State Laws and Hearing Aid Sales: Home Field Advantage or House of Cards? Federal Preemption, Disruptive Innovation, and Implications for Audiology Practices



Notice to Readers: The information provided in this issue brief is for informational purposes. Content and related materials do not, and are not intended to, constitute legal advice. Readers should contact their attorney to obtain advice with respect to any legal matter. No reader should act or refrain from acting on the basis of information provided without first seeking legal advice from counsel in the relevant jurisdiction. Only your individual attorney can provide assurances that the information contained herein and your interpretation of it is applicable or appropriate to your specific situation.
INTRODUCTION
State laws dictate who can practice audiology, what services licensed audiologists can perform, and where, when, and how audiology services may or must be delivered. However, when it comes to the sale of hearing aids, federal laws generally supersede state statutes and regulations. Conflicting laws cause confusion and create a conundrum for practicing audiologists, especially when conditions are new, uncertain, or controversial.

Initiative to Repeal Florida Hearing Aid Laws Causes National Controversy, Warrants Further Inquiry
A controversial 2021 Florida legislative proposal, if enacted, will dismantle state-mandated minimum testing requirements and fitting procedures tied to the sale of hearing aids to adult consumers, repeal Florida’s ban on mail order hearing aid sales, and introduce a medical examination requirement that could be waived by adult consumers for religious or personal reasons. The proposed statutory changes, shepherded by a private equity firm on behalf o f its start-up remote hearing care venture, have received significant public opposition from incumbent firms, providers, and legacy networks that rely heavily on traditional delivery channels. The legislation was introduced in the Florida Senate as Committee Amendments 302884 and 286824 to Senate Bill SB 700, Telehealth, by Senators Ana Maria Rodriguez and Aaron Bean respectively, in February 2021.1

The internal policy analysis, conducted by the Academy of Doctors of Audiology (ADA) concluded that the proposed amendments to SB700 align with U.S. Food & Drug Administration (FDA) regulations covering professional and patient labeling and conditions for sale of hearing aids, raising questions about the validity of requirements contained in the Florida statutes in light of conflicting federal regulations.2,3

Given the significance of t he legislative initiative to ADA members in Florida, the potential for broad applicability for other U.S. states and jurisdictions, and the complex nature of the legal issues involved, ADA sought a legal opinion from a licensed Florida attorney with relevant healthcare expertise. The legal opinion, drafted by Christine C. Whitney, Esq., along with subsequent research, uncovered several facts that are both important and urgent for audiology practice owners and dispensing audiologists to fully understand.4
LEGAL DETERMINATION: EXISTING FLORIDA STATUTES ARE NON-BINDING AND LIKELY UNENFORCEABLE
According to the Whitney determination, “any requirements for the fitting or selling of hearing aids that are different from, or in addition to, the federal Food and Drug Administration (FDA) requirements are subject to federal preemption. This means that if a Florida court is asked to enforce Florida regulations for the fitting or selling of hearing aids that add any requirements or contain different requirements not found in the FDA rules, the court could, and, in my view would, declare the Florida regulations to be federally preempted and unenforceable.”

Further, as currently written, many of the minimum testing and fitting procedures are conditional because they are followed by the phrase, “when indicated,” which leaves the decision about whether and when to perform them to the discretion of the professional. The full legal determination, ADA Florida Bill re Hearing aids and Audiologists SB 700 and two amendments proposed by the Committee on Health Policy, are available at audiologist.org.

MDA, FDA, Federal Preemption, and Hearing Aid Sales Requirements
As Whitney’s determination noted, the U.S. Constitution declares federal law as the supreme law of the land. The preemption doctrine prohibits state governments from interfering with the exercise of the federal government’s constitutional powers and from assuming any functions that are exclusively entrusted to the federal government.

