FDA.reportPublic FDA data

Earlens Tympanic Lens, Binaural

Primary DI
00850013007257
Brand
Earlens Tympanic Lens, Binaural
Company
EARLENS CORPORATION
Model
ITL01LR
Catalog number
ITL01LR
Device description
Inductive Tympanic Lens - 1 left and 1 right. Lenses are not individually packaged within this product box.
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
00850013007257PrimaryGS10
00850013007332Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850013007257008500130072578500130072570850013007257
00850013007332008500130073328500130073320850013007332

GMDN Terms#

Term, Definition table
TermDefinition
Tympanic membrane contact hearing aid tympanic transducerAn electronic component of a tympanic membrane (TM) contact hearing aid intended to be placed indirect contact with the TM and to convert signals into vibrations, which are then passed alongthe normal sound conduction pathway in the middle ear. The TM transducer is non-surgically placedby a healthcare professional in a clinical setting and is intended to remain in situ indefinitely. Thehearing aid is intended to compensate for mild/severe sensorineural impaired hearing bytransmitting transduced sound waves, via light waves or an oscillating electromagnetic field, to avibrator component in direct contact with the TM.

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
2
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
00850013007264Earlens Contact Hearing Solution, Monaural, LeftEARLENS CORPORATIONPLK2019-05-06
00850013007271Earlens Contact Hearing Solution, Monaural, RightEARLENS CORPORATIONPLK2019-05-06
00850013007288Earlens Contact Hearing Solution, BinauralEARLENS CORPORATIONPLK2019-05-06
00850013007295Earlens Fitting Software, USBEARLENS CORPORATIONPLK2019-05-06
08500130070208Earlens ProcessorEARLENS CORPORATIONPLK2019-05-06
08500130070215Earlens Ear TipEARLENS CORPORATIONPLK2019-05-06