## Facts

- The American Speech and Hearing Association (ASHA) brought a civil action challenging a federal regulation governing the sale of hearing aids.
- The challenged regulation was promulgated by the Food and Drug Administration (FDA), then administered within the U.S. Department of Health, Education, and Welfare (HEW) headed by Secretary Joseph A. Califano, Jr.
- The FDA rule required a prospective hearing-aid purchaser to obtain an examination by a physician as a condition of sale, rather than permitting an examination by an audiologist.
- ASHA alleged that the governing regulatory/statutory scheme required authorization of “licensed practitioners,” and that the FDA’s physician-only requirement conflicted with that broader category.
- ASHA maintained that, in most states, “licensed practitioners” included not only physicians but also audiologists and hearing-aid dealers.
- On ASHA’s account, limiting the required examination to physicians improperly excluded other state-licensed professionals from performing examinations connected to hearing-aid purchases.
- ASHA sought declaratory and injunctive relief aimed at preventing enforcement of the physician-examination requirement.

## Issues

1. Whether the FDA could lawfully require that the pre-sale examination for hearing-aid purchasers be performed only by a physician, where the governing scheme referred to authorization by “licensed practitioners” that could include audiologists under state law.

## Decision

- The case was heard in the United States District Court for the District of Columbia under Civ. No. 77-1327 (1977).
- Judge Gerhard A. Gesell issued a district-court decision resolving ASHA’s challenge to the FDA’s physician-examination requirement.
- Publicly accessible summaries identify the dispute and the court/judge, but do not provide the decision’s full holding, reasoning, or disposition in a form that can be verified without accessing the underlying opinion or a subscription case summary.

## Legal Principles

- In a suit seeking declaratory or injunctive relief against a federal health regulation, the central questions typically include whether the agency acted within its delegated authority and whether the regulation is consistent with the governing text.
- When a statute or regulatory framework uses a category such as “licensed practitioners,” the legality of a narrower agency requirement (such as “physician only”) commonly turns on statutory interpretation and the degree of discretion the agency has to define or limit the category for health and safety reasons.
- Courts reviewing such challenges generally examine the agency’s stated rationale and whether the agency’s line-drawing is adequately explained and tied to the purposes of the authorizing scheme, while also considering how federal requirements interact with state licensing regimes.

## Conclusion

American Speech and Hearing Association v. Califano (Civ. No. 77-1327 (1977)) involved ASHA’s challenge to an FDA hearing-aid regulation that conditioned sale on a physician examination rather than an audiologist’s examination; ASHA argued that the governing scheme’s reference to authorization by “licensed practitioners” could include audiologists and hearing-aid dealers under state law, making a physician-only rule unlawful, but publicly available materials do not supply a verifiable statement of the district court’s final holding or reasoning.


American Speech and Hearing Association v. Califano, Civ. No. 77-1327 (1977)