The Medical Device Amendments (MDA) of 1976 established a three-class, risk-based classification system for all medical devices (including hearing aids) and provided the FDA with broad regulatory authority.5 The statute contained an express preemption in section 21 U.S.C. § 360k(a), clearly prohibiting states from establishing any requirement “different from, or in addition to” a federal requirement that relates “to the safety or effectiveness” of a medical device.5,6

The law also outlined a mechanism and process for states to formally request exemptions from federal preemption, where state laws were more restrictive, but could be justified by public interest or protection. The FDA has addressed federal preemption exemption requests by 22 states over the past 42 years. The vast majority of FDA decisions regarding state preemption exemption requests were published on Friday, October 10, 1980.6 Most preemption requests were denied. View the ADA Compendium of State Preemption Requests and FDA Decisions in the table located at the bottom of this page.



The FDA Does Not Prohibit the Sale of Direct-To- Consumer Hearing Aids
The FDA does not prohibit the sale of direct-to-consumer (DTC) hearing aids, nor has any state been granted an exemption authorizing it to prohibit the sale of hearing aids through the mail or over the internet. Hearing aids are not designated by the FDA as prescription devices. Specifically:

  • Prescription devices, bear the label Rx only and are defined as, “A device which, because of any potentiality for harmful effect, or the method of its use, or the collateral measures necessary to its use is not safe except under the supervision of a practitioner licensed by law to direct the use of such device, and hence for which “adequate directions for use” cannot be prepared”8
  • Hearing aids are classified as restricted devices—and are only restricted by the conditions for sale and labeling requirements.3,4 Consumer information, published by the FDA on its website states, “Buy your hearing aid either direct-to-consumer, or from a licensed hearing healthcare professional (audiologist, a hearing aid dispenser, or an ear, nose, and throat physician).”9

The FDA Denied Requests for State Preemption Exemptions Requiring Medical or Audiologic Evaluations for Adults
The FDA has repeatedly denied federal preemption exemption requests from states seeking to mandate an audiologic evaluation for adult consumers prior to the purchase of a hearing aid and those seeking to prohibit adult consumers from waiving a medical evaluation for religious or personal reasons.10 The agency has provided the following rationales:

  • Regarding mandatory audiologic evaluation requirements for adults: “After reviewing the conflicting information in the public record regarding the predictive value of audiological testing in determining whether a patient would benefit from a hearing aid, FDA has concluded that audiological evaluation is not necessary to provide reasonable assurance of the safety or effectiveness of hearing aids. There is no evidence that audiological evaluation reduces or eliminates any risk to health presented by a hearing aid.”
  • Regarding the medical evaluation waiver for adult consumers: “The agency believes that examination by a physician is necessary to ensure that the organic causes of hearing loss are diagnosed and treated properly. The agency also believes, however, that any informed adult who objects to medical evaluation for religious or personal reasons should be permitted to waive the requirement.”

While the FDA has universally denied exemption requests for states imposing additional examination requirements on the sale of hearing aids to adult consumers, the FDA has consistently granted exemption requests from states imposing stricter audiologic and medical examination requirements for children under 18 years of age than federal law requires.10

The FDA has also granted exemption requests for states requiring additional written disclosures be provided to consumers purchasing hearing aids. The last FDA exemption determination occurred in 1988.7

Medical Evaluation and Waiver: Not Enforced but Not Repealed
In December 2016, the FDA issued updated guidance for conditions for sale for air-conduction hearing aids, stating, “FDA does not intend to enforce the medical evaluation (21 CFR 801.421(a)) or recordkeeping (21 CFR 801.421(d)) requirements prior to the dispensing of certain hearing aid devices to individuals 18 years of age and older.”11 The FDA has not issued a proposed rule repealing the regulation. Therefore, state laws with similar medical evaluation mandates are likely not vulnerable to federal preemption at this time. The FDA could elect to begin enforcing the rule again at any time. ADA speculates that the medical evaluation and waiver requirement was added as part of the proposed amendment to Florida’s SB 700 precisely to avoid a conflict with existing FDA regulations.

