Jabra ENHANCE SELECT 100 Rx, User Manual

Page 1: ...ENHANCE SELECT 100 Rx Life is richer when you can hear it User guide Receiver In Ear hearing aids ...

Page 2: ... Serial number Model number Model number Battery type Rechargeable Dome earmold type Closed dome Small Medium Large Open dome Small Medium Large Power dome Small Medium Large Tulip dome RIE earmold Program Beep Description 1 One beep 2 Two beeps 3 Three beeps 4 Four beeps 2 ...

Page 3: ...prospective hearing aid user to consult promptly with a doctor preferably an ear specialist such as an ENT before dispensing a hearing aid if you determine 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 Visible deformity of the ear either congenital or traumatic Fluid pus ...

Page 4: ...ts It is recommended to perform an RECD measurement in order to ensure the correct target for the fitted OSPL90 CAUTION This is not hearing protection You should remove this device if you experience overly loud sounds whether short or long lasting If you re in a loud place you should use the right kind of hearing protection instead of wearing this device In general if you would use ear plugs in a ...

Page 5: ...times need a few weeks to get used to them Similarly many people find that training or counseling can help them get more out of their devices If you have hearing loss in both ears you might get more out of using hearing aids in both especially in situations that make you tired from listening for example noisy environments Tell FDA about injuries malfunctions or other adverse events To report a pro...

Page 6: ...the medical evaluation and if appropriate the doctor will provide a written statement that the hearing loss has been medically evaluated and the person is a candidate for a hearing aid The doctor may refer the person to an audiologist for a hearing aid evaluation which is different from the medical evaluation and is intended to identify the appropriate hearing aid The audiologist will conduct a he...

Page 7: ... ears 14 Removing your hearing aids from your ears 18 Using your hearing aids 20 Using a telephone 23 Advanced options 28 Wireless accessories 32 Cleaning and caring for your hearing aids 33 General warnings and precautions 42 Troubleshooting 45 Regulatory information 49 Technical specifications 56 Additional information 64 FDA warnings and cautions US only 7 ...

Page 8: ...to compensate for impaired hearing The fundamental operating principle of hearing aids is to receive amplify and transfer sound to the eardrum of a hearing impaired person For devices including a dome The dome is intended to be connected to a receiver tube on the hearing aid The dome is intended to ensure that the sound outlet of the hearing aid is placed in the ear canal This accessory is intende...

Page 9: ...hearing aid 1 Receiver wire 2 Receiver 3 Dome an open dome is shown 4 Push button 5 LED green light 6 Microphone inlets 7 Left right indicator 8 Serial number and model 1 2 3 4 5 6 6 6 7 8 Your hearing aid 9 ...

Page 10: ...Closed dome Open dome Power dome Custom earmold The closed open and power domes are available in different sizes Tulip domes are one size Domes are all light gray NOTE Only use domes supplied by the manufacturer 10 Your hearing aid ...

Page 11: ...put your rechargeable hearing aid in your mouth Keep your rechargeable hearing aid away from pets children and people with cognitive intellectual or mental health challenges Never swallow lithium ion batteries nor place them inside any part of the body as this may lead to fatal injuries in two hours or less If a lithium ion battery is swallowed or placed inside any part of the body or if a recharg...

Page 12: ...ring care professional When traveling consult your airline about any rules for transportation of your hearing aid and charger NOTE For safety reasons use only the charger supplied with your hearing aids Use of other chargers may invalidate any approval or warranty To save battery power turn off your hearing aids when they are not in use Low battery alert When the batteries are low on power the vol...

Page 13: ...play every five minutes to let you know that the battery power is low The table below shows the functionality with different battery charge levels Battery level Signal Hearing aid Remote control Streaming Fully charged P P P Low 4 even tones P P x Depleted 3 even tones and 1 longer tone P x x You can check the battery status by placing the hearing aid in the hearing aid charger Premium charger onl...

Page 14: ...r the other for your right Do not swap them Please pay attention to this when cleaning storing and inserting the hearing aids Left hearing aid Right hearing aid You might want to ask your hearing care professional to mark your hearing aids with a colored Left and Right indication Left is blue and Right is red 14 Placing your hearing aids in your ears ...

Page 15: ... Hang the hearing aid over the top of your ear 2 Hold the receiver wire where it bends and gently place push the receiver dome into your ear canal 3 Push the dome far enough into your ear canal so that the wire rests against your head You can check in a mirror Placing your hearing aids in your ears 15 ...

