- Lowering maximum sound output to reduce the risk of hearing damage from over-amplification.
- Limiting how far the devices can be inserted in the ear canal, to prevent potential injury.
- Requiring that all OTC hearing aids have a user-adjustable volume control.
- Simplifying language used in device labeling so regular folks can understand it.
“The rule also includes certain device performance and design requirements, such as limits on distortion, noise, delay and the range of frequencies that the device can reproduce,” says Dr. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health.
Along with the new rule, the FDA also clarified the differences between hearing aids and personal sound amplification products (PSAP). PSAPs are low-cost consumer products intended to amplify sounds for average folks.
PSAPs are intended for people with normal hearing to amplify sounds in certain environments, such as recreational activities, Shuren shares.
“While hearing aids and PSAPs both amplify sounds to the user, PSAPs are not intended to aid persons with or compensate for impaired hearing,” he adds.
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Competition prompted by the new rule is expected to save consumers about $1,400 on each individual hearing aid or more than $2,800 per pair, says Brian Deese, White House director of the National Economic Council.
“And that’s the direct savings potential that comes from this rule,” Deese notes. “But we also expect this rule to unleash new innovation, which ultimately will mean better quality products and lower prices in ways that we cannot even estimate or model today.”
The action is the culmination of efforts dating back to 2017, when Congress
