Unitron Hearing UBTD1 Hearing Aid User Manual english
Unitron Hearing, Inc. Hearing Aid Users Manual english
Users Manual english
| Download: |  |
| Mirror Download [FCC.gov] | |
| Document ID | 3773409 |
| Application ID | kOM5cz8/I1XCD/K2lOdMVg== |
| Document Description | Users Manual english |
| Short Term Confidential | No |
| Permanent Confidential | No |
| Supercede | No |
| Document Type | User Manual |
| Display Format | Adobe Acrobat PDF - pdf |
| Filesize | 241.61kB (3020081 bits) |
| Date Submitted | 2018-03-08 00:00:00 |
| Date Available | 2018-03-09 00:00:00 |
| Creation Date | 2018-03-06 09:00:12 |
| Producing Software | Adobe PDF Library 15.0 |
| Document Lastmod | 2018-03-06 09:03:27 |
| Document Title | Users Manual english |
| Document Creator | Adobe InDesign CC 13.0 (Windows) |
Moxi All behind-the-ear (BTE) hearing aid guide Moxi All Guide d’instrument auditif contour d’oreille (BTE) A Sonova brand Thank you Merci Thank you for choosing these hearing aids. We care deeply about people with hearing loss. We work closely with hearing healthcare professionals to make advanced, purposedriven solutions available to everyone. Because hearing matters. Merci d’avoir choisi ces instruments auditifs. Nous nous dévouons entièrement aux personnes souffrant de perte auditive. Nous travaillons en étroite collaboration avec des audioprothésistes afin de proposer des solutions de pointe, adaptées aux besoins de tous. Parce que l’audition, c’est essentiel. This user guide applies to the following models: Year of introduction: 2018 Ce guide d’utilisation s’applique aux modèles suivants : Année d’introduction : 2018 T Moxi™ All Pro T Moxi™ All 800 T Moxi™ All 700 T Moxi™ All 600 T Moxi™ All 500 T Moxi T Moxi T Moxi T Moxi T Moxi MC MC MC MC MC All Pro All 800 All 700 All 600 All 500 Your hearing aids Hearing healthcare professional:________________ ___________________________________________ Telephone:__________________________________ Model: _____________________________________ Serial number:_______________________________ Battery size: 13 Rechargeable Non-rechargeable Warranty:___________________________________ Program 1 is for: _____________________________ Program 2 is for: _____________________________ Program 3 is for: _____________________________ Program 4 is for: _____________________________ Date of purchase:_____________________________ Quick reference Vos instruments auditifs On/Off Audioprothésiste :_________________________________ ________________________________________________ Téléphone :_______________________________________ Modèle : _________________________________________ On Low battery warning 2 beeps every 30 minutes Off Open Battery size 13 Numéro de série :_________________________________ Taille de la pile : 13 Rechargeable Non rechargeable Garantie :________________________________________ Le programme 1 correspond à : ______________________ Changing batteries Le programme 2 correspond à : _____________________ Le programme 3 correspond à : _____________________ Battery indicator Le programme 4 correspond à : _____________________ Date d’achat :_____________________________________ Aide-mémoire Marche/arrêt Activé Désactivé Avertissement de pile faible Ouvert Type de pile 13 2 bips toutes les 30 minutes Remplacement des piles Indicateur de charge Table of contents Table des matières Your hearing aids at a glance...................................................... 2 Warnings..................................................................................... 4 SoundCore technology.............................................................. 10 Tinnitus masker ......................................................................... 11 Putting your hearing aids on your ears......................................14 Turning your hearing aids on and off ........................................ 16 Battery information....................................................................17 Operating instructions..............................................................20 Pairing your mobile phone with your hearing aids........................................................................ 23 Phone calls with a mobile phone....................................... 25 Using your mobile phone with your hearing aids............... 26 Adjusting volume balance between mobile phone calls and your environment........................................................28 TV Connector...................................................................... 29 Tinnitus masker.................................................................. 30 Flight mode................................................................................31 Connectivity overview............................................................... 33 Caring for your hearing aids...................................................... 34 Accessories...............................................................................38 Troubleshooting guide.............................................................. 39 Warning to hearing aid dispensers (to comply with the U.S. Food and Drug Administration (FDA) regulations) ............ 