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Soundwave SONTRO User Manual

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  • Page 1 USER MANUAL...
  • Page 3 WARNINGS Warning against use of people younger than 18 WARNING: If you are younger than 18, do not use this. You should go to a doctor, preferably an ear-nose-throat doctor (an ENT), because your condition needs specialized care. Over-the-counter hearing aids are only for users who are age 18 or older. This OTC hearing aid is for users who are 18 and older.
  • Page 4 WARNINGS WARNING: When to See a Doctor If you have any of the problems listed below, please see a doctor, preferably an ear-nose-and-throat doctor (ENT). • Your ear had a birth defect or an unusual shape. • Your ear was injured or deformed in an accident. •...
  • Page 5 WARNINGS Important Safety Instructions Please read and keep all safety use instructions. Only use attachments/components specified by the manufacturer The battery provided with the product may present a risk of chemical burn if mishandled. Please dispose of used batteries properly, following local regulations. When a replacement is needed, use only size 312 zinc-air batteries.
  • Page 6 WARNINGS • Do NOT store or replace batteries near where you store medication or near children. Battery ingestion can cause serious harm. If you think that you or someone else has swallowed a battery or placed a battery inside any part of the body, seek immediate medical attention.
  • Page 7 • Do NOT Use accessories, components, or replacement parts other than those provided by Soundwave Hearing could result in increased electromagnetic emissions and decreased electromagnetic immunity, which could decrease performance.
  • Page 8 WARNINGS • Your hearing aid system can be used on an aircraft, as hearing aids are exempt from the rules applied to other personal electronic devices. • The wireless capabilities featured in your hearing aid system are approved to operate at a radio frequency specific to your country or region and may not be approved for use outside your country or region.
  • Page 9 • Use of accessories, components, or replacement parts other than those provided by Soundwave Hearing could result in increased electromagnetic emissions and decreased electromagnetic immunity, which could decrease performance. • If portable radio frequency communications equipment is used closer than 12 inches (30 centimeters) from your hearing aid system, performance may decrease.
  • Page 10 CAUTIONS • Be aware that some sounds may sound different when you’re using the hearing aids. Keep this in mind when you need to be aware of your surroundings. You should adjust to this over time. • Consult a hearing care professional if you experience any unusual side effects like skin irritation, excessive accumulation of earwax, dizziness, change in your hearing, or if you think there may be a foreign object in your ear canal.
  • Page 11 CAUTIONS • 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 loud place, you should remove this device and use ear plugs.
  • Page 12 CAUTIONS • Note: What you might expect when you start using a hearing aid. A hearing aid can benefit many people with hearing loss. However, you should know it will not restore normal hearing, and you may still have some difficulty hearing over noise.

  • Page 13: Table Of Contents

    Intended use Indications for Use Congratulations Support Guarantee Download the otoTune® app Getting to know your Sontro® OTC Hearing Aids Package Contents and Accessories Volume Button Customize Your Hearing Aids Adjusting Your Hearing Aids The otoTune User Manual Ear Domes...
  • Page 14 TABLE OF CONTENTS Maintenance and Care Battery Adjusting to Sound Troubleshooting Noise and Disclaimers Overall Care Items to Avoid Serial Number Warranty and Repairs Clinical Data Summary Technical Specifications Wireless Technology Warnings Safety and Effective Use as a Wireless Device FCC Information Features per Ansi/ CTA-2051:2017 Symbols...
  • Page 15 USER MANUAL...

  • Page 16: Safety And Health

    Safety and Health 1. Intended Use The Soundwave Hearing Sontro® Self-Fitting OTC Hearing Aids are intended to amplify sounds for use by individuals 18 years and older with perceived mild to moderate hearing impairment. The device is intended for over-the-counter sale and use without the assistance of a hearing care professional.

  • Page 17: Congratulations

    Hearing new sounds may feel unusual at first, but most people find that they feel more comfortable using their hearing aids after 3 weeks of use. Get Back to Hearing, Get Back to Life with Sontro Self-Fitting OTC Hearing Aids.

