History of Hearing Aids: The Federal Record, 1965 to 2022

1965: Medicare's law leaves hearing aids out

Medicare was created by Public Law 89-97, the Social Security Amendments of 1965, approved July 30, 1965. The law added § 1862(a)(7) to the Social Security Act, which excludes expenses "for routine physical checkups, eyeglasses or eye examinations for the purpose of prescribing, fitting, or changing eyeglasses, hearing aids or examinations therefor, or immunizations".

Hearing aids were left out of Medicare from the first day, in the same clause as eyeglasses. Our page on whether Medicare covers hearing aids explains what the different Medicare plans pay today.

1973 to 1976: three sets of Senate hearings

The FDA rule of 1977 lists the Senate hearings that came before it:

• September 10, 1973. "Hearing Aids and the Older American", hearings before the Subcommittee on Consumer Interests of the Elderly of the Senate Special Committee on Aging.
• May 1975. A Senate Small Business subcommittee chaired by Senator Thomas J. McIntyre held hearings on economic problems in the hearing aid industry, from competition and prices to advertising and government purchasing.
• April 1976. The Senate Permanent Subcommittee on Investigations, chaired by Senator Charles H. Percy, held hearings on the hearing aid industry.

Closing the 1976 hearings, Senator Percy said that "Twenty million hearing-impaired Americans are being denied top-flight treatment by a delivery system that simply is not working", in the words FDA quoted. He recommended that FDA restrict hearing aid sales to people who had been through a medical evaluation.

1975: the FTC's proposed rule, in 1975 dollars

On June 24, 1975 (40 FR 26646), the Federal Trade Commission published the initial notice of a proposed trade regulation rule for the hearing aid industry. Its core was a right for buyers, with some exceptions, to cancel a purchase for any reason within 30 calendar days.

The proposal also capped what a seller could keep when a buyer cancelled. The amounts are in 1975 dollars, shown here with no inflation adjustment:

• First option: the cancellation charge for 30 days of rental could not exceed $15 plus .5 percent of the purchase price, custom ear mold and batteries aside.
• Second option: it could not exceed $30 per cancelled hearing aid or 10 percent of the purchase price, whichever was lower, with the $30 cap adjusted each year by the Consumer Price Index.

The notice asked whether the new right should replace the FTC's Door-to-Door Sales Rule, in effect since June 7, 1974, which let a buyer cancel a door-to-door sale of $25.00 or more until midnight of the third business day after the sale.

1977: the FDA's medical evaluation rule

FDA published its hearing aid rule in the Federal Register of February 15, 1977. Along with labeling rules, it restricted "the sale of a hearing aid to those patients who have undergone medical evaluation within the past 6 months". Informed adults 18 years of age or older could waive the evaluation for personal or religious beliefs. The rule took effect August 15, 1977.

Cost came up in the comments: opponents said the requirement "would add an unnecessary cost to the already high cost of a hearing aid". FDA answered that it did not expect the evaluation to add much to that cost. The 1977 labeling rule also brought the serial number: FDA wrote in 2022 that manufacturers have been marking it on the device itself since 1977.

2017 to 2022: OTC hearing aids end the 1977 sale conditions

Congress reopened the 1977 framework with the FDA Reauthorization Act of 2017. Its § 709 directed FDA to "promulgate proposed regulations to establish a category of over-the-counter hearing aids".

FDA's final rule took effect October 17, 2022. It created the over-the-counter category and repealed the conditions for sale applicable to hearing aids, which ended the medical evaluation requirement and its waiver. Our OTC hearing aids page covers how those devices are sold now, and our hearing aid brands page covers the makers.