Duns Number:539177681
Device Description: Lexie B1 Hearing Aids, powered by Bose. Self-fit, app-controlled hearing aids
Catalog Number
In-Store
Brand Name
Lexie Hearing
Version/Model Number
Lexie B1 Self-fitting OTC Hearing Aids Powered by Bose
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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"
Yes
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
K211008,K211008
Product Code
QDD
Product Code Name
Self-Fitting Air-Conduction Hearing Aid
Public Device Record Key
8cbb8d69-50ff-408e-b6a8-fcdb7ebdc7d9
Public Version Date
October 13, 2022
Public Version Number
1
DI Record Publish Date
October 05, 2022
Package DI Number
10850022464574
Quantity per Package
6
Contains DI Package
00850022464577
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 3 |
2 | A medical device with a moderate to high risk that requires special controls. | 8 |