User Manual for Miracle-Ear models including: MEMINI I 5P CIC-10 NWL PH 5, MEMINI I 5P CIC-10 NWL PH Hearing Aid Device, MEMINI I 5P CIC-10 NWL PH, Hearing Aid Device, Aid Device, Device
Hearing Aid Device User Manuals | Miracle-Ear
Notice 1: 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 ...
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DocumentDocumentMiracle-EarSPARKTM User Manual MEMINI I 5P CIC-10 NWL PH Your hearing aid details Hearing aid models Battery size MEMINI I 5P CIC-10 NWL PH (5/4/3/2) 10 Welcome Thank you for choosing Miracle-Ear® hearing aids to accompany you through everyday life. Like anything new, it may take you a little time to become familiar with them. This guide, along with support from your hearing care professional, will help you understand the advantages and greater quality of life your hearing aids offer. Training is not required for handling of this device. To receive the most benefit from your hearing aids, it is recommended that you wear them every day, all day. This will help you get adjusted to them. 2 3 Contents Your hearing aid details Welcome 1. Quick guide 2. Parts of the hearing aid Using the hearing aid 3. Left and right hearing aid markings 4. On/Off 5. Batteries 6. Putting on the hearing aid 7. Removing the hearing aid 8. Push button 9. Volume control 10. Listening in public places 4 2 Further information 3 11. Care and maintenance 20 6 12. Environmental conditions 23 8 13. Service and warranty 25 14. Compliance information 26 10 15. Information and description of symbols 32 11 16. Troubleshooting 36 12 17. Important safety information 39 14 15 17 18 19 5 1. Quick guide Left and right hearing aid markings Left Right Changing batteries Blue marking for left hearing aid. Red marking for right hearing aid. 1 2 Remove the sticker Open the battery from the new battery door. and wait two minutes. 6 3 Place battery in the battery door with the flat side facing upwards. On/Off On Off Push button* The push button on your hearing aid can have various functions. Volume control* To increase the volume, turn the volume control forwards. To decrease the volume, turn the volume control backwards. *Applicable only for the models with this specific option. 7 2. Parts of the hearing aid The following pictures show the hearing aid model described in this user guide. You can identify your personal models by: · checking "Your hearing aid & charger details" on page 3. · comparing your earpiece and hearing aid with the following models. Pay attention to the shape of the hearing aid and if a push button or a volume control is present. 8 Model with a push button Sound outlet / wax protection system Push button (optional) Removal handle (optional) Custom-made shell Battery door Model with a volume control Sound outlet / wax protection system Battery door Removal handle (optional) Custom-made shell Volume control (optional) 9 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 as shown on the pictures below. Additionally, you can select a blue shell for the left device and a red shell for the right device. Blue marking for left hearing aid. Red marking for right hearing aid. 10 4. On/Off The battery door is also the on/off swith. 1 Closed battery door = hearing aid is on 2 Open battery door = hearing aid is off When you switch on the hearing aid, you may hear a start-up melody. 11 5. Batteries 1 2 Remove the sticker Open the battery from the new battery door. and wait two minutes. 3 Place 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. 12 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, depending on the hearing aid settings and battery). We recommend that you always have a new battery on hand. Replacement battery This hearing aid requires a size 10 zinc-air battery. Model Zinc-air Color IEC battery marking on code size package ANSI code MEMINI I 5P CIC-10 NWL PH 10 yellow PR70 7005ZD Please ensure you use the correct type of battery in your hearing aids (zinc-air). Please also read chapter 17.2 for further information on product safety. 13 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. 14 15 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. In order to help it along, make chewing movements with your jaw. 2 Grasp the protruding hearing aid and remove it. 16 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. 17 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. 18 10. 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, 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. 19 11. Care and maitenance Expected Service Life The hearing aids have the 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 the outstanding performance for the duration of the expected service life of your devices. The manufacturer 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 17.2. General information Before using hair spray or applying cosmetics, you should remove your hearing aid from your ear, because these products may damage it. 20 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 16. 21 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. 12. 