HP

GUDID 00850000562004

The HP Hearing PRO self-fitting air conduction hearing aid for Over-the-Counter (OTC) sale to consumers in the new OTC product classification QUH. HP Hearing PRO OTC hearing aids are intended to amplify sound for individuals 18 years of age or older with perceived mild to moderate hearing impairment. They are adjusted by the user to meet the user’s hearing needs. No pre-programming or hearing test is necessary.

NUHEARA LIMITED

Air-conduction hearing aid, in-the-ear
Primary Device ID00850000562004
NIH Device Record Keyb246f02e-eef5-4c76-baf4-a52e952b3b5b
Commercial Distribution StatusIn Commercial Distribution
Brand NameHP
Version Model NumberNU320-02
Company DUNS755982704
Company NameNUHEARA LIMITED
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS100850000562004 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

QUHSelf-Fitting Air-Conduction Hearing Aid, Over The Counter

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-03-28
Device Publish Date2023-03-20

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