Phonak Virto™ I User Guide

Your hearing aid details

If no box is checked and you do not know the model of your hearing aid, please ask your hearing care professional.

Hearing aid models

Introduction

Your hearing aids have been developed by Phonak, a world leader in hearing solutions based in Zurich, Switzerland. These premium products are the result of decades of research and expertise and are designed with your well-being in mind. We thank you for making such a great choice and wish you many years of listening pleasure. Please read the user guide carefully to make sure that you understand and get the best out of your device. Training is not required for handling of this device. A hearing care professional will help set up this device according to your individual preferences during the fitting consultation.

For more information regarding features, benefits, set up, use, maintenance or repairs of your hearing aid and accessories, please contact your hearing care professional or the manufacturer representative. Additional information can be found in the data sheet of your product.

Phonak – life is on www.phonak.com

Your hearing aid

1. Quick guide

Left and right hearing aid markings:

There is a blue marking for the left hearing aid and a red marking for the right hearing aid. These markings are located inside the battery door.

Changing batteries:

1. Remove the sticker from the new battery and wait two minutes.
2. Open the battery door.
3. Place the battery in the battery door with the flat side facing upwards.

On/Off:

The battery door also serves as the on/off switch. Closing the battery door turns the hearing aid ON. Opening the battery door turns the hearing aid OFF. When you switch on the hearing aid, you may hear a start-up melody. ?

Push button*:

The push button on your hearing aid can have various functions. *Applicable only for models with this specific option.

Volume control*:

To increase the volume, turn the volume control forwards (towards the nose). To decrease the volume, turn the volume control backwards (towards the back of the head). The volume control can be disabled by the hearing care professional. *Applicable only for models with this specific option.

2. Parts of the hearing aid

You can identify your personal model by checking "Your hearing aid details" on page 3 or by comparing your hearing aid with the models shown below. Pay attention to the shape and whether a push button or volume control is present.

Model with a push button (available for Virto I-Titanium and Virto I-10 NW O)

Components include: Sound outlet / wax protection system, Push button (optional), Removal handle (optional), Custom-made shell, Battery door.

Model with a volume control (available for Virto I-10 NW O)

Components include: Sound outlet / wax protection system, Battery door, Removal handle (optional), Custom-made shell, Volume control (optional).

Using the hearing aid

3. Left and right hearing aid markings

There is a blue or red marking on the hearing aid to indicate if it is a left or right hearing aid. The color mark is located inside the battery door. For Virto I-10 NW O, you can also select a blue shell for the left device and a red shell for the right device.

4. On/Off

The battery door is also the on/off switch. Closing the battery door turns the hearing aid ON. Opening the battery door turns the hearing aid OFF. ❌

? When you switch on the hearing aid, you may hear a start-up melody.

5. Batteries

This hearing aid requires a size 10 zinc-air battery.

Replacement battery

Please ensure you use the correct type of battery (zinc-air). Please also read chapter 18.2 for further information on product safety.

Battery insertion:

1. Remove the sticker from the new battery and wait two minutes.
2. Open the battery door.
3. Place the battery in the battery door with the flat side facing upwards.

? If it is difficult to close the battery door: Check that the battery is inserted correctly and the flat side is facing upwards. If the battery is not inserted correctly, the hearing aid will not work and the battery door can be damaged.

Low power: You will hear two beeps when the battery is low. You will have approximately 30 minutes to change the battery (this can vary). We recommend that you always have a new battery on hand.

6. Putting on the hearing aid

Take your hearing aid up to your ear and place the custom-made shell part into your ear canal.

7. Removing the hearing aid

7.1 Removing the hearing aid with a removal handle

Hold the removal handle and carefully pull the hearing aid up and out of the ear. ➡️

7.2 Removing the hearing aid without a removal handle

1. Put your thumb behind your lobe and gently press your ear upward to push the hearing aid out of the canal. Make chewing movements with your jaw to help it along.
2. Grasp the protruding hearing aid and remove it.

8. Push button*

The push button on your hearing aid can have various functions or can remain inactive. This depends on the programming of the hearing aid, which is indicated in your individual "Hearing aid instructions". Please ask your hearing care professional for this printout. *Applicable only for the models with this specific option.

9. Volume control*

To increase the volume, turn the volume control forwards (towards nose). To decrease the volume, turn the volume control backwards (towards back of head). The volume control can be disabled by the hearing care professional. *Applicable only for the models with this specific option.

10. Adjusting the hearing aid with the Phonak MiniControl

The MiniControl contains a magnet that functions like a remote control to change the settings of your hearing aid. Your hearing aid in combination with MiniControl can have various functions or can remain inactive, depending on your individual settings. Please ask your hearing care professional for your "Hearing aid instructions".

To use the MiniControl:

1. Unscrew the magnet from the keychain housing.

[Description of keychain housing and MiniControl magnet]

2. While the hearing aid is on, hold the magnet next to the hearing aid.

3. Remove the magnet promptly once your hearing aid is set to the desired program or the volume is ideal for you.

? If you use a medical device like a pacemaker or ICD device: Please read the specific user guide to clarify possible impact of magnetic fields. Do not place the MiniControl in your breast pocket. Keep a distance of at least 15 cm (6 inches) between the MiniControl and any medical device.

11. Listening in public places*

Your hearing aid has a telecoil option that can help you hear in various public spaces such as church, concert halls, train stations, and government buildings. When you see this symbol [Telecoil symbol], a loop system is present and is compatible with your hearing aids. Please contact your hearing care professional for further information and activation of the telecoil function.

How to use your telecoil function

Direct access to the telecoil program is possible via a long press of the push button on your hearing aid. Ensure that you are standing or are seated within the designated loop system area as noted by the official telecoil symbol. *Applicable only for the models with this specific option.

Further information

12. Care and maintenance

Expected Service Life

The hearing aids have an expected service life of five years. The devices are expected to remain safe for use for this duration.

Commercial service period

Routine and diligent care of your hearing aids will contribute to their outstanding performance for the duration of their expected service life. Sonova AG will provide a minimum of a five-year repair service period after the respective hearing aid and essential components have been phased out of the product portfolio.

Please use the following specifications as a guideline. For further information regarding product safety, see chapter 18.2.

General information

Before using hair spray or applying cosmetics, you should remove your hearing aid from your ear, as these products may damage it.

When you are not using your hearing aid, leave the battery door open so that any moisture can evaporate. Make sure that you always completely dry your hearing aid after use. Store the hearing aid in a safe, dry and clean place.

Your hearing aids are resistant to water, sweat, and dust under the following conditions:

• The battery door is fully closed. Ensure that no foreign object such as hair is caught in the battery door when it is closed.
• After exposure to water, sweat, or dust, the hearing aid is cleaned and dried.
• The hearing aid is used and maintained as described in this user guide.

? Use of your hearing aid around water can restrict air flow to the batteries, causing it to stop working. Should your hearing aid stop working after coming into contact with water, refer to the troubleshooting steps in chapter 17.

Daily

Daily cleaning and the use of a drying system is recommended. Never use household cleaning products (washing powder, soap, etc.) to clean your hearing aids. It is not recommended to rinse with water. Clean the surfaces of your hearing aids with a lint-free cloth or a soft brush.

If your hearing aid is performing weakly or fails to operate, clean or replace the wax guard system. If your hearing aid fails to operate after you have correctly cleaned or replaced your wax protection system and inserted new batteries, contact your hearing care professional for advice.

Weekly

For more in-depth maintenance instructions or for more than basic cleaning, please see your hearing care professional.

13. Environmental conditions

The product is designed such that it functions without problems or restrictions if used as intended, unless otherwise noted in this user guide. Please ensure to use, transport, and store the hearing aids according to the following conditions:

14. Service and warranty

Local warranty

Please ask the hearing care professional where you purchased your hearing aid about the terms of the local warranty.

International warranty

Sonova AG offers a one-year limited international warranty, valid from the date of purchase. This limited warranty covers manufacturing and material defects in the hearing aid, but not accessories such as batteries, tubes, earmolds, and external receivers. The warranty only comes into force if a proof of purchase is shown.

The international warranty does not affect any legal rights that you might have under applicable national legislation governing sale of consumer goods.

Warranty limitation

This warranty does not cover damage from improper handling or care, exposure to chemicals, or undue stress. Damage caused by third parties or non-authorized service centers renders the warranty null and void. This warranty does not include any services performed by a hearing care professional in their office.

Serial numbers: Hearing aid left side: ___________ Hearing aid right side: ___________

Date of purchase: ___________

Authorized hearing care professional (stamp/signature): ___________

15. Compliance information

Europe: Declaration of Conformity for the hearing aid

Hereby Sonova AG declares that this product meets the requirements of the Medical Device Regulation (EU) 2017/745. The full text of the EU Declaration of Conformity can be obtained from the manufacturer or the local Phonak representative whose address can be taken from the list on www.phonak.com/en-int/certificates.

Notice 1:

This device complies with Part 15 of the FCC Rules and ICES-003 of Industry Canada. 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.

Notice 2:

This device has been tested and found to comply with the limits for a Class B digital device, pursuant to Part 15 of the FCC Rules and ICES-003 of Industry Canada. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This device 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 device 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:

• Reorient or relocate the receiving antenna.
• Increase the separation between the device and receiver.
• Connect the device 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.

Electromagnetic emissions

Manufacturer's Declaration: The hearing aids are intended for use in the electromagnetic environments listed below. The user should assure that they are used in such environments.

16. Information and description of symbols

CE Mark: With the CE symbol, Sonova AG confirms that this product – including accessories – meets the requirements of the Medical Devices Regulation (EU) 2017/745. The numbers after the CE symbol correspond to the code of certified institutions that were consulted under the above-mentioned regulation and directive.

[Type B applied part symbol]: This symbol indicates that the products described in these user instructions adhere to the requirements for an applied part of Type B of EN 60601-1. The surface of the hearing aid is specified as an applied part of Type B.

[Manufacturer symbol]: Indicates the medical device manufacturer, as defined in the Medical Devices Regulation (EU) 2017/745.

[Date of manufacture symbol]: Indicates the date when the medical device was manufactured.

EC REP: Indicates the Authorized representative in the European Community. The EC REP is also the importer to the European Union.

[Read information symbol]: This symbol indicates that it is important for the user to read and take into account the relevant information in these user guides.

[Warning symbol]: This symbol indicates that it is important for the user to pay attention to the relevant warning notices in these user guides.

[Battery warning symbol]: This symbol indicates that it is important for the user to pay attention to the relevant warning notices related to batteries in these user guides.

[Handling and safety symbol]: Important information for handling and product safety.

[RSM/ACMA symbol]: Indicates a device's compliance with applicable Radio Spectrum Management's (RSM) and Australian Communications and Media Authority (ACMA) regulatory arrangements for the legal sale in New Zealand and Australia.

SN: Indicates the manufacturer's serial number so that a specific medical device can be identified.

REF: Indicates the manufacturer's catalogue number so that the medical device can be identified.

MD: Indicates that the device is a medical device.

[Electronic instructions symbol]: An indication that electronic instructions for use are available.

IP68: Ingress Protection Rating. IP68 rating indicates that the hearing aid is water and dust resistant. It survived continuous immersion in 1 meter of water for 60 minutes and 8 hours in a dust chamber as per the IEC60529 standard.

[Temperature limits symbol]: Indicates the temperature limits to which the medical device can be safely exposed.

[Humidity range symbol]: Indicates the range of humidity to which the medical device can be safely exposed.

[Atmospheric pressure symbol]: Indicates the range of atmospheric pressure to which the medical device can be safely exposed.

