oticon BTE SP Instructions For Use Manual
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oticon BTE SP Instructions For Use Manual

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Instructions for use
BTE SP
BTE UP
Oticon Xceed
Oticon Xceed Play

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  • Page 1 Instructions for use BTE SP BTE UP Oticon Xceed Oticon Xceed Play...
  • Page 2 available information concerning the WARNING: People younger than prospective user, that the prospective 18 should go to a doctor before user has any of the following conditions: using this. • Visible deformity of the ear, either People younger than 18 years old congenital or traumatic need specialized care, and using this •...
  • Page 3 WARNING to Hearing Aid Dispenser, Caution: You might need medical help Outputs over 132 dB SPL: if a piece gets stuck in your ear. You should exercise special care in If any part of your hearing aid, like the selecting and fitting a hearing aid with eartip, gets stuck in your ear, and you a maximum output that exceeds 132 dB can’t easily remove it with your fingers,...
  • Page 4 If you have hearing loss in both ears, you Note: Hearing loss in people younger than 18 might get more out of using hearing aids in both, especially in situations that make • People younger than 18 should see a you tired from listening —...
  • Page 5 Following the medical evaluation and assist in the evaluation and rehabilitation if appropriate, the doctor will provide a of hearing loss in people younger than 18. 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...
  • Page 6 Model overview This booklet is valid for Oticon Xceed and Oticon Xceed Play in the following hearing aid models: BTE SP (Battery size 13)  BTE UP (Battery size 675)  FW 8.0 Oticon Xceed 1 GTIN: (01) 05714464061075 ...
  • Page 7 Introduction to this booklet This booklet guides you on how to use and maintain your new hearing aid. Ensure you read this booklet carefully, including the Warnings section. This will help you get the most benefit from your hearing aid. Your hearing care professional has adjusted the hearing aids to meet your needs.
  • Page 8 Intended use Intended use The hearing aid is intended to amplify and transmit sound to the ear. Indications for use Bilateral or unilateral impaired hearing of sensorineural, conductive, or mixed type ranging from a mild (30 dB HL*) to profound (107 dB HL*) degree of hearing loss, with an individual frequency configuration.
  • Page 9 IMPORTANT NOTICE The hearing aid amplification is uniquely adjusted and optimized to your personal hearing capabilities during the hearing aid fitting performed by your hearing care professional.

  • Page 10: Table Of Contents

    Table of contents About Hearing aid parts and functions Identify left and right hearing aid MultiTool for handling batteries and cleaning Getting started Turn the hearing aid ON and OFF When to replace the battery How to replace the battery Daily use Put on the hearing aid Caring for the hearing aid...
  • Page 11 Use the hearing aid with iPhone and iPad Wireless accessories Other options Tamper-resistant battery drawer Tinnitus Tinnitus SoundSupport™ (optional) Guidelines for Tinnitus SoundSupport users Sound options and volume adjustment Limitation on use time Warnings related to Tinnitus Warnings General warnings...
  • Page 12 More info Troubleshooting Water and dust resistant (IP68) Conditions of use Cell phone Technical information Warranty Your individual hearing aid settings Sound and LED indicators Summary of relevant studies Technical Data...

  • Page 14: Hearing Aid Parts And Functions

    Hearing aid parts and functions Microphone openings LED (optional) Sound in Program, volume, and battery status Earhook Volume button Change volume Tube and mute Brings sound into the ear Push-button Mold Change program, Holds the flight mode hearing aid in the ear Nail grip Open the Battery drawer...
  • Page 15 The handling of BTE SP and BTE UP is the same. Therefore the illustrations in this booklet only show the BTE SP.

  • Page 16: Identify Left And Right Hearing Aid

    Identify left and right hearing aid It is important to distinguish between the left and the right hearing aid as they may be programmed differently. You can find left/right color indicators in the battery drawer. Indicators can also be found on the molds. A BLUE indicator marks the LEFT hearing aid A RED indicator marks...

  • Page 17: Multitool For Handling Batteries And Cleaning

    MultiTool for handling batteries and cleaning The MultiTool contains a magnet that makes it easier to replace the battery in the hearing aid. It also contains a brush and wire loop for cleaning and removing earwax. If you need a new MultiTool, please contact your hearing care professional.

