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U.S. Department of Health and Human Services

Product Classification

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Device hearing aid, air conduction with wireless technology
Regulation Description Wireless air-conduction hearing aid.
Definition Wireless hearing aids are intended as acoustic amplification devices for hearing impaired users.
Physical State The device is worn behind-the-ear or in-the-canal with audio output into the ear supported by an ear canal mold.
Technical Method A wireless air-conduction hearing aid is a wearable sound-amplifying device, intended to compensate for impaired hearing, that incorporates wireless technology in its programming or use.
Target Area The outer ear and the ear canal.
Regulation Medical Specialty Ear Nose & Throat
Review Panel Ear Nose & Throat
Product CodeOSM
Premarket Review Office of Device Evaluation (ODE)
Division of Ophthalmic and Ear, Nose and Throat Devices (DOED)
Ear, Nose, and Throat Devices Branch (ENTB)
Submission Type 510(K) Exempt
Regulation Number 874.3305
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
    Note: Class II devices the Food and Drug Administration (FDA) has also published a list of Class II (special controls) devices subject to certain limitations, that are now exempt from the premarket notification requirements under the Food and Drug Administration Modernization Act of 1997 (the Modernization Act). FDA believes that these exemptions will relieve manufacturers from the need to submit premarket notification submissions for these devices and will enable FDA to redirect the resources that would be spent on reviewing such submissions to more significant public health issues. FDA is taking this action in order to meet a requirement of the Modernization Act.
Recognized Consensus Standard
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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