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Summary of Contents for Beltone Serene
- Page 1 Custom hearing aids Beltone Serene User guide...
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Page 2: Hearing Aid Information
Hearing aid information Left hearing aid Right hearing aid Serial number Serial number Model number Model number Battery type Zinc-air 312 Program Beep Description One beep Two beeps Three beeps Four beeps 2 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 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. You might need medical help if a piece gets stuck in your ear If any part of your hearing aid, like the ear tip (dome), gets stuck in your ear, and you can’t easily remove it with your fingers, get medical help as soon as you can.
- Page 6 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 device, etc.
- Page 7 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 person’s ability to hear with and without a hearing aid.
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Page 9: Table Of Contents
Table of Contents Hearing aid information FDA warnings and cautions (US only) Introduction Getting to know your hearing aid Getting your hearing aid ready for use Placing your hearing aids in your ears Removing your hearing aids from your ears Using your hearing aids Using a telephone Advanced options Wireless accessories... -
Page 10: Introduction
Introduction 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. User profile •... - Page 11 • 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. • Audiometric air-bone gap equal to or greater than 15 dB at 500 Hertz (Hz), 1000 Hz, and 2000 Hz.
- Page 12 Symbols The symbols below are used in this user guide, on the device, or on the packaging. WARNING: Points out a situation CAUTION: Indicates a situation that could lead to serious injuries. that could lead to minor and moderate injuries. Legal manufacturer.
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Page 13: Getting To Know Your Hearing Aid
Getting to know your hearing aid Front view 1. Microphone sound inlets 2. Push button (optional) 3. Battery door 4. Volume control (optional) 5. Vent Side view 1. Wax filter Hearing aid data (including serial number) and color marking for left or right hearing aid are printed on the side. ... -
Page 14: Getting Your Hearing Aid Ready For Use
Getting your hearing aid ready for use Replacing the battery 1. Open the battery door completely by using your fingernail. Remove the used battery, if present. 2. Prepare the new battery. Remove the protective foil to activate the battery. Wait for 2 minutes before inserting the battery into the hearing aid. - Page 15 When the hearing aid is not in use, open the battery door to turn it off. Open the battery door completely to allow moisture to evaporate and prolong the hearing aids’ life span. If the hearing aids are experiencing frequent loss of connection to wireless accessories, contact your hearing care professional for a list of low impedance batteries.
- Page 16 NOTE: • Always use new zinc-air batteries with a minimum remaining shelf life of one year. • To save battery, turn off your hearing aids when they are not in use. Low battery alert When the batteries are low on power, the volume in your hearing aids will reduce and a melody will play every 15 minutes until there is no more power –...
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Page 17: Placing Your Hearing Aids In Your Ears
Placing your hearing aids in your ears How to tell left from right Your hearing aids are color-coded. If your hearing aids are not color coded, ask your hearing care professional to add color coding. Left hearing aid Right hearing aid (blue marking) (red marking) NOTE: Your hearing aids are made to fit exactly into your left and your right ear... - Page 18 Inserting the hearing aids 1. Hold the hearing aid between your thumb and index finger, either above and below or on the sides. 2. Insert the hearing aid into your ear canal: Place the sound outlet portion into your ear canal.
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Page 19: 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. 2. If your hearing aid has a pull-out wire, pull at the wire to remove the hearing aid. -
Page 20: Using Your Hearing Aids
Using your hearing aids Operation of the hearing aid The volume control (optional) allows you to adjust the volume of your hearing aids to your liking. • To increase the volume, turn the volume control forward (+). • To decrease the volume, turn the volume control towards the back of your head (-). - Page 21 Push button (optional) Your hearing aid may have a push button allowing you to use up to four different listening programs. See "Listening programs", page 21. 1. Push the program button to switch between programs. 2. You will then hear one or more beeps. The number of beeps indicates which program you have selected (one beep = program one, two beeps = program two, etc.).
- Page 22 Programs All-Around The best option if you want only one program. Hear in Noise Dedicated program for hearing speech in very noisy places such as restaurants or social gatherings. Music For listening to music. Acoustic phone A special program for phone conversations. Outdoor For outdoor use (to reduce wind noise).
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Page 23: Using A Telephone
Using a telephone Your hearing aid allows you to use your telephone as you normally do. Finding the optimal position for holding the phone may require practice. The following suggestions may be helpful: 1. Hold the telephone up to your ear canal as usual. 2. - Page 24 NOTE: • If you have a mobile device, you can pair it to connect directly to your hearing aids. See "Advanced options", page 25. • If you find it difficult to get a good result while using your mobile phone, your hearing care professional can give you advice on available wireless accessories to enhance listening capabilities.
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Page 25: Advanced Options
The Beltone HearMax™ app enables you to control your hearing aids from mobile devices. You can use the Beltone HearMax™ 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 26 NOTE: • The app must only be used with Beltone hearing aids for which they are intended, and Beltone takes no responsibility if the app is used with other hearing aids. • Do not disable app notifications. • Install updates to keep the app working correctly.
