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oticon Own SI IIC Instructions For Use Manual

oticon Own SI IIC Instructions For Use Manual

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Instructions for use
IIC - CIC
Oticon Own SI™

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Summary of Contents for oticon Own SI IIC

  • Page 1 Instructions for use IIC - CIC Oticon Own SI™...
  • 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 may need medical help if Outputs over 132 dB SPL: a piece gets stuck in your ear. You should exercise special care in selecting If any part of your hearing aid, like the and fitting a hearing aid with a maximum eartip, gets stuck in your ear, and you output that exceeds 132 dB SPL because...
  • 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 —for example, noisy doctor first, preferably an ear-nose- environments.
  • Page 5 Following the medical evaluation and if it is 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...

  • Page 6: Model Overview

    This booklet is valid for the following hearing aid models and styles: Styles Invisible-In-the-Canal  Completely-In-the-Canal  Battery Size 10 Oticon Own SI 1 GTIN: (01) 05714464139934  Oticon Own SI 2 GTIN: (01) 05714464139927  Oticon Own SI 3 GTIN: (01) 05714464139910 ...

  • Page 8: Introduction To This Booklet

    Introduction to this booklet This booklet guides you on how to use and maintain your new hearing aids. Ensure you read the booklet carefully including the Warnings section. This will help you get the most benefit of your new hearing aid. Warnings Text marked with a warning symbol must be read before using the device.
  • Page 9 For your convenience this booklet contains a navigation bar to help you navigate easily through the different sections. About Getting started Daily use Options Tinnitus Warnings More info...

  • Page 10: Intended Use

    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 slight (16 dB HL*) to severe (75 dB HL*) degree of hearing loss, with an individual frequency configuration.
  • Page 11 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 12: Table Of Contents

    Table of contents About Your hearing aid Identify left and right hearing aid MultiTool for handling batteries and cleaning Getting started Turn the hearing aid ON and OFF Low battery indication How to replace the battery Daily use Insert the hearing aid Remove your hearing aid Caring for your hearing aid Filter replacement...
  • Page 13 Tinnitus Tinnitus SoundSupport™ Guidelines for Tinnitus SoundSupport users Limitation on use time Sound options and volume adjustments Warnings related to Tinnitus Warnings General warnings More info Water & dust resistant (IP68) Conditions of use Cell phone Technical information International warranty Your individual hearing aid settings Sound indicators Troubleshooting guide Summary of relevant studies...

  • Page 14: Your Hearing Aid

    Your hearing aid (CIC shown) What it is and does Microphone inlet Push-button Sound outlet Sound in (Optional - CIC only) Sound out Mute, change volume and program Battery drawer Contains the battery and functions as ON/OFF switch Pull out string Pull out the hearing aid Vent...

  • Page 15: 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 might be shaped and programmed differently. A BLUE shell, dot or text identifies the LEFT hearing aid A RED shell, dot or text identifies the RIGHT hearing aid...

  • Page 16: 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 a wire loop for cleaning and removing earwax. If the vent is very small, a special tool may be required. If you need a new tool 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 also used to switch the hearing aid ON and OFF. To save battery life, make sure your hearing aid is switched OFF when you are not wearing it. If you wish to return to the standard settings of the hearing aid, simply open and then close the battery drawer (quick reset).

  • Page 19: Low Battery Indication

    Low battery indication The low battery indication is repeated periodically until the battery runs out. Your hearing care professional can set your hearing aids to match your preferences. The battery is running low The battery has run out Three alternate tones Four descending tones Voice Notification (Optional for select languages)

  • Page 20: Daily Use

    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 + side of drawer. Remove the into the battery drawer. battery. the new battery. Ensure that the + side of the battery and battery Tip: drawer align.
  • Page 21 4. Close MultiTool Close the battery drawer. The hearing The MultiTool can be used for battery aid will play a jingle. change. Use the magnetic end to Hold the hearing aid close to your ear remove and insert batteries. to hear the jingle.