[Keep dry symbol]: During transportation keep dry.

Rx: This symbol indicates that this is a Prescription Device. CAUTION: U.S. Federal law restricts this device to sale by or on the order of a physician or hearing care professional (for US only).

MR: This symbol indicates a device that is not safe to use in magnetic resonance (MR) environment (e.g. during an MRI scan).

[Disposal symbol]: The symbol with the crossed-out garbage bin is to make you aware that this hearing aid as well as batteries may not be thrown away as normal household waste. Please dispose of old or unused hearing aids at waste disposal sites intended for electronic waste, or give your hearing aid to your hearing care professional for disposal. Proper disposal protects the environment and health.

17. Troubleshooting

Problem: Hearing aid not functioning.

Problem: Hearing aid whistles.

Problem: Hearing aid too loud.

Problem: Hearing aid not loud enough or distorted.

Problem: Hearing aid plays two beeps.

Problem: Hearing aid switches on and off (intermittent).

Please check www.phonak.com/en-int/support for further information.

? If the problem persists, contact your hearing care professional for assistance.

18. Important safety information

Intended use

Hearing aid: The hearing aid is intended to amplify and transmit sound to the ear and thereby compensate for impaired hearing.

Tinnitus Balance feature: The feature is intended for use by people with tinnitus who also desire amplification. It provides supplementary noise stimulation which can help defocus the user's attention from their tinnitus.

Intended patient population

Hearing aid: The device is intended for patients from 18 years of age which fulfill the clinical indication for this product.

Tinnitus Balance feature: The feature is intended for patients from 18 years of age which fulfill the clinical indication for this product.

Intended user

Intended for people with hearing loss using a hearing aid and their caregivers. A hearing care professional is responsible for adjusting the hearing aid.

Intended medical indication

Clinical indications for the use of hearing aids are:

• Presence of hearing loss
• Uni- or bilateral
• Conductive, sensorineural or mixed
• Grades: mild to severe

Intended medical contraindications

Contraindications for the use of hearing aids and Tinnitus feature are:

• Acute tinnitus (<3 months, after occurrence)
• Deformity of the ear (i.e. closed ear canal)
• Neural hearing loss (retro-cochlear pathologies such as absent/non-viable auditory nerve)

Clinical benefit

Hearing aid: Improvement of speech understanding. Tinnitus Balance feature provides supplementary noise stimulation which can help defocus the user's attention from their tinnitus.

Side effects

Physiological side-effects of hearing aids like tinnitus, dizziness, wax build up, too much pressure, sweating or moisture, blisters, itching and/or rashes, plugged or fullness, and their consequences like headache and/or ear pain, may be resolved or reduced by your hearing care professional.

Conventional hearing aids have the potential to expose patients to higher levels of sound exposure, which might result in threshold shifts in the frequency range affected by acoustic trauma.

A hearing aid will not restore normal hearing and will not prevent or improve a hearing impairment resulting from organic conditions. Infrequent use of a hearing aid does not permit a user to attain full benefit from it. The use of a hearing aid is only part of hearing habilitation and may need to be supplemented by auditory training and instruction in lipreading.

Hearing aids are suitable for the home healthcare environment and due to their portability, it may happen that they are used in professional healthcare facility environments like physician offices, dental offices, etc.

Feedback, poor sound quality, too loud or too soft sounds, inadequate fitting, or problems when chewing or swallowing, can be resolved or improved during the fine-tuning process at the fitting procedure by your hearing care professional.

Any serious incident that has occurred in relation to the hearing aid should be reported to the manufacturer representative and the competent authority of the state of residence. The serious incident is described as any incident that directly or indirectly led, might have led, or might lead to any of the following:

• The death of a patient, user, or other person;
• The temporary or permanent serious deterioration of a patient's, user's, or other person's state of health;
• A serious public health threat.

To report an unexpected operation or event, please contact the manufacturer or a representative.

