ReSound ONE User Manual
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ReSound ONE User Manual

ReSound ONE User Manual

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ReSound Custom hearing aids, Rechargeable

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Summary of Contents for ReSound ONE

  • Page 1 User guide ReSound Custom hearing aids, Rechargeable...

  • Page 2: Hearing Aid Information

    Hearing aid information Left hearing aid Right hearing aid Serial number Serial number Model number Model number Battery type Rechargeable Program Beep Description One beep Two beeps Three beeps Four beeps Hearing aid information...

  • Page 3: Fda Warnings And Cautions (Us Only)

    FDA warnings and cautions (US only) WARNING: People younger than 18 should go to a doctor before using this People younger than 18 years old need specialized care, and using this without a medical evaluation may worsen impairment or disability. A hearing aid user who is younger than 18 should have a recent medical evaluation from a doctor, preferably an ear-nose-throat doctor (an ENT).
  • Page 4 • Hearing loss or ringing (tinnitus) only in one ear or noticeable difference in hearing between ears • Audiometric air-bone gap equal to or greater than 15 dB at 500 Hz, 1000 Hz, and 2000 Hz. Outputs over 132 dB SPL: You should exercise special care in selecting and fitting a hearing aid with a maximum output that exceeds 132 dB SPL because it may impair the remaining hearing of the hearing aid user.
  • Page 5 You might need medical help if a piece gets stuck in your ear If any part of your hearing aid, like the eartip (dome), gets stuck in your ear, and you can’t easily remove it with your fingers, get medical help as soon as you can. You should not try to use tweezers or cotton swabs because they can push the part further into your ear, injuring your eardrum or ear canal, possibly seriously.
  • Page 6 Hearing loss in people younger than 18 • People younger than 18 should see a doctor first, preferably an ear-nose-throat doctor (an ENT), because they may have different needs than adults. • The doctor will identify and treat medical conditions as appropriate. •...

  • Page 7: Table Of Contents

    Table of Contents Hearing aid information FDA warnings and cautions (US only) Introduction Getting to know your hearing aid Charging your hearing aids Placing your hearing aids in your ears Removing your hearing aids from your ears Using your hearing aids Advanced options Wireless accessories Cleaning and caring for your hearing aids...

  • Page 8: Introduction

    Introduction Thank you for choosing ReSound hearing aids. We recommend that you use your hearing aids every day. NOTE: Read this booklet carefully BEFORE using your hearing aids. Intended purpose • The hearing aid is intended to compensate for hearing impairment by amplifying and transmitting sound to the ear.
  • Page 9 • History of active drainage from the ear within the previous 90 days. • History of sudden or rapidly progressive hearing loss within the previous 90 days. • Acute or chronic dizziness. • Unilateral hearing loss of sudden or recent onset within the previous 90 days. •...
  • Page 10 Symbols WARNING: Points out a situation that Legal manufacturer. could lead to serious injuries. CAUTION: Indicates a situation that Medical Device. could lead to minor and moderate injuries. NOTE: Advice and tips on how to handle Date of manufacture. your hearing aid better. Follow instructions for use.

  • Page 11: Getting To Know Your Hearing Aid

    Getting to know your hearing aid Front view ITC model ITE model 1. Microphone sound inlets 2. LED green indicator light. Off during normal use. (See page 17) 3. Push button 4. Filter ring 5. Faceplate 6. Vent Side view 5. Faceplate 7.

  • Page 12: Charging Your Hearing Aids

    Charging your hearing aids We recommend that you fully charge your hearing aids before using them. This is just a precaution to make sure that you don't run out of power unexpectedly. To learn how to charge your hearing aids, please consult the user guide for your hearing aid charger.
  • Page 13 • Battery leakage can cause chemical burns. If you get exposed to battery leakage material, rinse immediately with warm water. If you get chemical burns, redness, or skin irritation from battery leakage, seek medical attention. • Batteries are harmful for the environment. Therefore, never try to burn them. Dispose of your used rechargeable hearing aids according to your country’s regulations or return them to your hearing care professional.