  • Page 18: Turn The Hearing Aid On And Off

    Turn the hearing aid ON and OFF The battery drawer is used to turn the hearing aid ON and OFF. To save battery life, make sure your hearing aid is turned OFF when you are not wearing it. When you turn ON the hearing aid, it will play a jingle. When you turn it OFF, it will play four descending tones.

  • Page 19: When To Replace The Battery

    When to replace the battery When it is time to replace the battery, you will hear three alternate tones repeated in moderate intervals until the battery runs out. Three alternate tones* Four descending tones = The battery is running low = The battery has run out Battery tip Keep a spare battery with you at all times to ensure your hearing aid...

  • Page 20: How To Replace The Battery

    How to replace the battery 1. Remove 2. Uncover 3. Insert Fully open the battery Remove the sticky Insert the new battery label from the drawer. Remove the side into the battery drawer. battery. of the new battery. Make sure the + side is facing up.
  • Page 21 4. Close MultiTool Close the battery drawer. The The MultiTool can be used to change hearing aid will play a jingle the battery. Use the magnetic end to through the earpiece. remove and insert batteries. Hold the earpiece close to your The MultiTool is provided by your ear to hear the jingle.

  • Page 22: Put On The Hearing Aid

    Put on the hearing aid Step 1 Step 2 The mold is Gently pull your Place the hearing aid ear outwards and behind your ear. customized for you and fits your ear press the mold in shape. The molds are the direction of the unique for the left or ear canal, twisting it...

  • Page 23: Caring For The Hearing Aid

    Caring for the hearing aid When handling the hearing aid, hold it over a soft surface to avoid damage in case you drop it. Clean the microphone openings Microphone openings Use the brush of the MultiTool to carefully brush debris away from the openings.
  • Page 24 Clean the mold Replace the tube The mold should be cleaned The tubing between the mold regularly. Use a soft cloth to clean and the hearing aid should be its surface. Use the MultiTool wire replaced if it becomes yellow or loop to clean the opening.
  • Page 25 Wash the mold Step 1 Step 2 Step 3 Make sure you are Disconnect the tube Wash the mold and tube able to identify which and mold from the using mild soap. Rinse mold is for which hook. Hold the hook and dry completely before reconnecting to hearing aid before...

  • Page 26: Flight Mode

    Flight mode When flight mode is activated, Bluetooth® is turned OFF. The hearing aid will still be working. Pressing the push-button on one hearing aid will activate flight mode on both hearing aids. Optional LED When flight mode is activated, the LED continuously flashes green, orange and orange.

  • Page 27: Optional Features And Accessories

    Optional features and accessories The features and accessories described in the following pages are optional. Please contact your hearing care professional for more information about features and accessories. If you experience difficult listening situations, a special program may be helpful. These are programmed by your hearing care professional. Write down any hearing situations in which you may need help.

  • Page 28: Change Program

    Change program Your hearing aid can have up to four different programs. You will hear one to four tones when you change program depending on the program. Optional LED The number of green flashes indicates the selected program. Press the push-button to switch between programs.

  • Page 29: Change Volume

    Change volume The volume button allows you to adjust the volume. You will hear a beep when you increase or decrease the volume. Optional LED A green flash confirms a change of volume. A long green flash indicates that start-up volume has been reached. An orange flash will appear when you reach the minimum or maximum level.

  • Page 30: Mute Your Hearing Aids

    Mute your hearing aids Use the mute function if you need to turn off the sounds temporarily, while wearing the hearing aid. The mute function only mutes the microphones on the hearing aid. Optional LED Continues orange and green flashes indicate mute. To mute the hearing aid Press either end of the volume button for at least four seconds.

  • Page 31: Use The Hearing Aid With Iphone And Ipad

    For assistance in using these products with your hearing aids, contact your hearing care professional or visit: www.oticon.com/support To see how to pair your hearing aid with your iPhone, visit: www.oticon.com/support For information on compatibility, visit: www.oticon.com/support/...