  • Page 22: Insert The Hearing Aid

    Insert the hearing aid Step 1 Step 2 Place the tip of the hearing aid in your Gently pull your ear outwards and ear canal. push the hearing aid into the ear canal, twisting slightly if necessary. Follow the natural contour of the ear canal. Push the hearing aid to make sure it fits comfortably in the ear.

  • Page 23: Remove Your Hearing Aid

    Remove your hearing aid Hold the hearing aid by the pull-out string (if available). Gently pull the hearing aid from the ear canal. If your hearing aid doesn’t have a pull-out string, you can remove it by pulling on the edge of the hearing aid. IMPORTANT NOTICE DO NOT use the battery door as a handle to insert or remove your hearing aids, as it is not designed for this purpose.

  • Page 24: Caring For Your Hearing Aid

    Caring for your hearing aid When handling your hearing aid, hold it over a soft surface to avoid damage if you drop it. Cleaning the hearing aid Carefully brush away debris from the microphone inlets with a clean brush. Gently brush the surface. Make sure that the filters do not fall off. Microphone inlet About Getting started...
  • Page 25 Clean the vent by pressing the brush through the hole while twisting it slightly. If the vent is very small, a special tool may be required. Please consult your hearing care professional. Vent Vent IMPORTANT NOTICE To clean the hearing aids, use a soft, dry cloth. The hearing aids must never be washed or immersed in water or other liquids.

  • Page 26: Filter Replacement

    Filter replacement The filters keep wax and debris from damaging the hearing aid. If the filters become clogged, please replace the filters or contact your hearing care professional. • ProWax miniFit filters protect the sound outlet. • T-cap filters protect the microphone inlet. Please refer to the following pages for instructions on how to replace the appropriate filters.

  • Page 27: Replace Prowax Minifit Filter

    Replace ProWax miniFit filter 1. Tool 2. Remove 3. Insert filter filter New filter Old filter Old filter Remove the tool from Push the empty pin Insert the new ProWax the shell. The tool has into the ProWax miniFit miniFit filter using the two pins, one empty filter in the hearing aid other pin, remove the...

  • Page 28: Replace T-Cap Filter

    Replace T-Cap fi lter 1. Tool 2. Remove 3. Insert new fi lter Remove the tool from Push the tool fork Insert the new T-Cap the packaging. The tool under the top edge of fi lter and remove the has two ends, one for the used T-Cap fi lter tool by twisting it removal and one with...

  • Page 29: Change Volume With Push-Button

    Change volume with push-button (Optional - CIC only) The push-button allows you to adjust the volume. You may hear a click when you turn the volume up or down. MAXIMUM A short press on the RIGHT hearing aid START-UP increases the volume VOLUME A short press on the LEFT hearing aid...

  • Page 30: Change Programs

    Change programs (Optional - CIC only) Your hearing aid can have up to four different programs. These are programmed by your hearing care professional. You will hear one to four tones when you change program depending on the program. Use a short press to switch between programs. If Volume control is enabled, use a long press to switch programs.
  • Page 31 For information regarding tones, see the Sound indicators section. For information regarding button press times see the table General settings overview for your hearing aid, in the Your individual hearing aid settings section at the end of this booklet.

  • Page 32: Options

    Mute the hearing aid Use the mute function if you need to silence the hearing aid. Only available for hearing aids with push-button. Press and hold the push-button for two seconds to mute the hearing aid. To unmute, press the push-button. NOTE: the mute function only mutes the microphone(s) on the hearing aids.

  • Page 33: Optional Features And Accessories

    Optional features and accessories The features and accessories described on the following pages are optional. Please contact your hearing care professional to find out how your hearing aid is programmed. If you experience difficult listening situations, a special program may be helpful.

  • Page 34: Tinnitus Soundsupport

    Tinnitus SoundSupport™ (Optional - CIC only) 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 of age). 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 hearing loss.

  • Page 35: Guidelines For Tinnitus Soundsupport Users

    Guidelines for Tinnitus SoundSupport users Your hearing care professional will be able to offer the appropriate follow-up care. It is important to follow his/her advice and directions regarding such care. 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.