Page 16: ...ever attempt to modify the shape of the receiver wire yourself Sport lock If you lead an active life your hearing aids may come loose To avoid this situation your hearing care professional can attach and adjust a sports lock to the receiver To insert a hearing aid with a sports lock 1 Insert the hearing aid as usual 2 Tuck the sports lock into the bottom part of the indentation above your earlobe ...

Page 17: ...ve the earmold up and down and press gently Opening and closing your mouth may be helpful 3 Place the hearing aid behind your ear and ensure it is secure When properly inserted your hearing aids should fit snugly and comfortably NOTE When inserting an earmold it may help to pull your ear up and back with the opposite hand CAUTION Never attempt to modify the shape of the hearing aids earmolds domes...

Page 18: ...s from your ears If your hearing aids have domes follow these instructions 1 Lift the hearing aid off your ear 2 Hold the receiver wire with your thumb and forefinger where it bends and pull the dome out of your ear canal 18 Removing your hearing aids from your ears ...

Page 19: ...entarily 2 Using your thumb and index finger gently pull the earmold not the hearing aid or the wire loose from your ear If your earmold has a removal cord pull it gently to assist The removal cord is a separate line that is additionally attached to the earmold if requested Remove the earmold completely by twisting it gently Removing your hearing aids from your ears 19 ...

Page 20: ...hem from the charger Your hearing aids always start in program 1 at the pre set volume Smart Start Smart Start delays the time before your hearing aid turns on after you remove the hearing aid from the charger With this function activated you will hear a beep for each second of the delay period either 5 or 10 seconds NOTE If you do not want to use this function ask your hearing care professional t...

Page 21: ...eless device pressing for one more second will switch to the next device A short press will end streaming and start the program you left Press and hold for 5 seconds to turn your hearing aid ON or OFF When you turn the hearing aids off and then back on they always return to the default setting program 1 and preset volume Your hearing care professional can configure your push button so that you can...

Page 22: ...fessional about the best settings for you For convenience you may control your hearing aids from the Smartphone app or the Remote Control 2 The LED light indicator Your hearing aid communicates with both sound and light whenever you change program or turn it on or off Action Light Turn on Press and hold the button for 5 seconds Green flash Turn off Press and hold the button for 5 seconds Flashes g...

Page 23: ...to your ear canal or hold it close to the hearing aid microphones as illustrated 2 If you hear whistling try holding the telephone in the same position for a few seconds The hearing aid may be able to cancel the whistling 3 You can also try holding the telephone slightly away from the ear NOTE Depending on your needs your hearing care professional may activate a function specifically for telephone...

Page 24: ... your hearing care professional can give you advice on available wireless accessories to enhance listening capabilities See also Wireless accessories page 32 Phone Now optional If you place a magnet on the telephone receiver your hearing aids will automatically switch the telephone program on when the receiver is close to your ear When you remove the receiver from your ear the hearing aids automat...

Page 25: ...sensitive device equipment pacemakers and defibrillators in question If the manufacturer cannot issue a statement we recommend keeping the magnet or a telephone equipped with the magnet 30 cm 12 away from magnetically sensitive devices e g pacemakers Phone Now precautions If you experience frequent signal loss or noise during calls move the magnet to another place on the telephone receiver Only us...

Page 26: ... from the magnet 3 Place the magnet on the phone CAUTION If you experience frequent signal loss or noise during calls move the Phone Now magnet to another place on the telephone receiver Only use magnets supplied by the manufacturer How to use Phone Now 1 Lift the telephone to your ear 2 When you hear a short melody the phone program is active 26 Using a telephone ...

Page 27: ... the hearing aid on the non phone ear automatically attenuates Do not cover the phone loudspeaker opening with the magnet If the function does not work to your satisfaction moving the magnet to another position may improve ease of use and comfort If your hearing aids do not switch to the telephone program consistently try repositioning the magnet or adding additional magnets Use a recommended clea...

Page 28: ...ssistance with pairing and using these products with your hearing aids contact your hearing care professional Controlling your hearing aid with the mobile device app optional The smartphone apps send and receive signals to and from the hearing aids via smartphones Do not disable app notifications Install updates to keep the app working correctly The app must only be used with the hearing aids for ...

Page 29: ...Live Assist optional Online Services If you have signed up to use Online Services available with your hearing aids you can allow your hearing aids to be adjusted remotely without having to visit your hearing care professional All you need is a compatible mobile device with internet enabled This allows you to Request assistance remotely to adjust your hearing aids to be a better fit for you Keep yo...

