Obstructive Sleep Apnea Treatment with Genio®

CPAP therapy is usually the first treatment option recommended to patients with obstructive sleep apnea (OSA). However, some patients are uncomfortable about using the rather cumbersome CPAP device or may be concerned about CPAP’s potential side effects or downsides. As a result, adherence to the therapy remains problematic, and the search for alternative therapies continues unabated.

Nyxoah has designed an alternative and more comfortable option for the treatment of obstructive sleep apnea: Genio®.

Genio device

What Is Genio?

Genio® is a scientifically proven treatment for obstructive sleep apnea (OSA), a common sleep disorder characterized by recurrent episodes of decreased or absent inspiratory airflow during sleep.

Unlike positive airway pressure (PAP), Genio does not involve the wearing of a mask. Instead, it uses an alternative treatment called hypoglossal nerve stimulation to prevent upper airway obstruction while you sleep.

Genio is intended to treat patients suffering from moderate to severe obstructive sleep apnea.

Genio is:

  • A scientifically proven treatment for obstructive sleep apnea
  • A comfortable alternative to CPAP therapy that works without a mask.

What Is Hypoglossal Nerve Stimulation?

Genio uses hypoglossal nerve stimulation.

Hypoglossal nerve stimulation (HGNS) is an alternative treatment for obstructive sleep apnea that electrically stimulates the nerves of the tongue – the hypoglossal nerve that enables tongue movement – to prevent upper airway obstruction.

Hypoglossal nerve stimulation is a serious option for people looking for an alternative to CPAP therapy:

  • Thousands of patients worldwide rely on hypoglossal nerve stimulation to treat their obstructive sleep apnea.
  • The effectiveness of this treatment has been scientifically proven.

The Genio nerve stimulator is implanted under the chin to provide the bilateral stimulation of the hypoglossal nerve while you sleep.

The Genio nerve stimulator is implanted under the chin to provide the bilateral stimulation of the hypoglossal nerve while you sleep.

How does Genio work?

Bilateral HNS using the Genio system reduces OSA severity and improves quality of life without device-related complications.

 

The Genio System

The Genio system is made up of an implantable nerve stimulator, an activation chip, a charging unit and an adhesive patch.
 

The Implantable Stimulator

The Implantable Stimulator

The implantable stimulator is placed under the chin via a small incision. 

Its electrodes are put in contact with both branches of the hypoglossal nerve resulting in bilateral stimulation of the nerve.

During your sleep, this stimulation triggers a small forward movement on the back of your tongue, thereby preventing your tongue from falling back and blocking your upper airway.

The Activation Chip, the Charging Unit and the Adhesive Patch

The activation chip controls the implantable stimulator.

Unlike other systems offering hypoglossal nerve stimulation, Genio uses an external activation chip.

This has 2 main benefits:

  • No battery inside your body needs to be replaced. This means there is no need for additional surgery to operate the replacement.
  • The external chip can be easily upgraded to the latest version. As a result, you benefit from the latest advances in stimulation and comfort.

The activation chip is charged using the charging unit.

Before going to bed, the activation chip is fixed using an adhesive patch that is then attached under your chin.

Together, the activation chip and the patch transmit energy to the implantable stimulator while you sleep.

The Activation Chip, the Charging Unit and the Adhesive Patch

How to Use Genio?

Quietly (there is no sound of machinery), comfortably and without the need of a mask, Genio keeps your airway open during the night.

The Daily Routine

  • Genio device

    1. During the Day

    You simply charge the activation chip using the charging unit:

    • Plug the charging unit into a power socket.
    • Place the activation chip on the charging area. The light on the charging unit turns on to let you know that the battery is charging. When the activation chip is fully charged, the light of the charging unit turns off.

    It takes approximately 3 hours to charge an empty activation chip to full capacity.

  • The Genio nerve stimulator is implanted under the chin to provide the bilateral stimulation of the hypoglossal nerve while you sleep.

    2. Before Going to Bed

    • Connect the activation chip to a new disposable patch. The LED of the chip will turn blue for 5 seconds.
    • After this, you can remove the foils from the adhesive patch and place it under your chin.
  • The Implantable Stimulator

    3. When you sleep

    The nerve stimulator receives a signal when connected to the activation chip.
    The stimulation starts when you fall asleep and this maintains your airway open throughout the night.
    Your breathing frequency is used as a reference to adjust the stimulation cycle to ensure you enjoy a good sleep.