  • Page 36: Sound Options And Volume Adjustments

    Sound options and volume adjustments Tinnitus SoundSupport is programmed by your hearing care professional to match your hearing loss and preferences for tinnitus relief. Tinnitus SoundSupport programs The sound generator can be activated in up to four different programs. Mute If you are in a program for which Tinnitus SoundSupport is activated, the mute functionality only mutes the environmental sounds, and not the sound from Tinnitus SoundSupport.
  • Page 37 Volume adjustments with Tinnitus SoundSupport Your hearing care professional can set the volume control for a hearing aid program for which Tinnitus SoundSupport is activated. For more information about volume adjustments with Tinnitus SoundSupport, see the table Tinnitus SoundSupport settings overview for your hearing aid in the Your individual hearing aid settings section at the end of this booklet.

  • Page 38: 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 reach of children and pets.

  • Page 39: General Warnings

    General warnings For your personal safety and to ensure To achieve the full benefit from your correct usage, you should familiarize hearing aids, you should use them yourself fully with the following general frequently. warnings before using your hearing aids. Usage of hearing aids Consult your hearing care professional Hearing aids should only be used as...
  • Page 40 General warnings If a battery, hearing aid or small part is Never dispose of batteries by burning swallowed, see a doctor immediately them. There is a risk that the batteries will and contact the National Poison Center explode. Follow local guidelines for proper at 1-800-222-1222 or National Battery and safe disposal of batteries.
  • Page 41 voltages into the human body defined damaged if exposed to strong magnetic or in the standards for human health electromagnetic fields. and coexistence with active medical Keep away from extreme heat implants, such as pacemakers and heart Never expose your hearing aids to extreme defibrillators.
  • Page 42 General warnings Potential side effects may result in reduced electromagnetic You may produce more earwax when using compatibility (EMC) of your hearing aid. hearing aids. Do not modify In rare cases, the non-allergenic materials Do not make any modifications to your in the product may cause skin irritation or hearing aid not expressly approved by the other side effects.

  • Page 43: Water & Dust Resistant (Ip68)

    Water & dust resistant (IP68) Your hearing aid is dust-tight and protected against ingress of water which means it is designed to be worn in all daily life situations. Therefore, you do not have to worry about humidity or getting wet in the rain.

  • Page 44: Conditions Of Use

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

  • Page 46: 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 47 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. For additional guidance, please ask your cell phone provider for the booklet entitled “Hearing Aid Compatibility with Digital Wireless Cell Phones.”...

  • Page 48: Technical Information

    Technical information The hearing aids contain a radio Radiated emissions requirements for a transceiver using short range magnetic CISPR 11 Group 1 Class B device as stated induction technology operating at in table 2 of IEC 60601-1-2. 3.84 MHz. The magnetic field strength of the transmitter is very weak and always Radiated emission for communication below 15 nW (typically below –15 dBμA/m...
  • Page 49 Additional fields at 30 kHz, 134.2 kHz and 13.56 MHz information can be found in the Technical as stated in table 11 of IEC 60601-1-2 data document on www.oticon.com AM1. RF radiated immunity field levels at selected bands stated in IEC 60118-13 between 25 V/m and 60 V/m and, for...
  • Page 50 Radio frequency radiation This device contains a radio module exposure information (AM_AU5_KIT10) with the following This device complies with FCC RF exposure certification ID number: limits set forth for an uncontrolled environment and has FCC ID: 2ACAHAU5CIC been tested for portable use. The device must not be co-located or used in conjunction with any other antenna or transmitter.
  • Page 51 Note: This device has been - Reorient or relocate the receiving tested and found to comply antenna. with the limits for a Class B digital device, - Increase the separation distance pursuant to part 15 of the between the equipment and receiver. FCC Rules.
  • Page 52 Declaration of Conformity is available at hearing aid is in compliance with the the headquarters. essential requirements and other relevant provisions of Directive 2014/53/EU. Oticon A/S Kongebakken 9 This medical device complies with Medical DK-2765 Smørum Device Regulation (EU) 2017/745.
  • Page 53 Description of symbols accompanying the product 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 54 Description of symbols accompanying the product Radio Frequency (RF) transmitter Your device contains an RF transmitter. Global Trade Item Number A globally unique 14-digit number used to identify medical device products including GTIN medical device software. GTIN in this booklet is related to medical device firmware (FW). GTIN on regulatory packaging label is related to medical device hardware.