Page 30: ... Live Assist With this service you can get face to face assistance from your hearing care professional from home Flight Mode optional Your hearing aids can be controlled from your mobile device or Remote Control an option that can be added by your hearing care professional However in some areas you are requested to turn off wireless communication CAUTION When boarding a flight or entering an area ...

Page 31: ...aids at the time you will hear double tones for about 10 seconds meaning the hearing aid is now in Flight Mode Activating wireless communication exit Flight Mode 1 Turn your hearing aid off and then on 2 Wireless communication will be activated after 10 seconds Advanced options 31 ...

Page 32: ...your settings A phone clip streams phone conversations and stereo sound to both hearing aids and doubles as a remote control A body worn microphone is a microphone that can be worn by others It improves speech comprehension in noisy situations A wireless microphone It works like the body worn microphone but doubles as a table microphone Furthermore it has a built in telecoil that allows it to conn...

Page 33: ...ausing damage 4 Do not immerse your hearing aid in any liquid 5 Keep your hearing aids away from excessive heat and intense direct sunlight The heat may deform the shell damage the electronics and deteriorate the surface 6 Do not swim shower or take steam baths while wearing your hearing aids Daily maintenance It is important to keep your hearing aid clean and dry On a daily basis clean the hearin...

Page 34: ...ts with the brush WARNING Do not use force to press the bristles on the small brush into the inlets because the microphones may be damaged NOTE Do not use the wire loop to clean the microphone inlets If the microphone inlets remain clogged after brushing the exterior ask a hearing care professional to help you clean them CAUTION Do not use alcohol or other solvents to clean your hearing aid or the...

Page 35: ... or more often according to the advice of your hearing care professional NOTE Incorrect dome replacement can result in a dome being left in your ear when you remove your hearing aid CAUTION If you suspect that you have a dome stuck in your ear consult your hearing care professional Only use original consumables from the manufacturer e g domes and wax filters Cleaning and caring for your hearing ai...

Page 36: ...d then discard it This may require a bit of force 2 Push the new dome over the ribbed end of the receiver 3 Check that the dome is securely mounted by carefully lifting the lower part of the dome and verifying that the collar completely covers the ribbed end of the receiver 4 OK NOTE Change the dome at least every three months Ask your hearing care professional for advice 36 Cleaning and caring fo...

Page 37: ...tructions 1 Remove the used dome by pulling it off the receiver and then discard it This may require a bit of force 2 Push the largest petal back then press the tulip dome over the ribbed end of the receiver Cleaning and caring for your hearing aids 37 ...

Page 38: ...g that the collar completely covers the ribbed end of the receiver 4 Push the larger petal toward the receiver This illustration shows a correctly mounted tulip dome Ensure the large petal is outside the small petal 38 Cleaning and caring for your hearing aids ...

Page 39: ...r advice on how often you need to change them It will depend on how much wax your ears produce If you wear a dome remove it before following this process for replacing the wax filter See Changing your hearing aid domes page 35 You will need your box of wax filter tools Box of 8 wax filter tools The wax filter tool has two functions a removal tip to collect the used filter and a replacement tip wit...

Page 40: ...take out one of the tools Each tool has a small hook removal tip in one end and a new wax filter in the other 3 Insert the removal tip into the used wax filter and then pull the tool straight out It is important to pull it straight and not on an angle 40 Cleaning and caring for your hearing aids ...

Page 41: ...the replacement straight into the sound outlet until the outer ring is touching the sound outlet 3 Pull the tool straight out Your new wax filter will remain in place Re attach your dome or a replacement dome CAUTION Only use original consumables from the manufacturer e g domes and wax filters Cleaning and caring for your hearing aids 41 ...

Page 42: ...quality or temporarily create undesired sounds from the hearing aids 3 Do not wear hearing aids in mines oil fields or other explosive areas unless those areas are certified for hearing aid use 4 Do not allow others to use your hearing aids 5 Hearing aid usage by children or mentally disabled persons should be supervised at all times to ensure their safety The hearing aid contains small parts that...

Page 43: ...in order to communicate with other wireless devices Although unlikely nearby electronic devices may be affected In that case move the hearing aid away from the affected electronic device 2 Use only original parts from the manufacturer e g wax guards 3 Only connect your hearing aids to accessories intended and qualified to be used with your hearing aids Cyber security warnings Failing to follow the...

