Safety Information

Indication for Use

The Genio system 2.1 is used to treat patients suffering from moderate to severe Obstructive Sleep Apnea (OSA), defined as AHI of greater or equal to 15 and less than or equal to 65, with and without Complete Concentric Collapse (CCC) at the soft palate level.

The Genio system 2.1 is used in adult patients who have not tolerated, have failed or refused PAP treatments.
PAP failure is defined as the inability to eliminate OSA (AHI of greater than 15 despite PAP usage).
PAP intolerance is defined as (a) the inability to use PAP (less than 5 nights per week of usage; usage defined as 4 hours or more of use per night) or (b) the unwillingness to continue to use PAP (after attempting to use it).

Contraindications

The Genio system 2.1 is contraindicated for:

• Children.
• Patients with an Apnea-Hypopnea Index below 15 or over 65 events/hour.
• Patients with combined central and mixed Apnea-Hypopnea Index > 25% of the total AHI.
• Pregnant women, or women planning to become pregnant.
• Patients with any functional or structural problem that would impair the ability of a hypoglossal nerve stimulator to treat OSA.
• Patients with any medical illness or condition that contraindicates a surgical procedure under general anesthesia or that would prevent the implantation of the Implantable Stimulator or the placement of Activation Chip/Disposable Patch.
• Patients with coagulopathy or requiring anticoagulant medications (such as warfarin, Clopidogrel (Plavix) or similar; prophylactic aspirin not exclusionary) that cannot be safely stopped in the perioperative period.
• Patients with major head and neck abnormalities narrowing the airway or the implantation site.
• Patients with hypersensitivity to any material of system components.
• Patients with other Active Implantable Medical Devices (AIMD).

Warnings

Pediatric Use

Safety and effectiveness of the use of the Genio system 2.1 has not been established in children.

Components

The use of charging adaptors not provided by Nyxoah may result in device malfunction, damaged devices or increase the risks to the users.

Body Mass Index (BMI)

Patients with a body mass index (BMI) equal to or lower than 32 kg/m² have been investigated in clinical studies with this device. The use of the Genio system 2.1 in patients with higher BMI (> 32 kg/m²) may lead to decreased likelihood of response to treatment.

MRI Safety Information

Potential Risks Associated With MRI Scans

The Genio IS device has been designed to minimize the potential adverse events that could result in patient harm.

The potential MRI-related adverse events are listed below:

• Implant heating causing damage to tissue in contact with the implant.
• Implant migration causing damage to tissue in contact with the implant.
• Implant migration causing the implant to be surgically removed (and replaced).
• Unintended overstimulation causing damage to tissue in contact with the implant.
• Unintended stimulation causing discomfort due to electrical stimulation.
• Device malfunction causing the implant to be surgically removed (and replaced).
• Diagnostic problems due to artifacts - shadowing on the MRI image in the vicinity of the implant causing loss or disturbance of diagnostic information.

MRI - Patient Warnings and Precautions

• Do not bring the Genio system 2.1 external devices (such as the Genio Disposable Patch or Genio Activation Chip) with you to the MRI scan room. The use of the Genio Disposable Patch and Activation Chip during an MRI scan is prohibited.
• Do not go through an MRI scan if you have a fever.
• In case you feel uncomfortable pain or heating during the MRI scan, notify the MRI technician so that the scan can be stopped. Consult your treating physician to determine if anesthetics may be administered to reduce pain or discomfort.
• The MRI scan should be conducted at least 6 weeks after your implantation or revision surgery. If you are required to undergo an MRI scan during this period, please consult your treating physician.
• In case you experience a change in implant functionality please contact your treating physician.

Precautions

Pregnancy

There might be unknown risks to pregnancy if the implanted device is used while pregnant. For this reason, you must inform your doctor if you are pregnant or if you are planning to become pregnant. If you become pregnant after the implantation of the device, the device will need to be turned off as soon as possible. The device should remain OFF during pregnancy.

Defibrillation/Cardioversion

If you have a serious heart rhythm problem (such as ventricular or atrial fibrillation), the first consideration is your survival. If it happens while you are wearing the devices, the Disposable Patch and the attached Activation Chip should be removed from your chin prior to the use of defibrillation or cardioversion. After defibrillation or cardioversion, your doctor should confirm the Genio system 2.1 is working as intended. Please note that possible interaction between the Genio system 2.1 and cardiac devices (implantable defibrillators) has not been investigated.

