aid use among older adults in the United States. Archives of Internal Medicine 172(3):292-293 — PubMed PMID: 22332170
3. Humes LE, Rogers SE, Quigley TM, Main AK, Kinney DL, Herring C (2017). The Effects of Service-Delivery Model and Purchase Price on Hearing-Aid Outcomes in Older Adults: A Randomized Double-Blind Placebo-Controlled Clinical Trial. American Journal of Audiology 26(1):53-79 — PubMed PMID: 28252160
4. Sabin AT, Van Tasell DJ, Rabinowitz B, Dhar S (2020). Validation of a Self-Fitting Method for Over-the-Counter Hearing Aids. Trends in Hearing 24:2331216519900589 — PubMed PMID: 32003285
5. De Sousa KC, Manchaiah V, Moore DR, Graham MA, Swanepoel W (2023). Effectiveness of an Over-the-Counter Self-fitting Hearing Aid Compared With an Audiologist-Fitted Hearing Aid: A Randomized Clinical Trial. JAMA Otolaryngology–Head & Neck Surgery 149(6):522-530 — PubMed PMID: 37052929
6. De Sousa KC, Manchaiah V, Moore DR, Graham MA, Swanepoel W (2024). Long-Term Outcomes of Self-Fit vs Audiologist-Fit Hearing Aids. JAMA Otolaryngology–Head & Neck Surgery 150(9):765-771 — PubMed PMID: 38990557
7. Lin FR, Pike JR, Albert MS, Arnold M, Burgard S, Chisolm T, Couper D, Deal JA, Goman AM, Glynn NW, et al.; ACHIEVE Collaborative Research Group (2023). Hearing intervention versus health education control to reduce cognitive decline in older adults with hearing loss in the USA (ACHIEVE): a multicentre, randomised controlled trial. The Lancet 402(10404):786-797 — PubMed PMID: 37478886

The first two papers are U.S. estimates of how common hearing loss is, by severity, and how few older adults with hearing loss use hearing aids. The third is a randomized trial in older adults comparing hearing-aid service-delivery models and purchase prices. The fourth through sixth study self-fitting hearing aids of the kind the OTC category allows, including a randomized comparison with audiologist fitting and its long-term follow-up. The last is a multicentre randomized trial of a hearing intervention and cognitive decline in older adults with hearing loss, published after the rule.

PubMed Topic Searches

1. PubMed: over-the-counter hearing aids
2. PubMed: self-fitting hearing aids
3. PubMed: hearing aid use and cognitive decline

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Connections

• FDA Actions of 2022
• FDA and Regulation
• Hearing Aids
• Hearing Loss
• Tinnitus
• ENT (Ear, Nose & Throat)
• Dementia
• Emergency Contraceptive Label Update (2022)
• First Over-the-Counter Naloxone Nasal Spray (2023)
• First Nonprescription Daily Birth Control Pill (2023)
• First Over-the-Counter Continuous Glucose Monitor (2024)

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