Page 44: ...he pairing sound at an unexpected time this could indicate someone has gained access to your device Only connect your hearing aid to the official mobile device app Only apply remote fine tuning updates that you are expecting Always use the newest software update available for your hearing aid Only accept live assistance calls from the hearing care professional that you are expecting 44 General war...

Page 45: ...the hearing aid Move your hand away to create more space between the hearing aid and the object Is your ear full of wax Visit your doctor No sound Is the hearing aid turned off Turn it on Is the hearing aid charged Charge the hearing aid See the user guide for your charger Is the receiver wire broken or the earmold clogged Visit your hearing care professional Is your ear full of wax Visit your doc...

Page 46: ...g aid 3 4 years old Visit your hearing care professional Hearing aid is not charging Is the hearing aid correctly inserted in the charger Put the hearing aid back in the charger See the user guide for your charger Is the hearing aid charger charged Premium charger only or plugged into a power source Plug the charger into a power source See the user guide for your charger FAQ on rechargeable batter...

Page 47: ...If you leave your hearing aids in the charger for more than 24 hours the charger will go into standby mode and turn off the hearing aids power If the charger runs out of battery power it will instruct the hearing aids to turn off to save energy When you remove the hearing aids from the charger they will not turn on automatically as normally Press the button for 5 seconds to turn the hearing aids o...

Page 48: ...rge immediately Charging must take place between 0 C 32 F and 40 C 104 F Can I charge at high temperatures The operating temperature range for the charger and the hearing aids is 0 C 32 F to 40 C 104 F 48 Troubleshooting ...

Page 49: ...hed replacement parts The warranty period of hearing aids is designated on your warranty card which is provided by your hearing care professional For hearing aids that require service please contact your hearing care professional for assistance Hearing aids that malfunction must be repaired by a qualified technician Do not attempt to open the case of hearing aids as this will invalidate the warran...

Page 50: ...ormed according to IEC 62479 2010 ANSI IEEE C63 19 2019 and IEC 60601 1 2 2014 A1 2020 Radio and Telecommunication testing is performed to be in compliance with applicable parts of the FCC rules in title 47 of the CFR Electroacoustic testing is performed according to ANSI ASA S3 22 2014 and ANSI CTA 2051 2017 Usability Engineering was performed in compliance with IEC 62366 1 2015 The devices cover...

Page 51: ...r hearing impairment by amplifying and transmitting sound to the ear Based on technical and clinical data presented for the device in question the equivalent predecessor and generally similar devices it is concluded to support the clinical performance expressed in user needs and claims The clinical data leaves no questions open regarding clinical performance and is for this reason deemed sufficien...

Page 52: ... if not installed and used according to the instructions may cause harmful interference to radio communications However there is no guarantee that interference will not occur in a particular installation If this equipment does cause harmful interference to radio or television reception which can be determined by turning the equipment off and on the user is encouraged to try to correct the interfer...

Page 53: ...egulatory requirements in countries outside the EU and US Please refer to local country requirements for these areas In Canada these hearing aids are certified under the rules of ISED Japanese Radio Law and Japanese Telecommunications Business Law Compliance This device has been certified pursuant to the Japanese Radio Law 電波法 and the Japanese Telecommunications Business Law 電気通信事業法 This device sh...

Page 54: ...i Receiver In the Ear RIE hearing aids of type LXR45 with FCC ID X26LXR45 IC number 6941C LXR45 are available in the following variants XZ461 C XZ361 C Nominal RF output power transmitted is 0 82 dBm 54 Regulatory information ...

Page 55: ... transmitter Complies with IMDA requirements Product is a Type B applied part Complies with ACMA requirements By prescription only US Do not dispose of your hearing aids and batteries with ordinary household garbage Your hearing aids and batteries should be disposed of at sites intended for electronic waste or returned to your hearing care professional for safe disposal Please ask your local heari...

Page 56: ...utput 90 dB SPL input Max HFA 113 109 dB SPL Total harmonic distortion 500 Hz 800 Hz 1600 Hz 0 5 0 8 0 5 Equivalent input noise w o noise reduction 21 dB SPL 1 3 Octave Equivalent input noise w o noise reduction 1600 Hz 9 dB SPL Frequency range IEC 60118 0 2015 100 8000 Hz Expected operating time 30 Hours Data in accordance with ANSI S3 22 2014 IEC 60118 0 2015 Measured in a 2cc coupler The expect...