Water and Humidity

You are advised to keep your Genio external devices away from extremely humid areas and sources of water. Water and humidity may result in device malfunctions.

Medical Procedures

Always inform medical staff that you have been implanted with a medical device in the chin area before undergoing any medical procedures or examinations. The following medical procedures may interfere with the Genio system 2.1 or cause permanent damage to your implant or to your body tissue.

You should therefore consult your doctor prior to undergoing the following procedures:

• Treatment of muscle and joint conditions using heating of the tissue by high frequency electric current (diathermy).
• Treating abnormal heartbeats with an internal or external defibrillation.
• Radiation therapy.
• Treating kidney stones with ultrasound (lithotripsy).
• Magnetic stimulation, or any other form of electrical stimulation.

Treatment with Therapeutic Ionizing Radiation

You should not undergo treatment with therapeutic ionizing radiation after the implantation of the Implantable Stimulator. If radiation therapy is required in the area of the device, the Genio Implantable Stimulator might need to be surgically removed. If radiation therapy is applied to an area far away from the implanted device, the device should be shielded, and its function confirmed after treatment.

Therapeutic Ultrasound

You should consult your doctor before undergoing treatment with ultrasound therapy as it might damage the Implantable Stimulator and/or might cause tissue damage.

Radio-Frequency or Microwave Ablation

You should not be exposed to radio-frequency or microwave ablation. The electrical current may cause heating resulting in device and/or tissue damage. If radio-frequency or microwave ablation is required in the area of the device, it might need to be surgically removed.

Hyperbaric Chambers

There may be possible safety hazards associated with hyperbaric chambers when you have the Implantable Stimulator in place. You should discuss the effects of high pressure with your doctor before entering hyperbaric chambers.

Entering Special Areas

Seek medical guidance before entering environments that are protected by a warning notice preventing entry by persons fitted with an Active Implantable Medical Device (AIMD) such as a pacemaker.

Metal Detectors

Interactions with metal detectors are unlikely to damage the Implantable Stimulator or cause clinically significant symptoms. However, the Implantable Stimulator contains metal parts that might possibly set off metal detector alarms. You must tell security personnel that you have an implanted device in the chin area and always have your Implant Identification Card with you. Security wands should not affect the device.

Theft Detector or Security Screening Devices

Please use care when approaching theft detectors and security devices (such as those found in airports, libraries, department stores, and government buildings).

When approaching these devices, you are advised to do the following:

1. Show the security personnel the Participant Card and notify them that you have an implanted medical device in the chin area.
2. If you must pass through the theft detector or security screening device, you are advised to proceed through the security device and keep as far from it as possible. You should not linger near or lean on the security device.

Note: Some theft detectors might not be visible.

Physical Activities and Sports

Use caution and consult your doctor prior to performing activities that may damage or displace your Implantable Stimulator such as diving, boxing, jack-hammering, extreme sports etc.

Implant Identification Card

Carry your implant Identification Card with you at all times. This card supplies information about your Genio system 2.1 and your doctor contact information. In case of a medical emergency or if you need to bypass security, present this card to security or medical personnel.

Device Charging

Your Activation Chip must be charged on a daily basis in order to be fully charged for the next night of use.

The Genio AC battery capacity may degrade by up to 20% following 500 charging and discharging cycles. When waking up after the treatment, if you do not feel stimulation, contact your doctor as soon as possible.

Cleaning your Devices

You shall ensure devices are kept in a clean environment. The Activation Chip should be kept in the provided protective cover when it is not in use or not being charged. Do not attempt to clean the devices. If functionality is compromised due to lack of cleanliness, please contact your physician.

Dental Procedures

Patients with the Genio Implantable Stimulator should avoid:

• Injections to the floor of the mouth.
• The use of retractors or other instruments that might exert pressure on or lacerate the floor of the mouth mucosa.

Additionally, it is suggested that a longer course of antibiotics be prescribed during dental procedures in patients implanted with the Genio Implantable Stimulator.

