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U.S. Department of Health and Human Services

Product Classification

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Device self-fitting air-conduction hearing aid, prescription
Regulation Description Self-fitting air-conduction hearing aid.
Definition A self-fitting air-conduction hearing aid is a wearable sound amplifying device that is intended to compensate for impaired hearing and incorporates technology, including software, that allows users to program their hearing aids. This technology integrates user input with a self-fitting strategy and enables users to independently derive and customize their hearing aid fitting and settings. This is a prescription hearing aid.
Physical State The self-fitting air-conduction hearing aid consists of the following components that are worn on the body, typically at ear level: microphone, receiver, and signal processor. In addition, the device will have a user interface for adjusting the hearing aid.
Technical Method A self-fitting air-conduction hearing aid incorporates technology, including software, used by the listener to configure parameters, settings, and listening modes to meet the user's listening needs.
Target Area The self-fitting air-conduction hearing aid provides amplification to the ear.
Regulation Medical Specialty Ear Nose & Throat
Review Panel Ear Nose & Throat
Product CodeQDD
Premarket Review Division of Dental and ENT Devices (DHT1B)
Division of Dental and ENT Devices (DHT1B)
Submission Type 510(k)
Regulation Number 874.3325
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? No
Life-Sustain/Support Device? No
Recognized Consensus Standard
Third Party Review Not Third Party Eligible