  • Page 14: Placing Your Hearing Aids In Your Ears

    Placing your hearing aids in your ears How to tell left from right Left hearing aid (blue marking on shell) Right hearing aid (red marking on shell) NOTE: Your hearing aids are made to fit exactly into your left and your right ear respectively. So each of them will only fit correctly to the ear it is made for.
  • Page 15 Your hearing aids are placed in the charger in such a way that it should be easy to remove them from the charger and insert them in the ear in one movement. When the hearing aid sits in the ear, the vent opening should be located in the notch just above your earlobe.

  • Page 16: Removing Your Hearing Aids From Your Ears

    Removing your hearing aids from your ears 1. Hold the edges of the hearing aid with your thumb and index finger. Pull out and slightly upward, while slightly rotating your hand forward. If your hearing aid has a pull-out wire, pull at the wire to remove the hearing aid.

  • Page 17: Using Your Hearing Aids

    Using your hearing aids Turning your hearing aids on and off Automatic mute function while charging When you take off your hearing aids, place them in the charger to charge. Make sure that the charger is plugged in (LED on back will light up). When you close the lid, the hearing aids will be muted (so as not to whistle) and charging will begin.
  • Page 18 For all other functions, see the section "Using the push button ". Explanation of indicator lights on the hearing aid • One 2-second green blink: The hearing aid turns on and is in operating mode. • Three 1-second green blinks: The hearing aid turns off.
  • Page 19 If you have two hearing aids with the Synchronized Volume Control function enabled, volume control adjustments to one hearing aid automatically repeats in the second hearing aid. When you change the volume in one of the hearing aids, it responds with one or more beeps. A beep in the second hearing aid follows.
  • Page 20 Programs All-Around The best option if you want only one program. Ultra Focus For use in very noisy places (more focused than the Restaurant program). Restaurant For use in noisy places such as restaurants and social gatherings. Music For listening to music.
  • Page 21 Customizing the button actions If you want to be able to adjust the volume on the hearing aids, the push button on one hearing aid can be set to reduce the volume, and the button on the other hearing aid can be set to increase the volume. Any increase or decrease made on one hearing aid will also apply to the other to ensure the volume is the same in both hearing aids.
  • Page 22 Using the ReSound Remote Control 2 or the ReSound Smart 3D™ app Alternatively, you can control your hearing aids by means of the ReSound Remote Control 2, or you can use the ReSound Smart 3D™ app to control your hearing aids from a mobile device.
  • Page 23 NOTE: Depending on your needs, your hearing care professional may activate a function specifically for telephone use. Mobile phones Your hearing aids comply with the most stringent Standards of International Electromagnetic Compatibility. Any degree of disturbance can be due to the nature of your particular mobile phone or of your wireless telephone service provider.

  • Page 24: Advanced Options

    The ReSound Smart 3D™ app sends and receives signals between the hearing aids and mobile devices. You can use the ReSound Smart 3D™ app designed for your hearing aids to obtain updates to your hearing aids, find your hearing aids, check their battery status, or as a remote control to change programs or adjust the volume.
  • Page 25 Only connect your hearing aid to the official ReSound mobile device app. • The app must only be used with ReSound hearing aids for which they are intended, and ReSound takes no responsibility if the app is used with other hearing aids.
  • Page 26 ReSound Assist and ReSound Assist Live (optional) ReSound Assist If you have signed up to use ReSound Assist available with your hearing aids, you can allow your hearing aids to be adjusted remotely without having to visit your hearing care professional.