44 Information and explanation of symbols.................................. 46 Compliance information............................................................48 Patient feedback........................................................................51 Additional notes........................................................................ 52 Aperçu de vos instruments auditifs..........................................54 Avertissements.........................................................................56 Technologie SoundCore............................................................62 Masqueur d’acouphènes .........................................................63 Mise en place des instruments auditifs sur vos oreilles...........66 Mise en marche et arrêt de vos instruments auditifs .............. 68 Information sur la pile...............................................................69 Instructions d’utilisation..........................................................72 Coupler votre téléphone mobile avec vos instruments auditifs............................................................................... 75 Appels téléphoniques avec un téléphone mobile.............. 77 Utiliser votre téléphone mobile avec vos instruments auditifs..........................................................78 Régler l’équilibre du volume entre les appels de votre téléphone mobile et votre environnement................80 Connecteur pour la télévision............................................ 81 Masqueur d’acouphènes...................................................82 Mode avion...............................................................................83 Aperçu de la connectivité..........................................................85 Entretien de vos instruments auditifs.......................................86 Accessoires...............................................................................90 Guide de dépannage................................................................. 91 Information et explications sur les symboles...........................96 Information sur la conformité.................................................. 98 Commentaires du client...........................................................101 Remarques supplémentaires.................................................. 102 Your hearing aids at a glance Moxi All BTE hearing aids 1 W ire - connects the speaker unit to your hearing aids 2 Microphones - sound enters your hearing aids through the microphones 3 Push button - switches between listening programs, changes the volume level, and accepts or rejects mobile phone calls depending on your customized fitting 4 Battery door (on & off) - close the door to turn on your hearing aids, partly open the door to turn off your hearing aids. Opening the door all the way gives you access to change the battery 5 Dome - holds the wire in place in your ear canal 6 Retention piece - helps prevent the dome and wire from moving out of the ear canal 7 S peaker unit - amplifies the sound and sends it directly into the ear canal 8 Custom mold - holds the hearing aids in place Warnings The intended use of hearing aids is to amplify and transmit sound to the ears and hereby compensate for impaired hearing. 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. Hearing aids should only be used as directed by your physician or hearing healthcare professional. Hearing aids will not restore normal hearing and will not prevent or improve a hearing impairment resulting from organic conditions. Do not use your hearing aids in explosion hazard areas. Allergic reactions to hearing aids are unlikely. However, if you experience itching, redness, soreness, inflammation or a burning sensation in or around your ears, inform your hearing healthcare professional and contact your physician. In the unlikely case that any parts remain in the ear canal after the removal of the hearing aid, contact a physician immediately. 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 interference can also be caused by power lines, electrostatic discharge, airport metal detectors etc. 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 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. Special care should be exercised in wearing hearing aids when maximum sound pressure levels exceed 132 decibels. There may be a risk of impairing your remaining hearing. Speak with your hearing healthcare professional to ensure the maximum output of your hearing aids is suitable for your particular hearing loss. Your hearing aids operate in the frequency range of 2.4 GHz–2.48 GHz. When flying please check if flight operator requires devices to be switched into flight mode. Battery warning Never leave hearing aids or batteries where small children and pets can reach them. Never put hearing aids or batteries in your mouth. If a hearing aid or battery is swallowed, call a physician immediately. Precautions The use of hearing aids is only part of hearing rehabilitation; auditory training and lip reading instruction may be required as well. In most cases, infrequent use of hearing aids does not provide full benefit. Once you have become accustomed to your hearing aids, wear your