Duns Number:002579431
Device Description: A self-fitting wireless air conduction hearing aid.
Catalog Number
861812-0300
Brand Name
Bose SoundControl Hearing Aid
Version/Model Number
BMD0012
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 17, 2022
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
QDD
Product Code Name
Self-Fitting Air-Conduction Hearing Aid
Public Device Record Key
d872d9b6-f7e7-4418-ac3a-fbab6e162799
Public Version Date
October 18, 2022
Public Version Number
2
DI Record Publish Date
May 18, 2021
Package DI Number
10017817827413
Quantity per Package
6
Contains DI Package
00017817827416
Package Discontinue Date
October 17, 2022
Package Status
Not in Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 16 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |