FCC ID: 2AUH802 SoundBite Hearing System

Patient Instructions for Use (IFU)

& Information Guide For the SoundBite Hearing System by Sonitus Medical Welcome Congratulations on your choice of the SoundBite Hearing System from Sonitus Medical, You are now ready to use Sonitus Medicals highly advance bone conduction sound processor, featuring sophisticated signal processing and wireless technology. This manual provides comprehensive tips and advice on the best way to use and care for your SoundBite device. By reading this manual and then keeping it handy for future reference, you will ensure that you get the most benefit out of your SoundBite device. Manual of SoundBite Hearing System G4 Table of Contents 1 . Indications for Use 2 . Operating Instructions 3 . Cleaning and Daily Care 4 . Troubleshooting 5 . Warnings and Cautions 6. Symbolic information and explanation 7. Technical Description 8 .Warranty 9 . EMC Compliance Statement 10. Parts List 02 04 07 09 10 12 13 15 16 20 1.Indications for Use The SoundBite Hearing System is a non-surgical and removable bone conduction hearing device designed to transmit sound through the teeth. 1.1 Intended use of product The SoundBite Hearing System is intended for patients 18 years and older with the following indications:

Patients with moderately severe, severe, or profound sensorineural hearing loss in one ear and normal hearing in the other ear (i.e. single sided deafness or "SSD"). Normal hearing is defined as a pure tone average (PTA) air-conduction (AC) hearing threshold

(measured at 0.5, 1, 2, and 4 kHz) of better than or equal to 25 dBHL. Patients with conductive hearing loss where the pure tone average bone-conduction hearing threshold (measured at 0.5, 1, 2, and 4 kHz) is better than or equal to 25 dB HL. Note The Physician must review the patient IFU with the patient as part of the fitting process. 1.2 Contraindications The SoundBite Hearing System and all portions of it are contraindicated for use in an MRI Environment and should be removed prior to MRI exposure. The SoundBite Hearing System is not to be used in patients with known hypersensitivity to any of the components including allergies to polymers. The SoundBite Hearing System is contraindicated for vulnerable populations that are unable to use their hands such as paraplegics or others that are unable to comply with the warnings in the product's labeling. 1.3 Product composition Additionally, use of SoundBite is intended for patients with:

At least two contiguous molar or premolar teeth with no untreated tooth decay. Patients with tooth decay present are to first have restorations before being fitted for SoundBite;

Healthy attachment to those teeth with tooth pockets limited to no more than 5mm;

No mobile teeth;

Bone loss no greater than a 34% average on the mesial and distal sides of the tooth as measured on X-ray on the teeth on which the device will be worn. The SoundBite Hearing System mainly consists of a behind-the-ear device (BTE), an In-the-mouth unit (ITM) and a charging system. Behind-the-ear (BTE) Microphone unit The BTE unit is worn on the ear that has the most hearing loss. A small tube connects the BTE unit to a microphone that is attached to a flexible ear dome and positioned in your ear canal. The BTE unit contains a signal processor that processes sound and transmits the signal wirelessly to your In-the-Mouth (ITM) device. It is removable and rechargeable when docked in the Charger. I n d i c a t i o n s f o r U s e 02 When fully charged, the BTE unit has an average of 10 hours of operational battery life. In-the-mouth (ITM) device The ITM device is individually made and worn on your upper molars on one side of your mouth. The ITM device receives the wireless signal from the BTE unit, and converts the sound signals into tiny vibrations that are sent via your teeth, to your skull, and ultimately to your working inner ear. It is removable and rechargeable when docked in the Charger. When fully charged, each ITM device has an average of 8 hours of operational battery life. Charging system The G4 SoundBite Hearing System is with charging system. The accessories include power adapter and connecting cable, which can charge both ITM and BTE, and can be fully charged within 4 hours. Charging system Behind-the-ear(BTE) Microphone unit In-the-mouth

(ITM) device Connecting cable Power Adapter Warning Use only the system Charger and power adapter provided. Other power adapters may look similar but may cause damage to your SoundBite device I n d i c a t i o n s f o r U s e 03 2. Operation instructions 2.1 Charging batteries 1. Connect the power adapter, cable and charger case, and switch on the power supply. 2. (As shown in the right), the LED indicator on the outside of case is flashing, which indicates power on. 3. Ensure that BTE and ITM dry. 4. Snap BTE and ITM into the slot of charging dock respectively (as shown in the right figure). 5. When the indicator light corresponding to the light flash, it indicates that the device is charging; when the corresponding three lights is on, it indicates that the charging of device is completed. 6. After the power is exhausted, it can be fully charged within 4 hours. Visual indicators (all light flashes are white) Light Charger battery LED indicator ITM dock LED indicator BTE dock LED indicator One light flash The second light flash The third light flash Three lights on All three lights flash Low Battery Less than 30%

Battery Battery Less than 60%

Less than 90%

100%

fully charged Charger failure ITM failure BTE failure 7. If the light is not on, make sure that the device is placed correctly in the charging dock. Attention Illustrations shown here demonstrate proper orientation of ITM and BTE Each device will snap into place. If lights do not illuminate, please ensure that devices are fully seated in dock Be sure that the ITM is dry before placing it in the Charger. Do not insert a wet ITM, wet finger, or any other wet instrument into the charger dock. O p e r a t i o n i n s t r u c t i o n s 04 2.2 Use of BTE and ITM 1. Once the ITM and BTE are fully charged (three indicator lights are on), remove them one at a time from the Charger. 2. Snap the ITM device on upper back teeth in the correct orientation for a snug fit. 3. Place the BTE unit on impaired ear as shown, with the BTE unit resting comfortably behind your ear and the dome just inside the ear canal. 4. Both BTE and ITM shall be comfortable to wear. If you feel uncomfor table, please re-wear or consult a hearing care professional. 5. The ITM device and BTE unit will link automatically when you put them on and immediately begin to transmit sound. The ITM and BTE remain on until the batteries are exhausted or they are placed in the charger. Beeps (the beeps are only audible to the ITM) Function on the device Audible indicator What it means Short press the top/bottom of the volume button Short press the top/bottom of the volume button 1 beep Volume level increased/

decreased by one step;

None reaction Volume limit reached;

Press and hold top/

bottom of the volume button for more than 3 seconds to change the program once 1-4 beeps Change program. Number of beeps indicates the number of the current program. P1 P4 P2 P3 6. Your SoundBite device can be fitted with up to four programs suitable for different listening environments. No press any button Note You can also change program and adjust the volume directly from Smart phone APP, for full compatibility details and more information visit www.sonitus.com. Low battery warning 3 sequential beeps Attention If BTE and ITM are placed in a distance within 23 cm, the connection will be established. It may give whistling. When BTE or ITM is inserted into the slot of charging dock, it will enter the standby state for power saving (stop whistling). Do not wear ITM when going to sleep. O p e r a t i o n i n s t r u c t i o n s 05 2.3 System reset When the BTE unit or ITM device is reinserted into its Charger dock, the device will reset itself after 10 seconds. This reset feature may be useful if the link between ITM and BTE is unexpectedly lost or should any unusual sounds or other conditions appear. Note System reset can be realized regardless of external power connected or not. This method can be used to reset the device in case of disconnection, abnormal sound and other conditions during use. 2.4 Low battery indicator When the BTE unit or ITM device battery is low, you will hear three sequential beeps that indicate you need to charge your device. Note To maximize battery life, place the ITM and BTE devices correctly into their charger docks when they are not in use. 2.6 Eating While Wearing Your In- The-Mouth (ITM) Device So that you may fully participate in social situations, the ITM device is designed so that it may be worn at your discretion while eating. For safety, the device is designed to be large enough to prevent accidental swallowing. Nonetheless, extra caution should be taken to avoid swallowing the ITM. Be sure to rinse the ITM device after each meal. Prior to eating with the ITM device in your mouth you should carefully read the General Warnings and Precautions section of this manual. 2.7 Signal interference The SoundBite Hearing System contains a wireless radio link that allows the BTE unit to transmit audio picked up from the impaired ear and transmit it to the ITM device. The low power wireless technology is designed to allow an operating range within the proximity of the head. As with any wireless system, SoundBite may be susceptible to interference from other common radio frequency (RF) devices, such as hand-held computer devices or mobile phones. Consult the Warnings and Precautions sections for more information. If the system encounters RF interference, the wireless link between the BTE and ITM may be affected, resulting in no audio output. The link will be reestablished automatically once the interference is removed and audio will resume. If the system does not recover, you may need to perform a System Reset before putting the devices back on. The system has been tested and complies with all applicable wireless and safety standards and has been tested for interference with O p e r a t i o n i n s t r u c t i o n s 06 typical RF devices. Consult the Technical Description for more detail regarding the wireless technology, testing performed on the system, compliance statements and additional electromagnetic guidance. 3. Cleaning and Daily Care Make sure that your SoundBite Hearing System is properly maintained on a daily basis. 2.8 Waste disposal 3.1 Cleaning your ITM Device Discards concerning this product, such as metals, electronic components and non-degradable substances, as well as the product end of life, would pose risks to the environment and health if not disposed properly. Please depose in accordance with the local regulations. Rinse the ITM thoroughly after each meal;

Clean the ITM daily within 24 hours of removal;

Soak the ITM in warm water (enough to cover the device) and antibacterial denture cleaner (e.g. Efferdent Antibacterial Denture Cleanser) for at least 15 minutes, Do not soak ITM in denture cleaner overnight;

Brush for at least 1 minute to remove food particles using a soft bristle toothbrush and warm water;

Rinse the device with warm water;

Dry with a clean, soft lint-free cloth;

Be careful not to drop the ITM to avoid damage;

Note Do not clean the ITM with denture cleaner more than once per day;

Do not use mouthwash or alcohol-containing detergent to clean ITM;

Do not wash ITM in dishwasher, microwave oven or boiling water;

Do not use oral irrigator or dental ultrasonic equipment to clean ITM;

Do not take drugs orally when wearing ITM;

C l e a n i n g a n d D a i l y C a r e 07 3.2 Cleaning your BTE unit 3.4 Cleaning the ITM tray Clean BTE and its components daily;

Wipe BTE, microphone and earplug with a soft and damp cloth;

Inspect the microphone and dome for earwax, and if earwax is Clean following the directions on the denture cleaner label Brush for 1 minute to remove food particles using a soft bristle toothbrush and water. found, clean with wax loop or pipe cleaner;

Ensure brush reaches corners of charger tray including gold metallic contacts After cleaning, rinse the tray under running water Dry with a clean lint-free cloth after cleaning Do not soak ITM tray in denture cleaner overnight Do not clean with denture cleaner more than once per day Be sure that the Charger is unplugged before cleaning. Be sure that the Charger docks are dry before plugging the Charger back into the wall. Note Remove the BTE before applying hair products to avoid staining or soiling the BTE Do not rinse the BTE underwater as this may damage the device Microphone tubes and domes may be replaced when they become stiff, brittle or discolored. To replace a dome, peel it gently from around the microphone barrel DO NOT pull excessively on the microphone tube If the dome comes off in your ear and you are unable to remove it safely, contact your treatment provider immediately. 3.3 Cleaning your Charger Wipe the exterior Charger surfaces with a damp cloth as necessary Remove the ITM charging dock tray (ITM tray) by pinching the finger rests and lifting up as shown Clean the ITM tray daily with antibacterial denture cleaner C l e a n i n g a n d D a i l y C a r e 08 4.Troubleshooting If the problem persists, please contact the customer service center of Sonitus Medical or your hearing health expert. Problem Measure No sound 1. Plug ITM and BTE into the charging dock for 10 seconds to reset the system. Then take out and bring them closer together to establish a 2. connection, and you will hear a whistling. If the whistling is not heard and the connection is not established, plug ITM and BTE into the charging dock for 20 minutes and repeat the step

"1". 3. Make sure there is no gap at the connection between BTE and microphone, and the transparent connecting tube is not damaged. Sound output is too low, or clicking or humming is heard Short working time of ITM or BTE 1. Inspect the transparent connector between your BTE and the microphone tube. If you see damage, contact Sonitus Medical Customer Service for a replacement microphone. 2. Inspect the end of the BTE microphone tube where the ear dome is attached to confirm that the open slots are unobstructed. If earwax is found, clean with wax loop or pipe cleaner. 1. Before wearing them, ensure that ITM and BTE devices are fully charged by leaving them in the charger until the indicator three lights all 2. illumined. If you carry your devices during the day for later use, we recommend that you place correctly them in the charger slots, which will power down the devices and preserve battery life. 3. The SoundBite Hearing System battery life is dependent on the sound environment. Reducing time spent in noisy environments can slightly extend battery life. Whistling when wearing 1. Whistling may occur in a closed environment, in a small space, or near a hard reflective surface. Adjust your position to eliminate whistling. 2. Make sure the microphone earplug is not inserted too deep into the ear canal. 3. Place ITM and BTE on the charging dock for 10 seconds to reset the system and then re-wear. If the whistling is frequent or persistent, it may require help from a hearing health expert. ITM fit is uncomfortable If the ITM fit is too tight or causes discomfort, you should make an appointment with your clinician for an adjustment. If you sense a sore spot in the soft tissue of your mouth from wearing the ITM, please contact your SoundBite Partner Dentist. Light of charging dock not on or flash 1. Check the charger power indicator light to ensure it is one light flash or three lights on when the unit is plugged in. If not, remove and reconnect Charger power adapter or try a different electrical outlet. 2. If the dock indicator lights do not illuminate or flash on and off, inspect BTE, ITM, and ITM Tray contacts for debris and ensure that the devices snap securely into the charger docks according to the instructions provided. T r o u b l e s h o o t i n g 09 5. Warnings and Cautions 5.1 Warnings 1. The SoundBite Hearing System and all portions of it are contraindicated for use in an MRI Environment and should be removed prior to an MRI exam or MRI Exposure. Keep the SoundBite Hearing System components away from strong magnetic fields. 2. If the ITM device is swallowed, seek emergency medical care immediately. Ask the emergency professional to contact your treatment provider for information regarding the SoundBite device. 3. Do not use alcohol or drugs while wearing the device as alcohol and drug use can affect your gagging reflex and could increase the chance that you could swallow the ITM device. or pain due to electrical current, immediately remove all components of the system and contact your treatment provider and Sonitus Medical. 8. Keep all components out of the reach of children, pets, or anyone who might swallow them or otherwise be at risk of being harmed by the device. If any component is swallowed, seek emergency medical attention immediately. 9. BTE and ITM are matched and customized for individuality and not applicable to others. Otherwise, it may cause harm. 10. If ITM is bitten by force inadvertently, please stop using it and contact a hearing care professional. 11. Only the components of the matching charging system (power adapter, charging line, charging dock or pocket charger) can be used. Even other power adapters look similar, but may cause damage to the product. 4. If your mouth or the skin in or behind your ear gets sore or irritated, please contact your treatment provider 12. Portable and mobile radio frequency communication equipment may affect BTE and ITM. 5. Do not play sports while wearing the device because physical contact with your mouth may damage your teeth and the device attached to those teeth. 6. Be sure that the ITM device unit is dry before placing it in the charger. Do not put a wet device, wet finger, or any other wet instrument into the charger or charging dock. 7. The ITM device and BTE unit components of the SoundBite Hearing System contain batteries that, in some rare occurrence, could malfunction in a way that may potentially cause discomfort or pain due to electrical current flow. If you notice any discomfort 13. Do not cross-use wi th other hearing equipment. If necessary, consult a hearing health expert. 14. Do not disassemble the product. Do not place the product in an environment with temperature higher than 60. Do not place the product in an incinerator that decomposes waste by thermal energy for disposal. 15. Make sure to clean the charging dock with power off. Make sure the power adapter is dry before inserting it into the socket. W a r n i n g s a n d C a u t i o n s 10 5.2 Precautions 1. Do not wear BTE when showering, bathing or swimming. 2. Do not throw BTE and ITM to avoid damage. Handle with care. Start with soft foods and chew with the side opposite to ITM as much as possible. Food that is too sticky or too hard is not easy to chew. Sticky food and chewing gum may cause difficult to clean ITM, 3. Keep BTE and ITM away from exposure to high temperature or and may also affect its function. Most foods and drinks are not harmful to ITM. After eating, ITM should be cleaned thoroughly to ensure its normal operation and maintain oral hygiene. 11. Please use the designated cleaning products to clean, and avoid other detergents which may cause damage to ITM. 12. The Company has not claimed that the mobile phone can be used in conjunction with the SoundBite Hearing System. 13. The multiple systems in distance less than 30cm may interfere with each other. 14. Some devices, including computers, burglary protection systems and mobile phones, may interfere with the SoundBite Hearing System even if they meet the radiation requirements of the International Special Committee on Radio Interference (CISPR). long-term sunshine. 4. If you have a history of recurrent dizziness or similar symptoms when wearing the hearing system, stop wearing it and consult a hearing health expert. 5. Approaching radiation devices such as X-ray machine or computed tomography (CT) may affect the working effect temporarily. Please remove BTE and ITM. 6. Do not stay in the area of electromagnetic security system such as burglar alarm system and metal detector security system for a long time to prevent interference with the hearing system. 7. At some security checks, such as near the airport security check system, remove all parts of the hearing system and inform the security personnel if necessary. 8. Do not disassemble any parts after the product has been adapted by the hearing health expert. Any change or maintenance of the product must be conducted by the Company's designated and certified agent. 9. If any part of the product fails or is damaged, stop using it and contact a hearing health expert. 10. If you wear an ITM to eat, the following precautions are recommended:

W a r n i n g s a n d C a u t i o n s 11 6. Symbolic information and explanation Manufacturer Consult the instructions Attention! Consult the attached documents Serial number Direct Current UDI Non-ionizing radiation BF type application part Alternating Current MR unsafe Dispose of in accordance with WEEE Upper and lower temperature limits to be marked near the upper and lower horizontal lines. Humidity limits to be shown near the upper and lower transverse lines. Atmospheric pressure limit to be shown near the upper and lower transverse lines. Important information on operation and product safety Class II equipment Non-sterile Keep dry No latex Indoor use only S y m b o l i c i n f o r m a t i o n a n d e x p l a n a t i o n 12 7.Technical Description Dimensions:

ITM 35 x 28 x 25mm (approximately) BTE 15 x 9 x 30mm Charger 60 x 30 x 100mm Weight:

ITM 5g BTE 1.5g Charger 75g 7.1 Classification of electrical safety Charger CLASS II ITM and BTE INTERNALLY POWERED EQUIPMENT TYPE BF ITM BTE IPX7 IPX2 7.2 Ambient Conditions Working conditions:

Power supply voltage and frequency: 100-240 VAC, 50/60 Hz;

Rated input: 0.2A. Charger and BTE: 0 ITM: 10 Atmospheric pressure: 70kPa~106 kPa. to 40

(50 to 104 to 40

(32

) to 104

) @ 5~95% Rel. Humidity;

@ up to 100% Rel. Humidity;

Storage and transport conditions:

-20 Atmospheric pressure: 61 kPa~101 kPa. to 113 to 45

(-4

) < 85% Rel. Humidity;

7.3 Wireless technology Type: Near Field Magnetic Induction (NFMI) Operating frequency: 10.597MHz Bandwidth of receiver: 380kHz Modulation type: CPFSK Channel data rate: 298 kbps Wireless range: 25cm(10 inches) Effective radiated power: < -10dBm 1. By degree of safety when using flammable anesthetic gas mixed with air or oxygen or nitrous oxide: device that cannot be used when there is flammable anesthetic gas mixed with air or flammable anesthetic gas mixed with oxygen or nitrous oxide. 2. By operation mode: uninterrupted operation. 3. By disinfection and sterilization method: subject to manufacturer's regulations. Security Safety features of wireless technology for SoundBite Hearing System include: SoundBite Patient-specific information is not stored in BTE or ITM. The wireless signal of SoundBite Hearing System is only close to the user's head, so any interference to the system requires a very close distance. T e c h n i c a l D e s c r i p t i o n 13 Audio sent over wireless connection is all compressed by ITU G.722 code. RF exposure The SoundBite Hearing System is tested to conform to IEEE C95.1 the IEEE Safety Level Standard for Human Contact with 3 kHz ~

300 GHz RF Electromagnetic Fields to ensure that the system will not produce unsafe radiation levels to patients. FCC Compliance Statement FCC ID: 2AUH802 This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. Changes or modifications not expressly approved by Sonitus Medical could void the user's authority to operate the equipment. This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures:

T e c h n i c a l D e s c r i p t i o n 14 Reorient or relocate the receiving antenna. Increase the separation between the equipment and receiver. Connect the equipment into an outlet on a circuit different from that to which the receiver is connected. Consult the dealer or an experienced radio/TV technician for help. 7.4 Acoustic performance 0SPL90 loudest output (dB re. 1 uN): max. < 135dB, System frequency response range (Hz): 1200Hz-8200Hz, Total harmonic distortion + Noise (dB) 1000Hz

() 1500Hz

() 4000Hz

() 6000Hz

-20dB

-15dB

-15dB

-15dB Equivalent input noise (dB re. 1 uN) (): 32 dB. 7.5 External power supply External equipment connected to this product must meet IEC60601 or equivalent safety standards if mains power is used. 7.6 IP classification description 8. Warranty This product has been reasonably controlled in the design and manufacturing process. Under normal wearing conditions, BTE and ITM have a warranty period up to 2 years. In your contract, it is clear when replacement and maintenance can be carried out due to manufacturing defects. classification Brief description Definition IPX0 IPX2 IPX7 Non-protected W h e n t h e v e r t i c a l planes of the ear-back machine are inclined a t 1 5 d e g r e e s , t h e ver tical drip should have no harmful effect. Strong spraying of water in all directions has no harmful effect to ITM. Vertically falling drops shall have no harmful e f f e c t s w h e n t h e enclosure is tilted at any angle up to 15 on either side of the vertical. Ingress of water in q u a n t i t i e s c a u s i n g h a r m f u l e f f e c t s shall not be possible when the enclosure i s t e m p o r a r i l y i m m e r s e d i n w a t e r under standardized conditions of pressure and time. W a r r a n t y 15 8. EMC Compliance Statement The SoundBite Hearing System has passed the compliance test of electromagnetic emission. Cable type Cable description Max. cable length Cable type Cable model List of all cables used in the SoundBite Hearing System USB Type C USB cable, charging cable, used with pocket charger 1m Various Various

Warning: Use of accessories, sensors and cables other than those specified by our Company may result in increased electromagnetic radiation or decreased electromagnetic radiation immunity of the product. The SoundBite Hearing System is expected to be used in the following specified electromagnetic environment, and the purchaser or user shall ensure that it is used in this electromagnetic environment:

Guidance and Manufacturer's Statement - Electromagnetic Emission Launching test Compliance Level Electromagnetic Environment - Guidelines RF emissions CISPR 11 Group 1 RF emissions CISPR 11 Class B Harmonic emissions IEC61000-3-2 Voltage fluctuations/flicker emissions IEC61000-3-3 Class A Compliant The SoundBite Hearing System only uses radio frequency energy for its internal function. Therefore, RF radiation is very low and will not cause interference to nearby electronic equipment. The SoundBite Hearing System is suitable for all places, including family houses and buildings directly connected to the public low-voltage power supply network for civil buildings. E M C C o m p l i a n c e S t a t e m e n t 16 Guidelines and Manufacturer's Statement - Electromagnetic Immunity The SoundBite Hearing System is expected to be used in the following specified electromagnetic environment, and the purchaser or user shall ensure that it is used in this electromagnetic environment:

Immunity test Basic EMC standard or test method Home healthcare facility environment Electrostatic discharge IEC 61000-4-2

+/- 8 kV contact

+/- 2 kV, +/- 4 kV, +/- 8 kV, +/- 15 kV air Radiated RF EM fields IEC 61000-4-3 10V/m 80MHz-2.7GHz 80%AM at 1kHz Proximity fields from RF wireless communications equipment IEC 61000-4-3 See the RF wireless communication equipment table in "Recommended minimum separation distances". Rated power frequency magnetic fields IEC 61000-4-8 30A/m; 50 Hz or 60Hz Electric fast transients bursts IEC 61000-4-4 2kV 100kHz repetition frequency Surges IEC 61000-4-5 Line to line: 0.5kV, 1kV Conducted disturbances induced by RF fields IEC 61000-4-6 3 V in 0.15 MHz - 80 MHz 6 V in ISM and/or amateur radio bands between 0.15 MHz and 80 MHz Voltage dips IEC 61000-4-11 0% UT: 0.5 cycle at 0, 45, 90, 135, 180, 225, 270, and 315 0% UT: 1 cycle and 70% UT: 25/30 cycles sine phase at 0 Voltage interruptions IEC 61000-4-11 0% UT: 250/300 cycle UT: rated voltage(s); E.g. 25/30 cycles means 25 cycles at 50Hz or 30 cycles at 60Hz E M C C o m p l i a n c e S t a t e m e n t 17 Recommended separation distances between portable and mobile RF communications equipment and this device Nowadays, many RF wireless equipments have being used in various healthcare locations where medical equipment and/or systems are used. When they are used in close proximity to medical equipment and/or systems, the medical equipment and/or systems basic safety and essential performance may be affected. This SoundBite Hearing System has been tested with the immunity test level in the below table and meet the related requirements of IEC 60601-1-2:2014. The customer and/or user should help keep a minimum distance between RF wireless communications equipment and this SoundBite Hearing System as recommended below. Test frequency(MHz) Band (MHz) Service Modulation Maximum power (W) Distance (m) Immunity test level (V/m) 385 450 710 745 780 810 870 930 380-390 TETRA 400 430-470 GMRS 460 RFS 460 704-787 LTE Band 13, 17 Pulse modulation 18 Hz FM 5 kHz Deviation 1 kHz sine Pulse modulation 217 Hz 800-960 GSM 800/900; TETRA 800;

iDEN 820; CDMA 850;

