Search Results
Found 3 results
510(k) Data Aggregation
K Number
K182480Device Name
Earlens Contact Hearing Aid
Manufacturer
Date Cleared
2019-01-25
(137 days)
Product Code
Regulation Number
874.3315Why did this record match?
Applicant Name (Manufacturer) :
Earlens Corporation
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Earlens Contact Hearing Aid transmits amplified sound by vibrating the eardrum through direct contact. It is indicated for individuals 18 years and older with a mild to severe sensorineural hearing impairment who can benefit from amplification. The device can provide the full spectrum of amplification that includes 125 Hz - 10,000 Hz.
Device Description
The Earlens Hearing Aid consists of several components including a Processor worn behind the pinna, an Ear Tip that is placed in the external ear canal, and a Tympanic Lens that is placed in the anterior sulcus near the tympanic membrane. Sound waves are received by the two directional microphones on the Processor and converted into electrical signals, digitally processed, amplified and sent to the Ear Tip through a cable. The Ear Tip houses a transmit coil, which converts the electrical signal containing the amplified sound into electromagnetic energy. This energy is transmitted to a receive coil on the Tympanic Lens. Both data and power are sent from the transmit coil to the receive coil by resonant inductive coupling. The receive coil converts the electromagnetic energy back into electrical signals, thereby activating the microactuator of the Tympanic Lens to transmit sound vibrations to the umbo.
The Tympanic Lens is placed deep in the ear canal and adiacent to the tympanic membrane by a trained ENT physician through a non-invasive and non-surgical procedure. The Tympanic Lens makes contact with the umbo of the tympanic membrane and is intended to remain in the ear for greater than 30 days.
An Audiologist uses the Earlens Fitting software (ELF) to prescribe the gain and overall output of the Processor based on the recipient's hearing profile.
A Charger is provided to the recipient to recharge the Lithium-Ion battery of the Processor daily.
Ask a Question
Ask a specific question about this device
K Number
K153634Device Name
Wireless Earlens Light Driven Hearing Aid
Manufacturer
Date Cleared
2016-04-06
(110 days)
Product Code
Regulation Number
874.3315Why did this record match?
Applicant Name (Manufacturer) :
EARLENS CORPORATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The wireless Earlens Light Driven Hearing Aid (a.k.a. Earlens Hearing Aid) transmits amplified sound by vibrating the eardrum through direct contact. It is indicated for individuals 18 years and older with a mild to severe sensorineural hearing impairment who can benefit from amplification. The device can provide the full spectrum of amplification that includes 125 Hz - 10,000 Hz.
Device Description
Not Found
Ask a Question
Ask a specific question about this device
K Number
DEN150002Device Name
EarLens Contact Hearing Device
Manufacturer
Date Cleared
2015-09-29
(270 days)
Product Code
Regulation Number
874.3315Why did this record match?
Applicant Name (Manufacturer) :
EARLENS CORPORATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The EarLens™ Contact Hearing Device transmits amplified sound by vibrating the eardrum through direct contact. It is indicated for individuals 18 years and older with a mild to severe sensorineural hearing impairment who can benefit from amplification. The device can provide the full spectrum of amplification that includes 125 Hz - 10,000 Hz.
Device Description
The EarLens™ Contact Hearing Device (CHD) transmits amplified sound to compensate for hearing impairment by direct vibration of the tympanic membrane (eardrum). The EarLens™ CHD is composed of an external Audio Processor, which includes a Behind-the-Ear (BTE) Unit and an Ear Tip, a Tympanic Membrane Transducer (TMT), the EarLens™ Fitting Software (ELF), and a Charger with a Power Adapter. In this device, light is used to wirelessly transmit both signal and power from the Audio Processor to the TMT. The BTE sits behind the outer ear, housing the rechargeable battery, digital signal processor (DSP), microphones and drive electronics. The Ear Tip contains the light emitter and directs the light signal down the ear canal. The TMT resides at the end of the ear canal on the skin around the tympanic membrane. The TMT receives the light signal and converts it into direct vibration of the umbo of the tympanic membrane. The EarLens™ Charger charges two BTEs at the same time when connected to either the wall power adapter or from the internal battery contained in the Charger. The CHD is patientmatched for single patient use. The ELF enables the hearing professional to program the device specific to the patient's hearing needs. The EarLens™ Impression System is provided to the physician to enable the collection of a deep ear canal impression to create patient-matched TMTs for each patient.
Ask a Question
Ask a specific question about this device
Page 1 of 1