Page 57: ... Battery type Rechargeable 0 5 mA Attack release time 2 kHz syllabic 12 70 ms Input Output response measured in a 2cc coupler at the reference test gain 2 KHz 70 80 90 100 110 120 130 40 50 60 70 80 90 100 Output dB SPL Input dB SPL Input Output Response LP Ref Test Gain 2 kHz 2cc coupler Technical specifications 57 ...

Page 58: ...PL input Max HFA 116 113 dB SPL Total harmonic distortion 500 Hz 800 Hz 1600 Hz 0 3 0 4 0 7 Equivalent input noise w o noise reduction 24 dB SPL 1 3 Octave Equivalent input noise w o Noise reduction 1600 Hz 11 dB SPL Frequency range IEC 60118 0 2015 100 8060 Hz Expected operating time 30 Hours Data in accordance with ANSI S3 22 2014 IEC 60118 0 2015 Measured in a 2cc coupler The expected operating...

Page 59: ... Battery type Rechargeable 0 5 mA Attack release time 2 kHz syllabic 12 70 ms Input Output response measured in a 2cc coupler at the reference test gain 2 KHz 70 80 90 100 110 120 130 40 50 60 70 80 90 100 Output dB SPL Input dB SPL Input Output Response MP Ref Test Gain 2 kHz 2cc coupler Technical specifications 59 ...

Page 60: ...PL input Max HFA 120 117 dB SPL Total harmonic distortion 500 Hz 800 Hz 1600 Hz 0 3 0 7 0 5 Equivalent input noise w o noise reduction 22 dB SPL 1 3 Octave Equivalent input noise w o noise reduction 1600 Hz 10 dB SPL Frequency range IEC 60118 0 2015 100 6750 Hz Expected operating time 30 Hours Data in accordance with ANSI S3 22 2014 IEC 60118 0 2015 Measured in a 2cc coupler The expected operating...

Page 61: ...Battery type Rechargeable 0 5 mA Attack release time 2 kHz syllabic 12 70 ms Input Output response measured in a 2cc coupler at the reference test gain 2 KHz 80 90 100 110 120 130 140 40 50 60 70 80 90 100 Output dB SPL Input dB SPL Input Output Response HP Ref Test Gain 2 kHz 2cc coupler Technical specifications 61 ...

Page 62: ...PL input Max HFA 128 124 dB SPL Total harmonic distortion 500 Hz 800 Hz 1600 Hz 1 0 1 6 0 1 Equivalent input noise w o noise reduction 23 dB SPL 1 3 Octave Equivalent input noise w o noise reduction 1600 Hz 9 dB SPL Frequency range IEC 60118 0 2015 130 4920 Hz Expected operating time 30 Hours Data in accordance with ANSI S3 22 2014 IEC 60118 0 2015 Measured in a 2cc coupler The expected operating ...

Page 63: ...Battery type Rechargeable 0 5 mA Attack release time 2 kHz syllabic 12 70 ms Input Output response measured in a 2cc coupler at the reference test gain 2 KHz 90 100 110 120 130 140 150 40 50 60 70 80 90 100 Output dB SPL Input dB SPL Input Output Response UP Ref Test Gain 2 kHz 2cc coupler Technical specifications 63 ...

Page 64: ...nd the following disclaimer in the documentation and or other materials provided with the distribution THIS SOFTWARE IS PROVIDED BY THE COPYRIGHT HOLDERS AND CONTRIBUTORS AS IS AND ANY EXPRESS OR IMPLIED WARRANTIES INCLUDING BUT NOT LIMITED TO THE IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE ARE DISCLAIMED IN NO EVENT SHALL THE COPYRIGHT HOLDER OR CONTRIBUTORS BE LIAB...

Page 65: ...peration of this device or its compliance with safety and regulatory standards 2023 GN Hearing A S All rights reserved Jabra is a trademark of GN Audio A S Apple the Apple logo iPhone iPad iPod touch are trademarks of Apple Inc registered in the U S and other countries App Store is a service mark of Apple Inc registered in the US and other countries Android Google Play and the Google Play logo are...

Page 66: ...Notes 66 Additional information ...

Page 67: ...Notes Additional information 67 ...

Page 68: ... Care Corporation 8001 E Bloomington Freeway Bloomington MN 55420 USA 1 888 735 4327 Any serious incident that has occurred in relation to the device should be reported to the Legal manufacturer GN Hearing A S and the competent authority of the EU Member State in which the user and or patient is established 402105011US 23 03 Rev C Date of issuance 2023 03 01 ...