- Page 27 Beltone Remote Care and Beltone Remote Care Live (optional) Beltone Remote Care If you have signed up to use Beltone Remote Care available with your hearing aids, you can allow your hearing aids to be adjusted remotely without having to visit your hearing care professional.
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Page 28: Wireless Accessories
Wireless accessories A variety of wireless accessories is available as an enhancement to your hearing aids. These accessories enable direct streaming of sound and speech to your hearing aids, enhancing your ability to hear and communicate in various everyday situations. Available wireless accessories and their features •... - Page 29 Accessing wireless accessories To access a wireless accessory that has already been paired with your hearing aids, press the push button for 2 seconds. The hearing aid will emit a sound to confirm the connection. NOTE: • Please contact your hearing care professional for an overview of compatible wireless accessories that are approved by GN Hearing A/S.
- Page 30 Battery level Signal Hearing aid Remote control Streaming New battery 4 even tones Depleted 3 even tones 1 longer tone These will work again when you insert a new battery. 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 31 Turning off wireless communication (enter Flight Mode) 1. Open and close the battery door on each hearing aid three times within 10 seconds. 2. A 10-second double tone ( ) means the hearing aid is now in Flight Mode. It is important to wait an additional 15 seconds after you activate Flight Mode before opening and closing the battery door again for any reason.
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Page 32: Cleaning And Caring For Your Hearing Aids
Cleaning and caring for your hearing aids Cleaning tools These cleaning tools come with your hearing aids: • Soft cloth. • A brush with a battery magnet. • A cleaning wire (not shown). Your hearing care professional may give you a set of wax filters. 32 Cleaning and caring for your hearing aids... - Page 33 General instructions for care and maintenance 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. To maintain your hearing aids, clean and disassemble them one at a time to prevent mixing them up.
- Page 34 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 35 Daily care and maintenance It is important to keep your hearing aids clean and dry on a daily basis. Use a cloth and brush to clean the hearing aids. 1. Wipe your hearing aids with a 2. Swipe a small brush across the cloth.
- Page 36 How to replace wax filters Custom hearing aids may have wax filters 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. This will depend on how much wax your ears produce.
- Page 37 The wax filter tool has Removal tip two functions: A removal tip to collect the used filter, and a Replacement tip replacement tip with a white filter. Box of 8 wax filter tools. 1. To remove the old wax filter, insert the removal tip into the used wax filter. Slowly pull the wax filter straight out.
- Page 38 The replacement tool Removal tip has two functions: A removal tip to collect the used filter and a Replacement tip replacement tip to grab the new filter Dispenser with replacement tool. from the dispenser. Extract the used filter from the hearing aid 1.
- Page 39 5. Return the tool to its storage place in the dispenser. NOTE: Your hearing aid may have a vent hole next to the wax filter outlet. Make sure not to put the wax filter tool into the vent. Storing your hearing aids The best storage for your hearing aids is the case they came in.
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Page 40: Tinnitus Management
Tinnitus management Tinnitus Breaker Pro module Your Beltone hearing aid includes the Tinnitus Breaker Pro (TBP) module, a tool for generating sounds to be used in tinnitus management programs to temporarily relieve suffering from tinnitus. The TBP can generate sounds adjusted to the specific therapeutic needs and your personal preference as determined by your doctor, audiologist, or hearing care professional. - Page 41 initial fitting of the Tinnitus Breaker Pro module must be done during an in-office visit by a hearing professional participating in a Tinnitus Management Program. If deemed feasible by the hearing professional, subsequent fittings of the Tinnitus Breaker Pro module may be performed remotely and in real time while having live communication via live audio, video, and chat on the user's dedicated app.
- Page 42 If you have two wireless hearing aids that support ear-to-ear synchronization, this functionality can be enabled by your hearing care professional. This will cause the Tinnitus Breaker Pro to synchronize the sound in both hearing aids. If your tinnitus only troubles you in quiet environments, your doctor, audiologist, or hearing care professional can set the TBP Module so that it becomes audible exclusively in such surroundings.
- Page 43 TBP volume control The sound generator is set to a specific loudness level by the hearing care professional. When switching the sound generator on, the volume will have this optimal setting. Therefore, it might not be necessary to control the volume (loudness) manually. However, the volume control provides the ability to adjust the volume, or amount of stimulus, to the liking of the user.
- Page 44 Available sounds White noise signal which can be shaped with the following configurations: High-pass filter Low-pass filter 500 Hz 2000 Hz 750 Hz 3000 Hz 1000 Hz 4000 Hz 1500 Hz 5000 Hz 2000 Hz 6000 Hz 8000 Hz The white noise signal can be modulated in amplitude with an attenuation depth of up to 14 dB.
- Page 45 perception, you should discontinue the use of the sound generator and seek medical evaluation. Target population The target population is primarily the adult population over 18 years of age. This product may also be used for children 12 years of age or older. However, children and physically or mentally challenged users will require training by a doctor, audiologist, hearing care professional or the guardian for the insertion and removal of the hearing aid containing the TBP module.