hearing aids everyday all day. Your hearing aids use the most modern components to provide the best possible sound quality in every listening situation. However, communication devices such as digital mobile phones can create interference (a buzzing sound) in hearing aids. If you experience interference from a mobile phone being used close by, you can minimize this interference in a number of ways. Switch your hearing aids to another program, turn your head in a different direction or locate the mobile phone and move away from it. Note to hearing healthcare professional Domes should never be fitted on patients with perforated eardrums, exposed middle ear cavities, or surgically altered ear canals. In the case of such a condition, we recommend to use a customized earmold. Labeling The serial number and year of manufacture are located inside the battery door. Mobile phone compatibility rating Some hearing aid users have reported a buzzing sound in their hearing aids when they are using mobile phones, indicating that the mobile phone and hearing aid may not be compatible. According to the ANSI C63.19 standard (ANSI C63.19-2011 American National Standard Methods of Measurement of Compatibility Between Wireless Communications Devices and Hearing Aids), the compatibility of a particular hearing aid and mobile phone can be predicted by adding the rating for the hearing aid immunity to the rating for the mobile phone emissions. For example, the sum of the hearing aid rating of 4 (M4) and a telephone rating of 3 (M3) would result in a combined rating of 7. Any combined rating that equals at least 5 would provide “normal use”; a combined rating of 6 or greater would indicate “excellent performance.” The immunity of this hearing aid is at least M4. The equipment performance measurements, categories and system classifications are based upon the best information available but cannot guarantee that all users will be satisfied. T he performance of the individual hearing aids may vary with individual mobile phones. Therefore, please try this hearing aid with your mobile phone or, if you are purchasing a new phone, please be sure to try it with your hearing aid prior to purchase. For additional guidance, please ask your hearing healthcare professional for the booklet entitled “Hearing aid compatibility with digital wireless mobile phones.” SoundCore technology SoundCore™ includes four intelligent features working together to understand your listening environment making the fluid adjustments needed so you can actively participate in every conversation across every environment. 10 Tinnitus masker Tinnitus masker uses broadband noise to provide temporary relief of tinnitus. Tinnitus masker warnings The tinnitus masker is a broadband sound generator. It provides a means of sound enrichment therapy that can be used as part of a personalized tinnitus management program to provide temporary relief from tinnitus. 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. Air conduction hearing aids with the tinnitus masker are to be fitted by a hearing healthcare professional familiar with the diagnosis and management of tinnitus. 11 Should you develop any side effects while using the tinnitus masker, such as headaches, nausea, dizziness or heart palpitations or experience a decrease in auditory function such as decreased loudness tolerance, worsening of tinnitus, or speech not as clear, you should discontinue use of the device and seek medical attention. The volume of the tinnitus masker can be set to a level which could lead to permanent hearing damage when used for a prolonged period of time. Should the tinnitus masker be set to such a level in your hearing aid, your hearing healthcare professional will advise you of the maximum amount of time per day you should use the tinnitus masker. The tinnitus masker should never be used at uncomfortable levels. 12 Important information The tinnitus masker generates sounds that are used as part of your personalized temporary tinnitus management program to provide relief from tinnitus. It should always be used as prescribed by a hearing healthcare professional who is familiar with the diagnosis and treatment of 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 that medically treatable conditions, which may be causing tinnitus, are identified and treated prior to using a sound generator. The tinnitus masker is intended for adults 18 years of age or older who have both hearing loss and tinnitus. 13 Putting your hearing aids on your ears Your hearing aids will be color-coded with a dot on the outside of the hearing aid: red = right ear; blue = left ear. Hearing aids with domes 1. 1. Place the hearing aid over the top of your ear. 2. Hold the wire where it attaches to the dome and gently push the dome into 2. your ear canal. The wire should lie flush against your head and not stick out. 3. If there is a retention piece, place it in your ear so it rests at the bottom of the 3. opening of your ear canal. 14 Hearing aids with custom molds 1. Hold the custom mold 1. between your thumb and index finger. The opening should be pointing in towards your ear canal with the hearing aid 2. resting above your ear. 2. Carefully insert the custom mold into your ear. The mold should fit into your ear snugly and comfortably. 