Q. I have tinnitus and have seen other doctors who told me there is no cure and I just have to live with it. What can your clinic do for my tinnitus?

A. We hear that all the time. That’s a common misconception. While it’s true tinnitus cannot be cured, it can be treated and managed effectively. We have an 85% success rate at reducing or even eliminating the perception of tinnitus.

Q. What is Lenire and how does it work?

A. Lenire (Len-ear), which is Latin for ‘soothe’, is the only commercially available, clinically trialed, dual mode tinnitus treatment device approved by the US FDA. It works using bimodal neuromodulation, which is the stimulation of not one but two nerves at the same time. With Lenire, for example, you have the combination of electrical stimulation via the tongue as well as auditory stimulation via the ear. Research has suggested that the combined stimulation of these two nerves drives stronger adaptive neuroplasticity, which in turn can reduce the brain’s attention and sensitivity to the tinnitus sound to a greater extent than when stimulating only a single nerve at a time.

Q. What is your treatment for tinnitus- is it just Lenire?

A. We create a customized treatment plan for each patient based on the results of our tinnitus evaluation. This may include the Lenire device and/or hearing technology.

Q. How much does Lenire cost?

A. Treatment with Lenire (including the consultation, the custom-programmed device, and follow up care) is $4150.00 USD. This must be paid before you are issued as device, as it is a single-user medical device. We do have a no-interest 12 month credit-based option for those who qualify.

Q. Will I need hearing aids as well as Lenire?

A. This will depend on the results of our initial examination. If the exam reveals that your tinnitus is caused by hearing loss, your provider will recommend a treatment plan using hearing aids and/or Lenire therapy.

Q. How long does it take to work?

A. While some people experience almost immediate relief, for many others, it can take 6 weeks -12 months of following the treatment plan to achieve the desired results. During your fitting appointment with the Lenire device, your provider will help you set some treatment goals and milestones and during your follow-up appointments, those treatment goals will be discussed and evaluated. If a revision to your treatment plan is necessary to achieve your goals, your provider will discuss those options with you at that time.

Q. Is Lenire guaranteed to work?

A. Unfortunately there are no guarantees with any medical treatment and because the Lenire device can only be used by a single patient, it is non-refundable.

Q. How effective is Lenire?

A. Lenire has been proven as a safe and effective tinnitus treatment in clinical trials with more than 600 participants.

>TENT-A1 (Trial 1): This study showed that 86.2% of treatment compliant participants reported an improvement in their THI score after 12 weeks of treatment. 80.1% reporting improvement that sustained for 12 months after treatment.

>TENT-A2 (Trial 2): 91%of compliant patients had sustained relief from tinnitus that lasted 12-months. The average reduction in tinnitus was 20.3 THI points, equal to a full THI grade.

>TENT-A3 (Trial 3): Lenire has been proven to be more effective than sound-alone for the majority of people with moderate or worse tinnitus.

>All Trials: Across all clinical trials, 83% would recommend Lenire to treat tinnitus.

Lenire also conducted real world trials with more than 200 people. The results of Lenire’s real world trials closely matched clinical trial results.

Q. What are the contraindications for using Lenire?

A. Lenire is intended to treat patients 18 years of age and older suffering from at least moderate, subjective tinnitus.

The Lenire device is contraindicated for persons:

- Who have a pacemaker, defibrillator or any other active implantable device, unless directed by a physician.

- Who are pregnant, unless directed by a physician.

- Who suffer from epilepsy or any other condition that may result in loss of consciousness, unless directed by a physician.

- Who suffer from any condition that causes impaired sensitivity of the tongue, unless directed by a physician or dentist

- Who have lesions, sores, or inflammation of the oral cavity that could be in contact with the Tonguetip (i.e., tip of tongue and lip area), unless directed by a physician or dentist.

- Who are suffering from any intermittent or chronic neuralgia in the head and neck area, unless directed by a physician.

- Who have tinnitus caused by Meniere’s disease, unless directed by a physician. The use of this device has not been evaluated in the TENT clinical studies for Meniere’s disease.

- Who have tinnitus confirmed to be from an objective source.

- Who have oral piercings present.

Q. Does insurance cover Lenire?

A. Currently we know of no insurance company covering the cost of Lenire. We do have a no-interest 12 month payment plan (OAC) for those who qualify. You may be able to use your HSA or Flex-spending benefits to purchase the device.

Q. How many follow-up visits are required?

A. When you are fit with the device in our office, we will schedule three more appointments at that time, one at 2 weeks, one at 6 weeks, and one at 12 weeks. All three can be done via telephone. After that, we will continue to provide support for you as needed- just give us a call and schedule another appointment.

Q. Why do I need a hearing exam to get the Lenire device?

A. The Lenire device is tailored specifically for each patient based on their hearing profile. Therefore, the device needs to be prescribed through qualified healthcare professional after a detailed tinnitus consultation, including an audiogram. Assuming Lenire has been recommended for an individual, it’s also important that the treatment is demonstrated and explained to each patient by a trained provider prior to beginning the treatment itself (so as to ensure that the patient is comfortable and confident using Lenire).

Q. Can you use Lenire with a hearing loss?

A. Lenire has hardware limitations that restrict the sound pressure levels of the acoustic stimuli, in which the capability of fully compensating for the patient’s hearing loss is limited to hearing thresholds up to 80 dB HL at {2k,3k,4k,6k,8k} Hz and up to 40 dB HL at {250,500,1k} Hz. Fitting a patient with hearing thresholds outside of the above-mentioned range may result in a lower perceived loudness of the acoustic stimuli but does not present any additional risks to the patients.