  • Page 27: Wireless Accessories

    Wireless accessories Our wireless eco-system features a comprehensive range of seamlessly integrated wireless accessories. These let you stream high quality stereo sound and speech directly to your hearing aids. Available wireless accessories and their features • A TV streamer streams audio from a TV and most other audio sources to your hearing aids at a volume that suits you.
  • Page 28 Please contact your hearing care professional for an overview of compatible wireless accessories that are approved by GN ReSound A/S. • You should only use ReSound wireless accessories with your wireless hearing aids. Low battery alert when paired with wireless accessories NOTE: •...
  • Page 29 3 even tones and 1 longer tone You can check the battery status in the ReSound Smart 3D™ app. Flight Mode / Wireless Communication Off Mode Your hearing aids can receive wireless signals. For example, they can be controlled from your mobile device or remote control.
  • Page 30 Turning off wireless communication (activating Flight Mode) 1. Turn off your hearing aid. 2. Press the button for 9 seconds. 3. Your hearing aid will double-flash four times. If you are wearing your hearing aids at the time, you will hear double tones ( ) for about 10 seconds, meaning the hearing aid is now in Flight Mode.

  • Page 31: Cleaning And Caring For Your Hearing Aids

    Cleaning and caring for your hearing aids Cleaning tools These cleaning tools come with your hearing aids: 1. Soft cloth. Your hearing care professional may give you a set of wax filters. 2. A brush with a battery magnet. 3. A cleaning wire (not shown). Cleaning and caring for your hearing aids...
  • Page 32 General instructions for care and maintenance NOTE: To ensure you get the highest quality experience and longest useful lifetime out of your hearing aids, it is important to clean and care for them. Keeping your hearing aids in perfect working order is easily done. Just follow these steps: 1.
  • Page 33 CAUTION: • Never use alcohol or other cleaning solutions to clean your hearing aids. This can damage your hearing aids and may cause a skin reaction. • Ear wax or other residue on your hearing aids can cause an infection. To avoid this, clean your hearing aids as instructed.
  • Page 34 Daily care and maintenance It is important to keep your hearing aids clean and dry on a daily basis. Use the supplied cleaning tools. 1. Wipe your hearing aids with the cloth. 2. Swipe the small brush across the microphones. 3.
  • Page 35 Replacing the wax guards Custom hearing aids may have wax guards that protect against wax and moisture. It is recommended that these are changed as needed. Consult your hearing care professional for advice on how often you need to change them.
  • Page 36 For information on obtaining more wax guards contact your hearing care professional to ensure you get the correct wax guards for your hearing aids. CAUTION: Use only original consumables from the manufacturer (e.g., wax guards). Replacement of the filter ring The push button is surrounded by a replaceable filter ring.

  • Page 37: Tinnitus Management

    Tinnitus Management Tinnitus Sound Generator module Your ReSound hearing aid includes the Tinnitus Sound Generator (TSG) module, a tool for generating sounds to be used in tinnitus management programs to temporarily relieve suffering from tinnitus. The TSG can generate sounds adjusted to the specific therapeutic needs and your personal preference as determined by your doctor, audiologist, or hearing care professional.
  • Page 38 Explanation of how the device functions The TSG module is a frequency and amplitude shaped white-noise generator. The noise signal level and frequency characteristics can be adjusted to the specific therapeutic needs as determined by your doctor, audiologist, or hearing care professional. Your doctor, audiologist, or hearing care professional can modulate the generated noise in order to make it more pleasant.
  • Page 39 The scientific concepts that form the basis for the device The TSG module provides sound enrichment with the aim of surrounding the tinnitus sound with a neutral sound which is easily ignored. Sound enrichment is an important component of most approaches to tinnitus management, such as tinnitus retraining therapy (TRT).
  • Page 40 NOTE: To use smartphone apps, the hearing aid must be connected with the smartphone or mobile device. TSG - Technical specifications Digital. Audio signal technology: Available sounds White noise signal which can be shaped with the following configurations: High-pass filter Low-pass filter 500 Hz 2000 Hz...
  • Page 41 Prescription use of this device The TSG module should be used as prescribed by your doctor, audiologist or hearing healthcare professional. In order to avoid permanent hearing damage, the maximum daily usage depends on the level of the generated sound. To adjust TSG, please consult your hearing healthcare professional.
  • Page 42 The purpose of medical evaluation is to assure that all medically treatable conditions that may affect tinnitus are identified and treated before the sound generator instrument is used. The sound generator instrument is a tool to generate sounds to be used with appropriate counseling and/or in a tinnitus management program to relieve patients suffering from tinnitus.
  • Page 43 • Use of the ReSound Assist for remote settings of the tinnitus sound generator should only be performed by the parent or legal guardian in cases where the user is a minor.
  • Page 44 Tinnitus Sound Generator warning to hearing care professionals A hearing care professional should advise a prospective sound generator user to consult promptly with a licensed physician (preferably an ear specialist) before getting a sound generator, if the hearing care professional determines through inquiry, actual observation, or review of any other available information concerning the prospective user that the prospective user has any of the following conditions: 1.

