The FDA Regulation: 1977 Final Rule


By 1977, the momentum driving hearing aids into the medical device arena was unstoppable. On Feb. 15, 1977, the FDA published its Final Rule, which made hearing aids restricted devices, promulgated regulations governing professional and patient labeling, and set forth conditions for the sale of hearing aids.1

The detail and scope of the Final Rule was astonishing, if not always logical.2 A section was included which defined hearing aids, hearing aid dispensers, otolaryngologists, and Audiologists.  The logic of including Audiologists in the definitions was unclear because the Final Rule did not require an audiometric evaluation nor did it assign any special roles to Audiologists in the fitting of hearing aids.

The Final Rule had two other parts, components of which are condensed in Tables 1 and 2 to capture their comprehensive nature without going into pages of detail.

Table 1.  Section 801.420 of FDA Hearing Aid Final Rule
(exact wording requirements shown in italics)

Patient and Professional Labeling

  • Device model
  • serial number
  • date (year) of manufacture

User Instructional Brochure

  • Warnings (described below)
  • Technical data[3]
  • instructions for use, maintenance, and care
  • Accessories
  • New/Used condition of instrument
  • Repair locations
  • commonly occurring avoidable conditions that could damage the hearing aid
    • any known side effects associated with the use of a hearing aid that may warrant  consultation with a physician
 
Table 2.  Section 801.421 of FDA Hearing Aid Final Rule
(survey estimates of percentage of occurrence shown in parentheses)

Conditions for Sale

  • Medical evaluation/hearing aid candidacy within 6 months of hearing aid purchase (32% of the cases)[4]
  • Medical waiver if 18 years of age or older, “fully informed,” personal/religious beliefs (64% of fittings)
  • Record retention for 3 years by dispenser

Contractual Consummation

  • (ensure that the wearer has) Read the User Instructional Brochure
  • (fitter must recommend that wearer) Consult a physician if any of 8 red flags observed/reported.  NOTE:  these are repeated in the “Warnings” section of the User Brochure (see below).
    • Visible congenital or traumatic deformity
    • Ear drainage, last 90 days
    • sudden or rapidly progressive HL last 90 days
    • Sudden or rapidly progressive unilateral HL, last 90 days
    • Acute or chronic dizziness
    • Audiometric air-bone gap => 15 decibels at 3 frequencies
    • significant cerumen or a foreign body in the canal
    • Pain or discomfort in the ear
The 1977 Final Rule focused heavily on specifications for the Information Brochure (see Table 2), which had to include the following warnings, exact wording, and statements:

• WARNING TO HEARING AID DISPENSERS.

A hearing aid dispenser should advise a prospective hearing aid user to consult promptly with a licensed physician (preferably an ear specialist) before dispensing a hearing aid if the hearing aid dispenser determines through inquiry, actual observation, or review of any other available information concerning the prospective user, that the prospective user has any of the following conditions.

• NOTICE ABOUT THE MEDICAL EVALUATION REQUIREMENT.

“I have been advised by (Hearing aid dispenser’s name) that the Food and Drug Administration has determined that my best health interest would be served if I had a medical evaluation by a licensed physician (preferably a physician who specializes in diseases of the ear) before purchasing a hearing aid. I do not wish a medical evaluation before purchasing a hearing aid.”

STATEMENTS THAT:

  • the hearing aid will not restore normal hearing or improve a hearing impairment resulting from organic conditions;
  • in most cases infrequent use of a hearing aid does not permit a user to attain full benefit from it;
  • the use of a hearing aid is only part of hearing habilitation and may need to be supplemented by auditory training and instruction in lip-reading.

Finally, the Rule authorized FDA employees to “enter and inspect any facilities where restricted devices are manufactured, processed, packed, or held, and provides that the inspection shall extend to all things therein (including records, files, papers, processes, controls, and facilities).”

It is really and truly a wonder that any hearing aids were ever dispensed again in the USA after the Hearing Aid Rule went into effect.  It is little wonder that hearing aid prices increased as Rule compliance drove up cost of sales. Did this help or hurt consumers? Tune in again for all the fun and excitement brought about by the Rule!

Editor’s Note:  This is Part 5 in a 7-part series.  Click links for Part 4 or Part 6, or to begin the series at Part 1.

 

References and Footnotes

 

142 Fed. Reg. 9286

2Supporting Statement for Hearing Aid Devices, Professional and Patient Labeling and Conditions for Sale. 21 CFR 801.420 and 801.421. OMB No. 0910-0171.

 

Feature image courtesy of right pundits


References    (↵ returns to text)

  1.  ANSI Standards for Saturation output curve (SSPL 90 curve); Frequency response curve; (iii) Average saturation output (HF-Average SSPL 90); (iv) Average full-on gain (HF-Average full-on gain); (v) Reference test gain; Frequency range;  Total harmonic distortion;  Equivalent input noise;  Battery current drain;  Induction coil sensitivity (telephone coil aids only); Input-output curve (ACG aids only); Attack and release times (ACG aids only).  
  2. Supporting Statement for Hearing Aid Devices, Professional and Patient Labeling and Conditions for Sale. 21 CFR 801.420 and 801.421. OMB No. 0910-0171.

4 Responses to Regulation of Hearing Aids in the US, Part 5

  1. Audicus says:

    A few good examples on that topic, were the recent clashes between mail order companies and state regulators… the more prominent one being Hearing Help Express vs. the state of Missouri. In this particular case, the mail order company was faced wit legal action by the state regulator, but made its case for federal preemption.
    You can read more about it here: http://goo.gl/ltwUU

    • Holly Hosford-Dunn says:

      Thanks, Audicus. I’m also thinking about State of California opinion re AARP’s agreement with HearUSA, which I’ll eventually get to writing about. But, would love to have you write more on this topic, about which you are clearly very knowledgeable. Would you like to do a post?

  2. Audicus says:

    thanks for this great post!
    where the complexities of the regulatory environment become even more evident is when you also layer in the local regulation in every state… which is often not entirely consistent with the federal statutes.

    • Holly Hosford-Dunn says:

      This is such a good observation and, I admit, one I hadn’t really considered. I know that states vary enormously with regard to Medicaid funding of hearing aid fitting, but I didn’t think about controlling distribution beyond that. Can you provide an example or two to get this discussion moving?