Primary criteria for referral:

The primary criteria for the referral of a patient for a medical or other specialist opinion and/or treatment are as follows:

• Visible congenital or traumatic deformity of the ear;
• History of active drainage from the ear in the previous 90 days;
• History of sudden or rapidly progressive hearing loss in one or both ears within the previous 90 days;
• Acute or chronic dizziness;
• Audiometric air-bone gap equal to or greater than 15 dB at 500 Hz, 1000 Hz, and 2000 Hz;
• Visible evidence of significant cerumen accumulation or a foreign body in the ear canal;
• Pain or discomfort in the ear;
• Abnormal appearance of the eardrum and ear canal such as:
  • Inflammation of the external auditory canal,
  • Perforated eardrum,
  • Other abnormalities which the hearing care professional believes are of medical concern.

When referral may not be appropriate:

The hearing care professional may decide that referral is not appropriate or in the best interests of the patient when the following applies:

• When there is sufficient evidence that the condition has been fully investigated by a medical specialist and any possible treatment has been provided;
• The condition has not worsened or changed significantly since the previous investigation and/or treatment.

If the patient has given their informed and competent decision not to accept advice to seek a medical opinion, it is permissible to proceed to recommend appropriate hearing aid systems subject to the following considerations:

• The recommendation will not have any adverse effects on the patient's health or general well-being;
• The records confirm that all necessary considerations about the patient's best interests have been made. If legally required, the patient has signed a disclaimer to confirm that the referral advice has not been accepted and that it is an informed decision.

18.1 Hazard warnings

⚠️ Changes or modifications to the hearing aid that were not explicitly approved by Sonova AG are not permitted. Such changes may damage your ear or the hearing aid.

⚠️ Explosive areas: Do not use the hearing aids in explosive areas (mines or industrial areas with danger of explosions, oxygen-rich environments, or areas where flammable anesthetics are handled). This device is not ATEX certified.

⚠️ WARNING: Device batteries are hazardous and can cause serious injuries if they are swallowed or placed inside any part of the body, whether the battery is used or new! Keep out of the reach of children, individuals with cognitive impairment, or pets. If you suspect that a battery was swallowed or placed inside any part of the body, immediately consult your physician without any delay.

⚠️ Pain or irritation: If you feel pain in or behind your ear, if it is inflamed, or if skin irritation and accelerated accumulations of earwax occur, please check with your hearing care professional or physician.

⚠️ Cerumen stop: In very rare cases, if not securely attached, a cerumen stop can remain in your ear canal when removing the hearing aid from the ear. In the unlikely case that such part gets stuck in your ear canal, it is strongly recommended to see a physician for safe removal.

⚠️ Directional microphone mode: Hearing programs in the directional microphone mode reduce background noises. Please be aware that warning signals or noises coming from behind, e.g., cars, are partially or entirely suppressed.

⚠️ Implantable medical devices: The following is only applicable for persons with active implantable medical devices (i.e., pacemakers, defibrillators, etc.):

• Keep the wireless device at least 15 cm (6 inches) away from the active implant. If you experience any interference, do not use the wireless hearing aids and contact the manufacturer of the active implant. Please note that the interference can also be caused by powerlines, electrostatic discharge, airport metal detectors, etc.
• Keep magnets (i.e., battery handling tool, EasyPhone magnet, etc.) at least 15 cm (6 inches) away from the active implant.

⚠️ Accessories: 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.

⚠️ Physical impacts: Avoid strong physical impacts to the ear when wearing in-the-ear hearing aids. The stability of in-the-ear shells is designed for normal use. A strong physical impact to the ear (e.g., during sports) may cause the in-the-ear shell to break. This may lead to perforation of the ear canal or eardrum. After mechanical stress or shock to the hearing aid, please ensure that the hearing aid shell is intact before placing it in the ear.

⚠️ Adjacent equipment: 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.

⚠️ Intended person use: The hearing aids (specially programmed for each hearing loss) must only be used by the intended person. They should not be used by any other person as they could damage hearing.