3. Place the hearing aid over the top of your ear. 3. 15 Turning your hearing aids on and off Battery information The battery door acts as an on and off switch. 1. On: Close the battery door 1. fully. Low battery warning Two long beeps indicate the hearing aid battery is low. After the low battery warning, sounds may not be as clear. This is normal and can be fixed by changing the batteries. If you can’t hear the low battery warning, your hearing healthcare professional can change its pitch or loudness. If you prefer, it can be turned off entirely. It may take five seconds before the hearing aid turns on. Your hearing healthcare professional can increase the start up delay 2. if required. 2. Off: Partially open the battery door 3. Open: Fully open the battery door to access and change 3. the battery. When turning your hearing aid on and off while it is on the ear, grasp the top and bottom of the device with your index finger and thumb. Use the index finger of your opposite hand to open and close the battery door. 16 If you have the rechargeable option, charge your hearing aids every night. If you hear the low battery warning, place your hearing aids in the charging base. Your hearing aids are designed to generate a low battery warning every 30 minutes until you change the batteries, but depending on the condition of the batteries, they may die before another low battery warning occurs. Therefore, it is recommended that the batteries are replaced as soon as possible once you hear the low battery warning. 17 Replacing the battery 1. 1. Gently swing out the battery door with your fingernail. 2. Push the battery with your fingernail towards the open 2. side, and remove. 3. Insert the new battery into the battery compartment with the plus (+) sign on the battery facing the same way as the 3. battery indicator on the battery door. This will ensure that the battery door closes properly. If the battery is inserted incorrectly, the hearing aid will not turn on. 4. Close the battery door. 18 Caring for batteries If you have the rechargeable option, please see the Charging base guide for instructions on how to care for your rechargeable batteries. • Always discard batteries in a safe and environmentally friendly way. • To prolong battery life, remember to turn your hearing aids off when not in use, especially when asleep. • Remove the batteries and keep the battery door open while hearing aids are not being worn, especially when asleep. This will allow internal moisture to evaporate. 4. 19 Operating instructions Your hearing aids come with a push button that allows you to further adjust them. You may also use the button to accept and reject calls to your paired mobile phone. These instructions describe the default push button functions. Your hearing healthcare professional may change the functionality of the push buttons. See your hearing healthcare professional for more information. Push button The push button on your hearing aids is both a volume control and a program control. Program control Each time you push the button longer than 2 seconds, you will move to the next hearing aid program. Your hearing aids beep to indicate which program you are in. Program setting Beeps Program 1 (e.g. automatic program) 1 beep Program 2 (e.g. speech in noise) 2 beeps Program 3 (e.g. Telephone) 3 beeps Program 4 (e.g. music) 4 beeps Please see the front of this booklet for a listing of your personalized programs. 20 21 Volume control To adjust the volume of your environment when you are wearing two hearing aids: • Push the button on your right hearing aid to increase the volume, and • Push the button on your left hearing aid to decrease the volume To adjust the volume with one hearing aid: • Push the button to step through your volume levels As you change the volume, your hearing aids will beep. Volume setting Beeps Suggested volume level 1 beep Turning volume up short beep Turning volume down short beep Maximum volume level 2 beeps Minimum volume level 2 beeps Pairing your mobile phone with your hearing aids 1. On your phone, go to your settings menu to ensure Bluetooth® is on and to search for Bluetooth-enabled devices. 2. Turn your hearing aids on by closing the battery door. Your hearing aids will remain in pairing mode for 3 minutes. 3. Your phone will show a list of found Bluetooth-enabled devices. Select your hearing aid from the list to pair both hearing aids at once. You will hear a melody when your phone has been successfully paired to your hearing aids. It is only necessary to perform the pairing procedure once with each Bluetooth-enabled phone. Consult your phone user guide for instructions on pairing a Bluetooth device with your phone. Bluetooth® is a registered trademark owned by the Bluetooth SIG, Inc. 22 23 Connecting to your mobile phone After your hearing aids have been paired to your phone, they will automatically connect again when your phone and hearing aids are turned on and in range. This can take up to 2 minutes. The connection will be maintained as long as the phone remains ON and within a range of up to 10 m (30 ft). Your hearing aids can connect to two phones at the same time, but you can only hear one phone call at any time through your hearing aids. To switch a call between your hearing aids and the speaker on your mobile phone, select the audio source you would like from your phone. If you are not sure how to do this, consult the instruction manual that came with your mobile phone. 