Sony CRE-C10 Maintenance Information
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Sony CRE-C10 Maintenance Information

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Self-fitting hearing aid
CRE-C10

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Summary of Contents for Sony CRE-C10

  • Page 1 Safety and maintenance information Self-fitting hearing aid CRE-C10...

  • Page 2: Table Of Contents

    Content Safety information  Intended use  Who should use this device  What to do in loud environments  Click Sleeves  Adjusting your hearing aid  Batteries  Damaged devices, unauthorized changes  Explosive atmospheres  Exposure to Nickel  Choking hazard  Restricted areas for wireless devices  Interference by strong radiation ...
  • Page 3 Cleaning and maintenance  Explanation of symbols  Important information  Operating, transport and storage conditions  Conformance information  Regulatory information  For hearing aid users  Quality of Service (QoS) for the ear-to-ear wireless technology  Cybersecurity   For children with hearing loss  Support ...

  • Page 4: Safety Information

    The device is intended for direct-to-consumer sale and use without the assistance of a hearing care professional. The Sony | Hearing Control app is intended to support self- fitting and fine-tuning of the hearing aid.

  • Page 5: Who Should Use This Device

    Who should use this device For adults 18 years and older with mild to moderate hearing loss. WARNING Contact your primary care provider before using this product if you currently experience any of these conditions as it may not be appropriate for you: severe hearing loss or deafness in at least one ear a steep decline in hearing ability within the last 90 days in one or both ears...
  • Page 6 WARNING In case you have any doubt whether this device is appropriate for you, consult a licensed physician before using this device. WARNING This hearing aid is intended for you only and should not be worn by others. NOTICE Do not use your hearing aids while swimming or while taking a shower.
  • Page 7 WARNING In case of a known contact allergy, consult the customer service regarding the presence of the allergen before using the hearing aid. If an allergic reaction develops after wearing the hearing aid, immediately discontinue use and consult a licensed physician.

  • Page 8: What To Do In Loud Environments

    What to do in loud environments WARNING Do not use this device as hearing protection in loud environments. WARNING Remove hearing aids before using hearing protection equipment. Noise-cancelling headphones should not be used as hearing protection.
  • Page 9 WARNING Frequent exposure to loud sounds may harm your hearing. Keep the loudness at comfortable listening levels. Wear hearing protection when exposed to loud environmental noise. NOTICE The smartphone generates short tone sequences to control the hearing aids. Do not hold the smartphone close to the ear while using the app.

  • Page 10: Click Sleeves

    Click Sleeves WARNING Risk of injury! Always wear the hearing aid with a Click Sleeve. Make sure that the Click Sleeve is completely attached. You should feel that it snaps into place. Ensure that only a single Click Sleeve is attached to each hearing aid.
  • Page 11 NOTICE Push the device into the intended position, making sure there is no discomfort/resistance. NOTICE Select the Click Sleeve size that gives you the best wearing comfort in each ear. Left and right ear sizes may differ. Choose a larger size in case of whistling problems.

  • Page 12: Adjusting Your Hearing Aid

    Adjusting your hearing aid WARNING Do not adjust the hearing aid when your attention is required on other activities, for example when crossing a street or driving a car. WARNING Your hearing devices may reduce certain background sounds, potentially also traffic or warning signals. Adjust the hearing aid to ensure you can hear surrounding sounds, including alarms and warning signals.
  • Page 13 NOTICE Set up the hearing aids in a quiet environment without interruptions for the best result.

  • Page 14: Batteries

    Batteries NOTICE Leaking batteries damage the hearing aids. Turn the hearing aids off when not in use to preserve the battery. Remove batteries when the hearing aids are not in use for a prolonged period of time.
  • Page 15 The following table helps you to identify the correct zinc air battery for your hearing aid: Battery IEC code ANSI code Typical color size code PR70 7005ZD yellow NOTICE To avoid environmental pollution, do not throw batteries or hearing aids into household trash. Recycle or dispose of batteries or hearing aids according to local regulation.

  • Page 16: Damaged Devices, Unauthorized Changes

    Damaged devices, unauthorized changes WARNING Risk of injury! Do not use damaged devices. Please consult the customer service. WARNING Note that any unauthorized changes to the device may cause damage to the device or cause injury. Use only approved parts and accessories. Contact the customer service for suitable accessories.

  • Page 17: Explosive Atmospheres

    Explosive atmospheres WARNING Risk of explosion! Do not use your hearing aids in explosive atmospheres (e. g. mining areas).

  • Page 18: Exposure To Nickel

    Exposure to Nickel WARNING This product can expose you to nickel, which is known to the State of California to cause cancer. For more information, go to www.P65Warnings.ca.gov.