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: Operating Transport Storage Temperature +5 to +40 °C (+41 to +104 °F) -20 to +60 °C (-4 to +140 °F) -20 to +60 °C (-4 to +140 °F) Humidity (non condensing) 0 to 90 % Atmospheric pressure 500 to 1060 hPa 0 to 93 % 0 to 93 % 500 to 1060 hPa 500 to 1060 hPa 22 23 The hearing aids are classified as IP68. This means that they are water and dust resistant and designed to withstand daily life situations. They can be worn in the rain but should not be fully submerged in water or used when taking a shower, swimming or other water activities. The hearing aids should never be exposed to chlorinated water, soap, salt water or other liquids with a chemical content. If the device has been subject to storage and transport conditions outside of the recommended use conditions, wait 15 minutes before starting the device. 24 13. 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 The manufacturer 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. 25 14. Compliance information Notice 1: 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. Notice 2: Changes or modifications made to this device not expressly approved by the manufacturer may void the FCC authorization to operate this device. 26 Notice 3: 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. 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. 27 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. Emissions Compliance Test Electromagnetic environment guidance RF emissions CISPR 11 Group 1 The hearing aids generate or use RF energy only for their internal functioning. Therefore, the RF emissions are very low and are not likely to cause any interference to nearby electronic equipment. RF emissions CISPR 11 Class B The hearing aids are suitable for use in domestic establishment and in establishment directly connected to a low voltage power supply network which supplies buildings used for domestic purposes. 28 Electromagnetic immunity Immunity Test Electrostatic Discharge (ESD) IEC 61000-4-2 IEC60601-1-2 Test Level +/- 8 kV contact +/- 2 kV , +/- 4 kV, +/- 8 kV, +/- 15 kV air Compliance Level +/- 8 kV contact +/- 2 kV , +/- 4 kV, +/- 8 kV, +/- 15 kV air Radiated RF Electromagnetic Field Immunity Test IEC 61000-4-3 10 V/m 80 MHz 2.7 GHz 80% AM at 1 kHz 10 V/m 80 MHz 2.7 GHz 80% AM at 1 kHz 29 Immunity Test Proximity Magnetic Field IEC 61000-4-3 IEC60601-1-2 Test Level 9 V/m; 710, 745, 780 MHz; Pulse modulation 18 Hz 9 V/m; 5240, 5500, 5785 MHz; Pulse modulation 217 Hz Compliance Level 9 V/m; 710, 745, 780 MHz; Pulse modulation 18 Hz 9 V/m; 5240, 5500, 5785 MHz; Pulse modulation 217 Hz 27 V/m; 385 MHz; Pulse modulation 18 Hz 27 V/m; 385 MHz; Pulse modulation 18 Hz 28 V/m; 450 MHz FM +/- 5 28 V/m; 450 MHz FM +/- 5 kHz kHz deviation; 1 kHz sine deviation; 1 kHz sine 28 V/m; 810, 870, 930 MHz; 28 V/m; 810, 870, 930 MHz; Pulse modulation 18 Hz Pulse modulation 18 Hz 28 V/m; 1720, 1845, 1970, 2450 MHz; Pulse modulation 217 Hz 28 V/m; 1720, 1845, 1970, 2450 MHz; Pulse modulation 217 Hz Immunity Test Rated power frequency magnetic fields IEC 61000-4-8 IEC60601-1-2 Test Level 30 A/m 50 Hz or 60 Hz Test frequency 30kHz, modulation: CW, Immunity test level 8 Enclosure Port Immunity to Proximity Magnetic Fields IEC 61000-4-39 Test frequency 134, 2 kHz, Pulse modulation: 2.1 kHz, Immunity test level 65 Test frequency 13.56 kHz, Pulse modulation: 50kHz, Immunity test level 7.5 Compliance Level 30 A/m 50 Hz or 60 Hz Test frequency 30kHz, modulation: CW, Immunity test level 8 Test frequency 134, 2 kHz, Pulse modulation: 2.1 kHz, Immunity test level 65 Test frequency 13.56 kHz, Pulse modulation: 50kHz, Immunity test level 7.5 30 31 15. Information and description of symbols 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. Indicates the date when the medical device was manufactured. This symbol indicates that it is important for the user to read and take into account the relevant information in these user guides. This symbol indicates that it is important for the user to pay attention to the relevant warning notices in these user guides. 32 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. Important information for handling and product safety. Indicates the manufacturer's serial number so that a specific medical device can be identified. Indicates the manufacturer's catalogue number so that the medical device can be identified. 33 This symbol indicates that electronic instructions for use are available. IP Rating = 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. Indicates the temperature limits to which the medical device can be safely exposed. Indicates the range of humidity to which the medical device can be safely exposed. Indicates the range of atmospheric pressure to which the medical device can be safely exposed. 34 During transportation keep dry. This symbol indicates a device that is not safe to use in magnetic resonance (MR) environment (e.g. during an MRI scan). 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. 35 16. Troubleshooting Cause What to do Problem: Hearing aid not functioning Dead battery. Change battery (chapter 5). Blocked sound outlet. Clean sound outlet, e.g. replace wax guard system. Battery not inserted correctly. Insert battery correctly (chapter 5). Battery not inserted correctly. Switch hearing aid on by completely closing the battery door (chapter 4). Problem: Hearing aid whistles Hearing aid not inserted correctly into ear. Earwax in ear canal. Insert hearing aid correctly (chapter 6). Contact your ENT/GP or hearing care professional. Problem: Hearing aid too loud Volume too loud. 36 Decrease volume if volume control available (chapter 9). Cause What to do Problem: Hearing aid not loud enough or distorted Low battery. Change battery (chapter 5). Blocked sound outlet. Volume too low. Physical hearing condition has changed. Clean sound outlet, e.g. replace wax guard system. Turn volume up if volume control available (chapter 9). Contact you hearing care professional. Problem: Hearing aid plays two beeps Indication for low battery. Change battery within the next 30 minutes (chapter 5). 