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User Manual | Users Manual | 3.26 MiB | July 25 2023 / August 30 2023 | |||
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1 2 | User Manual | Users Manual | 3.26 MiB | July 25 2023 / August 30 2023 |
Hearing Aid User Manual Warnings, Cautions,
& Notices Warnings, Cautions,
& Notices REQUIRED HEARING AID INFORMATION The following additional information is provided in compliance with U.S. Food and Drug Administration (FDA) regulations:
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). Before using this, a doctor should determine that the use of a hearing aid is appropriate. WARNING to Hearing Aid Dispensers:
You should advise a prospective hearing aid user to consult promptly with a doctor, preferably an ear specialist such as an ENT, before dispensing a hearing aid if you determine 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:
Visible deformity of the ear, either congenital or traumatic Fluid, pus, or blood coming out of the ear within the previous 6 months Pain or discomfort in the ear History of excessive ear wax or suspicion that something is in the ear canal Dizziness, either recent or long-standing Sudden, quickly worsening, or fluctuating hearing loss within the previous 6 months Hearing loss or ringing (tinnitus) only in one ear or a 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 WARNING to Hearing Aid Dispenser, 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. International Use Your hearing aids are approved to operate at a radio frequency that is specific to your country or region and might not be approved for use outside your country or region. Be aware that operation during international travel may cause interference to other electronic instruments, or other electronic instruments may cause interference to your hearing aids. We are required by regulations to provide the following warnings:
WARNING: Use of wireless hearing aids directly next to other electronic equipment should be avoided because it could result in improper performance. If such use is necessary, note as to whether your hearing aids and the other equipment are operating normally. WARNING: Use of accessories, components or replacement parts other than those provided by the manufacturer of your hearing aids could result in increased electromagnetic emissions and decreased electromagnetic immunity and could result in degradation of performance. WARNING: If Portable Radio Frequency communications equipment is used closer than 30 cm (12 inches) from your hearing aid, degradation of the performance of your hearing aid could result. If this occurs, move away from the communications equipment. WARNING: The stability of the hearing aid is designed for normal use. Avoid physical impacts to the ear when wearing a hearing aid that may cause the device to break or component of the device to become detached. This may lead to lacerations of the ear canal or perforation of the ear drum. If this occurs, it is strongly recommended to see a physician for evaluation and safe removal. WARNING: If the hearing aid drops onto a hard surface, it could cause the hearing aid to break or become damaged. This includes mechanical stress or shock of the device. Ensure the hearing aid is intact before placing it in the ear. If you find the device is damaged, discontinue use and see your hearing professional. WARNING: Repeated stress to the removal handle may cause it to break. If the removal handle breaks and youre unable to remove the device carefully, it is recommended to see a physician for safe removal. WARNING TO HEARING CARE PROFESSIONAL A hearing care professional should advise a prospective sound generator (tinnitus masker) user to consult promptly with a licensed physician (preferably an ear specialist) before using a sound generator if the hearing care professional determines through inquiry, actual observation or review or any other available information concerning the prospective user that the prospective user has any of the following conditions:
Visible congenital or traumatic deformity of the ear 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 2 | Warnings, Cautions, & Notices 3 | Warnings, Cautions, & Notices Warnings, Cautions,
& Notices Warnings, Cautions,
& Notices WARNING: There are some potential concerns associated with the use of any sound generating tinnitus therapy instrument. Among them are the potential for worsening of tinnitus, a possible change in hearing thresholds, and possible skin irritation at the point of contact with the hearing aid. Multiflex Tinnitus Technology has been designed to minimize these concerns. However, should you experience or notice any of the above conditions or any dizziness, nausea, headaches or heart palpitations, you should immediately discontinue use of the hearing aid and seek a consultation with a medical, audiology or other hearing care professional. As with any hearing aid, misuse of the tinnitus therapy instrument could present some potentially harmful effects. Care should be taken to prevent the unauthorized use and to keep the hearing aid out of the reach of children and pets. FALL ALERT FEATURE The Fall Alert feature can be used to notify others should you fall or experience a non-fall-related event. This feature can be configured to send an SMS text message to predefined contacts. Fall Alert can be configured to send automated and/or manually-initiated alerts. WARNING: Auto Alert may not detect 100 percent of falls WARNING: Decreasing the Auto Alert Sensitivity may prevent some falls from being detected by your Fall Alert system. For example, Auto Alert may not detect a fall if:
The Sensitivity setting is not appropriate for the user The fall is very slow, or you slide down gradually You get up and begin walking immediately after a fall WARNING: Auto Alert may initiate false alerts. To prevent false-alert text messages from being sent to your contact(s), you may cancel the alert from either your smartphone or by pressing the user control on either hearing aid. WARNING: To reduce Fall Alert communication failures:
Your hearing aid(s) need to be powered on, paired and connected with your smartphone using Bluetooth connectivity The mobile device must be powered on, with the hearing aid mobile app open (in the foreground or background) The mobile device must have a connection to the Internet
