FDA.reportPublic FDA data

MIRACLE-EAR

Primary DI
00842318193865
Brand
MIRACLE-EAR
Company
Starkey Laboratories, Inc.
Model
MIRACLE-EAR LINK TV STREAMER AV
Published
2025-06-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Product Codes#

Code, Name table
CodeName
OSMHearing Aid, Air-Conduction with Wireless Technology, Prescription

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OSMHearing Aid, Air-Conduction With Wireless Technology, PrescriptionEar, Nose, Throat2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842318193865PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842318193865008423181938658423181938650842318193865

GMDN Terms#

Term, Definition table
TermDefinition
Television set listening aidA device used by a person that is hard of hearing to listen to a television (TV) set. It takes the sound output from a TV, either by a direct electrical connection or by means of a microphone placed close to the TV loudspeaker, amplifies the signal which is then fed to the user by means of an earphone or an induction loop in conjunction with an appropriate hearing aid.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-40 Degrees Celsius60 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
055461479
Device count
1
DM exempt
true
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840388213773OUIEZENOuieZen SL2 Charger RIC R/RT 2026-02-13
00840388213780OUIEZENOuieZen SL2 Prm Charger RIC R/RT2026-02-13
00840388213797NUEARNUEAR NE SERIES AI P BTE 132026-02-13
00840388213803NUEARNUEAR NE SERIES AI UP BTE 132026-02-13
00840388207161KINDKINDviano 3 RIC R2026-02-11
00840388210024OUIEZENOuieZen 24 OM CIC2026-02-11
00840388210246OUIEZENOuieZen 16 OM CIC2026-02-11
00840388210505OUIEZENOuieZen 16 OM mRIC R2026-02-11
00840388211908STARKEYStarkey G Series AI 24 UP BTE 132026-02-08
00840388211915STARKEYStarkey G Series AI 20 UP BTE 132026-02-08
00840388211922STARKEYStarkey G Series AI 16 UP BTE 132026-02-08
00840388211939STARKEYStarkey G Series AI 12 UP BTE 132026-02-08
00840388211946STARKEYStarkey G Series AI 10 UP BTE 132026-02-08
00840388211953STARKEYStarkey G Series AI UP BTE 132026-02-08
00840388211960STARKEYStarkey G Series AI 24 UP BTE 13 (DEMO)2026-02-08
00840388211977STARKEYStarkey G Series AI UP BTE 13 (TIER DEMO)2026-02-08
00840388211991STARKEYStarkey G Series AI 24 UP BTE 13 (GS DEMO)2026-02-08
00840388212004AUDIBELAudibel A Series AI 24 UP BTE 132026-02-08
00840388212011AUDIBELAudibel A Series AI 20 UP BTE 132026-02-08
00840388212028AUDIBELAudibel A Series AI 16 UP BTE 132026-02-08

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Primary DI, Brand, Company table
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