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FDA Issues Landmark Proposal to Improve Access to Hearing Aid Technology for Millions of Americans
Proposed Rule Would Establish New Category of Over-the-Counter Hearing Aids
To ensure patient safety, the proposed rule also addresses a maximum output (volume) limit for OTC hearing aids that would prevent injuries from overamplification of sound. In addition, the proposed rule includes certain device performance and design requirements, such as distortion control limits, self-generated noise limits, latency limits (how quickly an OTC hearing aid processes, amplifies and relays a sound), the range of frequencies that the device can reproduce and how uniformly the OTC hearing aid amplifies different frequencies over its bandwidth, as well as a requirement to limit the insertion depth of the device. The proposed rule also includes labeling requirements for OTC hearing aids.
Proposed Rule Would Establish New Category of Over-the-Counter Hearing Aids
To ensure patient safety, the proposed rule also addresses a maximum output (volume) limit for OTC hearing aids that would prevent injuries from overamplification of sound. In addition, the proposed rule includes certain device performance and design requirements, such as distortion control limits, self-generated noise limits, latency limits (how quickly an OTC hearing aid processes, amplifies and relays a sound), the range of frequencies that the device can reproduce and how uniformly the OTC hearing aid amplifies different frequencies over its bandwidth, as well as a requirement to limit the insertion depth of the device. The proposed rule also includes labeling requirements for OTC hearing aids.