(via a cellular network or WiFi) CAUTION: This is not hearing protection. You should remove this device if you experience overly loud sounds, whether short or long-lasting. If youre 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. CAUTION: The sound output should not be uncomfortable or painful. You should turn down the volume or remove the device if the sound output is uncomfortably loud or painful. If you consistently need to turn the volume down, you may need to further adjust your device. CAUTION: You might need medical help if a piece gets stuck in your ear. If any part of your hearing aid, like the eartip, gets stuck in your ear, and you cant 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 farther into your ear, injuring your eardrum or ear canal, possibly seriously. 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. Further, a hearing aid will not prevent or improve a medical condition that causes hearing loss. People who start using hearing aids sometimes need a few weeks to get used to them. Similarly, many people find that training or counseling can help them get more out of their devices. If you have hearing loss in both ears, you might get more out of using hearing aids in both, especially in situations that make you tired from listeningfor example, noisy environments. NOTE: Tell FDA about injuries, malfunctions, or other adverse events. To report a problem involving your hearing aid, you should submit information to FDA as soon as possible after the problem. FDA calls them adverse events, and they might include: skin irritation in your ear, injury from the device (like cuts or scratches, or burns from an overheated battery), pieces of the device getting stuck in your ear, suddenly worsening hearing loss from using the devices, etc. Instructions for reporting are available at https://www.fda.gov/Safety/
MedWatch, or call 1-800-FDA-1088. You can also download a form to mail to FDA. NOTE: 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 The doctor may refer the person to an audiologist for a separate test, a hearing aid evaluation The hearing aid evaluation will help the audiologist select and fit the appropriate hearing aid 4 | Warnings, Cautions, & Notices 5 | Warnings, Cautions, & Notices Warnings, Cautions,
& Notices Warnings, Cautions,
& Notices A hearing aid will not restore normal hearing and will not prevent or improve a hearing impairment resulting from organic conditions. Use of a hearing aid is only part of hearing habilitation and may need to be supplemented by auditory training and instruction in lip reading. In most cases infrequent use of a hearing aid does not permit a user to attain full benefit from it. Some hearing instrument users have reported a buzzing sound in their hearing instrument when they are using mobile phones, indicating that the mobile phone and hearing instrument may not be compatible. It is well-known that mobile phones are potential sources of noise for hearing aids. Your Starkey Hearing Aids have been tested for compliance to two standards that define hearing aid immunity to digital wireless devices and meet the requirements of ANSI C63.19-
2019 as well as the criteria for user compatibility as defined by IEC 60118-13:2019. CAUTION: The following are potential physiological side effects from use of hearing aids. Consult a physician if the following occur:
Worsening of Hearing Loss or Tinnitus Pain or Discomfort from heat (burns), abrasion (cuts and scratches), infection, shock Dermal Allergic Reaction (inflammation, irritation, swelling, discharge) Excessive production of cerumen (Earwax) A person who is younger than 18 years old with hearing loss should have a medical evaluation by a doctor, preferably an ENT, before buying a hearing aid. The purpose of a medical evaluation is to identify and treat medical conditions that may affect hearing but that a hearing aid wont treat on its own. Following the medical evaluation and if 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 the appropriate hearing aid. The audiologist will conduct a hearing aid evaluation to assess the persons ability to hear with and without a hearing aid. This will enable the audiologist to select and fit a hearing aid for the persons individual needs. An audiologist can also provide evaluation and rehabilitation since, for people younger than 18, hearing loss may cause problems in language development and educational and social growth. An audiologist is qualified by training and experience to assist in the evaluation and rehabilitation of hearing loss in people younger than 18. IMPORTANT NOTICE FOR PROSPECTIVE Rx HEARING AID USERS:
It is good health practice for a person with a hearing loss to have a medical evaluation by a licensed physician (preferably a physician who specializes in diseases of the ear) before purchasing a prescription hearing aid. Licensed physicians who specialize in diseases of the ear are often referred to as otolaryngologists, otologists or otorhinolaryngologists. The purpose of the medical evaluation is to assure that all medically treatable conditions that may affect hearing are identified and treated before the hearing aid is purchased. Following the medical evaluation, the physician will give you a written statement that states that your hearing loss has been medically evaluated and that you may be considered a candidate for a hearing aid. The physician will refer you to an audiologist or hearing aid dispenser, as appropriate, for a hearing aid evaluation. The audiologist or hearing aid dispenser will conduct a hearing aid evaluation to assess your ability to hear with and without a hearing aid. The hearing aid evaluation will enable the audiologist or dispenser to select and fit a hearing aid to your individual needs. If you have reservations about your ability to adapt to amplification, you should inquire about the availability of a trial-rental or purchase option program. Many hearing aid dispensers now offer programs that permit you to wear a hearing aid for a period of time for a nominal fee after which you may decide if you want to purchase the hearing aid. In some geographies, you must have a medical evaluation before purchasing a prescription hearing aid. Some States allow an adult to waive the medical evaluation. 6 | Warnings, Cautions, & Notices 7 | Warnings, Cautions, & Notices Congrats!