24 Phone calls with a mobile phone Your hearing aid allows direct communication with Bluetooth enabled phones. When paired and connected to a phone, you will hear the caller’s voice directly in your hearing aid. Your hearing aid picks up your voice through its own microphones. You do not need to hold your mobile phone close to your mouth, your voice is transmitted through the hearing aids to your mobile phone. Your voice Caller’s voice 25 Using your mobile phone with your hearing aids Making a phone call Start a call on your paired mobile phone as you normally would. You will hear the audio through your hearing aids. Your hearing aids pick up your voice through its own microphones. Accepting a mobile phone call When receiving a call, an incoming call notification will be heard in the hearing aids. The call can be accepted by a short push of less than 2 seconds on the hearing aid push button or on your phone as you normally would. Ending a phone call End a call by holding down the push button on the hearing aid for more than 2 seconds or on your phone as you normally would. Rejecting a phone call An incoming call can be rejected by holding down the push button on the hearing aid for more than 2 seconds or on your phone as you normally would. long push > 2 sec short push < 2 sec 26 27 Adjusting volume balance between mobile phone calls and your environment During a call using a paired mobile phone, when you are wearing two hearing aids: • Push your right hearing aid button to increase the call volume and decrease the volume of sounds in your environment • Push your left hearing aid button to decrease the call volume and increase the volume of sounds in your environment To adjust the balance with one hearing aid: • Push the button to increase the call volume and decrease the volume of sounds in your environment Call volume down Left ear 28 Call volume up Right ear TV Connector Adjusting volume balance between the TV and the sounds in your environment While listening to TV sound through the TV Connector accessory, when you are wearing two hearing aids: • Push your right hearing aid button to increase the TV volume and decrease the volume of sounds in your environment • Push your left hearing aid button to decrease the TV volume and increase the volume of sounds in your environment To adjust the balance with one hearing aid: • Push the button to increase the TV volume and decrease the volume of sounds in your environment TV volume down TV volume up Left ear Right ear 29 Tinnitus masker Flight mode If your hearing healthcare professional has configured a tinnitus masker program, you can adjust the tinnitus masker level while you are in the tinnitus masker program. To adjust the noise level, either: With two hearing aids: • Push the button on your right hearing aid to increase the tinnitus masker, and • Push the button on your left hearing aid to decrease the tinnitus masker With one hearing aid: • Push the button to step through your tinnitus masker volume levels App: • Tap the arrow to move to the second screen where you can adjust the tinnitus masker volume up or down As you change the level, your hearing aids will beep. Your hearing aids operate in the frequency range of 2.4 GHz–2.48 GHz. When flying, some airlines require all devices to be switched into flight mode. Entering flight mode will not disable normal hearing aid functionality, only the Bluetooth connectivity functions. 30 Entering flight mode To disable the Bluetooth wireless function and enter flight mode: 1. 1. Open the battery door. 2. Hold down the push button on the hearing aid while closing the battery door, and keep the button pushed 2. down for 10 seconds. 31 Exiting flight mode 1. To enable the Bluetooth wireless function and to exit flight mode: 1. Open the battery door. 2. Close the battery door. 2. Connectivity overview The illustration below shows the connectivity options available for your hearing aid. Mobile phone TV Connector connected to TV The TV Connector can be connected to any audio source such as a TV, stereo system, computer and other audio sources. Your hearing aids are not compatible with previous wireless accessories. Talk to your hearing healtchare professional for more information. 32 33 Caring for your hearing aids Protecting your hearing aids • If your hearing aids are rechargeable: • Place in charging base when not in use. If your hearing aids are non-rechargeable: • Open the battery doors when not in use. • Always remove your hearing aids when using hair care products. The hearing aids can become clogged and cease to function properly. • Do not wear your hearing aids in the bath or shower or immerse them in water. • If your hearing aids do become wet, do not attempt to dry them in an oven or microwave. Do not adjust any controls. Open the battery doors immediately, remove the batteries and allow your hearing aids to dry naturally for 24 hours. • Protect your hearing aids from excessive heat (hair dryer, vehicle glove box or dashboard). • Ensure you do not twist or squeeze the wire when your hearing aids are placed in their case. 34 • Regular use of a dehumidifier, such as a Clean Dry kit, can help prevent corrosion and prolong the life of your hearing aids. Remove batteries before using a dehumidifier. • Do not drop your hearing aids or knock them against hard surfaces. 