  • Page 18: Support

    GUARANTEE Your satisfaction is 100% guaranteed! If you’re not happy with your Sontro Self-Fitting OTC Hearing Aids , you can return them within 45 days for a 100% refund! We’ll be sad to see you go - and we’ll be here when you need us.

  • Page 19: Download The Ototune® App

    Download the otoTune ® Sontro® Self-Fitting OTC Hearing Aids are designed to be used with the otoTune app. Download the otoTune app to properly fit and operate your Sontro Self- Fitting OTC Hearing Aid. In order to download the otoTune app you will need to have one of the following: iOS14.0 or later for iPhone, OS 6.0 or later for...
  • Page 20 Getting to Know your Sontro Self-Fitting OTC Hearing Aids ®...

  • Page 21: Package Contents And Accessories

    Medium Right Receiver Medium Left Receiver Receiver Measurement Tool 2 medium Open Ear Domes are attached to your Hearing Aids 1 Sontro Self-Fitting OTC Hearing Aid User Manual Extra Ear Domes include: 2 Small Power Ear Domes 2 Small Open Ear Domes...

  • Page 22: Volume Button

    VOLUME BUTTON...
  • Page 23 Customize your Hearing Aids with the Volume Button You can further customize how your hearing aid sounds by using the otoTune app or by using the volume button on the Sontro Self-Fitting OTC ® ® Hearing Aid. A Short Press (1 second) of the top or bottom button will change the volume up or down.
  • Page 24 Adjusting Hearing Aid Modes Sontro Self-Fitting OTC Hearing Aids have 4 modes: Automatic, Quiet, ® Noise, and Entertainment. You can also control all of these modes on the otoTune app. ® Automatic mode will automatically adjust the proper mode to your surroundings.

  • Page 25: The Ototune User Manual

    Resources. It is available for download as a PDF. If you are unable to access this electronic version you may call customer support and Soundwave will mail you a printed copy at no additional cost. Call Customer Support at 833-367-HEAR (4327) Monday - Friday 8:00 am - 4:30 pm, CST Email Customer Support at support@hearsoundwave.com...

  • Page 26: Ear Domes

    EAR DOMES...
  • Page 27 • Proper receiver size • Proper ear dome fit As you read on to assess the proper fit and comfort of your Sontro Self- Fitting OTC Hearing Aids, caution should be noted: Never push the ear dome far inside the ear canal, it should sit just inside the ear canal opening and remain in place.
  • Page 28 We recommend you take the otoTune 3-minute hearing test with the Open Ear Domes that are already installed on your hearing aids. We also suggest you wear your Sontro Self-Fitting OTC Hearing Aids for a couple ® of hours before making a final decision on ear dome fit for everyday use.
  • Page 29 Ear domes are small, bell shaped silicone pieces that attach to the end of the receiver and fit in the ear canal. Ear domes come in three variations: Open Ear Domes, Power Ear Domes, and Tulip Ear Domes. Open Ear Domes come installed on your hearing aids. If an ear dome feels too loose or too tight in your ear canal, remove the ear dome by pulling it from the receiver and then attach a larger or smaller ear dome.
  • Page 30 Open Ear Domes come in three sizes: small, medium and large. Soundwave replacement Open Ear Domes are sold in sets of 10. Tulip Ear Domes come in just one size and they fit the widest variety of ear canals.
  • Page 31 Replacing Your Hearing Aid Ear Domes It is important you know how to change and replace ear domes, incorrect ear dome replacement may result in the ear dome being left in the ear when you remove the hearing aid. Open and Power Ear Dome Replacement STEP 1 : Hold the receiver with your thumb and forefinger and firmly pull the base of the ear dome entirely off the receiver with your thumb and...
  • Page 32 Tulip Ear Dome Replacement Tulip Ear Domes consist of two petals. Use a bit more caution replacing them. STEP 1 : On the ear dome, push the largest petal away from the receiver using a finger. This bends the petal forward. Hold the receiver with your thumb and forefinger and firmly pull the base of the ear dome entirely off the receiver with your thumb and forefinger of your other hand.