Your best life begins with better hearing. Introducing your new hearing aids. Great to have you hear. Use this helpful manual to get to know your new hearing aids and get the most out of your hearing experience. After all when you hear better, you live better. Thanks to your new hearing aids. Did you know you can get even more hearing aid features using your mobile device? See the Setting Up Your Compatible Mobile App guide for details. 9 | Intro Whats included Table of contents Hearing aid styles covered in this user manual (select yours):
1. Warnings, Cautions, & Notices 2 2. Get to know your hearing aids Meet your hearing aids Use your hearing aids Care for your hearing aids 3. Troubleshooting guide 4. Additional guidance Intended use FCC information Regulatory information 14 16 25 32 36 40 41 Serial Number Left:
Right:
10 | Whats included 11 | TOC Get to know your hearing aids Meet your hearing aids Use your hearing aids Care for your hearing aids Meet your hearing aids Overview 1. Cable 2. Microphones 3. User control 4. Receiver 5. Wax guard (included accessory) 6. Manufacturer, model name, 7. 8. Side indicator 2 3 1 4 RED is for right ear, BLUE is for left ear 5 9. Retention lock (optional) 10. Receiver indicator RED is for right ear, BLUE is for left ear 11. Earbud (included accessory) 12. Custom earmold (optional) 13. Custom power earmold (optional) 6 8 7 9 11 12 10 13 14 | Get to know your hearing aids 15 | Get to know your hearing aids Use your hearing aids Use your hearing aids STEP 2: Put on your hearing aids 1. your ear, so the cable and earbud
(or earmold) hang in front. 2. Ease the earbud or earmold into your ear canal until secure. (For earmolds, gently press into place with your fingertip.) The cable should sit flat against your head. 16 | Get to know your hearing aids 17 | Get to know your hearing aids Use your hearing aids Use your hearing aids 3. Tuck the optional retention lock into the bottom curve of your ear, so that the tip bends toward the back of your head. Done!
2. Lift your hearing aid out from behind your ear. STEP 3: Remove your hearing aids 1. Gently pull the optional retention lock from the bottom curve of your ear then pull the earbud or earmold from your ear canal. 18 | Get to know your hearing aids 19 | Get to know your hearing aids Use your hearing aids Use your hearing aids Turning ON Turning OFF Low battery: An indicator voicing the word battery will sound when battery voltage is low. From there, battery life left. NOTE: Actual time between low battery indicator and shutdown will vary depending on environmental noise levels and your use of the product. Battery shutdown: An indicator may also sound just before the battery stops working. User control Rocker switch) If you turned OFF each hearing aid by pressing the top or bottom button of the rocker switch, pressing the top of the rocker switch will turn it ON. A 3-second delay occurs before your hearing aid turns ON, allowing time to place it in your ear. Turn OFF each hearing aid by pressing and holding the top or bottom button of the rocker switch for 3 seconds. 20 | Get to know your hearing aids 21 | Get to know your hearing aids Use your hearing aids Use your hearing aids Expected battery operating time Battery life varies based on wireless usage. The following smart features have been programmed to your user control by your hearing care professional:
User control Smart feature User control Your hearing aid user control lets you control your hearing aids by hand. This is set up by your hearing care professional, who can also program the button to let you use many smart features. Your user control operates in 3 ways:
Short press: Press the user control for 1 second then release. Long press: Press and hold the user control for 3 seconds or more. Tap Control: Firmly double-tap on or near the user control on your hearing aid. Short press
(1 second) Long press
(3 seconds) Tap Control Did you know you can also control your hearing aids using your mobile phone or other smart device? See the Setting Up Your Compatible Mobile App guide to learn more. Phone calls and hearing aids Your hearing aids are designed to accommodate calls on your mobile or landline phone. Landline calls To use your landline phone while wearing hearing aids, talk to your hearing care professional. They can help you set up a telephone setting on your hearing aids and offer tips. 22 | Get to know your hearing aids 23 | Get to know your hearing aids Use your hearing aids Care for your hearing aids Mobile calls To stream mobile phone calls to your hearing aids, see the Setting Up Your Compatible Mobile App guide included. This shows how to connect (pair) your smartphone to your hearing aids. Questions? Your hearing care professional can help. Keep your hearing aid clean at all times. Heat, moisture and foreign substances can result in poor performance. 1. Do not clean using water, solvents, cleaning fluids or oils. Do not take your hearing aid apart or insert a cleaning tool inside of them. 2. Using the cleaning tool included debris from microphone, wax guard, 3. Wipe hearing aids daily over a soft cloth to prevent damage should they drop to a hard surface. If the hearing aid falls/drops onto a hard surface, it could cause the shell or casing to break and/or become damaged. This includes mechanical stress or shock of the device. See your hearing care professional for more care and maintenance tips. 24 | Get to know your hearing aids 25 | Get to know your hearing aids Care for your hearing aids Care for your hearing aids Storage tips Replacing wax guards When youre not wearing your hearing aids, protect them from damage using these storage tips:
Store them inside your storage again). Choose a cool, dry location, away from heat and moisture. Avoid direct sunlight if you can. Ensure you can easily find your hearing aids and your kids and pets cannot. A nightstand or dresser spot is ideal. See your hearing care professional for more storage tips. The wax guards in your hearing aids prevent earwax from building up in the receiver. Its best to replace these if you notice built-up debris or poor sound from your hearing aids. To replace your wax guards:
1. Insert the empty end of the application stick straight into the used wax guard of your hearing aid. 2. Pull the application stick straight out to remove the used wax guard. Do not twist. 26 | Get to know your hearing aids 27 | Get to know your hearing aids Care for your hearing aids Care for your hearing aids 3. Use the opposite end of the Replacing earbuds application stick to insert the new wax guard straight into the hearing aid. Push firmly. 4. Pull straight out to remove the application stick. Do not twist. Discard the application stick. Done!