35 Cleaning your hearing aids Use a soft cloth to clean your hearing aids at the end of each day. Regular cleaning of the microphone ports with the supplied cleaning brush will ensure that your hearing aids will maintain their sound quality. Your hearing healthcare professional can demonstrate this for you. If you have rechargeable hearing aids, place them in the charging base overnight. If you have non-rechargeable hearing aids, place them in their case with the battery doors open to allow moisture to evaporate. Ear wax is natural and common. Ensuring your hearing aids are free of ear wax is an important step in your daily cleaning and maintenance routine. Cleaning your custom molds and domes Clean the domes and molds on the outside daily with a damp cloth. Avoid getting any water in and around the speaker units and custom molds. The wires, speakers, domes or custom molds should never be rinsed or submerged in water as water drops may block sound or damage the electrical components of the hearing aids. Domes should be replaced by your hearing healthcare professional every 3-6 months or when they become stiff, brittle, or discolored. If your molds require further cleaning, the speaker waxguard may be plugged and require replacing. See your hearing healthcare professional. Never use alcohol to clean your hearing aids, earmolds or domes. Do not use sharp tools to dislodge ear wax. Sticking household items into your hearing aids or custom molds can seriously damage them. 36 37 Accessories TV Connector The TV Connector is an optional accessory that sends sound from your TV directly to your hearing aids. The TV Connector can also transmit sound from stereo systems, computers and other audio sources. Please see the user guide that came with your TV Connector for more information. Please contact your hearing healthcare professional to get a TV Connector. Troubleshooting guide Cause Possible remedy Issue: no sound Not turned on Turn on Low/dead battery Replace battery or place rechargeable hearing aids in charging base* Poor battery contact Consult your hearing healthcare professional Battery upside down Insert battery according to battery symbol inside battery door Custom molds/domes blocked with ear wax Clean custom molds/domes. See “Cleaning your hearing aids.” Consult your hearing healthcare professional Plugged microphones Consult your hearing healthcare professional *If needed, you can temporarily replace the Silver Zinc rechargeable battery with a traditional 13 Zinc-air battery. Do not throw away your rechargeable battery. 38 39 Cause Possible remedy Issue: not loud enough Cause Possible remedy Issue: intermittent sound Low volume Turn up volume; see hearing healthcare professional if problem persists Low battery Replace battery or place rechargeable hearing aids in charging base* Low battery Replace battery or place rechargeable hearing aids in charging base* Dirty battery contact Consult your hearing healthcare professional Custom molds/domes not inserted properly See “Putting your hearing aids on your ears.” Remove and reinsert carefully Issue: two long beeps Change in hearing Consult your hearing healthcare professional Custom molds/domes blocked with ear wax Clean custom molds/domes. See “Cleaning your hearing aids.” Consult your hearing healthcare professional Custom molds/domes not inserted properly Plugged microphones Consult your hearing healthcare professional See “Putting your hearing aids on your ears.” Remove and reinsert carefully Hand/clothing near ear Move hand/clothing away from ear Poorly fitting custom molds/domes Consult your hearing healthcare professional 40 Low battery Replace battery or place rechargeable hearing aids in charging base* Issue: whistling *If needed, you can temporarily replace the Silver Zinc rechargeable battery with a traditional 13 Zinc-air battery. Do not throw away your rechargeable battery. 41 Cause Possible remedy Cause Possible remedy Issue: not clear, distorted Issue: low volume on landline telephone Poorly fitting custom molds/domes Consult your hearing healthcare professional Telephone not positioned properly Move telephone receiver around ear for clearer signal Custom molds/domes blocked with ear wax Clean custom molds/domes. See “Cleaning your hearing aids.” Consult your hearing healthcare professional Hearing aid requires adjustment Consult your hearing healthcare professional Low battery Replace battery or place rechargeable hearing aids in charging base* Plugged microphones Consult your hearing healthcare professional Issue: custom molds/domes falling out of ear Poorly fitting custom molds/domes Consult your hearing healthcare professional Custom molds/domes not inserted properly See “Putting your hearing aids on your ears.” Remove and reinsert carefully Issue: mobile phone calls not being heard through hearing aid Hearing aid is in flight mode Exit flight mode: open battery door, then close battery door Hearing aid is not paired Pair your hearing aid to your to the phone mobile phone (again) For any problems not listed in the guide, contact your hearing healthcare professional. *If needed, you can temporarily replace the Silver Zinc rechargeable battery with a traditional 13 Zinc-air battery. Do not throw away your rechargeable battery. 