  • Page 33: Placement

    PLACEMENT...
  • Page 34 Placement of Your Sontro Self-Fitting OTC Hearing Aid on ® Your Ear The LEFT receiver is BLUE and the RIGHT receiver is RED STEP 1 : Take each hearing aid and hang it over the corresponding Left and Right ear, so that the body of the hearing aid is behind each ear.
  • Page 35 Hold the receiver wire where it bends near the ear canal with your thumb and forefinger and gently pull the receiver with the attached dome from your ear. It’s that simple! Customizing the Fit of Your Sontro Self-Fitting OTC Hearing Aids The receiver delivers the sound to the eardrum. It is important that the receiver and the dome fit correctly in your ear.
  • Page 36 Right and Left Hearing Aids Soundwave manufactures the Sontro Self-Fitting OTC Hearing Aids as a ® paired set. When we manufacture hearing aids we program one as left, and one as right. The hearing aid with the blue tip receiver is the left hearing aid.

  • Page 37: Sontro Self-Fitting Otc Hearing Aid And Ototune

    SONTRO SELF-FITTING OTC HEARING AIDS AND OTOTUNE APP CONTROL...
  • Page 38 How Connect you Hearing Aids to your Phone The Sontro® Self-Fitting Hearing Aids are both ASHA and MFi certified. Insert batteries into the Hearing Aids and close battery doors to power on your hearing aids. ANDROID, Model AI and AIS Settings>...
  • Page 39 Self-Fitting OTC Insert batteries into the Sontro Hearing Aids and close battery doors to power on your hearing aids. (See battery section in the Sontro Hearing Aid User Manual) Step 2 You can connect your Hearing Aids by pressing the connect button for both the Left and Right Hearing Aids.
  • Page 40 How to take the 3-minute Hearing Test Step 1 After the hearing aids have been connected to the otoTune ® app, My Hearing Page will appear. This page allows you to initiate a hearing test, by pressing TAKE TEST. NOTE: If no previous hearing test has been conducted, no hearing test result will appear on your page.
  • Page 41 On the Control Screen, the Volume and Mode may be changed, and the Equalizer settings modified for either the left or right or both Hearing Aids. The Control Screen, helps you customize the ® sound of your Sontro Self-Fitting OTC Hearing Aids to your personal preference.
  • Page 42 Step 3 The Equalizer Settings (Bass, Mid, Treble) may be modified for the left and right or both Hearing Aids. The Equalizer settings are not available when in Automatic Mode. There are three Equalizer Settings Bass, Mid and Treble that can be changed to personalize your listening preference.
  • Page 43 The otoTune app provides 4 Modes. Swipe the icon to toggle between them. Quiet Mode Picks up sounds from all sides and directions including sounds coming from the front, back or side of the wearer. Quiet Mode can be used when a wearer is in a quiet environment such as home with a loved one or while outside walking in the woods.

  • Page 44: Receivers

    RECEIVERS...
  • Page 45 Receivers Soundwave ships all Sontro Self-Fitting OTC Hearing Aids with one size ® fits most receivers. Occasionally your ear size may require a longer or shorter receiver to help the ear dome and receiver stay in your ear canal. Should this be the case, call Customer Support (833)-367-Hear (4327) or email support@hearsoundwave.com and we will happily help you order...
  • Page 46 Using the Receiver Measurement Tool To find the correct size Receiver, use the Receiver Measurement Tool. Place the tool over the appropriate ear (see diagram). Pick the number that is the closest to the top of the ear canal opening. If you are between numbers, we recommend you choose the higher number.
  • Page 47 Placement of Sport Locks on Hearing Aid and Ear Your Hearing Aids also come with (2) sport locks to hold the receiver and ear dome in your ear canal if needed. To install a sport lock onto each receiver simply push the smaller end of the sport lock into the loop on the end of the receiver and gently pull it completely through to the wider end of the sport lock.

