Personal sound amplification products removed from FDA Reauthorization Act
By Christen Smith
Hunters and bird watchers fond of personal sound amplification products won’t see the devices face any extra government scrutiny this year after all.
House lawmakers approved the Food and Drug Administration Reauthorization Act of 2017 Wednesday without language redefining the hearing devices after Gun Owners of America and legislative Republicans characterized an earlier version of the bill as regulatory overreach.
“Today’s bill is critical because it will keep the innovation pipeline for cures, treatments and drugs open for patients,” said North Carolina Republican Rep. Richard Hudson in a press release Wednesday. “Additionally, it includes my language that protects hearing enhancers and devices used by hunters and bird watchers from potential bureaucratic government overreach. It’s a small win for common sense, our freedoms and our Second Amendment rights.”
The controversy began in March when Massachusetts Democratic Sen. Elizabeth Warren sponsored the Over-the-Counter Hearing Aid Act, a proposal to allow stores to sell hearing aids over-the-counter.
The devices as-is face intense FDA regulation, cost upwards of thousands of dollars and can be obtained via prescription only.
Warren said her bill would have fixed all that by creating a new class of over-the-counter hearing aids. The proposal’s language also mandated the federal government reconsider the definition of Personal