Earlens is intended to treat individuals 18 years and older with a mild to severe sensorineural hearing impairment who can benefit from amplification.
Yes. The patient must not have any known or active medical issues that would preclude having a hearing device. Please visit earlens.com/ifu/ for a detailed list of contraindications.
Research suggests that high frequencies are extremely important for enhanced speech clarity and hearing in noisy situations. See more in our Research section. Low frequencies provide temporal cues that enhance the overall quality of sound, particularly with regard to speech and music. The Earlens is the first to deliver a full spectrum of audibility that brings patients closer to normal hearing than any conventional hearing aid can. Please visit our Research page for related studies.
Just as with any hearing solution, patients may need some time to adjust to the new way that they are hearing. Some patients prefer to ease into their prescribed high frequency gain with the Earlens acclimatization program. Others immediately adapt to the prescribed high frequency gain without additional adjustments.
The Tympanic Lens is not a surgical implant. It is placed in the ear during a quick in-office procedure that does not require anesthesia, and it can be removed at any time by an Ear, Nose and Throat Physician.
The custom Lens is suspended directly adjacent to the Tympanic Membrane (TM) in the sulcus area, with a small 3 mm umbo platform resting directly on the TM. The ear’s natural anatomy, along with drops of mineral oil applied to the ear canal, creates surface tension that keeps the Lens in place—similar to how a contact lens stays in place.
The Lens is designed to stay in place over extended periods. The ENT physician should evaluate the Lens in the first 3 months and again at 6 months, with annual check-ups thereafter or as prescribed by the physician.
Patients should not have an MRI with the Lens in place. A physician will need to remove the Lens for an MRI and replace it once the MRI is complete.
Cerumen and epithelial debris are expected. Therefore, management is required for optimal Lens stability and system performance. Routine otologic management in addition to our recommended daily mineral oil regimen will facilitate the process.
Yes. Earlens uses the ear impressions taken by the ENT physician to create a custom-molded Ear Tip and Lens for each ear fit with the Earlens solution. The Ear Tip emits energy to power the Lens at calibrated power levels for each patient.
The Earlens System is Bluetooth compatible with Apple’s MFi capability. Users can adjust the volume, programming settings and more through the Earlens app (available in the Apple App store). Detailed device compatibility information is available at: earlens.com/connectivity/
The Processor has an internal rechargeable battery that is designed to last for the duration of the 3-year warranty, or 1100 cycles.
All providers of the Earlens solution, including Ear, Nose, and Throat physicians and audiologists are required to participate in an approved Earlens training program.
Neither the impression process nor Lens placement/removal require anesthesia.
Trained ENT physicians take an impression of the full ear canal and TM using proprietary material.
Placing or removing a Tympanic Lens is a short procedure. It takes about 15 minutes and is performed in the doctor’s office without anesthesia. Most people report mild or no discomfort.
Programming or fitting the Earlens via our NOAH compatible software is very similar to fitting a traditional hearing aid. We recommend reserving the same amount of time that you would for a Hearing Aid Fitting Appointment.
The Earlens solution typically takes 2-3 visits for optimization. These visits include an initial consultation and impression appointment, followed by the Lens placement and Processor fitting. After the initial fit, regular follow ups help ensure the Earlens solution is providing the maximum benefit to the patient.
Clinical studies show that the Tympanic Lens does not damage the Tympanic Membrane or ear canal. In our Feasibility and Definitive trials, investigators saw no change in hearing thresholds after 120 days of use (p<0.0001). Learn more in our Research section.
When the Lens is in place on the TM, our studies have shown a slight reduction of sound in some patients due to the loading effect of the Lens (<5dB PTA). This reduction in sound is temporary and is immediately reversed when the Lens is removed and/or when the Processor is in place to provide gain that overcomes any TM damping effect.
The price of Earlens is set by the Earlens provider.
Earlens offers a trial period during which time the patient has the option to return the devices. Earlens comes with a 3-year warranty. Within the warranty period, there is no charge for component replacement due to manufacturing defects, and software upgrades are provided at no charge. The system is also protected against loss or damage with one-time replacement coverage.
Earlens Products may be covered by one or more U.S. Patents and/or Trademarks.
Please click here to see patents and trademarks associated with individual Earlens Products.