42 43 Warning to hearing aid dispensers (to comply with the U.S. Food and Drug Administration (FDA) regulations) A hearing aid dispenser should advise a prospective hearing aid user to consult promptly with a licensed physician (preferably an ear specialist) before dispensing a hearing aid if the hearing aid dispenser determines through inquiry, actual observation, or review of any other available information concerning the prospective user, that the prospective user has any of the following conditions: (i) Visible congenital or traumatic deformity of the ear. (ii) History of active drainage from the ear within the previous 90 days. (iii) History of sudden or rapidly progressive hearing loss within the previous 90 days. (iv) Acute or chronic dizziness. (v) Unilateral hearing loss of sudden or recent onset within the previous 90 days. (vi) Audiometric air-bone gap equal to or greater than 15 decibels at 500 hertz (Hz), 1,000 Hz, and 2,000 Hz. (vii) Visible evidence of significant cerumen accumulation or a foreign body in the ear canal. (viii) Pain or discomfort in the ear. Special care should be exercised in selecting and fitting a hearing aid whose maximum sound pressure level exceeds 132 decibels because there may be risk of impairing the remaining hearing of the hearing aid user. [This provision is required only for those hearing aids with a maximum sound pressure capability greater than 132 decibels (dB).] The purpose of medical evaluation is to assure that all medically treatable conditions that may affect hearing are identified and treated before the hearing aid is purchased. Following the medical evaluation, the physician will give you a written statement that states that your hearing loss has been medically evaluated and that you may be considered a candidate for a hearing aid. The physician will refer you to an audiologist or a hearing aid dispenser, as appropriate, for a hearing aid evaluation. The audiologist or hearing aid dispenser will conduct a hearing aid evaluation to assess your ability to hear with and without a hearing aid. The hearing aid evaluation will enable the audiologist or dispenser to select and fit a hearing aid to your individual needs. If you have reservations about your ability to adapt to amplification, you should inquire about the availability of a trial-rental or purchase-option program. Many hearing aid dispensers now offer programs that permit you to wear a hearing aid for a period of time for a nominal fee after which you may decide if you want to purchase the hearing aid. Federal law restricts the sale of hearing aids to those individuals who have obtained a medical evaluation from a licensed physician. Federal law permits a fully informed adult to sign a waiver statement declining the medical evaluation for religious or personal beliefs that preclude consultation with a physician. The exercise of such a waiver is not in your best health interest and its use is strongly discouraged. Important notice for prospective hearing aid users Children with hearing loss Good health practice requires that a person with a hearing loss have a medical evaluation by a licensed physician (preferably a physician who specializes in diseases of the ear) before purchasing a hearing aid. In addition to seeing a physician for a medical evaluation, a child with a hearing loss should be directed to an audiologist for evaluation and rehabilitation since hearing loss may cause problems in language development and the educational and social growth of a child. An audiologist is qualified by training and experience to assist in the evaluation and rehabilitation of a child with a hearing loss. 45 Licensed physicians who specialize in diseases of the ear are often referred to as otolaryngologists, otologists or otorhinolaryngologists. 44 Information and explanation of symbols xxxx With the CE symbol, Unitron confirms that this Unitron product – including accessories – meets the requirements of the Medical Devices Directive 93/42/EEC as well as the Radio Equipment Directive 2014/53/EU on radio and telecommunications transmitters. This symbol shall be accompanied by the name and the address of the authorised representative in the European Community. This symbol shall be accompanied by the name and the address of the manufacturer (who are placing this device on the market). Operating conditions: The numbers after the CE symbol correspond to the code of certified institutions that were consulted under the above-mentioned directives. This device is designed such that it functions without problems or restrictions if used as intended, unless otherwise noted in these user guides. This