Applicability of Whitney Opinion to Hearing Aid Sales Laws in Other States
Regardless of whether SB700 and its proposed amendments make their way successfully through the Florida legislature and into law, or existing Florida statutes are tested through the courts, the legal precedents outlined in the Whitney determination are broadly applicable to all U.S. states, territories, and the District of Columbia – and have implications for audiologists practicing nationwide. Courts have consistently held that federal hearing aid sales regulations preempt state laws that mandate minimum testing or fitting requirements for adults and state laws that prohibit internet or mail order sales.4
IMPLICATIONS OF WHITNEY DETERMINATION FOR STATES, AUDIOLOGISTS, AND AUDIOLOGY PRACTICES
The Whitney determination confirms concerns that many state audiology licensing boards and audiologists have been operating under a false set of assumptions about the validity and enforceability of their state laws related to the sale of hearing aids.

An Opportunity to Enhance Enforceability, Transparency, Access, Equity, Flexibility, and Competition
Exposing federal preemption vulnerabilities should prompt states to do the following:

  • Align state laws with federal requirements,
  • Apply state laws equitably for audiologists and other hearing aid dispensers,
  • Increase transparency regarding available consumer protections, and
  • Fortify existing laws by seeking exemption from federal preemption in areas where it is likely to be granted, such as for state hearing aid dispensing laws that have consumer disclosure requirements and/or that require audiologic evaluations for children which are “different from” or “in addition to” FDA mandates, but where the FDA has previously granted similar exemptions.

State and federal laws do not mandate the actions that an adult consumer must take to purchase hearing aids. They only mandate the actions that manufacturers, distributors, and dispensers must take to sell them. Audiologists practicing in states where hearing aid sales laws go beyond the federal requirements are quite literally playing by a different, more difficult set of rules than their competitors. Upstart firms, organized to sell DTC hearing aids and associated services, are keenly aware of the doctrine of federal preemption and are exploiting state law vulnerabilities in Florida and elsewhere.12,13 So too are incumbent manufacturers and networks, some of whom already offer products for distribution through DTC and hybrid channels.

Removing antiquated (and likely unenforceable) state laws that prescribe minimum testing and treatment procedures beyond the FDA mandates will help level the playing field for audiologists and will not prohibit audiologists from performing those tests and treatments when they are indicated. It will simply authorize audiologists to employ their training and clinical judgment to evaluate each patient and each situation independently, and to deliver the course of treatment that is most appropriate, under a given set of circumstances. Had the federal preemption doctrine and its implications for state laws been brought to light sooner, audiologists may have been able to deliver more essential, clinically appropriate services during the height of the COVID-19 pandemic when practices were shuttered, and patients were isolated.

Audiologists, unlike online out-of-state dispensers, are already bound by extensive state-imposed ethical, legal, and educational requirements to obtain and maintain a license to practice audiology. They are also accountable for medical errors as measured against the reasonable standard of care. Taking the clinical decision-making process out of the hands of the state and putting it into the hands of licensed audiologists is prudent, responsible, and pro-competitive.

OTC Hearing Aid Act—Clarity or Confusion?
The Over-the-Counter Hearing Aid Act, signed into law in 2017, directs the FDA to make certain hearing aids available for sale over-the-counter (OTC) to consumers with a perceived mild-to-moderate hearing loss. The law contains an express federal preemption superseding state laws requiring the “supervision, prescription, or other order, involvement, or intervention of a licensed person.”14

Designed to provide consumers with greater access, affordability, and choice when purchasing hearing aids, passage of the OTC Hearing Aid Act may have inadvertently reinforced misconceptions about the enforceability of current state laws related to the sale of hearing aids, by implying that provider involvement is required for the purchase of traditional hearing aids. The FDA has not released proposed regulations for OTC hearing aids, missing the Congressionally-mandated August 2020 deadline. The timing of the release of proposed regulations remains uncertain, as does their potential impact on current regulations. In the meantime, DTC disruptors are already filling the void.

DTC Disruptors May Redistribute Power Centers Ahead of OTC
The hearing industry has long been characterized by high consumer costs, inadequate access to services across populations, incremental technological advances, significant barriers to entry for new competitors, high variability in perceived quality, and slow industry growth. Over the past decade, industry consolidation, together with intensified vertical integration between manufacturers, distributors, third-party administrators, and affiliated clinics has deepened power imbalances and blurred the lines between the sale of a device and the practice of audiology.