  • Page 48: Cleaning Tool

    Cleaning Tool Use the cleaning tool only on the hearing aids, do not insert into your ears. The cleaning tool is provided to use on a daily basis, to remove wax buildup from your hearing aids. When using the brush make sure to brush the wax with the tip of the dome facing down on the cleaning brush.

  • Page 49: Wax Guards

    WAX GUARDS...
  • Page 50 Changing Wax Guards STEP 1 : Remove the ear dome on your receiver. STEP 2 : Open a box of Cerustop Wax Guards ™ The wax guard tool that comes with the Cerustop Wax Guards has a removal tip to collect the used filter, and a replacement tip with a white filter to insert the new wax filters.
  • Page 51 STEP 4 : Gently press the new wax guard straight into the opening. Then pull the holder straight out. The new wax guard will automatically release from the tool. If the wax guard fits loosely, discard it and insert another. STEP 5 : Replace the ear dome on your receiver.

  • Page 52: Maintenance And Care

    MAINTENANCE & CARE...
  • Page 53 Daily Cleaning It is important to keep your hearing aids clean and dry. Clean the hearing aids using a dry soft cloth. Do not use water to clean the receiver wire or ear dome. In order to avoid damage due to humidity or excessive perspiration, you may consider purchasing a hearing aid dryer.
  • Page 54 (3) months to keep you hearing all of life’s moments. Over time, these parts may become stiff and discolored, affecting comfort, fit, and sound quality. Regular replacement will keep your Sontro Self- Fitting OTC Hearing Aids sounding and feeling like new.
  • Page 55 Overall Care for Optimal Hearing with your Hearing Aids • Keep your hearing aids dry and clean. • Store your Sontro Self-Fitting OTC Hearing Aids in a cool dry place, such ® as a hearing aid dehumidifier, with the battery door open when not wearing them.

  • Page 56: Battery

    BATTERY...
  • Page 57 312 battery. Please only use this size. Battery Door The battery door of the Sontro Self-Fitting OTC Hearing Aid is designed to have two functions, to power on/off and to hold the battery. Powering the Hearing Aid On and Off Open the battery door to power off the Hearing Aid, when not in use.
  • Page 58 How to Insert the Battery STEP 1: Remove brown adhesive tab on a new battery. Wait one full minute for the battery to fully activate. NOTE: Remove excess adhesive film that occasionally adheres to the top of the battery. STEP 2: Gently pull battery door tab located on the base of the hearing aid.
  • Page 59 Low Battery Indicator There are two ways to know that you have a low battery in your Hearing Aid. Your Hearing Aids will remind you by saying “low battery” when they have a low battery level. The otoTune app also allows you to visualize your battery life on the “Devices”...
  • Page 60 Factors that Affect Your Hearing Aid Batteries INDIVIDUAL HEARING LOSS: As hearing loss increases, more power is required to effectively amplify sounds. This increases the current needed from the battery and reduces battery life. In general, the more severe the hearing loss, the shorter the battery life.
  • Page 61 This can cause a battery to reach the end point earlier. Expected Battery Life With normal usage, your 312 hearing aid batteries should last up to 4 to 6 days with your Sontro® Self-Fitting OTC Hearing Aids.