  • Page 32: Wireless Accessories

    Wireless accessories As an enhancement to your wireless hearing aids, a range of accessories is available. These can enable you to hear and communicate better in many everyday situations. ConnectClip Phone Adapter 2.0 A device that can be used as A device that when used together remote microphone and hands- with hearing aids and ConnectClip,...
  • Page 33 Oticon ON app from the official app stores. For more information visit www.oticon.com or contact your hearing care professional. Apple, the Apple logo, iPhone, iPad, and iPod touch are trademarks of Apple Inc., registered in the U.S. and other countries.

  • Page 34: Other Options

    Other options Telecoil Direct Audio Input (DAI) Telecoil can help you Allows your hearing aid to receive hear better when using a signals directly from external phone with a built-in loop sources such as TV, radio, music or when in buildings with teleloop players, etc.
  • Page 35 Allows you to receive speech or audio signals directly to your hearing aid from a dedicated transmitter. CROS Solution for people with an unaidable hearing loss in one ear. A transmitter on the poorer ear transmits sound to a hearing aid on the better ear.

  • Page 36: Tamper-Resistant Battery Drawer

    Tamper-resistant battery drawer To keep the battery out of reach of infants, small children, and people with learning difficulties, a tamper-resistant battery drawer should be used. IMPORTANT NOTICE Avoid excessive force when opening the battery drawer in the locked position. Do not force the battery drawer beyond its fully opened position. Make sure to insert the battery correctly.
  • Page 37 Lock the battery Tool to unlock the Unlock the battery drawer battery drawer drawer Close the battery door Use this small Insert the tip of the tool completely and make tool provided by into the small hole at sure it is locked. your hearing care the back of the battery professional.

  • Page 38: Tinnitus Soundsupport™ (Optional)

    Tinnitus SoundSupport™ (optional) Intended use of Tinnitus SoundSupport Tinnitus SoundSupport is a tool intended to generate sounds to provide temporary relief for patients suffering from tinnitus as part of a tinnitus management program. The target population is the adult population (over 18 years old). Tinnitus SoundSupport is targeted to licensed hearing care professionals (audiologists, hearing aid specialists, or otolaryngologists) who are familiar with the evaluation and treatment of tinnitus and...

  • Page 39: Guidelines For Tinnitus Soundsupport Users

    Guidelines for Tinnitus SoundSupport users These instructions contain information about Tinnitus SoundSupport, which may have been enabled in your hearing aids by your hearing care professional. Tinnitus SoundSupport is a tinnitus management device intended to generate sound of sufficient intensity and bandwidth to help manage tinnitus.

  • Page 40: Sound Options And Volume Adjustment

    Sound options and volume adjustment Tinnitus SoundSupport is programmed by your hearing care professional to match your hearing loss and preferences for tinnitus relief. It offers a number of different sound options. Together with your hearing care professional, you can select your preferred sound(s). Tinnitus SoundSupport programs Together with your hearing care professional you decide for which programs you may want to have Tinnitus SoundSupport activated.
  • Page 41 Volume adjustments with Tinnitus SoundSupport When you select a hearing aid program for which Tinnitus SoundSupport is activated, your hearing care professional can only set the push-button on your hearing aid to work as a volume control for the tinnitus relief sound. Your hearing care professional will set the volume control for the sound generator in one of two ways: A) Change volume in each ear separately, or...
  • Page 42 A) How to change Tinnitus SoundSupport volume in each ear separately To increase volume (on one hearing aid only), use a short press on the upper part of the push-button repeatedly until desired level is reached. To decrease volume (on one hearing aid only), use a short press on the lower part of the push-button repeatedly until desired level is reached.

  • Page 43: Limitation On Use Time

    Limitation on use time Daily use The volume levels of Tinnitus SoundSupport can be set to a level which could lead to permanent hearing damage when used for a prolonged period of time. Your hearing care professional will advise you of the maximum amount of time per day you should use Tinnitus SoundSupport.
  • Page 44 Important information for hearing care professionals about Tinnitus SoundSupport Device description Tinnitus SoundSupport is a module function that can be enabled in the hearing aids by the hearing care professional. Maximum wearing time The wearing time of Tinnitus SoundSupport will decrease as you increase the level above 80 dB(A) SPL.
  • Page 45 If the volume control is activated A warning may be displayed if you activate the tinnitus volume control in the “Buttons & Indicators” screen. This occurs if the relief sound can be listened to at levels that may cause hearing damage. The “Max wearing time”...