Corporations have been selling hearing aids directly to consumers (legally) for more than 50 years.15 A staff report released by the Federal Trade Commission’s Consumer Protection Bureau, in 1978 states:

“Lloyd’s has sold over 100,000 hearing aids by mail in the 15 years since its founding, at prices up to 50% less than the prices charged by traditional sellers for comparable aids, and has for over 10 years allowed its customers a completely free trial of their hearing aids (TR6556). Hearing aids are manufactured according to Lloyd’s specifications and sold under the Lloyd brand name (TR6576). Since Lloyd’s sells by mail, it obviously does not test the hearing of its customers although it sometimes receives their audiograms (TR 6577– 78).”15

Early DTC efforts were largely ignored and often discredited by incumbent firms. Most manufacturers were unwilling to distribute products through DTC channels. Substitute products were not readily available and consumer reach was limited by high advertising costs and the association between mail order and low-quality products. Disruptive innovations require technological or business model advantages that can be sustained upmarket. While the hearing industry has been ripe for disruption for many years, suitable disruptors did not emerge until very recently.

Advances in technology and changing consumer attitudes shifted the DTC hearing aid paradigm and attracted relevant innovators. Today, respected companies such as United Healthcare (UHC) are dispensing DTC hearing aids supplied by well-known hearing aid manufacturers and delivering hearing healthcare services using virtual, hybrid, and physical models, customized to patient preferences.16 These models are becoming readily normalized and widely adopted. Legacy firms, big retailers, and reputable start-ups are entering the virtual and hybrid hearing care space, armed with big data and big plans to democratize healthcare delivery.

Will industry disrupters upend predicted OTC implementation and impact – and if so, could it result in greater benefits for audiologists and consumers? That remains to be seen, but audiologists should act now to prepare for the future.
RECOMMENDATIONS FOR AUDIOLOGISTS: POLICY, PREEMPTION, PATIENT CARE, AND PANDEMONIUM
New technologies and new applications of existing technologies have aligned with new markets. Quality care cannot be sustained by the execution of a one-size-fits-all set of processes, and excellence will not be defined merely by the presence of a physical location. Consumer demand for alternative hearing healthcare models is accelerating. Audiologists can use the information contained in the Whitney determination to transform audio-vestibular care and improve the lives of the patients they serve using the following recommendations:

  1. Audiologists should seek a legal opinion to determine if their state audiology statutes and regulations “are different from, or in addition to” federal requirements for the sale of hearing aids or are otherwise vulnerable to federal preemptions that may impact the practice of audiology. Audiologists may be able to combine resources and obtain a single determination applicable to practices throughout the state by working through their state audiology association.
  2. Audiologists should petition their state to seek preemption exemptions to fortify state laws that require audiologic evaluations for children and that require disclosures to consumers that are more expansive than federal regulations.
  3. Audiologists should petition their state government to eliminate laws that are vulnerable to federal preemption when the FDA has consistently denied similar state requests for exemptions. Doing so will promote transparency, consumer choice, patient access, and provider flexibility.
  4. Audiologists should assert their professional sovereignty and advocate to prevent industry interests from interfering in the clinical practice of audiology. It is inappropriate for medical device manufacturers, distributors, and representative trade groups to lobby the government to impose minimum procedure requirements on licensed providers as a condition for sale of non-prescription medical devices, particularly when many of those same industry stakeholders are themselves selling or allowing the sale of the same devices through other channels without such requirements.
  5. Audiologists should redesign their services to meet the needs of current patients and unserved markets. Audiologists should seek upmarket opportunities that maximize the value of their doctoral education and training. Activities and services that can be delivered effectively by less qualified staff, should be. Services can be differentiated by cost, access, quality, and quantity:

