Catalog Number

In-Store

Brand Name

Lexie Hearing

Version/Model Number

Lexie B2 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

8492c2ea-d9ac-46ef-9607-f690caf4831d

Public Version Date

October 13, 2022

Public Version Number

1

DI Record Publish Date

October 05, 2022

Package DI Number

10850022464642

Quantity per Package

6

Contains DI Package

00850022464645

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case