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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device air-conduction hearing aid software
Definition Air-conduction hearing aid software is a device that is intended to be used with a compatible wearable hardware platform to compensate for impaired hearing. The software also allows for customization to the user's hearing needs. Devices in this classification are also subject to the requirements in § 800.30 or § 801.422 of this chapter, as applicable. This classification does not include software that is used with hardware as part of a hearing-aid device system classified in other regulations, e.g., § 874.3300, § 874.3305, or § 874.3325.
Product CodeSCR
Regulation Number 874.3335
Device Class 2


Premarket Reviews
ManufacturerDecision
APPLE INC.
  GRANTED 1

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