Its a good idea to replace your earbud regularly or if your earbud is loose, misshaped, or discolored from oils and moisture. A change in sound quality can also be a signal to replace your earbuds. To replace your earbuds:
1. Pull the old earbud from the receiver of your hearing aid. 2. Hold your hearing aids cable where it meets the receiver. 28 | Get to know your hearing aids 29 | Get to know your hearing aids Troubleshooting guide Care for your hearing aids 3. Place the end of the receiver into the middle of your new earbud. 4. Push firmly to ensure the earbud attaches securely to the receiver. 5. Ensure the earbud fully covers the threaded portion of the receiver. Done!
30 | Get to know your hearing aids Troubleshooting guide Troubleshooting guide If, for any reason, your hearing aid does not operate properly, do NOT attempt to fix it yourself. Not only are you likely to violate any applicable warranties or insurance, you could easily cause further damage. Should your hearing aid fail or perform poorly, check this troubleshooting guide for possible solutions. If problems continue, contact your hearing care professional for advice and assistance. Many common problems may be solved in your hearing care professionals office or clinic. Symptom Possible causes Solutions Blocked earbud, earmold, or tubing. Hearing aids are not loud enough. Buildup of debris. 1. Clean your hearing aids. 2. Replace the wax guards as needed. Clean the microphone and receiver with your cleaning tool brush. Symptom Possible causes Solutions Blocked earbud, earmold, or tubing. 1. Clean your hearing aids. 2. Replace the wax guards as needed. Inconsistent hearing aid performance. Blocked earbud, earmold, or tubing. 1. Clean your hearing aids. 2. Replace the wax guards as needed. Unclear and distorted hearing aid performance. Change in your hearing. Contact your hearing care professional. Defective hearing aids. Contact your hearing care professional. 32 | Troubleshooting guide 33 | Troubleshooting guide Troubleshooting guide Symptom Possible causes Blocked earbud, earmold, or cable. Solutions 1. Clean your hearing aids. 2. Replace the wax guards as needed. No sound coming from your hearing aids. Crimped cable. Contact your hearing care professional. Receiver cable may not be fully connected to your hearing aid. Disconnect and reconnect receiver cable to your hearing aid. Additional guidance Intended use FCC information Regulatory information 34 | Troubleshooting guide Intended use Intended use INTENDED USE:
An air conduction hearing aid is a wearable sound-amplifying device intended to compensate for impaired hearing. Hearing aids are available in multiple gain/output levels appropriate to treat hearing losses ranging from mild to profound. Your hearing aids are designed to operate in public and residential environments and are designed to comply with international Electromagnetic Compatibility emissions and immunity standards for medical devices. However, it is still possible that you may experience interference caused by power line disturbances, airport metal detectors, electromagnetic fields from other medical devices, radio signals and electrostatic discharges. If you use other medical devices or wear implantable medical devices such as defibrillators or pacemakers and are concerned that your hearing aids might cause interference with your medical device, please contact your physician or the manufacturer of your medical device for information about the risk of disturbance. Your hearing aids should not be worn during an MRI procedure or in a hyperbaric chamber or other oxygen-rich environments. Your hearing aids are classified as a Type B applied part under the IEC 60601-1 medical device standard. Your hearing aids are not formally certified to operate in explosive atmospheres such as may be found in coal mines or certain chemical factories. 95% rH 45 C Your hearing aids should be stored and 10% rH
-10 C transported within the temperature, humidity, and pressure ranges of -10C (14F) to +45C
(113F),10%-95% rH, and 70 kPa 106 kPa
(equivalent to altitudes from 1,200 ft (380 m) below sea level to 10,000 ft (3,000 m). Your hearing aids are designed to operate beyond the range of CAUTIONS:
If the product is hot, do not touch it until cool. If the product is not working, do not disassemble. Due to a shock hazard, please send in for repair. Keep out of reach from children. Do not ingest anything in the package, including desiccant, cleaning tool, etc. Clinical benefit The hearing aid is designed to provide better speech understanding to help ease communication with the aim of improving quality of life. Clinical Study Summary A clinical study, including adults aged 18 years and over with hearing losses ranging from mild to profound, assessed hearing aid performance and benefit. Over the course of 2-6 weeks of device wear, users completed various laboratory and field assessments to determine if the devices met clinical expectations. The results of the study confirm that the devices provide amplification appropriate for the users hearing losses, and that users perceive benefit from amplification consistent with normative data. There were no serious or lasting adverse events encountered during the study. Use on Aircrafts The wireless capabilities that may be featured in your Hearing Instruments can be used on an aircraft as Hearing Instruments are exempt from the rules applied to other personal electronics instruments on an aircraft. DO NOT OPEN HEARING AID, NO USER-