LTE Band 5 Pulse modulation 18 Hz 1970 1700-1990 GSM 1800; CDMA 1900;

GSM 1900; DECT;

LTE Band 1,3,4,25; UMTS Pulse modulation 217 Hz 2450 2400-2570 Bluetooth, WLAN, 802.11 b/g/n, RFID 2450, LTE B Pulse modulation 217 Hz 1.8 2 0.2 2 2 2 5240 5500 5785 5100-5800 WLAN 802.11 a/n Pulse modulation 217 Hz 0.2 0.3 0.3 0.3 0.3 0.3 0.3 0.3 27 28 9 28 28 28 9 E M C C o m p l i a n c e S t a t e m e n t 18 For the maximum rated output power of the transmitter not listed in the table above, the recommended isolation distance d, in meter (m), can be determined by the formula in the corresponding frequency column of transmitter, where P is the maximum rated output power of the transmitter provided by the transmitter manufacturer, in watts (W). Note 1: At frequency points of 80 MHz and 800 MHz, the formula of higher frequency band is used. Note 2: These guidelines is possible not suitable for all situations. Electromagnetic propagation is affected by the absorption and reflection of buildings, objects and human bodies. Warning: SoundBite Hearing System may not be used close to or superimposed on other devices. If it must be close to or superimposed in use, it shall be observed and verified that it can operate normally under the configuration applied. E M C C o m p l i a n c e S t a t e m e n t 19 10. Parts List Part name Number In-the-Mouth ITM hearing device Behind the ear BTE microphone unit Charger Power Adapter Cable Instructions Warranty card (include certificate of quality) 1 1 1 1 1 1 1 Standard Standard Standard Standard Standard Standard Standard P a r t s L i s t 20 Manufacturer: Sonitus Medical (Shanghai) Co., Ltd. Address: Room 501, No. 11, Lane 500, Furonghua Rd., Pudong New Area, Shanghai, China Tel: (86) 021-60879088 Zip: 201318 Date of Production: See product package Service life: 5 years Preparation date of manual: Feb of 2023 Revision: 01 This Manual only lists general information. If you have any questions and/or demand about this Manual, please contact your hearing care professional or customer service of Sonitus Medical. Copyright 2023 Sonitus Medical (Shanghai) Co., Ltd. 1 0

2 0 2 0

1 1

P M

SoundBite HEARING SYSTEM Model: G4 FCC ID: 2AUH802 Input: 100-240V~,50/60Hz,0.2A Charger LOT: 80XXXXXXXX_ Ww) Gl &

rm | Sonitus Medical (Shanghai) Co., Ltd. fee) Consult Instructions for Use(Mark is Blue) LBLO207-1 a eee Hilt n

Sonitus Medical (Shanghai) Co., Ltd. Dec 25, 2023 Eurofins Electrical and Electronic Testing NA, Inc. 914 West Patapsco Avenue Baltimore, MD 21230 RE: LETTER OF AGENT AUTHORIZATION To Whom It May Concern:

We, the undersigned, hereby authorize (ZhaoZixuan at TA Technology(Shanghai) Co., Ltd.) to act on our behalf in all matters relating to application for equipment authorization, including the signing of all documents relating to these matters. We also hereby certify that no party to the application authorized hereunder is subject to the denial of benefits, including FCC benefits, pursuant to Section 5301 of the Anti-Drug Abuse Act of 1988, 21 U.8.C.853(a). This agreement expires one year from the current date. Sincerely, Signature: 7 t jana Print name: Ji Yang Company: Sonitus Medical (Shanghai) Co., Ltd.

