FDA.reportPublic FDA data

Earlens Contact Hearing Solution, Binaural

Primary DI
00850013007288
Brand
Earlens Contact Hearing Solution, Binaural
Company
EARLENS CORPORATION
Model
IBK01
Catalog number
IBK01
Device description
Inductive Kit containing Left and Right Ear Tip & Processor AssembliesLeft and Right Tympanic LensChargerProcessor comes in different colors: CH - Champagne, SI - Sliver, BL - Black
Published
2019-05-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Product Codes#

Code, Name table
CodeName
PLKTympanic Membrane Direct Contact Hearing Aid

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PLKTympanic Membrane Direct Contact Hearing AidEar, Nose, Throat2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K182480000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K182480000Earlens Contact Hearing AidEarlens Corporation2019-01-25PLK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850013007288PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850013007288008500130072888500130072880850013007288

GMDN Terms#

Term, Definition table
TermDefinition
Tympanic membrane contact hearing aidA collection of electronic devices intended to compensate for mild/severe sensorineural impairedhearing by transmitting transduced sound waves, either via light waves or an oscillatingelectromagnetic field, to a vibrator component in direct contact with the tympanic membrane (TM). Itconsists of a behind-the-ear (BTE) sound processor that receives sound waves and converts theminto electrical signals, which are relayed to a light transducer or transmission coil in the external earcanal where they are converted into light or electromagnetic signals, which are transmittedto a transducer on the TM where they are converted to vibrations.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure525 Millimeter of Mercury795 Millimeter of Mercury
Handling Environment Humidity0 Percent (%) Relative Humidity93 Percent (%) Relative Humidity
Handling Environment Temperature-20 Degrees Celsius50 Degrees Celsius
Storage Environment Atmospheric Pressure525 Millimeter of Mercury795 Millimeter of Mercury
Storage Environment Humidity0 Percent (%) Relative Humidity93 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius50 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
611658795
Device count
1
Kit
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08500130070192Earlens ELF USBELFW01ELFW012016-09-24
00850013007417Earlens Fidelity SoftwareELF003ELF0032020-10-20
00850013007042Earlens ELF USBELF001ELF0012016-09-24
00850013007295Earlens Fitting Software, USBELF002ELF0022019-05-06
00850013007387Impression DispenserIDG01IDG012023-06-09
00850013007516Earlens Processor, Champagne IPR01CHIPR01CH2023-06-09
00850013007523Earlens Processor, SilverIPR01SIIPR01SI2023-06-09
00850013007530Earlens Processor, BlackIPR01BLIPR01BL2023-06-09
00850013007547Earlens Ear Tip, LeftET01LET01L2023-06-09
00850013007554Earlens Ear Tip, RightET01RET01R2023-06-09
00850013007561Earlens Tympanic Lens, LeftITL01LITL01L2023-06-09
00850013007578Earlens Tympanic Lens, RightITL01RITL01R2023-06-09
00850013007370Medial Impression CartridgesIMC03IMC032021-10-06
00850013007479Soft Medial Mixing TipsIDT04IDT042021-06-22
00850013007509Lateral Mixing TipsIDT05IDT052021-12-03
00850013007493Lateral Impression CartridgesIMC04IMC042021-10-06
00850013007349Earlens Hybrid Impression KitHIK02HIK022020-09-10
00850013007110Earlens Wireless ProgrammerWPUSB01WPUSB012016-09-24
00850013007202Earlens ProcessorIPR01XXIPR01XX2019-05-06
00850013007219Earlens Ear TipET01XET01X2019-05-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06932503535519Disposable Dual Action Tissue Closure DeviceMicro-Tech (Nanjing) Co., Ltd.PLK2023-06-28
06932503535526Disposable Dual Action Tissue Closure DeviceMicro-Tech (Nanjing) Co., Ltd.PLK2023-06-28
06932503535533Disposable Dual Action Tissue Closure DeviceMicro-Tech (Nanjing) Co., Ltd.PLK2023-06-28
06932503535540Disposable Dual Action Tissue Closure DeviceMicro-Tech (Nanjing) Co., Ltd.PLK2023-06-28
16932503535516MTMicro-Tech (Nanjing) Co., Ltd.PLK2023-06-28
16932503535523MTMicro-Tech (Nanjing) Co., Ltd.PLK2023-06-28
16932503535530MTMicro-Tech (Nanjing) Co., Ltd.PLK2023-06-28
16932503535547MTMicro-Tech (Nanjing) Co., Ltd.PLK2023-06-28
06932503535557Disposable Dual Action Tissue Closure DeviceMicro-Tech (Nanjing) Co., Ltd.PLK2023-06-28
06932503535564Disposable Dual Action Tissue Closure DeviceMicro-Tech (Nanjing) Co., Ltd.PLK2023-06-28
00850013007516Earlens Processor, Champagne EARLENS CORPORATIONPLK2023-06-09
00850013007523Earlens Processor, SilverEARLENS CORPORATIONPLK2023-06-09
00850013007530Earlens Processor, BlackEARLENS CORPORATIONPLK2023-06-09
00850013007547Earlens Ear Tip, LeftEARLENS CORPORATIONPLK2023-06-09
00850013007554Earlens Ear Tip, RightEARLENS CORPORATIONPLK2023-06-09
00850013007561Earlens Tympanic Lens, LeftEARLENS CORPORATIONPLK2023-06-09
00850013007578Earlens Tympanic Lens, RightEARLENS CORPORATIONPLK2023-06-09
00850013007462Earlens ProcessorEARLENS CORPORATIONPLK2021-06-18
00850013007417Earlens Fidelity SoftwareEARLENS CORPORATIONPLK2020-10-20
00850013007202Earlens ProcessorEARLENS CORPORATIONPLK2019-05-06
00850013007219Earlens Ear TipEARLENS CORPORATIONPLK2019-05-06
00850013007226Earlens Ear Tip, BinauralEARLENS CORPORATIONPLK2019-05-06
00850013007233Earlens Processor & Ear TipEARLENS CORPORATIONPLK2019-05-06
00850013007240Earlens Tympanic LensEARLENS CORPORATIONPLK2019-05-06
00850013007257Earlens Tympanic Lens, BinauralEARLENS CORPORATIONPLK2019-05-06
00850013007264Earlens Contact Hearing Solution, Monaural, LeftEARLENS CORPORATIONPLK2019-05-06
00850013007271Earlens Contact Hearing Solution, Monaural, RightEARLENS CORPORATIONPLK2019-05-06
00850013007295Earlens Fitting Software, USBEARLENS CORPORATIONPLK2019-05-06
08500130070208Earlens ProcessorEARLENS CORPORATIONPLK2019-05-06
08500130070215Earlens Ear TipEARLENS CORPORATIONPLK2019-05-06