  • Page 62: Adjusting To Sound

    ADJUSTING TO SOUND...
  • Page 63 It can take up to 2-3 weeks for your brain to adjust. Slowly begin to turn the volume up as you become more comfortable with sound. The Sontro® Self-Fitting OTC Hearing Aid has several modes that you can test to manage your sound: Automatic, Quiet, Noise, and Entertainment.
  • Page 64 If something sounds loud, you probably have the volume too high, or you may need to switch to a different mode. Once you begin to acclimate to your Sontro® Self-Fitting OTC Hearing Aids you may find that you enjoy conversations more and that it is easier to talk to people in restaurants and other noisy environments.
  • Page 65 My Hearing Aid's volume is too loud. • Reduce the volume, with your app or the volume buttons on your Sontro Self-Fitting OTC Hearing Aids. I am not hearing clearly with my Hearing Aids. • The receiver wire may not be connected properly, make sure it is attached to the Hearing Aid and the ear dome fits snugly.
  • Page 66 • Check that the battery door is completely closed so the Hearing Aid is turned on. • Check that you have a battery properly inserted in your Sontro® Self- Fitting OTC Hearing Aid. The sound coming from my Hearing Aids is distorted or weak.
  • Page 67 For a medical evaluation of your hearing, you should consult a hearing health professional. Soundwave Hearing advises anyone who has a history of: (1) Visible congenital or traumatic deformity of the ear; (2) active drainage from the ear within the previous ninety days;...
  • Page 68 Sontro Self-Fitting OTC Hearing Aids. If this ® occurs, please contact Soundwave Hearing. If an actual allergic reaction occurs or you experience inflammation, discharge from the ear, excessive wax or other unusual conditions, contact a physician immediately. If, for any reason, your hearing devices do not operate properly, do NOT attempt to fix them yourself, as you could cause further damage.
  • Page 69 Hearing Aids. • Avoid the use of the Sontro OTC Hearing Aids directly next to other electronic equipment, which could result in decreased performance. If...
  • Page 70 Commonly Occurring Events to Avoid (cont’d) • Be aware that some sounds may sound different when you’re using the hearing aids. Keep this in mind when you need to be aware of your surroundings. You should adjust to this over time. •...
  • Page 71 • Check before using the Hearing Aids in areas where electronics or wireless devices are restricted. This may cause interference. • Do NOT Use accessories, components, or replacement parts other than those provided by Soundwave Hearing could result in increased electromagnetic emissions and decreased electromagnetic immunity, which could decrease performance.

  • Page 72: Serial Number

    Serial Number There are two ways to locate your serial number: The serial number is located on the blue side of the Sontro Self-Fitting ® OTC Hearing Aids box, on a white sticker. The otoTune app will automatically register your serial number when it ®...

  • Page 73: Warranty And Repairs

    WARRANTY & REPAIRS...
  • Page 74 ONE (1) YEAR from its date of purchase (“Warranty Period”). Proof of purchase is required for warranty service on your Soundwave Hearing Aid(s) or other product. If our examination of your Soundwave OTC Hearing Aid(s) or other product determines that there is a defect in materials or workmanship within the Warranty Period, the affected hearing aid(s) or other products will be repaired or replaced free of charge.
  • Page 75 Out of Warranty Repairs Even after the Warranty Period expires, we’re still here to help you with your Soundwave Self- Fitting OTC Hearing Aid(s) or other products. Should you need repairs, please call Customer Support at (833) 367-HEAR (4327), Monday - Friday, 8:00 am - 4:30 pm CST, for instructions and pricing information.
  • Page 76 Return (Money Back Guarantee) Policy “Your satisfaction is 100% guaranteed. If you are not completely satisfied with your Sontro Self-Fitting OTC Hearing Aids or other products, you have 45-days from the date you receive your devices (or date of purchase from your local retail store) to return them for a refund. No...
  • Page 77 Rebuilt Hearing Aids If a Soundwave Self-Fitting OTC Hearing Aid has been used or rebuilt, Soundwave shall declare this on the container in which the hearing ad is packaged and on a tag that is physically attached to the hearing aid.

  • Page 78: Clinical Data Summary

    Clinical Data Summary Statement The results of our clinical study for the Sontro® Self-Fitting OTC Hearing Aids show that the device’s self-fit procedure is comparable to a hearing aid fitted in a clinical setting for patients with mild to moderate hearing loss. The results divide into three groups;...