  • Page 19: Choking Hazard

    Choking hazard WARNING Choking hazard! Your hearing aids contain small parts which can be swallowed. Keep hearing aids, batteries and accessories out of reach of children and pets. If parts have been swallowed consult a physician or hospital immediately.

  • Page 20: Restricted Areas For Wireless Devices

    Restricted areas for wireless devices WARNING Switch off the hearing aid in areas where the use of wireless devices is restricted.

  • Page 21: Interference By Strong Radiation

    Interference by strong radiation NOTICE Different types of strong radiation, e. g. during X-ray or MRI head examinations, may damage hearing aids. Do not wear the hearing aids during these or similar procedures like electrosurgery (diathermy, electrocautery, HF-surgery). Weaker radiation, e. g. from radio equipment or airport security, does not damage the hearing aids.
  • Page 22 NOTICE Your devices comply with international standards. However, it cannot be guaranteed that all products on the market work interference-free, for example some induction cookers, electromagnetic security systems (e.g. anti-theft systems and metal detectors) cellular telephones, RFID, room surveillance systems may cause audible interference.

  • Page 23: Cleaning And Maintenance

    Cleaning and maintenance Ear wax may accumulate in the Click Sleeves which may affect sound quality. NOTICE Clean your hearing aids daily with a soft and dry tissue. Never use water. Only use cleaning products declared for use with hearing aids. NOTICE Protect your hearing aids from high humidity.
  • Page 24 NOTICE Protect your hearing aids from extreme heat. Do not store them in direct sunlight. NOTICE Do not dry your hearing aids in the microwave oven.

  • Page 25: Explanation Of Symbols

    Explanation of symbols Symbols used in this document Points out a situation that could lead to serious, moderate, or minor injuries. Indicates possible property damage.
  • Page 26 Symbols on the device or packaging Do not dispose of the device with general domestic waste. Read more in section "Disposal information". Read and follow the instructions in the user guide. According to IEC 60601-1, the applied parts of this device are classified as type B. Keep dry during transportation and storage.
  • Page 27 Symbols on the device or packaging Temperature during transportation and storage. Read more in section "Operating, transport and storage conditions". Relative humidity during transportation and storage. Read more in section "Operating, transport and storage conditions". Atmospheric pressure during transportation and storage. Read more in section "Operating, transport and storage conditions".

  • Page 28: Important Information

    Important information Expected service life time of the hearing aids is 5 years. Operating, transport and storage conditions The hearing instruments operate in the following environmental conditions (also valid in between uses): Temperature 0 to 50 °C (32 to 122 °F) Relative humidity 5 to 93 % Atmospheric pressure...
  • Page 29 During extended periods of transport and storage, please observe the following conditions: Storage Transport Temperature 10 to 40 °C -20 to 60 °C (50 to 104 °F) (-4 to 140 °F) Relative humidity 10 to 80 % 5 to 90 % Atmospheric pressure 700 to 1060 hPa 700 to 1060 hPa For other parts, such as batteries, other conditions may apply.

  • Page 30: Conformance Information

    Conformance information Devices with the FCC marking comply with the standards of the FCC regarding electromagnetic interference. Notices Changes or modifications made to this equipment not expressly approved by the legal manufacturer may void the FCC authorization to operate this equipment. This device complies with Part 15 of the FCC Rules and with ISED's licence-exempt RSSs.
  • Page 31 Operation is subject to the following conditions: ● this device may not cause harmful interference, and ● this device must accept any interference received, including interference that may cause undesired operation. 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.
  • Page 32 particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures: ●...
  • Page 33 For body worn operation, this device has been tested and meets the FCC RF exposure guidelines when used with the legal manufacturer’s accessories supplied or designated for this product. Use of other accessories may not ensure compliance with FCC RF exposure guidelines.

  • Page 34: Regulatory Information

    Regulatory information FDA identifies this generic type of device as: Self-fitting air-conduction hearing aid. A self-fitting air-conduction hearing aid is a wearable sound amplifying device that is intended to compensate for impaired hearing and incorporates technology, including software, that allows users to program their hearing aids. This technology integrates user input with a self-fitting strategy and enables users to independently derive and customize their hearing aid fitting and settings.