  • The Activation Chip, the Charging Unit and the Adhesive Patch

    4. When you wake up

    • Detach the adhesive patch from your chin
    • Disconnect the activation chip from the patch and throw the patch in the trash.
    • Recharge the activation chip.

Can the activation chip detach from the patch during my sleep?

The activation chip and patch are meant to function as one part.
The chip clicks firmly into place on the patch to prevent any possible disconnection during the night.

Do I need to keep shaving my chin from the moment I start using Genio?

It’s important that the patch sticks to your chin so that there is an optimal signal between the chip and the nerve stimulator. For this reason, it is better when the chin is free of any facial hair to ensure the adhesive part stays in place better.

Any questions? Contact our medical advisors to learn more about Genio.

Does it Work?

Hypoglossal nerve stimulation demonstrated clinically significant improvements in obstructive sleep apnea severity, daytime sleepiness, and sleep-related quality of life.

The BLAST OSA study has demonstrated the effectiveness of Genio.

TEST IMAGE

Improvement in the Severity of Sleep Apnea

45.6% reduction in apnea hypopnea index (AHI)
48.7% decrease in oxygen desaturation index (ODI)

TEST IMAGE

Positive Impact on Snoring

61% of patients showed a decrease in snoring intensity. 

TEST IMAGE

Comfortable and Easy to Use

91% of patients reported using the Genio system more than 5 days a week

TEST IMAGE

Satisfied Patients

82% of patients reported being satisfied with the Genio treatment.

If you are an adult with moderate to severe sleep apnea, who has either failed or refused CPAP therapy, or does not tolerate it, you should consider Genio as an alternative treatment option.

Am I eligible?

Users’ stories

Hundreds of people use Genio to treat their obstructive sleep apnea.

  • Michael

    I’d recommend the Genio system for other people who have Obstructive Sleep Apnea if they’ve failed with other treatments. It’s been a life changer for me and for my wife. My life has changed considerably. I find that I’m happier, I'm healthier, and I’ve got a better outlook on life – it works.

  • Stefan

    I was diagnosed with OSA (Obstructive Sleep Apnea) more than five years ago. I would wake up drenched in sweat at night, just feeling an urgent need to breathe. The Genio® system was recommended to me by the sleep apnea team of Professor Dr. Heiser. Everyone should know about the available treatment options. You don’t have to live with the disease. You can treat it.

  • Susan

    Genio has positively changed my life. I am not exhausted anymore during the day; I am able to do my daily activities again. I feel more well balanced and happier, and am not being elbowed by my husband anymore during the night.

Interested in Genio? Contact us to verify that you meet Genio’s patient eligibility requirements.

Implantation - Activation - Optimization

  1. Genio device

    Implantation of the hypoglossal nerve stimulator

    The implant is placed through a small incision under your chin.

    The implantation procedure is short and minimally invasive. It usually takes about an hour and is performed under general anesthesia by a Genio-trained and certified surgeon.

  2. The Genio nerve stimulator is implanted under the chin to provide the bilateral stimulation of the hypoglossal nerve while you sleep.

    First activation

    The activation happens usually takes place 6 to 8 weeks after the implantation. It is usually done in a sleep lab. While the patient is asleep, the nerve stimulator is activated during a sleep study.

    The settings of the activation chip are then personalized to each patient.

  3. The Implantable Stimulator

    Optimization

    After activation, additional follow-up visits and sleep studies may be scheduled to monitor and optimize the parameters of the Genio therapy.

What Doctors Say About Genio

  • Prof. Dr. med. Clemens Heiser

    ENT, Head and Neck surgeon at Klinikum rechts der Isar, Technical University of Munich

    Prof. Clemens Heiser shares his views of the Obstructive Sleep Apnea landscape, including the role of ENTs in the sleep practice, as well as current state of the art treatments using bilateral hypoglossal nerve stimulation.

    Video highlights:

    • Bilateral stimulation of the hypoglossal nerve explained
    • Genio as an alternative to CPAP therapy

    Two patients have been in our Sleep Lab and showed a reduction of AHI by more than 70%. And both patients reported an improvement in daily life quality. It is such a smart idea to stimulate the upper airway without altering the anatomy of the pharynx.