  • Page 46: Warnings Related To Tinnitus

    Warnings related to Tinnitus If your hearing care professional As with any device, misuse of the sound has activated the sound generator generator feature may cause potentially Tinnitus SoundSupport, please pay harmful effects. Care should be taken to attention to the following warnings. prevent unauthorized use and to keep the device out of the reach of children There are some potential concerns...

  • Page 48: General Warnings

    General warnings For your personal safety and to ensure Usage of hearing aids correct usage, you should familiarize Hearing aids should be used only as yourself fully with the following general directed and adjusted by your hearing care warnings before using your hearing aids. professional.
  • Page 49 Children under 36 months must always Use in explosive environments – only applies to BTE UP hearing aid use a hearing aids with a tamper-resistant battery drawer. Talk to your hearing care The hearing aid is safe to use under normal professional about the availability. usage conditions.
  • Page 50 General warnings Active implants If you have an active brain implant, contact The hearing aid has been thoroughly the manufacturer of your implantable tested and characterized for human health device for information about the risk of according to international standards for disturbance.
  • Page 51 X-ray/CT/MR/PET scanning, Power hearing aids electrotherapy and surgery Special care should be exercised in Remove your hearing aids before X-ray selecting, fitting, and using hearing aids examinations and CT/MR/PET scans, where the maximum sound pressure electrotherapy, surgery, etc. as your capability exceeds 132 dB SPL (IEC 60318- hearing aids may be damaged when 4 / IEC 711) as there may be a risk of...
  • Page 52 General warnings Connection to external equipment Interference The safety of the hearing aids, when The hearing aids have been connected to external equipment (with thoroughly tested for interference, in an auxiliary input cable and/or with USB accordance with the most stringent cable and/or directly), is determined by the international standards.
  • Page 53 Modification of hearing aids is not allowed Changes or modifications not expressly approved by the manufacturer will void the warranty of the equipment.

  • Page 54: Troubleshooting

    Troubleshooting Symptom Possible causes Dead battery No sound Clogged mold Microphones muted Clogged sound outlet Intermittent or Moisture reduced sound Dead battery Mold inserted incorrectly Squealing noise Earwax accumulated in ear canal Ear has grown If your hearing aid plays 8 beeps, 4 times consecutively, and/or repeatedly Beeping/orange flashes orange 4 times with small pauses, your hearing aid needs a flashes (optional)
  • Page 55 Contact your hearing care professional 1) Unpair your hearing aid. 2) Turn Bluetooth off and on again. 3) Open and close battery drawer on hearing aid. 4) Re-pair hearing aid (visit www.oticon.com/support). If none of the above solutions work, consult your hearing care professional.

  • Page 56: Water And Dust Resistant (Ip68)

    Water and dust resistant (IP68) Your hearing aid is dust tight and 1. Gently wipe off any water protected against ingress of water, 2. Open the battery drawer, remove which means it is designed to be worn the battery, and gently wipe off in all daily life situations.

  • Page 57: Conditions Of Use

    Conditions of use Operating Temperature: +1°C to +40°C (34°F to 104°F) conditions Humidity: 5% - 93% relative humidity, non-condensing Atmospheric pressure: 700  hPa to 1060 hPa Transportation Temperature and humidity shall not exceed the below limits and storage for extended periods during transportation and storage: conditions Transportation: Temperature: -25°C to + 60°C (-13°F to 140°F)

  • Page 58: Cell Phone

    Cell phone Some hearing aid users have reported The hearing aid is compliant with a buzzing sound in their hearing aid ANSI C63.19 in both microphone when using cell phones, indicating that and telecoil mode. the cell phone and hearing aid may not be compatible.
  • Page 59 IMPORTANT NOTICE The performance of individual hearing aids may vary with individual cell phones. Therefore, ensure you try this 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.