  • Page 45: General Warnings And Cautions

    General warnings and cautions WARNING: • Consult a hearing care professional: – If you think there may be a foreign object in your ear canal – If you experience skin irritation – If excessive ear wax accumulates with the use of the hearing aid •...
  • Page 46 • Do not attempt to dry your hearing aids in an oven, microwave oven, or other heating equipment. This will cause them to melt and may cause burns to your skin. • No modification of this device is allowed. Warnings related to power hearing aids •...
  • Page 47 • Do not try to modify the shape of your hearing aid or accessories. This can cause skin reactions or sharp edges leading to scratches or sores. • If you have two hearing aids, they may each be programmed differently. Do not swap them as this could damage your hearing.

  • Page 48: Cyber Security Warnings

    CAUTION: • Only connect your hearing aid to a trusted computer or mobile device, or one used by a hearing care professional. • For 3 minutes after being turned on, your hearing aid is open to connections. Do not restart your hearing aid if requested by someone you don’t trust as this may compromise the safety of your device.

  • Page 49: Troubleshooting

    Troubleshooting Issue Potential cause Potential solution Feedback, "whistling" Is the hearing aid inserted correctly in Put it back in. the ear? Is the hearing aid in the correct ear? Check for the red mark on the right hearing aid and the blue mark on the left hearing aid. Is the volume very loud? If you have turned up the volume, try turning it down.
  • Page 50 Potential cause Potential solution Is sound distorted or Is the wax guard clogged? Replace it with a new one.See " Replacing the weak? wax guards", page 35. Is the microphone filter ring dirty? The filter ring on the faceplate may need replacement.

  • Page 51: Regulatory Information

    Regulatory information Warranties and repairs The manufacturer provides a warranty on hearing aids in the event of defects in workmanship or materials, as described in applicable warranty documentation. In its service policy, the manufacturer pledges to secure functionality at least equivalent to the original hearing aid. As a signatory to the United Nations Global Compact initiative, the manufacturer is committed to doing this in line with environment-friendly best practices.
  • Page 52 During use During normal operation the temperature should not exceed the limit values of +5 °C (+41 °F) to +40 °C (104 °F), at a relative humidity range of 15% to 90%, non-condensing, but not requiring a water vapor partial pressure greater than 50 hPa. An atmospheric pressure between 700 hPa and 1060 hPa is appropriate. While charging, the ambient temperature should not exceed the limit values of +5 °C (+41 °F) to +30 °C (86 °F).
  • Page 53 Expected service lifetime The expected service lifetime for the product when used as intended is: Product Lifetime Hearing aid 5 years Built-in rechargeable battery 5 years Electronic accessories (e.g., wireless accessories) 5 years Non-clinical testing (US only) The devices covered within this user guide have undergone tests for the relevant non-clinical performance testing and biological endpoints in accordance with standards identified below: •...
  • Page 54 The devices covered in this user guide passed all tests for the relevant non-clinical performance testing and biological endpoints, namely cytotoxicity (ISO 10993-05:2009), sensitization, and intracutaneous reactivity (ISO 10993-10:2010). Similarly, usability testing and software verification and validation demonstrated mitigation of risks to an acceptable level as well as reasonable assurance of safe and effective device performance.
  • Page 55 – Redirect or relocate the receiving antenna. – Increase the separation between the equipment and the receiver – Connect the equipment to an outlet or a circuit that is different from the one to which the receiver is connected – Consult the dealer or an experienced radio/TV technician for help.
  • Page 56 The products are in compliance with the following regulatory requirements: • In the US: FCC CFR 47 Part 15, subpart C. • 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...
  • Page 57 This device transmits and receives RF signals in the frequency range of 2.4 GHz - 2.48 GHz. Nominal RF output power transmitted at 2.4 GHz is: -0.49 dBm. In-the-ear (ITE) hearing aids (including type CAIR1L with FCC ID X26CAIR1L, IC number 6941C-CAIR1L, and type CAIR1R with FCC ID X26CAIR1R, IC number 6941C-CAIR1R models) and Lithium-Ion battery, are available in the following variants: RT9ITE-DWC-MP, RT7ITE-DWC-MP, RT5ITE-DWC-MP RT9ITE-DWC-HP, RT7ITE-DWC-HP, RT5ITE-DWC-HP...