SERVICEABLE PARTS INSIDE Required Multiflex Tinnitus Information for Hearing Care Professionals INDICATIONS FOR USE The Multiflex Tinnitus Technology is a tool to generate sounds to be used in a Tinnitus Management Program to relieve patients suffering from tinnitus. The target population is primarily the adult population over 18 years of age. The Multiflex Tinnitus Technology is targeted for hearing care professionals, which are treating patients suffering from tinnitus, as well as conventional hearing disorders. The fitting of the Multiflex Tinnitus Technology must be done by a hearing care professional participating in a Tinnitus Management Program. INSTRUMENT DESCRIPTION Multiflex Tinnitus Technology is a software function that generates sound which is programmed into a hearing aid. The hearing aid may be used in one of three modes of operation: as a hearing aid, as a tinnitus treatment instrument or as a hearing aid and tinnitus treatment instrument. When enabled, the Multiflex Tinnitus Technology generates the sound and allows a patients hearing care professional to design and program appropriate settings for an individually prescribed sound treatment plan. The treatment plan should be used in a tinnitus management program for relief of tinnitus. Multiflex Tinnitus Technology generates a broadband white noise signal that varies in frequency and amplitude. These characteristics are adjustable by the hearing care professional and are specific to the prescribed therapy designed by the professional for the patients needs and comfort. The patient may have some control of the level or volume of the signal and the patient should discuss this adjustment as well as his or her comfort level and sound of the signal with their hearing care professional. 36 | Additional guidance 37 | Additional guidance Intended use Intended use CAUTION: If set to the maximum output level and worn for periods of time exceeding the recommendations below, the patients exposure to sound energy has the potential to exceed noise exposure limits. This hearing aid is intended for use for a maximum of sixteen
(16) hours a day when set at the maximum output level. For the Patient A tinnitus therapy instrument is an electronic instrument intended to generate noise of sufficient intensity and bandwidth to treat ringing in the ears. It can also be used as an aid in hearing external sounds and speech. Multiflex Tinnitus Technology is a tool to generate sounds. It is recommended that this tool be used with appropriate counseling and/or in a tinnitus management program to relieve patients suffering from tinnitus. TINNITUS THERAPY CONCEPTS AND BENEFITS Multiflex Tinnitus Technology can be used as a part of a tinnitus treatment program. Multiflex Tinnitus Technology plays a white noise through the hearing aid. Multiflex Tinnitus Technology is programmed according to your hearing loss and preference, and your hearing care professional can adjust the settings of Multiflex Tinnitus Technology to meet your needs. Multiflex Tinnitus Technology may provide temporary relief of your tinnitus. PRESCRIPTION USE ONLY CAUTION: Federal law restricts this hearing aid to sale by or on the order of a doctor, audiologist or other hearing care professional licensed to dispense hearing aids in your state. The use of any sound generating tinnitus therapy instrument should be only on the advice and in consultation with your audiologist or hearing care professional. Your hearing professional will properly diagnose and fit the hearing aid to your personal needs and requirements. This should include its use in a prescribed tinnitus treatment program. Your hearing care professional will also be able to offer the appropriate follow-up care .It is important that you follow your hearing care professionals advice and direction regarding such care. CAUTION: If set to the maximum output level and worn for periods of time exceeding the recommendations below, your exposure to sound energy has the potential to exceed noise exposure limits. You should not use your hearing aid for more than sixteen (16) hours a day if your hearing aid is set at the maximum output level, nor should you use your hearing aid if your hearing care professional has set the hearing aid at levels that exceed your comfort level. Important Notice for Prospective Sound Generator Users Good health practice requires that a person with tinnitus have a medical evaluation by a licensed physician (preferably a physician who specializes in diseases of the ear) before using a sound generator. Licensed physicians who specialize in diseases of the ear are often referred to as otolaryngologists, otologists or otorhinolaryngologists. The purpose of a 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. TINNITUS TECHNICAL DATA Multiflex Tinnitus Technology Maximum Output = 87 dB SPL (typical) when measured in a 2cc coupler per ANSI S3.22 or IEC 60118-7. WIRELESS TECHNICAL DESCRIPTION Your hearing aids contain a radio transceiver utilizing Bluetooth Low Energy wireless technology operating in the 2.4-2.4835 GHz frequency band with a maximum effective radiated power of -4.2 dBm using GFSK transmission modulation. The receiver section of the radio has a bandwidth of 1.5 MHz. This hearing aid also contains a radio transceiver utilizing Near Field Magnetic Induction operating on 10.281 MHz with induced magnetic field strength of less than -60 dBuA/m at a measurement distance of 30 meters with 8-DPSK transmission modulation. The receiver section of the NFMI radio has a bandwidth of 400 kHz. This hearing aid model has been tested to, and has passed, the following emissions and immunity tests:
IEC 60601-1-2 radiated emissions requirements for a Group 1 Class B device as stated in CISPR 11. RF radiated immunity at a field level of 10 V/m between 80 MHz and 2.7 GHz as well as higher field levels from communications devices as stated in Table 9 of IEC 60601-1-2. Immunity to power frequency magnetic fields at a field level of 30 A/m, as well as proximity magnetic fields as defined in table 11 of 60601-1-2. Immunity to ESD levels of +/- 8 kV conducted discharge and
+/- 15 kV air discharge. The expected service life is 3 years. 38 | Additional guidance 39 | Additional guidance Intended use WIRELESS NOTICES EU ADVERSE EVENT REPORTING Any serious incident that has occurred in relation to your Starkey device should be reported to your local Starkey representative and the Competent Authority of the Member State in which you are established. A serious incident is defined as any malfunction, deterioration in the characteristics and/or performance of the device, or inadequacy in the device user manual/ labeling which could lead to the death or serious deterioration in the state of health of the user, OR could do so upon recurrence. FCC information These devices comply with part 15 of the FCC rules and with ISED Canada license-exempt RSS standards.Operation is subject to the following two conditions: (1) The device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation of the device. NOTE: The manufacturer is not responsible for any radio or TV interference caused by unauthorized modifications to this equipment. Such modifications could void the users authority to operate the equipment. Regulatory information For service or repair, please contact your hearing care professional first. If necessary, you can send your hearing aids to:
Starkey Laboratories, Inc. 6700 Washington Ave. South Eden Prairie, MN 55344 USA www.starkey.com Starkey Laboratories (Germany) GmbH Weg beim Jger 218-222 22335 Hamburg Germany EEA/EU/EC European Authorised Representative symbol UK Authorised Person:
Starkey UK William F. Austin House Pepper Rd, Hazel Grove Stockport SK7 5BX, UK www.starkey.co.uk Waste from electronic equipment must be handled according to local regulations Consult user manual Keep dry Instructions for Disposal of Old Electronics Starkey Laboratories, Inc. encourages, the EU requires, and your local community laws may require, that your hearing aids be disposed of via your local electronics recycling/disposal process. 40 | Additional guidance 41 | Additional guidance Regulatory information Symbol Symbol Meaning Manufacturer Authorized representative in the European Community Date of Manufacture Catalogue Number Serial Number Medical Device Keep Dry Temperature Limit Humidity Limitation Caution General warning sign Refer to instruction manual/booklet Collect Separately Class II equipment Regulatory Compliance Mark
(RCM) Manufacturer symbol To identify the manufacturer of a product EEA/EU/EC European Authorised Representative symbol Date of manufacture symbol To indicate the date on which a product was manufactured Indicates the manufacturers catalogue number so the medical device can be identified WEEE (Waste Electrical and Electronic Equipment) Directive symbol Class II or double insulated electrical appliance symbol Australias ACMA Regulatory Compliance Mark Applicable Standard BS EN ISO 15223-1:2021 BS EN ISO 15223-1:2021 BS EN ISO 15223-1:2021 BS EN ISO 15223-1:2021 BS EN ISO 15223-1:2021 BS EN ISO 15223-1:2021 BS EN ISO 15223-1:2021 BS EN ISO 15223-1:2021 BS EN ISO 15223-1:2021 BS EN ISO 15223-1:2021 Symbol Number 5.1.1 5.1.2 5.1.3 5.1.6 5.1.7 5.7.7 5.3.4 5.3.7 5.3.8 5.4.4 EC 60601-1, Reference no. Table D.2, Safety sign 2 EC 60601-1, Reference no. Table D.2, Safety sign 10 DIRECTIVE 201 2/19/EU (WEEE) IEC 60417 Reference no. Table D.1 ISO 7010-
W001 ISO 7010-
M002 Annex IX Symbol 9
(IEC 60417-
5172) AS/NZS 4417.1:2012 N/A Giteki Mark Japanese Radio Law N/A Direct current Recycling Symbol IEC 60601-1 Reference no. Table D.1 European Parliament and Council Directive 94/62/EC IEC 60417-
5031 Annex I-VII 42 | Additional guidance 43 | Notes Notes Use of the Made for Apple badge means that an accessory has been designed to connect specifically to the Apple product(s) identified in the badge, and has been certified by the developer to meet Apple performance standards. Apple is not responsible for the operation of this device or its compliance with safety and regulatory standards. Apple, the Apple logo, iPhone, iPad and iPod touch are trademarks of Apple Inc., registered in the U.S. and other countries. iOS is a trademark or registered trademark of Cisco in the U.S. and other countries and is used under license. Google Play is a trademark of Google LLC. The Bluetooth word mark and logos are registered trademarks owned by Bluetooth SIG, Inc. and any use of such marks by Starkey is under license. Genesis, Starkey, and StarLink are trademarks of Starkey Laboratories, Inc. 2023 Starkey Laboratories, Inc. All Rights Reserved. P00001426 2/23 BKLT3143-00-EN-XX Patent: www.starkey.com/patents