  • Page 55: International Warranty

    International warranty Your device is covered by an international may also have issued a warranty that goes warranty issued by the manufacturer. beyond the clauses of this international This international warranty covers warranty. Please consult him/her for manufacturing and material defects in the further information.

  • Page 56: Your Individual Hearing Aid Settings

    Your individual hearing aid settings To be filled out by your hearing care professional. 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...
  • Page 57 Tinnitus SoundSupport settings overview for your hearing aid Left Right Tinnitus SoundSupport A) How to change Tinnitus SoundSupport volume in each ear separately To increase or decrease the volume (on one hearing aid only), use a short press on the push-button repeatedly until you reach your desired level. B) How to change Tinnitus SoundSupport volume in both ears simultaneously You can use one hearing aid to increase the volume and the other hearing aid...

  • Page 58: Sound Indicators

    Sound indicators Different sounds indicate the hearing aid status. The different indicators are listed below. Your hearing care professional can set sound indicators to match your preferences. Program Sound Voice Notification When to use 1 tone 2 tones 3 tones 4 tones About Getting started Daily use Options Tinnitus Warnings More info...
  • Page 59 General settings overview for your hearing aid Left Right Short press Short press Change program Long press Long press Change volume Volume control indicators Beeps at min/max volume Beeps when changing volume Beeps at start-up volume Battery indicators Low battery warning To be filled out by your hearing care professional.

  • Page 60: Troubleshooting Guide

    Troubleshooting guide Symptom Possible causes Worn-out battery Clogged sound outlet No sound Clogged microphone inlet Hearing aid microphone muted Clogged sound outlet Intermittent or Moisture reduced sound Worn-out battery Hearing aid not inserted properly Squealing noise Ear wax accumulated in ear canal Service alert voice Issue detected by hearing aid...
  • Page 61 Solutions Replace the battery Clean sound outlet* or replace the wax filter Clean microphone inlet* or replace filter (T-Cap) Unmute the hearing aid microphone Clean sound outlet or replace the wax filter Wipe battery and hearing aid with a dry cloth Replace the battery Re-insert the hearing aid Have ear canal examined by your doctor...

  • Page 62: 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 64: Technical Data

