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 Inte
| Device Type ID | 1643 |
| Device Name | Self-fitting Air-conduction 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 Heari |
| 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 |
| Submission Type | 510(k) |
| CFR Regulation Number | 874.3325 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | QDD |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 1643 |
| Device | Self-fitting Air-conduction Hearing Aid |
| Product Code | QDD |
| FDA Device Classification | Class 2 Medical Device |
| CFR Regulation Number | 874.3325 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
BOSE CORPORATION | ||
GRANTED | 1 | |