symbol indicates that it is important for the user to read and take into account the relevant information in this user guide. Transport conditions: This symbol indicates that it is important for the user to pay attention to the relevant warning notices in this user guide. Temperature: –20° to +60° Celsius (–4° to +140° Fahrenheit). Humidity: Up to 90% (non condensing). The symbol with the crossed-out garbage bin is to make you aware that this device may not be thrown away as normal household waste. Please dispose of old or unused devices, at waste disposal sites intended for electronic waste, or give your device to your hearing healthcare professional for disposal. Proper disposal protects the environment and health. Important information for handling and effective use of the product. This symbol indicates that the products described in these user instructions adhere to the requirements for an application part of Type B of EN 60601-1. The surface of the hearing aid is specified as applicated part of Type B. © The Bluetooth® word mark and logos are registered trademarks owned by Bluetooth SIG, Inc. and any use of such marks by Unitron is under license. Other trademarks and trade names are those of their respective owners. Copyright symbol Moxi 46 Moxi is a trademark of Unitron. 47 Compliance information Declaration of conformity Hereby, Unitron Hearing declares that this product meets the requirements of the Medical Device Directive 93/42/EEC and complies with Radio Equipment Directive 2014/53/EU. The full text of the Declarations of Conformity can be obtained from the manufacturer. Australia/New Zealand: 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. The compliance label R-NZ is for radio products supplied in the New Zealand market under conformity level A1. The hearing aid described in this user guide is certified under: Standard hearing system USA - FCC ID: Canada - IC: VMY-UBTD1 2756A- UBTD1 Notice 1 This device complies with Part 15 of the FCC Rules and with RSS210 of Industry Canada. Operation is subject to the following two conditions: 1) this device may not cause harmful interference, and Notice 2 Changes or modifications made to this device not expressly approved by Unitron may void the FCC authorization to operate this device. 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 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 equipment 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 2) this device must accept any interference received, including interference that may cause undesirable operation. 48 49 Radio information of your wireless hearing aid Antenna type Resonant loop antenna Operation frequency 2.402 – 2.480 GHz Modulation GFSK, Pi/4 DPSK Radiated power <1mW (EIRP) Bluetooth® Range Bluetooth Profiles supported ~ 1m (class 3) Version 4.2 HFP (Hands-free profile) Patient feedback Record your specific needs or concerns and bring to your first office visit after getting your hearing aids. This will help your hearing healthcare professional to address your needs. _________________________________________ _________________________________________ _________________________________________ _________________________________________ _________________________________________ _________________________________________ _________________________________________ _________________________________________ _________________________________________ _________________________________________ 50 51 Additional notes ___________________________________________ ___________________________________________ ___________________________________________ ___________________________________________ ___________________________________________ ___________________________________________ ___________________________________________ ___________________________________________ ___________________________________________ ___________________________________________ ___________________________________________ 52 53
Source Exif Data:
File Type : PDF File Type Extension : pdf MIME Type : application/pdf PDF Version : 1.6 Linearized : Yes Create Date : 2018:03:06 09:00:12-05:00 Creator : Adobe InDesign CC 13.0 (Windows) Modify Date : 2018:03:06 09:03:27-05:00 Has XFA : No Language : en-US XMP Toolkit : Adobe XMP Core 5.6-c015 84.159810, 2016/09/10-02:41:30 Metadata Date : 2018:03:06 09:03:27-05:00 Creator Tool : Adobe InDesign CC 13.0 (Windows) Instance ID : uuid:0f062adb-9e6d-4a45-9e25-ee53b426e98e Original Document ID : xmp.did:F77F1174072068118083BFA7B79EF3D0 Document ID : xmp.id:5ba6bf7d-8405-2549-8406-b54aba3eb16a Rendition Class : proof:pdf Derived From Instance ID : xmp.iid:a5197177-ba51-6b42-8a2b-71a839fc88a8 Derived From Document ID : xmp.did:a5197177-ba51-6b42-8a2b-71a839fc88a8 Derived From Original Document ID: xmp.did:F77F1174072068118083BFA7B79EF3D0 Derived From Rendition Class : default History Action : converted History Parameters : from application/x-indesign to application/pdf History Software Agent : Adobe InDesign CC 13.0 (Windows) History Changed : / History When : 2018:03:06 09:00:12-05:00 Format : application/pdf Producer : Adobe PDF Library 15.0 Trapped : False Page Count : 32EXIF Metadata provided by EXIF.tools