Hearing Aid Feature 2.0 (HAF 2.0)

GUDID 00195950732405

Hearing Aid Feature AirPods Pro 2 or later Firmware (2.X)

APPLE INC.

Air-conduction hearing aid, in-the-ear
Primary Device ID00195950732405
NIH Device Record Keyfa75931b-52dc-49f7-aea9-403f6502d67e
Commercial Distribution StatusIn Commercial Distribution
Brand NameHearing Aid Feature 2.0 (HAF 2.0)
Version Model NumberFeature version 2.X
Company DUNS060704780
Company NameAPPLE INC.
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 Numberfalse
Manufacturing Datefalse
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
GS100195950732405 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

SCRAir-Conduction Hearing Aid Software

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-09-17
Device Publish Date2025-09-09

On-Brand Devices [Hearing Aid Feature 2.0 (HAF 2.0)]

00195950732412Hearing Aid Feature macOS (2.X)
00195950732405Hearing Aid Feature AirPods Pro 2 or later Firmware (2.X)
00195950732399Hearing Aid Feature watchOS (2.X)
00195950732382Hearing Aid Feature iOS (2.X)

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