  • Page 58: Technical Specifications

    Technical specifications Hearing aid model Maximum output Low Power (LP) models (ITC only) 114 dB SPL (typical) All Medium Power (MP) models 118 dB SPL (typical) All High Power (HP) models 121 dB SPL (typical) All Ultra Power (UP) models 130 dB SPL (typical) Battery Lifetime: Up to 24 hours...
  • Page 59 Low Power (LP) models (US only) Additional technical data Latency, mid frequency delay (2 kHz) Battery current drain, Low Power (LP) models (ITC) 12 / 70 Attack/release time (2 kHz syllabic) Input/Output response, measured in a 2cc coupler at the reference test gain @ 2 KHz (ITC) Input/Output Response - LP Ref.Test Gain @ 2 kHz 2cc coupler...
  • Page 60 Medium Power (MP) models (US only) Additional technical data Latency, mid frequency delay (2 kHz) Battery current drain, (ITC) Battery current drain, (ITE) 12 / 70 Attack/release time (2 kHz syllabic) Input/Output response, measured in a 2cc coupler at the reference test gain @ 2 KHz Input/Output Response - MP Input/Output Response - MP Ref.Test Gain @ 2 kHz...
  • Page 61 High Power (HP) models (US only) Additional technical data Latency, mid frequency delay (2 kHz) Battery current drain, (ITC) Battery current drain, (ITE) 12 / 70 Attack/release time (2 kHz syllabic) Input/Output response, measured in a 2cc coupler at the reference test gain @ 2 KHz Input/Output Response - HP Input/Output Response - HP Ref.Test Gain @ 2 kHz...
  • Page 62 Ultra Power (UP) models (US only) Additional technical data Latency, mid frequency delay (2 kHz) Battery current drain, (ITC) Battery current drain, (ITE) 12 / 70 Attack/release time (2 kHz syllabic) Input/Output response, measured in a 2cc coupler at the reference test gain @ 2 KHz Input/Output Response - UP Input/Output Response - UP Ref.Test Gain @ 2 kHz...

  • Page 63: Additional Information

    Additional information Acknowledgements Portions of this software are written by Kenneth MacKay (micro-ecc) and licensed under the following terms and conditions: Copyright ® 2014, Kenneth MacKay. All rights reserved. Redistribution and use in source and binary forms, with or without modification, are permitted provided that the following conditions are met: •...
  • Page 64 © 2023 GN Hearing A/S. All rights reserved. ReSound is a trademark of GN Hearing 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.
  • Page 65 Notes Additional information...
  • Page 66 Notes Additional information...
  • Page 67 Notes Additional information...
  • Page 68 Manufacturer according to FDA: Manufacturer according to Health Canada:  GN ReSound North America ReSound Canada 8001 E Bloomington Freeway 2 East Beaver Creek Road, Building 3 Bloomington, MN 55420 Richmond Hill, ON L4B 2N3 Canada 1-888-735-4327 1-888-737-6863 resound.com resound.com ReSound Government Services...

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