Risks

Medical treatments often cause side effects. You may have none, some or all the side effects listed below, and they may be mild, moderate or severe. If you have any side effects, or are worried about them, consult your doctor. Risks of using the Genio system 2.1 can be minimized by following the Instructions for Use, and by following your doctor’s instructions.

In addition to the risks described below, the device may have other risks that are currently unknown. You should immediately inform your doctor or a member of his/her team if you have any side effects, and you should inform them upon appearance of any other health issues. You should also inform them about any other treatments prescribed to you by doctors other than those caring for you.

If a severe side effect or reaction occurs, your doctor may need to stop your therapy. Your doctor will discuss the best way of managing any side effects with you.

If you have any questions on these adverse events, consult your doctor.

Risks Associated With the Implantation Procedure

For the purpose of device implantation, you will undergo a surgery procedure under general anesthesia. Whilst anesthesia is generally very safe nowadays, there is always the possibility of some risks associated with anesthesia. The commonly known risks associated with use of anesthesia can include cardiac events, thrombo-embolic events, respiratory complications, allergic reactions, gastro-intestinal disturbances amongst others. Most of these anesthesia-related events are uncommon and are generally resolved quickly. The risk of brain damage or death due to anesthesia is very low.

The risk of problems from anesthesia increases for people who have frequent surgical procedures within a short timeframe and participants with other high-risk diseases. If you have any concerns about these issues, you should discuss them with your doctor.

The anesthesia and implantation surgery may involve the following risks:

Very common risks (which may affect more than 1 in 10 participants)

• Post-surgical mild to moderate pain, discomfort, stiffness or tenderness at the implant site.
• Impaired or painful swallowing.
• Impaired or painful speaking due to the procedure.
• Paraesthesia (sensation of tingling or itching).
• Bleeding (including haematoma).
• Abnormal scarring or healing problems.

Common risks (which may affect between 1 in 10 and 1 in 100 participants)

• Bruising or inflammation at the site of injections.
• Post-surgical hoarse voice due to anesthesia.
• Post-surgical headache, dizziness.
• Damage or trauma to nerves, blood vessels or muscles.
• (Transient) tongue weakness or soreness Local skin irritation.
• Post-surgical diarrhea.
• Tongue fasciculations (twitching of tongue) or spasm.
• Muscle or skin tightness.
• Post-surgical pain/complication due to the position on the table during the procedure (head extension, body position).
• Infection.

Uncommon risks (which may affect less than 1 in 100 participants)

• Post-surgical numbness, tingling or other sensory changes related to the skin incision.
• Pain or irritation in the throat or nasal passage from intubation.
• Feeling unwell or vomiting.
• Dry mouth.
• Post-surgical discomfort.
• Temporary lip weakness.
• Post-surgical fever.
• Superficial skin infection.
• Impaired sense of taste.
• Increase or decrease in size of the tongue muscle and/or fat.
• Persistent pain at the implant site.
• Post-surgical irritability, nervousness, confusion, fatigue.
• Post-surgical sleep problems like insomnia or sleepiness.
• Post-surgical respiratory complications requiring ventilation.
• Aspiration (i.e. food/fluid directed to windpipe when swallowing).
• Allergic reaction to anesthetics or other medications used before, during, or after the surgery.
• Risks associated with use of anesthesia including cardiac events, thrombo-embolic events, respiratory complications, allergic reactions, gastro-intestinal disturbances amongst others.

Risks associated with the devices and the use of the devices

The potential device-related adverse events are listed below:

Very common risks (which may affect more than 1 in 10 participants)

• Temporary local skin irritation.
• Impaired or painful swallowing due to the device.

Common risks (which may affect between 1 in 10 and 1 in 100 participants)

• Discomfort or pain due to electrical stimulation.
• Mild tongue abrasion.
• Abnormal scarring.
• Tongue fasciculations (twitching of tongue).
• Dry mouth .
• Temporary tongue muscle weakness or soreness.
• Temporary usability or functionality issues with an external device leading to temporary delay of treatment.
• Permanent usability or functionality issues with an external device leading to no therapy.
• Usability or functionality issues with the implanted device.
• Increased or continued snoring.
• Pain or irritation in the throat or nasal passage.
• Mild to moderate pain, swelling, stiffness or tenderness at the implant site or with the use of the device.
• Infection.