⚠️ CSF shunt valves: Patients implanted with magnetic externally programmable CSF shunt valves may have a risk of experiencing an unintended change in their valve setting when exposed to strong magnetic fields. The receiver (loudspeaker) of hearing aids and the MiniControl contain static magnets. Keep a distance of 2 inches (approx. 5 cm) or more between the magnets and the site of the implanted shunt valve.

⚠️ Hearing deterioration: The majority of hearing aid users have a hearing loss for which a deterioration in hearing is not to be expected with regular use of a hearing aid in everyday situations. Only a small group of hearing aid wearers with hearing loss may be at risk of deterioration in hearing after a long period of use.

⚠️ Itching/redness: If you experience itching, redness, blisters, swelling, inflammation in or around your ears, inform your hearing care professional and contact your physician.

⚠️ Medical/Dental examinations: Special medical or dental examination including radiation described below may adversely affect the correct functioning of your hearing aids. Remove and keep them outside the examination room/area before undergoing:

• Medical or dental examination with X-ray (also CT scan).
• Medical examinations with MRI/NMRI scans, generating magnetic fields.

Hearing aids do not need to be removed when passing security gates (airports etc.). If X-ray is used at all, it will be in very low doses, and will not affect the hearing aids.

⚠️ Acrylates/Methacrylates: The device and its components contain acrylates or methacrylates. People who are sensitive to such substances may potentially experience an allergic skin reaction. Stop using the device immediately if such a reaction occurs and contact your hearing care professional or physician.

⚠️ RF Communications Equipment: 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 hearing aids, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.

18.2 Information on product safety

⚠️ Water immersion: Never immerse your hearing aid in water! Protect it from excessive moisture. Always remove your hearing aid before showering, bathing, or swimming, as the hearing aid contains sensitive electronic parts.

⚠️ Heat and sunlight: Protect your hearing aid from heat and sunlight (never leave near a window or in the car). Never use a microwave or other heating devices to dry your hearing aid. Ask your hearing care professional about suitable drying methods.

⚠️ Moisture evaporation: When you are not using your hearing aid, leave the battery door open so that any moisture can evaporate. Make sure that you always completely dry your hearing aid after use. Store the hearing aid in a safe, dry and clean place.

⚠️ Dropping: Do not drop your hearing aid! Dropping onto a hard surface can damage your hearing aid.

⚠️ Batteries: Always use new batteries for your hearing aid. In case a battery is leaking, replace it immediately with a new one to avoid any skin irritation. You can return used batteries to your hearing care professional.

⚠️ Battery voltage: The batteries used in these hearing aids should not exceed 1.5 Volts. Please do not use silver-zinc or Li-ion (lithium-ion) rechargeable batteries as these may cause severe damage to your hearing aids.

⚠️ Long-term storage: Remove the battery if you are not using your hearing aid for a long period of time.

⚠️ Prohibited areas: Do not use your hearing aid in areas where electronic equipment is prohibited.

⚠️ Removal handle: Do not kink or buckle the removal handle. Repeated stress to the removal handle may cause it to break. In case of a broken removal handle, the battery door (if available) may exceptionally be used to carefully pull the hearing aid out of the ear canal. If you are not able to remove the hearing aid, contact your hearing care professional or physician.

⚠️ Storage for long periods: If you are not using your hearing aid for a long period of time, store it in a box with a drying capsule or in a well-ventilated location. This allows moisture to evaporate from your hearing aid and prevents a potential impact on its performance.

⚠️ Water resistance: These hearing aids are water resistant and not waterproof. They are designed to withstand normal activities and occasional accidental exposure to extreme conditions. Never immerse your hearing aid in water! These hearing aids are not specifically designed for extended periods of water submersion on a continual basis, that is worn in activities such as swimming or bathing. Always remove your hearing aid before these activities, as the hearing aid contains sensitive electronic parts.

