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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device hearing aid, air-conduction, over the counter
Definition An air-conduction hearing aid is a wearable sound amplifying device intended to compensate for impaired hearing that conducts sound to the ear through the air. This is an over the counter hearing aid. For information on the final rule “Establishing Over-the-Counter Hearing Aids,” please see 87 FR 50698, available at https://www.govinfo.gov/content/pkg/FR-2022-08-17/pdf/2022-17230.pdf.
Product CodeQUF
Regulation Number 874.3300
Device Class 1