(Sonitus Medical (Shanghai) Co., Ltd. ) Federal Communications Commission Authorization and Evaluation Division 7435 Oakland Mills Road Columbia, MD 21046 USA Date: 12-25-2023 Ref: Attestation Statements Part 2.911(d}{5)(i) Filing FCC ID: {2AUH802)

[Sonitus Medical (Shanghai) Co., Ltd. ] (the applicant) certifies that the equipment for which authorization is sought is not covered equipment prohibited from receiving an equipment authorization pursuant to section 2.903 of the FCC rules. Sincerely,

(Applicant signature) yi fond

(Applicant printed name): Ji Yang Rev 1/26/2023

(Sonitus Medical (Shanghai) Co., Ltd. ) Federal Communications Commission Authorization and Evaluation Division 7435 Oakland Mills Road Columbia, MD 21046 USA Date:12-25-2023 Ref: Attestation Statements Part 2.911(d)(5)(ii) Filing FCC ID: (2AUH802)

{Sonitus Medical (Shanghai) Co., Ltd. ] (the applicant) certifies that, as of the date of the filing of the application, the applicant is not identified on the Covered List as an entity producing covered equipment. Sincerely,

(Applicant signature) J i [aug

(Applicant printed name): Ji Yang Rev 1/26/2023

Request for Confidentiality Date: _2023/08/08_ Subject: Confidentiality Request for: FCC ID: 2AUH802 Pursuant to FCC 47 CRF 0.457(d) and 0.459 and IC RSP-100, Section 10, the applicant requests that a part of the subject FCC application be held confidential. Type of Confidentiality Requested Exhibit

[1 Short Term {X] Permanent Block Diagrams XX] Short Term External Photos Short Term (] Permanent*! Internal Photos L] Short Term Permanent Operation Description/Theory of Operation LJ Short Term Permanent Parts List & Placement C1 Short Term LJ Permanent Tune-Up Procedure

(1 Short Term ><] Permanent Schematics Short Term Test Setup Photos X] Short Term CD Permanent* Users Manual

*Note: (Insert Explanation as Necessary) Sonitus Medical (Shanghai) Co.,Ltd. __has spent substantial effort in developing this product and it is one of the first of its kind in industry. Having the subject information easily available to "competition" would negate the advantage they have achieved by developing this product. Not protecting the details of the design will result in financial hardship. Permanent Confidentiality:

The applicant requests the exhibits listed above as permanently confidential be permanently withheld from public review due to materials that contain trade secrets and proprietary information not customarily released to the public. Short-Term Confidentiality:

The applicant requests the exhibits selected above as short term confidential be withheld from public view for a period of _180___ days from the date of the Grant of Equipment Authorization and prior to marketing. This is to avoid premature release of sensitive information prior to marketing or release of the product to the public. Applicant is also aware that they are responsible to notify TCB in the event information regarding the product or the product is made available to the public. TCB will then release the documents listed above for public disclosure pursuant to FCC Public Notice DA 04-1705. NOTE for Industry Canada Applications:

The applicant understands that until such time that IC distinguishes between Short Term and Permanent Confidentiality, either type of marked exhibit above will simply be marked Confidential when submitted to IC. Sincerely, By _ Jt Jang vP JiYang

(Signature/Title?) (Print name)

Sonitus Medical Co., Ltd.

(Shanghai) Bldg. 11-F5, 500 Furonghua Rd, Pudong, Shanghai 201318 Shanghai,201318 China Date: Nov 7,2023 Federal Communications Commission Authorization and Evaluatio11

. Divlsi9h 7435 Oakland Mills Road Columbia, MD 21046 FCC ID: 2AUH802 FRN0028790053 U Agnt Statement I Part 2.911 (d)(7) Attestation co:,Ltd. that as of Nov 1,2023, certifies, we have designated of process on our behalf for FCC ID: 2AUH802. Sonitus Medical ALEMC,LLC to accept

(Shanghai) service Sonitus Medical

{Shanghai)

. UnitStatesfor: no less than one year after either of the applicable Co., Laptsto maintain and Importation on-related within or judicial proceeding involving equipment administrative the grantee has permanently an agent of service of process in the terminated all of any the U.S., or the conclusion is whichever the equipment, marketing Commissf later. ALEMBIC, designated

(Shanghai) as of the date of the filing LLC, accepts agent for the purpose of accepting service Co., Ltd. for FCC ID: 2AUH802. of this application, the obligation of being the of Sonitus on behalf of process Medical Designated Agent Information:

Company Name: ALEMBIC, LLC FRN: 0034461376 Address:

MOUNTAIN VIEW CALIFORNIA, 94043, UNITED STATES 627 NATIONAL AVE MOUNTAIN 94043, VIEW, CALIFORNIA, UNITED STATES Contact Person:

Aaron L. Berez1 MD Phone:650-3885088