1 2 | Attestation regarding covered list | Attestation Statements | 397.72 KiB | July 25 2023 |
Sta rkey Hear better. Live better. 6700 Washington Avenue S Eden Prairie, Minnesota 55344 T: 1.800.328.8602 Sarkeyeer March 30, 2023 Federal Communications Commission Authorization and Evaluation Division 7435 Oakland Mills Road Columbia, Maryland 21046 Re: Attestation regarding covered equipment and the Covered List FCC ID: EOA-24GENR312 To whom it may concern, Per 2.911(d)(5)(i), Starkey Laboratories, Inc. certifies that the equipment for which authorization is sought is not covered equipment prohibited from receiving an equipment authorization pursuant to section 2.903 of the FCC rules. Per 2.911(d)(5) (ii), Starkey Laboratories, Inc. certifies that, as of the date of the filing of the application, the applicant is not identified on the Covered List as an entity producing covered equipment. Sincerely, Bi f< Chatehel/
William J. Mitchell, PE Principal Wireless and Safety Regulatory Engineer 952-918-5683 bill_mitchell@starkey.com Starkey logo and Hear better. Live better. are registered trademarks of Starkey Laboratories, Inc.
1 2 | Cover letter | Cover Letter(s) | 415.85 KiB | July 25 2023 |
Sta rkey Hear better. Live better. 6700 Washington Avenue S Eden Prairie, Minnesota 55344 T: 1.800.328.8602 Starkeyicom March 30, 2023 Federal Communications Commission 45 L Street, NE Washington, DC 20554 Attention:
Application Examiner Reference:
Certification:
Applicant:
Equipment:
Model #:
| Parts 15.209 and 15.247 Intentional Radiator Starkey Laboratories, Inc. Low Power Device (2400-2483.5 MHz) Low Power Device (10.281 MHz) Genesis AI RIC 312 Hearing Aid FCC ID: EOA-24GENR312 Dear Sir/Madam:
Enclosed please find an FCC EOA-24GENR312 certification application. The device is a wireless hearing aid intended for use by the hearing impaired. The wireless features are used during the initial fitting of a hearing aid to program the hearing aid and used during normal usage to communicate control information and digital audio to and from any properly configured Bluetooth Low Energy compliant accessory and between a binaural pair of Genesis hearing aids. Further details and supporting documents are attached. Should you have any questions, please feel free to contact the undersigned. Qi ie J. Mitchell, PE Principal Wireless and Safety Regulatory Engineer 952-918-5683 bill_mitchell@starkey.com Starkey logo and Hear better. Live better. are registered trademarks of Starkey Laboratories, Inc.
1 2 | Request for Confidentiality | Cover Letter(s) | 587.81 KiB | July 25 2023 |
6700 Washington Avenue S Eden Prairie, Minnesota 55344 T: 1.800.328.8602 Starkey.com Sta rkey Hear better. Live better. March 30, 2023 Federal Communications Commission Authorization and Evaluation Division 7435 Oakland Mills Road Columbia, Maryland 21046 Re: Request for confidentiality Applicant: Starkey Laboratories, Inc. FCC ID: EOA-24GENR312 To whom it may concern:
Permanent Confidentiality Request is hereby submitted by Starkey Laboratories, Inc. to withhold permanently from public review certain portions of the application for equipment certification for the referenced FCC identifiers. This request for confidentiality is made pursuant to 47 CFR 0.457(d) and 0.459 of the FCC Rules. In particular, the following sections of the application are to be kept permanently confidential:
e e e Schematics Detailed Block diagrams Detailed Operational/Functional Description Short-term Confidentiality Request is hereby submitted by Starkey Laboratories, Inc. to withhold from public review for a period of 180 days from the date of the Grant of Equipment Authorization and prior to marketing, certain portions of the application for equipment certification for the referenced FCC identifiers. This request for confidentiality is made pursuant to 47 CFR 0.457(d) and 0.459 of the FCC Rules. In particular, the following sections of the application are to be kept confidential for a period of 180 days from the date of Authorization:
e e e e Test setup photos External photos Internal photos User manual has Inc. Laboratories, Rationale for request for confidentiality:
Starkey and invested considerable time development to produce the referenced product. Disclosure of the permanently confidential portions of this application to competitors would not only give them significant competitive advantages in developing similar products, but would also disclose successful implementation of unpublished, leading edge technology developed by us. Disclosure of the short-term confidential portions of this application during the period of importation and/or distribution would reveal key aspects of proprietary technology to competitors and diminish the value of our investment in research and development. Sincerely, materials research and in Dile-
ut hil William J. Mitchell, PE Principal Wireless and Safety Regulatory Engineer 952-918-5683 bill_mitchell@starkey.com Starkey logo and Hear better. Live better. are registered trademarks of Starkey Laboratories, Inc.