  • Page 79: Technical Specifications

    TECHNICAL SPECIFICATIONS...
  • Page 80 The Sontro® Self-Fitting OTC Hearing Aid contains a Bluetooth radio transmitter operating in the ISM band (2.400 to 2.4835 GHz) at less than 10 mW of power. The output power level at these operating frequencies is deemed sufficiently safe in terms of human exposure to nonionizing radiation for the intended use.
  • Page 81 This product does not contain natural rubber latex. This product is provided non-sterile. Do NOT use if package is damaged. The Sontro® Self-Fitting OTC Hearing Aids comply with the following domestic regulations for medical devices: IEC 60601-1:2005/A1:2012 IEC 60601-1-2:2014 IEC 60601-2-66:2019 IEC 60601-1-6:2010 FCC 47 Part 15.247...
  • Page 83 • Turn the Bluetooth feature off and then on. • Delete the hearing aids from the Bluetooth list on your phone. On the Sontro Self-Fitting OTC Hearing Aid: • Hold the lower volume button down for 10 seconds to clear the hearing aid.
  • Page 84 • If another previously-connected phone is within range, turn the Bluetooth feature off on that phone. Safety and effectiveness of Sontro® Self-Fitting OTC Hearing Aid, otoTune® app a wireless medical device Your Sontro Self-Fitting OTC hearing Aid device is classified as a Class II Type B Medical Device per IEC 606001-1 Medical Electric Equipment.
  • Page 85 Security of Wireless Signals and Data Bluetooth 5.2 provides five different security features. That is, pairing, bonding, device authentication, encryption, and message integrity. •Pairing: Establishing shared keys among Bluetooth devices paired. •Bonding: Establishing a trusted bonding relationship between two Bluetooth devices relying on pairing. •Authentication: Verifying that the same key exists between two Bluetooth devices.

  • Page 86: Fcc Information

    Test data summaries (cont’d): FCC Information This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC Rules. MODEL: AI, AIS FCC ID 2AYY5-AI, FCC ID 2AYY5-AIS Radio Technology: Bluetooth Low Energy (BLE) and proprietary technologies.
  • Page 87 This design makes the Sontro Self-Fitting OTC Hearing Aid susceptible to spurious EMC emissions either radiated or conducted unto the device. For this reason the device has been subjected to EMC testing to determine the limitations on the devices environments under IEC 60601-1 guidelines.

  • Page 88: Features Per Ansi/Cta-2051:2017

    Features per ANSI/CTA-2051:2017 The Sontro Self-Fitting OTC Hearing Aids have level-dependent frequency equalization that is ® adjusted via user controls. Level-Dependent Gain/Compression utilize 16-channel wide dynamic range compression to make conversation easier without making loud sounds too loud. Noise Reduction make steady noises less loud.
  • Page 89 ANSI S3.22 / IEC 60118-7 2CC Coupler...
  • Page 90 Frequency Response Curve IEC 60318-5 2CC Coupler...
  • Page 91 Input / Output Curve IEC 60318-5 2CC Coupler coupler...
  • Page 92 Relative humidity: Store between 0% - 90% RH. 1000 Atmospheric pressure should be 600hPa - 1000hPa. Consult instructions for use. Contains electronics, dispose according to Soundwave Hearing, LLC. Do not use if package is damaged. Single use only. Keep away from sunlight.
  • Page 93 This product does not contain natural rubber latex. LATEX Keep out of reach of children. This product contains magnetic material. Manufactured for Soundwave Hearing, LLC. 619 Enterprise Drive, Suite 205 Oak Brook, IL 60523 Summary Technical Specifications (i) The maximum output limit value (OSPL90).
  • Page 94 (2) Output limit for a device with activated input-controlled compression. An OTC hearing aid that has input-controlled compression activated shall not exceed an output limit of 117 dB SPL at any frequency. (e) Electroacoustic performance limits. An OTC hearing aid shall perform within all of the following electroacoustic limits.
  • Page 95 Android and Google Play are trademarks of Google LLC. Wi-Fi is a registered trademark of Wi-Fi Alliance®. Sontro® Self-Fitting OTC Hearing Aids and the otoTune® app icon are registered trademarks of Soundwave Hearing, LLC. ©2021 Soundwave Hearing, LLC. No part of this work may be...
  • Page 97 hearsoundwave.com SWH-97411.A4.V21...

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