    • Cost-based services (standardized processes, highvolume).
    • Access-based services (hours of operation, geography/ telehealth, technology).
    • Quality-based services (complex, comprehensive).
    • Quantity-based services (depth, breadth, scarcity/ unique).
  6. Audiologists should decouple clinical services from devices. The hearing aid is a commodity and can be readily substituted. There is no equal substitute for audiologists who provide professional, unique, accessible, and valuable services.
  7. Audiologists should contact hearing aid manufacturer and network suppliers and request their DTC distribution policy in writing. It is important for audiologists to have a clear understanding of supplier protocols for segment and channel-level distribution policies that impact audiology practices, particularly in such a tightly regulated, highly consolidated industry, where suppliers sometimes compete with downstream customers.
  8. Audiologists should adopt the ADA practice accreditation standards in their clinics to signify their commitment to deliver exceptional, patient-centered care. The most effective way to differentiate the profession of audiology from available substitutes for the sale, dispensing, and fitting of a hearing aid is by consistency in the delivery of high-quality hearing and balance services that improve the health and quality of life for all patients served.
CONCLUSION
Existing Florida statutes, banning hearing aid sales through the mail and mandating testing requirements and fitting procedures, are likely vulnerable to federal preemption and, thus, unenforceable. The legal determination, obtained by ADA, has applicability to other state and territorial jurisdictions and broad-reaching implications for audiologists practicing throughout the United States. Audiologists and audiology practice owners, empowered with this knowledge, should seek legal advice, specific to their state and situation, which can be used to inform clinical and business decisions and advocacy initiatives that benefit and protect their patients, practices, and the public.    