frequency | equipment class | purpose | ||
---|---|---|---|---|
1 | 2023-07-25 | 2402 ~ 2480 | DTS - Digital Transmission System | Original Equipment |
2 | 10.28 ~ 10.28 | DXX - Part 15 Low Power Communication Device Transmitter |
app s | Applicant Information | |||||
---|---|---|---|---|---|---|
1 2 | Effective |
2023-07-25
|
||||
1 2 | Applicant's complete, legal business name |
Starkey Laboratories Inc
|
||||
1 2 | FCC Registration Number (FRN) |
0015964463
|
||||
1 2 | Physical Address |
6700 Washington Avenue So
|
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1 2 |
Eden Prairie, Minnesota 55344
|
|||||
1 2 |
United States
|
|||||
app s | TCB Information | |||||
1 2 | TCB Application Email Address |
j******@element.com
|
||||
1 2 | TCB Scope |
A4: UNII devices & low power transmitters using spread spectrum techniques
|
||||
1 2 |
A1: Low Power Transmitters below 1 GHz (except Spread Spectrum), Unintentional Radiators, EAS (Part 11) & Consumer ISM devices
|
|||||
app s | FCC ID | |||||
1 2 | Grantee Code |
EOA
|
||||
1 2 | Equipment Product Code |
24GENR312
|
||||
app s | Person at the applicant's address to receive grant or for contact | |||||
1 2 | Name |
W****** J****** M********
|
||||
1 2 | Title |
Principal Regulatory Affairs Engineer
|
||||
1 2 | Telephone Number |
952-9********
|
||||
1 2 | Fax Number |
952 8********
|
||||
1 2 |
b******@starkey.com
|
|||||
app s | Technical Contact | |||||
n/a | ||||||
app s | Non Technical Contact | |||||
n/a | ||||||
app s | Confidentiality (long or short term) | |||||
1 2 | Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | Yes | ||||
1 2 | Long-Term Confidentiality Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | Yes | ||||
1 2 | If so, specify the short-term confidentiality release date (MM/DD/YYYY format) | 01/21/2024 | ||||
if no date is supplied, the release date will be set to 45 calendar days past the date of grant. | ||||||
app s | Cognitive Radio & Software Defined Radio, Class, etc | |||||
1 2 | Is this application for software defined/cognitive radio authorization? | No | ||||
1 2 | Equipment Class | DTS - Digital Transmission System | ||||
1 2 | DXX - Part 15 Low Power Communication Device Transmitter | |||||
1 2 | Description of product as it is marketed: (NOTE: This text will appear below the equipment class on the grant) | Genesis AI | ||||
1 2 | Related OET KnowledgeDataBase Inquiry: Is there a KDB inquiry associated with this application? | No | ||||
1 2 | Modular Equipment Type | Does not apply | ||||
1 2 | Purpose / Application is for | Original Equipment | ||||
1 2 | Composite Equipment: Is the equipment in this application a composite device subject to an additional equipment authorization? | Yes | ||||
1 2 | Related Equipment: Is the equipment in this application part of a system that operates with, or is marketed with, another device that requires an equipment authorization? | No | ||||
1 2 | Grant Comments | Output power listed is conducted. The antenna(s) used for the transmitter must not be collocated or operating in conjunction with any other antenna or transmitter, except in accordance with FCC multi-transmitter product procedures. | ||||
1 2 | Is there an equipment authorization waiver associated with this application? | No | ||||
1 2 | If there is an equipment authorization waiver associated with this application, has the associated waiver been approved and all information uploaded? | No | ||||
app s | Test Firm Name and Contact Information | |||||
1 2 | Firm Name |
Element Materials Technology Minneapolis - Brookly
|
||||
1 2 | Name |
R****** W********
|
||||
1 2 | Telephone Number |
503 8********
|
||||
1 2 |
r******@element.com
|
|||||
Equipment Specifications | |||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Line | Rule Parts | Grant Notes | Lower Frequency | Upper Frequency | Power Output | Tolerance | Emission Designator | Microprocessor Number | |||||||||||||||||||||||||||||||||
1 | 1 | 15C | CC | 2402.00000000 | 2480.00000000 | 0.0007000 | |||||||||||||||||||||||||||||||||||
Line | Rule Parts | Grant Notes | Lower Frequency | Upper Frequency | Power Output | Tolerance | Emission Designator | Microprocessor Number | |||||||||||||||||||||||||||||||||
2 | 1 | 15C | CC | 10.28000000 | 10.28000000 |
some individual PII (Personally Identifiable Information) available on the public forms may be redacted, original source may include additional details
This product uses the FCC Data API but is not endorsed or certified by the FCC