Regulation of Hearing Aids in the US, Part 5

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…

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