37 Cause What to do Problem: Hearing aid switches on and off (intermittent). Moisture on battery or hearing aid. Wipe battery and hearing aid with dry cloth. If the problem persists, contact your hearing care professional for assistance. 38 17. Important safety information Please read the relevant safety information and limitations-of-use information on the following pages before using your hearing aid. 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. 39 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 indications 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 software feature are: · Acute tinnitus (<3 months, after occurrence) · Deformity of the ear (i.e. closed ear canal) · Neural hearing loss ( i.e. retro-cochlear pathologies such as absent / non-viable auditory nerve) 40 Clinical benefit Hearing aids: 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. 41 The use of ahearing aid is only part of hearing habilitation and mayneed 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. To report an unexpected operation or event, please contact the manufacturer or a representative. 42 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. 43 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 patients 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. 44 17.1 Warnings 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. Changes or modifications to the hearing aid that were not explicitly approved by the manufacturer are not permitted. Such changes may damage your ear or the hearing aid. 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). The device is not ATEX certified. 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. 45 If you experience itching, redness, blisters, swelling, inflammation in or around your ears, inform your hearing care professional and contact your physician. 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. 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. 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. 46 The following is only applicable for persons with active implantable medical devices (i.e. pacemakers, defibrillators, etc.) · Keep the wireless hearing aid 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.g. battery handling tool, EasyPhone magnet, etc.) at least 15 cm (6 inches) away from the active implant. 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. 47 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 hearing aids, including cables specified by the 48 manufacturer. Otherwise, degradation of the performance of this equipment could result. Avoid strong physical impacts to the ear when wearing in-the-ear hearing aids. The stability of in-theear 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 ear drum. After mechanical stress or shock to the hearing aid, please ensure that the hearing aid shell is intact before placing it in the ear. 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. 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. 49 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. 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 50 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 don't 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. 17.2 Information on product safety 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. 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. 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. Do not drop your hearing aid! Dropping onto a hard surface can damage your hearing aid. Do not use your hearing aid in areas where electronic equipment is prohibited. 51 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. 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. Remove the battery if you are not using your hearing aid for a long period of time. 52 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. Never wash the microphone inputs. Doing so could cause it to lose its special acoustic features. 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. The usage of this device by children and individuals with cognitive impairment should be supervised at all times to ensure their safety. 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. 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. 53 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. 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. 54 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. 55 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. 56 Important notice for prospective noise generator users 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. 57 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. 58 59 Your Miracle-Ear® Representative: Manufactured for Miracle-Ear, Inc. 150 South Fifth Street, Suite 2300 Minneapolis, MN 55402 7 613389 807660 029-1419-03/V1.00/2024-11/ZTAdobe PDF Library 17.0 Adobe InDesign 20.0 (Windows)