  • Page 35: For Hearing Aid Users

    For hearing aid users Hearing aids will not restore normal hearing and will not prevent or improve a hearing impairment resulting from organic conditions. In most cases infrequent use of hearing aids prohibits the wearer from attaining the full benefit from it.
  • Page 36 Health considerations If soreness or skin irritation develops, discontinue wearing your hearing aids. Battery tips If a battery is accidentally swallowed, seek medical attention immediately, or call the National Button Battery Ingestion Hotline collect at 1-800-498-8666. Identification information Your hearing aids have a serial number imprinted on them. The location of the serial number will vary according to the style of hearing aid you have chosen.
  • Page 37 The year of manufacture is incorporated into the serial number. For in-the-ear devices, the year of manufacture is derived from the first two digits. The month of manufacture is derived from the first digit, the year of manufacture from the second digit:...
  • Page 38 Code (first digit) Month Code (first digit) Month A, N G, U B, P H, V C, Q J, W D, R K, X E, S L, Y F, T M, Z Code (second digit) Year Code (second digit) Year B, C 2022 F, G...
  • Page 39 Wireless functionality The following tables summarizes the technical details of the wireless technology: Wireless technology Nearfield magnetic induction Antenna type Inductive antenna Antenna dimensions Ø: 3.3 mm, L: 4.2 mm, respectively, Ø: 2.0 mm, L: 6.7 mm Modulation PSK (Phase Shift Key) Magnetic field 0.07 A/m, (1 cm coil;...
  • Page 40 EIRP = Equivalent isotropically radiated power Range < 20 cm between hearing aids Center frequency 3.28 MHz Channel Single channel radio Bandwidth 138 kHz Data rate 324 kbit/sec (raw channel capacity) Data flow Simplex or semi-duplex capability Protocol Random access, no collision avoidance S.A.R.
  • Page 41 EMI/EMC compliance Wireless hearing aids comply with the following EMC/EMI standards: Standard Test Type Note 47 CFR RF emissions U.S. FCC requirements Part 15, for intentional radiators. Subpart C EN 300 330 RF emissions EMC and radio spectrum including matters for short range spurious devices in the frequency emission...
  • Page 42 Standard Test Type Note EN 301 489- Immunity, Standard for low 1/3/17 RF and ESD power transmitters in the frequency range 9 kHz - 40 GHz. IEC 60118-13 RF immunity International product standard for hearing aids to ensure adequate immunity to radio interference from mobile telephones.
  • Page 43 Standard Test Type Note ANSI C63.19 RF immunity American National Standard method of measurement of compatibility between wireless communication devices and hearing aids. ANSI/AAMI RF emissions Implantable medical PC69 device EMC immunity, American National Standard.
  • Page 44 Standard Test Type Note ISO 14117 RF emissions Implantable medical device EMC immunity, International Standard. EN 45502-2-1 RF emissions Particular requirements for pacemakers.
  • Page 45 Emissions CISPR 11, Class B. Immunity ESD, Conducted up to +/-8 kV, Air discharge up to +/-15 kV Power frequency magnetic fields: 30 A/m, 50/60 Hz Immunity 80 MHz-2.7 GHz 10 V/m, to RF fields 2.7 GHz-6 GHz 3 V/m Proximity to wireless Up to 28 V/m –...
  • Page 46 Wireless security measures Wireless signal security is assured through the device system design that includes: ● A built-in pairing table which specifies valid and legitimate pairing among units. ● A proprietary communication protocol which checks the package numbers during each transmission. ●...

  • Page 47: Quality Of Service (Qos) For The Ear-To-Ear Wireless Technology

    Quality of Service (QoS) for the ear-to-ear wireless technology Synchronization/exchange of low data rate ear-to-ear signals Similar QoS as with remote controls in typical households. In typical environment it can happen that electromagnetic noise from appliances (light switch, car ignition) lead to non-valid data.
  • Page 48 Exchange of high data rate ear-to-ear signals (microphone signal) Parameter for QoS is the bit error (BER) of the gross data link. This parameter is estimated and monitored during data receive. For BER > 3.5% the channel coding will become less effective thus the transferred microphone signal is automatically muted and not used until the QoS is good enough again.

  • Page 49: Cybersecurity

    Cybersecurity Proper set-up and operation of your hearing aids requires a safe, private and secure operating environment. The U.S. Federal Trade Commission’s guidance for online security https://consumer.ftc.gov/online-security provides examples of best practices for securing your home network and mobile device to ensure your security.

  • Page 50: For Children With Hearing Loss

    For children with hearing loss In addition to seeing a physician for a medical evaluation, a child with a hearing loss should be directed to an audiologist for evaluation and rehabilitation since hearing loss may cause problems in language development and the educational and social growth of a child.

  • Page 51: Support

    Support For more detailed information or in case of unexpected events: ● Visit our website: sony.net/hearing-support ● Phone: 877-864-7669...
  • Page 52 Manufactured for: Sony Electronics Inc. 115 West Century Road Suite 250 Paramus, NJ US 07652 Document No. 05195-99T02-7600 EN Order/Item No. 210 224 47 Master Rev02, 08.2022 Printed in Singapore.

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