Uncommon risks (which may affect less than 1 in 100 participants)

• Impaired sense of taste or metallic taste.
• Increased acid reflux.
• Headache or dizziness.
• Fatigue or sleep disturbances, while acclimating to the stimulation.
• Increased upper airway secretions.
• Paresthesia (sensation of tickling or itching).
• Mouth blisters (due to tongue rubbing against teeth during stimulation).
• Allergic and/or rejection response to the implanted device.
• Damage to tissue (nerves, blood vessels or muscles) in contact with the implant or in the vicinity of the implant.
• Damage to tissue in contact with external devices.
• Persistent pain at the implant site.
• Impaired or painful speaking due to the device.
• Clinically significant implant migration (device moving from implanted location and potential partial or complete expulsion of the device from its intended place).
• Risks related to additional surgery or anesthesia, and any unstudied potential effect.
• Change in salivary flow.

Risks Associated With a Revision Surgery

If an additional surgery is performed in order to have the implant removed, replaced or repositioned the risks associated with the implantation procedure detailed above, along with some new risks, would apply to the revision surgery. The risks of a revision surgery are higher because scar tissue builds up around the implanted device. Also, the risk of infection from the surgery is slightly higher. Injury to nerves, blood vessels or tissues around the implanted device could occur.

Risks Associated With Pregnancy

The general anesthesia performed for the implantation surgery may present risks for the embryo if you are pregnant. In addition, the effects of the Genio system 2.1 on the unborn child and on the new-born are not known. Because of this, you cannot be implanted if you are pregnant or trying to become pregnant.

If you become pregnant after being implanted, the device should remain OFF during pregnancy.

Storage and Handling

External system components must be stored at a secure, cool and dry place.

Do NOT expose the products to direct sunlight.

Temperature

Keep your Genio external devices at ambient temperature conditions, 15°C-27°C.

Humidity

Keep your Genio external devices away from extremely humid areas and sources of water.

Expiration Date

Disposables Patches should not be used after the expiration date. Expiration date is indicated on component’s packaging labels.

Handling

The components of the Genio system 2.1 should be handled with care.

• The Activation Chip metal pins at the bottom of the chip should not be in contact with any surface except for the Disposable Patch, the Charging Unit docking area or the Activation Chip protection cover.
• The devices should not be placed on any metallic surfaces.
• We recommend that you leave the Activation Chip in the Charging Unit all day to ensure it will be fully charged for the next night of use.
• Make sure to close the zipper of the bag containing the new Disposable Patches, to avoid any moisture/humidity that may affect the adherence properties of the patches.
• In case the AC mechanical interface with DP is loosened, the device should be returned to your doctor.

Traveling with your Devices

Be cautious when traveling with your devices.

Follow the package and transport conditions of the different components:

• Transportation conditions: temperature -10 to 55°C, humidity 15%-80%.
• Always transport the Activation Chip in its protective cover.
• Do not fold the Disposable Patches before use.
• Disconnect the Charging Unit from its adapter.

In case of damage to the device or the package due to exposure to environmental conditions outside the specifications, Do NOT use the device and report the problem to your doctor at the earliest opportunity.

EMC Warnings

• Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally.
• Use of accessories, transducers and cables other than those specified or provided by the manufacturer of this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation.
• Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the Genio System 2.1, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.
• The Genio System 2.1 needs special precautions regarding EMC and needs to be installed and put into service according to the specific instructions for maintaining basic safety and essential performance with regard to electromagnetic disturbances for the expected service.

Wireless Communication

Communication interference between the smartphone and the activation chip may be temporarily disturbed by other wireless devices or proximity of your activation chip to large metallic surfaces. To reduce or stop interference, move away from the source. The effect is temporary and will not damage your device.

Devices Disposal

Genio External devices are considered electronic waste. At the end of use return AC and CU to your doctor at the earliest opportunity. DP should be disposed according to local laws and regulations for electronic waste disposal.

Summary of Safety and Clinical Performance

Summary of Safety and Clinical Performance reports are available below. They will be published in the European Database on Medical Devices (EUDAMED) upon database official release.

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Published on January 20, 2025 | Reference LAB-0001240 Rev. 4.0

Instructions for Use (IFUs) for Genio system 2.1

Surgeon IFU

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Patient IFU

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Technical Sleep Lab IFU

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Published on March 18, 2025