  • Page 60: Technical Information

    33 feet)). Additional information can be found in the Technical Data Sheet on The hearing aids also contain a radio www.oticon.com transceiver using Bluetooth Low Energy technology and a proprietary, short-range radio technology both operating at ISM band 2.4 GHz. The radio transmitter is weak and always below 3 mW equal to 4.8 dBm in total radiated...
  • Page 61 BTE SP only Radiofrequency radiation This device contains a radio module exposure information with the following certification This device complies with FCC RF ID numbers: FCC ID: 2ACAHSBOBTESP exposure limits set forth for an uncontrolled environment and has BTE UP only been tested for portable use.
  • Page 62 Note: This device has been - Reorient or relocate the receiving tested and found to comply antenna. with the limits for a Class B digital - Increase the separation between the device, pursuant to part 15 of the equipment and receiver. FCC Rules.
  • Page 63 The manufacturer declares that this Declaration of Conformity is available at hearing aid is in compliance with the the headquarters. essential requirements and other relevant provisions of Directive Oticon A/S 2014/53/EU. Kongebakken 9 DK-2765 Smørum This medical device complies with Denmark Medical Device Regulation (EU) www.oticon.global/doc...
  • Page 64 Description of symbols and abbreviations used in this booklet Warnings Text marked with a warning symbol must be read before using the device. Manufacturer The device is produced by the manufacturer whose name and address are stated next to the symbol. Indicates the medical device manufacturer, as defined in EU Regulation 2017/745.
  • Page 65 Made for Apple badges The device is compatible with iPhone, iPad and iPod touch. Hearing loop This logo incorporates the universal symbol for hearing assistance. The “T” signifies that a hearing loop is installed. Radio Frequency (RF) transmitter Your hearing aid contains an RF transmitter. Global Trade Item Number A globally unique 14-digit number used to identify medical device products including GTIN...
  • Page 66 Description of additional symbols used on labels Keep dry Indicates a medical device that needs to be protected from moisture. Catalog number Indicates the manufacturer’s catalog number so that the medical device can be identified. Serial number Indicates the manufacturer’s serial number so that a specific medical device can be identified.
  • Page 68 International warranty Your device is covered by an you have bought your device. Your international warranty issued by the hearing care professional may also have manufacturer. This international issued a warranty that goes beyond the warranty covers manufacturing clauses of this international warranty. and material defects in the device Please consult him/her for further itself, but not in accessories such as...

  • Page 69: Warranty

    Warranty Certificate Name of owner: _______________________________________________________ Hearing care professional: _______________________________________________ Hearing care professional’s address: _______________________________________ Hearing care professional’s phone: ________________________________________ Purchase date: ________________________________________________________ Warranty period: _______________ Month: ________________________________ Model left: ____________________ Serial no.: ______________________________ Model right: ___________________ Serial no.: ______________________________...

  • Page 70: Your Individual Hearing Aid Settings

    Your individual hearing aid settings To be filled out by your hearing care professional. Settings overview for your hearing aid Left Right Change volume Change program Mute Tinnitus SoundSupport Volume control indicators Beeps at min/max volume Beeps when changing volume Beeps at start-up volume Battery indicators Low battery warning About Getting started Daily use Options Tinnitus Warnings...
  • Page 71 Tinnitus SoundSupport: Limitation on use No limitation on use Program Start-up volume (Tinnitus) Max volume (Tinnitus) Max _______ hours per day Max _______ hours per day Max _______ hours per day Max _______ hours per day Max _______ hours per day Max _______ hours per day Max _______ hours per day Max _______ hours per day...

  • Page 72: Sound And Led Indicators

    Sound and LED indicators Different sounds and LED lights indicate the hearing aid status. The different indicators are listed on the following pages. Your hearing care professional can set sound and LED indicators to match your preferences. Program When to use Sound 1 tone 2 tones...
  • Page 73 ON/OFF Sound LED comments Shown one time Jingle Volume Sound Start-up volume 2 beeps Minimum/maximum Shown one time 3 beeps volume Volume up/down 1 beep Continuous or repeated Descending Mute three times tone Ascending Unmute tone Long green flash Green flash Orange flash Continues on next page...
  • Page 74 LED comments Accessories Sound FM and wireless 2 different tones Continuous or programs repeated three FM and wireless times 2 different tones programs LED comments Flight mode Sound Flight mode active Short jingle Continuous or repeated three times Flight mode inactive Short jingle Long green flash Green flash...
  • Page 75 Warnings Sound LED comments Continuously 3 alternate Low battery flashing tones 4 descending Battery shut down tones Microphone service 8 beeps Repeated four times check needed repeated 4 times Orange flash Long orange flash...

