Regulatory Framework and Safety Standards
In 2022, the Food and Drug Administration (FDA) finalized rules establishing the OTC hearing aid category. This regulation ensures that devices meet specific safety and effectiveness standards.
Output Limits: To prevent ear damage, general output is limited to 111 dB SPL, with a maximum of 117 dB SPL for devices using active input-controlled compression.
Insertion Depth: Manufacturers must design devices so the innermost component remains at least 10 mm from the eardrum to minimize the risk of injury to the tympanic membrane.
Technical Quality: Devices must adhere to strict limits on self-generated noise (not exceeding 32 dBA) and latency (no more than 15 ms) to ensure a high-quality auditory experience.
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