ADA Compendium of State Preemption Requests and FDA Decisions
Exemption Request Description Under 21 CFR 808 Data States Requesting FDA Exemption Decision Rationale
State laws that require the disclosure of certain information to hearing aid purchasers that goes beyond what FDA requires (for example, whether a hearing aid is refurbished, new, used). October 10, 1980 Massachusetts, New York, Ohio, Oregon, Texas, Washington, California, Maine, District of Columbia Granted These requirements are more stringent than the Federal requirements. However, FDA believes that the additional information required by these State provisions may be useful to the consumer and will not impose a significant burden on the hearing aid dispenser or manufacturer. Therefore, FDA is granting exemption from preemption for these requirements. To ensure uniformity, the agency is requiring that the States apply the Federal definition of "used hearing aid" (21 CFR 801.420(a)(6)] in enforcing their disclosure requirements.
State laws that require hearing aid dispensers to advise prospective purchasers in writing to consult with a physician if any of eight specified medical conditions are found to exist. October 10, 1980, September 13, 1988 Connecticut, New Jersey, Washington, West Virginia Granted These requirements are more stringent than the FDA regulation because they require the dispenser to advise the prospective purchaser in writing. This requirement places only a slight additional burden on the dispenser and does not conflict with the FDA requirement- Therefore, the agency is exempting these requirements from preemption. FDA's requirements with respect to medical evaluation and waiver still apply in these states.
State law requires that the sales receipt contain a statement that State law requires a medical examination and a hearing test evaluation before the sale of a hearing aid (for adults). October 10, 1980 Massachusetts Denied Informed adults are not required to undergo medical exam or hearing test evaluation.
State laws that prohibit advertising of any drug or device represented to have an effect on disorders of the ear. October 10, 1980 California Denied The law prohibits not only false and misleading advertising but also truthful representations that hearing aids have an effect on hearing loss. This puts a burden on interstate commerce.
State laws that require a hearing test evaluation for persons 18 years of age or older. October 10, 1980, August 14, 1985 Massachusetts, West Virginia, Rhode Island, Hawaii Denied FDA believes that an informed adult should be permitted to waive a medical evaluation.
States laws that prohibit a waiver of medical evaluation for persons over 18 years of age, when certain medical conditions are observed in or disclosed by the prospective purchaser. October 10, 1980 Florida, Pennsylvania, Maine, Nebraska, Minnesota Denied FDA believes that an informed adult should be permitted to waive a medical evaluation even if one of these conditions is present. The existence of such a condition does not necessarily mean that the individual could not safely benefit from using a hearing aid.
State laws prohibiting the sale of a hearing aid unless the purchaser has been examined by a licensed physician and has received an audiological evaluation within the past 90 days. October 10, 1980 Kentucky, New York, Pennsylvania, District of Columbia Denied FDA requires medical evaluation within six months of hearing aid purchase (waiver permitted). Audiological evaluation should not be required, even if a waiver is permitted, because it has not been shown that evaluation by an audiologist is necessary to ensure the safety or effectiveness of hearing aids. Requirement may erect an unnecessary barrier to the purchase of a hearing aid by leading people to believe that audiological evaluation is as important as medical evaluation.
State laws permitting the parent or guardian of a child under 18 years of age to waive the medical evaluation requirement October 10, 1980 Arizona, Ohio, Oregon, Washington, Mississippi, Texas Denied The laws are less stringent than the FDA regulations and permit the sale of hearing aids to children without a medical evaluation by a licensed physician.
State laws that allow the mandated evaluation for persons younger than 18 years of age to be performed by an audiologist. October 10, 1980 Maine, Minnesota, New York, District of Columbia Denied These laws are less stringent than the FDA regulations because they permit the sale of a hearing aid to children on the recommendation of an audiologist, without a medical evaluation by a licensed physician.
State laws requiring children under 18 years of age to undergo physical exam by an otolaryngologist or a physician and an audiologist; requirements that are more comprehensive than those prescribed by FDA. October 10, 1980, July 29, 1985 California, Connecticut, District of Columbia, Massachusetts, Nebraska, New Jersey, New Mexico, Washington, Hawaii Granted Comments from physicians, audiologists, and hearing aid dealers supported FDA's proposal to exempt from preemption State requirements of audiological evaluation for children. Audiologists are specially qualified to assist in the language development and educational and social growth of a child with hearing loss. Consequently, mandatory audiological or otologic evaluation of a minor will serve an important public health purpose.