⚠️ Microphone inputs: Never wash the microphone inputs. Doing so could cause it to lose its special acoustic features.

⚠️ Acrylates/Adhesives: Custom hearing aids and earpieces with titanium shell can contain small quantities of acrylates from adhesives. People who are sensitive to such substances may potentially experience an allergic skin reaction. Stop using the device immediately if such a reaction occurs and contact your hearing care professional or physician.

⚠️ Child safety: Hearing aids and their parts should be kept out of reach of children and anyone who might swallow, choke on, or otherwise cause injury to themselves with them. If swallowed, consult a physician or hospital immediately as the hearing aid or its parts can be poisonous. In the event of choking, immediately administer treatment or contact emergency services.

⚠️ Supervision: The usage of this device by children and individuals with cognitive impairment should be supervised at all times to ensure their safety.

⚠️ Nickel components: Some internal components of the device contain nickel. Although not expected, exposure to nickel cannot be excluded. People who are sensitive to nickel may potentially experience an allergic skin reaction. Stop using the device immediately if such a reaction occurs and contact your hearing care professional or physician.

19. For the US market only, complies with the FDA regulations

Important information: Cell phones

Some hearing aid users have reported a buzzing sound in their hearing aids when they are using cell phones. According to the ANSI 63.19 (American National Standard Methods of Measurement of Compatibility between Wireless Communications Devices and Hearing Instruments) standard, the compatibility of a particular hearing aid and cell phone can be predicted by adding the rating for the hearing aid immunity to the rating for the cell phone emissions. The sum of the hearing aid rating (e.g., M2/T2=2) and the telephone rating (e.g., M3/T3=3) is 5, and any combination that equals 5 will provide "normal use"; a sum of 6 or greater would indicate "excellent performance". The equipment performance measurements, categories, and system classifications are based upon the best information available but cannot guarantee that all users will be satisfied. The immunity of this hearing aid is at least M2/T2.

Note: The performance of individual hearing aids may vary with individual cell phones. Therefore, please try the hearing aid with your cell phone or, if you are purchasing a new phone, be sure to try it with your hearing aid prior to purchase. For additional guidance, please ask your hearing care professional for the booklet entitled "hearing aid compatibility with digital wireless cell phones".

Important information in case of battery ingestion

If a battery is swallowed, call the 24-hour National Battery Ingestion Hotline at 800-498-8666 or consult your physician immediately.

Tinnitus Balance noise generator

The Tinnitus Balance noise generator is a broadband sound generator which may have been enabled in your hearing aid. It provides a means of sound enrichment that can be used as part of a personalized tinnitus management program to provide temporary relief from tinnitus. It should always be used as prescribed by your audiologist. The underlying principle of sound enrichment is to provide supplementary noise stimulation which can help defocus your attention from your tinnitus and avoid negative reactions. Sound enrichment, coupled with instructional counseling, is an established approach to managing tinnitus.

Good health practice requires that a person reporting tinnitus have a medical evaluation by a licensed ear physician before using a sound generator. The purpose of such an evaluation is to ensure medically treatable conditions that may be causing tinnitus are identified and treated prior to using a sound generator.

Should you develop any side effects whilst using the noise generator such as headaches, nausea, dizziness, or heart palpitations, or experience a decrease in auditory function, you should discontinue use and seek a medical evaluation.

According to OSHA (Occupational Safety & Health Administration, U.S. Department of Labor) regulations, the volume of the noise generator can be set to a level which could lead to permanent hearing damage when used for a prolonged period of time. Should the noise generator be set to such a level in your hearing aid, your audiologist will advise you of the maximum amount of time per day you should use the noise generator. The noise generator should never be used at uncomfortable levels.

For more information visit www.phonak.com

Manufacturer: Sonova AG, Laubisrütistrasse 28, CH-8712 Stäfa, Switzerland

EC REP: Sonova Deutschland GmbH, Max-Eyth-Strasse 20, 70736 Fellbach-Oeffingen, Germany