  • Prof. Dr. Olivier Vanderveken

    ENT, Head and Neck Surgeon at Antwerp, University Hospital

    Prof. Olivier Vanderveken talks about the potential of hypoglossal nerve stimulation to become the first-line therapy for OSA patients in the future.

    Video highlights:

    • The future of hypoglossal nerve stimulation
    • Snoring decreases
    • Benefits of the therapy
    • Only one incision

    This is a truly innovative therapy in a field where, for a long time, everything remained the same. Now we have the feeling that the field can move on because of that innovation. I personally think that this could be a first-line therapy.

  • Prof. Dr. Kurt Tschopp

    ENT surgeon, Liestal (CH)

    Prof. Kurt Tschopp shares his experience with Genio as a treatment option for patients suffering from moderate to severe OSA.

    Video highlights:

    • Alternative to CPAP
    • Advantages of Genio
    • Future of hypoglossal nerve stimulation

  • Dr. Richard Lewis

    ENT surgeon and OSA expert - Perth, Australia

    Dr. Richard Lewis gives an overview of the Genio system and shares his positive experience with the therapy.

    Video highlights:

    • Activation of the hypoglossal nerve
    • Genio settings are personalized to each patient

    There’s no doubt that this form of therapy is the way forward for many patients to treat obstructive sleep apnea. I’ve been so impressed with the treatment outcomes and the improvement of their quality of life.

  • Prof. Stuart MacKay & Dr. Jennifer Walsh

    ENT surgeon and OSA expert - Adelaide, Australia / Centre of Sleep Science, University of Western, Australia

    Prof. Stuart MacKay and Dr Jennifer Walsh explain the Genio system for bilateral hypoglossal nerve stimulation.

    Video highlights:

    • Reduction in sleep apnea severity
    • Improvement in daytime sleepiness and snoring
    • Programming the Genio for the patient 

    We found that patients going through our center who are using our therapy, a lot of them have been having a great improvement in their sleepiness. So they’re less sleepy during the day, and they find the therapy really easy to use.
     

Find a Doctor

We work with the best ENT and sleep apnea specialists to bring Genio to the greatest number of patients looking for an alternative treatment for obstructive sleep apnea.

Download the leaflet

You can also download the Genio leaflet and give it to your doctor.

Download the Genio leaflet

Find Genio trained doctors in your area

If you are interested in Genio, consult a Genio-trained doctor.

Find Genio trained doctors in your area

Frequently Asked Questions

Which patients are right for Genio?

Genio is indicated to adults suffering from moderate to severe OSA (AHI from 15 to 65) who do not tolerate, or have failed or refused CPAP therapy.

Is Genio available in Europe?

Genio received CE mark in March 2019 and is approved for use in Europe.

Is Genio available in the US?

For now, Genio is limited by U.S. federal law to investigational use in the United States.

Is Genio therapy covered by health insurance?

Right now, the Genio treatment is fully reimbursed by health insurances in Germany and Switzerland. We are working hard to obtain reimbursement in other countries soon. 

Please contact us for more detailed information.

Contact us

Don’t hesitate to contact our medical advisors. They are available to answer all your questions about Genio, and how to start this alternative treatment of obstructive sleep apnea.

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References

  1. Eastwood PR, Barnes M, MacKay SG, et al. Bilateral hypoglossal nerve stimulation for treatment of adult obstructive sleep apnoea. Eur Respir J. 2020;55(1):1901320. Published 2020 Jan 9. doi:10.1183/13993003.01320-2019. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6949509/
  2. Heiser C, Sommer JU, Hofauer B, et al. Bilateral vs Unilateral Hypoglossal Nerve Stimulation in Patients With Obstructive Sleep Apnea. OTO Open. 2022;6(3):2473974X221109794. Published 2022 Jul 6. doi:10.1177/2473974X221109794. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9272182/
  3. Kent DT, Carden KA, Wang L, Lindsell CJ, Ishman SL. Evaluation of Hypoglossal Nerve Stimulation Treatment in Obstructive Sleep Apnea. JAMA Otolaryngol Head Neck Surg. 2019;145(11):1044-1052. doi:10.1001/jamaoto.2019.2723. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6764149/