State law provisions that require that a prospective hearing aid user with a significant air bone gap or apparent unilateral sensorineural hearing loss receive an audiological evaluation, although they permit a waiver of this requirement October 10, 1980 Arizona Denied Such a requirement places audiological evaluation on a par with medical evaluation and that this is inconsistent with the position of FDA. An audiological evaluation is not necessary to provide reasonable assurance of the safety or effectiveness of hearing aids.
State law requiring that hearing examination be conducted in an environment that meets or exceeds the American National Standards Criteria for Background Noise in Audiometer Rooms (A.N.S.I. S3.1- 1971). October 10, 1980 New Jersey Denied The requirement that the testing be conducted in an environment that meets the A.N.S.I. standard is unnecessarily restrictive because it has not been shown that such an environment is necessary for proper testing.
State laws requiring that the physician's written recommendation and any signed waiver statements be kept on file for 7 years. October 10, 1980 Pennsylvania, West Virginia Granted FDA is also granting exemption from preemption for section 507(2), which requires that the physician's written recommendation and any signed waiver statements be kept on file for 7 years.
REFERENCES
  1. Florida Senate Committee Amendments 302884 and 286824 to Senate Bill SB 700, Telehealth. Senators Ana Maria Rodriguez and Aaron Bean. February 17, 2021. Accessed at the following link on March 30, 2021: https://www.flsenate.gov/Session/Bill/2021/700/ Amendment/286824/PDF.
  2. U.S. Electronic Code of Federal Regulations. §801.420 Hearing aid devices; professional and patient labeling. Accessed at the following link on March 30, 2021: https://www.ecfr.gov/cgi-bin/text-idx?SID=7724f1faaac6653e9e00f61929b4e683&mc=true&node=se21.8.80 1_1420&rgn=div8
  3. U.S. Electronic Code of Federal Regulations. Title 21 Food and Drugs. Chapter I, Subchapter H, Medical Devices. §801.421 Hearing aid devices; conditions for sale. Accessed at the following link on March 30, 2021: https://www.ecfr.gov/cgi-bin/retrieveECFR? gp=&SID=535f7db19565c53a5a22bf247b060799&mc =true&n=pt21.8.801& r=PART&ty=HTML #se21.8.801_1421.
  4. Whitney, Christine C. ADA Florida Bill re Hearing aids and Audiologists SB 700 and two amendments proposed by the Committee on Health Policy. March 11, 2021.
  5. The Medical Device Amendments of 1976. Amending the Food, Drug, and Cosmetic Act. 21 USC 301. Public Law 94-295. 94th Congress of the United States. Accessed on March 31, 2021 at the following location. https://www.govinfo.gov/content/pkg/STATUTE-90/pdf/ STATUTE-90-Pg539.pdf.
  6. U.S. Electronic Code of Federal Regulations. Title 21 Food and Drugs. Chapter I, Subchapter H, Medical Devices. Part 808, Exemptions from Federal Preemption of State and Local Medical Device Requirements. Accessed on March 30, 2021 at the following location: https:// www.ecfr.gov/cgi-bin/textidx?SID=b17a4c900e361186d53aff4a2da2884c&mc=true&tpl=/ecfrbrowse/Title21/21cfr808_main_02.tpl.
  7. ADA Compendium of State Preemption Requests and FDA Decisions.
  8. U.S. Electronic Code of Federal Regulations. Title 21 Food and Drugs. Chapter I, Subchapter H, Medical Devices. Part 801, Labeling. Subpart D Exemptions from Adequate Directions for Use. §801.109 Prescription devices. Accessed on March 30, 2021 at the following location: https://www.ecfr.gov/cgi-bin/text-idx?SID=9a35c54910c1d9d847fe9c5d5aaca76d&mc=true&node=se21.8.801_1109&rgn=d iv8.
  9. U.S. Food & Drug Administration website. Consumer Checklist. Accessed on March 31, 2021 at the following location: https://www. fda.gov/medical-devices/hearing-aids/recommended-checklist.
  10. Federal Register. Volume 45. No. 199. Page 67329. October 10, 1980.
  11. U.S. Food & Drug Administration. Center for Devices and Radiological Health. Immediately in Effect Guidance Document: Conditions for Sale for Air-Conduction Hearing Aids. Docket Number FDA-2016-D-3466. December 2016. Accessed on March 30, 2021 at the following location: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/immediately-effect-guidancedocument- conditions-sale-air-conduction-hearing-aids.
  12. Carr Kate, Dobyan Bridget, Powers Thomas. OTC and the Changing Landscape of Hearing Healthcare. Presentation for the Washington Hearing Society. March 11, 2021. Accessed on March 31, 2021 at the following location: http://washingtonhearing.org/wp-content/ uploads/Course-01_OTC-and-The-Changing-Landscape-of-Hearing-Healthcare.pdf.
  13. Eargo, Inc. Securities and Exchange Commission. Form S-1: Registration Statement under the Securities Act of 1933. Accessed on March 31, 2021 at the following location: https://www.sec.gov/Archives/edgar/data/1719395/000119312520254743/d808052ds1.htm.
  14. Congress.gov website. SB 670. The Over-the-Counter Hearing Aid Act. 115th Congress. Accessed on March 30, 2021 at the following location: https://www.congress.gov/bill/115th-congress/senate-bill/670.
  15. Federal Trade Commission. Bureau of Consumer Protection. Appendices C-F of the Hearing Aid Staff Report Final Report to the Federal Trade Commission and Proposed Trade Regulation Rule. September 1978. Accessed on March 31, 2021 at the following location: https://books.googleusercontent.com/books/content?req=AKW5Qadltqgr8Zd5d6igun-HyE2M7HkEHy9BP5AUYamTfi7h9Td5_ OCfVbIvjXZTr9Btp8Zi7qcgXAewOS7poG3jQnUA_v9LiedBkRgl_jDIEUkSdVWb3VuRLs7Fd2LeJj58prGnNkz-ceJq10GK39MCuDYYfD cSHkUM8dN6u6aAddG8iieMm4w_k6f9d3uj5JY5_s3zQYdomAq8rhw0ZZLN_pbAigbXwR2ba07nSr0Gb_ssDmQzl5UL_A2T1O8OHWJPqrd97TFGUY4auce6F9HLDZTomcdpA.
  16. United Healthcare Newsroom. Virtual care program helps members access hearing treatment from the comfort of their home. Accessed on March 31, 2021 at the following location: https://newsroom.uhc.com/experience/virtual-hearing-care-tips.html.