  • Page 76: Summary Of Relevant Studies

    Summary of relevant studies Clinical evaluations conducted by or Non-clinical data supporting the overall for the manufacturer provide evidence performance of the hearing aids includes to support the intended use and software verification, electroacoustic clinical benefits outlined in the IFU and verification, electrical and mechanical demonstrate regulatory conformity.

  • Page 78: Technical Data

    BTE SP Measured according to American National Standard ANSI S3.22-2014 and ANSI S3.55-2014/Part 5 Supply voltage: Zinc Air 0 dB SPL ref. 20 μPa Oticon Xceed 1, 2 & 3 Peak 139 dB SPL OSPL90 HF Average 130 dB SPL...
  • Page 79 0 dB SPL ref. 20 μPa Oticon Xceed 1, 2 & 3 Typical 2.5 mA Battery Consumption Quiescent 1.4 mA Expected battery life Hours 75-115 hrs (bat. size 13) Latency 8.4 ms Measured output at 1 mA/m 110 dB SPL...
  • Page 80 BTE UP Measured according to American National Standard ANSI S3.22-2014 and ANSI S3.55-2014/Part 5 Supply voltage: Zinc Air 0 dB SPL ref. 20 μPa Oticon Xceed 1, 2 & 3 Peak 142 dB SPL OSPL90 HF Average 130 dB SPL...
  • Page 81 0 dB SPL ref. 20 μPa Oticon Xceed 1, 2 & 3 Typical 4.1 mA Battery Consumption Quiescent 1.5 mA Expected battery life Hours 80-250 hrs (bat. size 675) Latency 8.4 ms Measured output at 1 mA/m 110 dB SPL...
  • Page 82 BTE SP Measured according to American National Standard ANSI S3.22-2014 and ANSI S3.55-2014/Part 5 Supply voltage: Zinc Air 0 dB SPL ref. 20 μPa Oticon Xceed Play 1 & 2 Peak 139 dB SPL OSPL90 HF Average 130 dB SPL...
  • Page 83 0 dB SPL ref. 20 μPa Oticon Xceed Play 1 & 2 Typical 2.5 mA Battery Consumption Quiescent 1.4 mA Expected battery life Hours 75-115 hrs (bat. size 13) Latency 8.4 ms Measured output at 1 mA/m 110 dB SPL...
  • Page 84 BTE UP Measured according to American National Standard ANSI S3.22-2014 and ANSI S3.55-2014/Part 5 Supply voltage: Zinc Air 0 dB SPL ref. 20 μPa Oticon Xceed Play 1 & 2 Peak 142 dB SPL OSPL90 HF Average 130 dB SPL...
  • Page 85 0 dB SPL ref. 20 μPa Oticon Xceed Play 1 & 2 Typical 4.1 mA Battery Consumption Quiescent 1.5 mA Expected battery life Hours 80-250 hrs (bat. size 675) Latency 8.4 ms Measured output at 1 mA/m 110 dB SPL...
  • Page 86 Technical Data BTE SP Oticon Xceed 1, 2 & 3 Oticon Xceed Play 1 & 2 OSPL90 – Output Sound dB SPL dB SPL Pressure Level Input: 90 dB SPL Technical setting: A0 Standard tube, undamped hook Standard tube, 1000...
  • Page 87 Technical Data BTE UP Oticon Xceed 1, 2 & 3 Oticon Xceed Play 1 & 2 OSPL90 – Output Sound dB SPL dB SPL Pressure Level Input: 90 dB SPL Technical setting: A0 Standard tube, undamped hook Standard tube, 1000...
  • Page 88 0000249180000001 0000251657000001...

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