    Technical Data Measured according to American National Standard ANSI S3.22-2014, IEC 60118-0:2015 and IEC 60318-5:2006 Supply voltage: Zinc-Air Oticon Own SI Oticon Own SI 0 dB SPL ref. 20 μPa 2,3,4 Peak 109 dB SPL 109 dB SPL OSPL90 HF Average...
  • Page 65 Oticon Own SI Oticon Own SI 0 dB SPL ref. 20 μPa 2,3,4 Typical 1.8 mA 1.8 mA Battery Consumption Quiescent 1.7 mA 1.7 mA Expected battery life Hours 45-55 45-55 (bat. size 10) Latency 8,2 ms 8,2 ms...
  • Page 66 Technical Data Measured according to American National Standard ANSI S3.22-2014, IEC 60118-0:2015 and IEC 60318-5:2006 Supply voltage: Zinc-Air Oticon Own SI Oticon Own SI 0 dB SPL ref. 20 μPa 2,3,4 Peak 119 dB SPL 119 dB SPL OSPL90 HF Average...
  • Page 67 Oticon Own SI Oticon Own SI 0 dB SPL ref. 20 μPa 2,3,4 Typical 2.4 mA 2.4 mA Battery Consumption Quiescent 1.8 mA 1.8mA Expected battery life Hours 40-55 40-55 (bat. size 10) Latency 8,2 ms 8,2 ms...
  • Page 68 Technical Data Measured according to American National Standard ANSI S3.22-2014, IEC 60118-0:2015 and IEC 60318-5:2006 Supply voltage: Zinc-Air Oticon Own SI Oticon Own SI 0 dB SPL ref. 20 μPa 2,3,4 Peak 109 dB SPL 109 dB SPL OSPL90 HF Average...
  • Page 69 Oticon Own SI Oticon Own SI 0 dB SPL ref. 20 μPa 2,3,4 Typical 1.7 mA 1.7 mA Battery Consumption Quiescent 1.6 mA 1.6 mA Expected battery life Hours 50-55 50-55 (bat. size 10) Latency 8,2 ms 8,2 ms...
  • Page 70 Technical Data Measured according to American National Standard ANSI S3.22-2014, IEC 60118-0:2015 and IEC 60318-5:2006 Supply voltage: Zinc-Air Oticon Own SI Oticon Own SI 0 dB SPL ref. 20 μPa 2,3,4 Peak 119 dB SPL 119 dB SPL OSPL90 HF Average...
  • Page 71 Oticon Own SI Oticon Own SI 0 dB SPL ref. 20 μPa 2,3,4 Typical 1.9 mA 1.9 mA Battery Consumption Quiescent 1.6 mA 1.6 mA Expected battery life Hours 30-55 30-55 (bat. size 10) Latency 8,2 ms 8,2 ms...
  • Page 72 Technical Data Oticon Own SI Oticon Own SI 2,3,4 OSPL90 – Output Sound Pressure Level (dB SPL) Input: 90 dB SPL Technical setting: A0 10k Hz 10k Hz Frequency response (dB SPL) Input: 60 dB SPL Technical setting: N0 10k Hz...
  • Page 73 Oticon Own SI Oticon Own SI 2,3,4 Input-Output dB SPL dB SPL Technical Setting: N0 500 Hz 500 Hz 800 Hz 800 Hz 1600 Hz 1600 Hz 2000 Hz 2000 Hz dB SPL dB SPL...
  • Page 74 Technical Data Oticon Own SI Oticon Own SI 2,3,4 OSPL90 – Output Sound Pressure Level (dB SPL) Input: 90 dB SPL Technical setting: A0 10k Hz 10k Hz Frequency response (dB SPL) Input: 60 dB SPL Technical setting: N0 10k Hz...
  • Page 75 Oticon Own SI Oticon Own SI 2,3,4 Input-Output dB SPL dB SPL Technical Setting: N0 500 Hz 500 Hz 800 Hz 800 Hz 1600 Hz 1600 Hz 2000 Hz 2000 Hz dB SPL dB SPL...
  • Page 76 Technical Data Oticon Own SI Oticon Own SI 2,3,4 OSPL90 – Output Sound Pressure Level (dB SPL) Input: 90 dB SPL Technical setting: A0 10k Hz 10k Hz Frequency response (dB SPL) Input: 60 dB SPL Technical setting: N0 10k Hz...
  • Page 77 Oticon Own SI Oticon Own SI 2,3,4 Input-Output dB SPL dB SPL Technical Setting: N0 500 Hz 500 Hz 800 Hz 800 Hz 1600 Hz 1600 Hz 2000 Hz 2000 Hz dB SPL dB SPL...
  • Page 78 Technical Data Oticon Own SI Oticon Own SI 2,3,4 OSPL90 – Output Sound Pressure Level (dB SPL) Input: 90 dB SPL Technical setting: A0 10k Hz 10k Hz Frequency response (dB SPL) Input: 60 dB SPL Technical setting: N0 10k Hz...
  • Page 79 Oticon Own SI Oticon Own SI 2,3,4 Input-Output dB SPL dB SPL Technical Setting: N0 500 Hz 500 Hz 800 Hz 800 Hz 1600 Hz 1600 Hz 2000 Hz 2000 Hz dB SPL dB SPL...
  • Page 81 < > 8,15 mm Placeholder for FSC logo < 15 mm >...
  • Page 82 0000280510000001...

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