- Page 46 Warning information WARNING: • Sound generators can be dangerous if improperly used. • Sound generators should be used only as advised by your doctor, audiologist, or hearing care professional. • Sound generators are not toys and should be kept out of reach of anyone who might cause themselves injury (especially children and pets).
- Page 47 • Use of the Beltone Remote Care 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 48 2. History of active drainage from the ear within the previous 90 days. 3. History of sudden or rapidly progressive hearing loss within the previous 90 days. 4. Acute or chronic dizziness. 5. Unilateral hearing loss of sudden or recent onset within the previous 90 days. 6.
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Page 49: General Warnings And Cautions
General warnings and cautions WARNING: • Consult a hearing care professional or a physician: – 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 See also "Contraindications", page 10 •... - Page 50 • Never use your hearing aids in places with explosive gases such as mines, oil fields, or similar unless these areas are certified for hearing aid use. Using your hearing aids in places that are not certified for hearing aid use can be dangerous.
- Page 51 CAUTION: • Use your hearing aids as your hearing care professional recommends. Incorrect use may damage your hearing. • Do not use a broken or modified hearing aid. It may not work properly and may be harmful to your hearing. It may also cause scratches or sores due to sharp edges.
- Page 52 For hearing care professionals WARNING: • Special care should be exercised in selecting and fitting hearing aids with a maximum sound pressure level that exceeds 132 dB SPL or higher maximum OSPL 90 measured with an IEC 60711:1981 occluded ear simulator. The remaining hearing may risk further impairment.
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Page 53: Cyber Security
If your device plays the pairing sound at an unexpected time, this could indicate someone has gained access to your device. • Only connect your hearing aid to the official Beltone mobile device app. • Only apply remote fine tuning updates that you are expecting. -
Page 54: Troubleshooting
Troubleshooting Issue Potential cause Potential solution Feedback, Is the hearing aid inserted Put it back in. "whistling" correctly? Is the volume very loud? Reduce it. Are you holding an object (e.g., Move your hand away to create a hat or a telephone receiver) more space between the hearing close to the hearing aid? aid and the object. - Page 55 Issue Potential cause Potential solution Battery runs out Did you leave your hearing aid Always switch off your hearing aids very quickly turned on for long periods of when you are not using them (e.g., time? during the night). Is the battery old? Check the date on the battery pack.
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Page 56: 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. - Page 57 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.
- Page 58 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: • Electrical safety testing is performed according to IEC 60601-1:2005 + A1:2012+A2:2020, IEC 60601-2-66:2019, IEC 60601-1-11 Edition 2.0 2015-1, IEC 62133-2 Edition 1.0 2017- 02 and IEC 62368-1:2018/COR1:2020.
- Page 59 Clinical data (US only) The devices have been evaluated clinically through equivalence, and the devices have been compared to equivalent devices and similar devices on the market with similar intended purpose, e.g., to compensate for hearing impairment by amplifying and transmitting sound to the ear. Based on technical and clinical data presented for the device in question, the equivalent predecessor and generally similar devices, it is concluded to support the clinical performance expressed in user needs and claims.
- Page 60 cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a 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 61 Type designations Hearing aid type designations for models included in this user guide are: LHI12 04, FCC ID: X26LHI12 04, IC: 6941C-LHI12 04. Hearing aid variants Availability of models may vary by country. In-the-canal (ITC) hearing aids (including type LHI12 04 with FCC ID X26LHI12 04, IC number 6941C-LHI12 04 models) with size 312 battery, are available in the following variants: SER4ITC-DW-LP, SER6ITC-DW-LP, SER9ITC-DW-LP, SER17ITC-DW-LP...
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Page 62: Technical Specifications
Technical specifications Hearing aid model Maximum output Low Power (LP) models 114 dB SPL (typical) All Medium Power (MP) models 117 dB SPL (typical) All High Power (HP) models 120 dB SPL (typical) All Ultra Power (UP) models 130 dB SPL (typical) Data in accordance with IEC60118-0 Edition 3.0 2015-06, IEC60118-7 and ANSI S3.22- 2009, supply Voltage 1.3V For further technical data in accordance with IEC60118-0 Edition 3.0 2015-06, IEC60118-... - Page 63 Low Power (LP) models (US only) Additional technical data Latency, mid frequency delay (2 kHz) Attack/release time (2 kHz syllabic) 12 / 70 Input/Output response, measured in a 2cc coupler at the reference test gain @ 2 KHz Input/Output Response - LP Ref.Test.Gain @ 2 kHz 2cc coupler Input [dB SPL] Technical specifications 63...
- Page 64 Medium Power (MP) models (US only) Additional technical data Latency, mid frequency delay (2 kHz) Attack/release time (2 kHz syllabic) 12 / 70 Input/Output response, measured in a 2cc coupler at the reference test gain @ 2 KHz Input/Output Response - MP Ref.Test.Gain @ 2 kHz 2cc coupler Input [dB SPL] 64 Technical specifications...
- Page 65 High Power (HP) models (US only) Additional technical data Latency, mid frequency delay (2 kHz) Attack/release time (2 kHz syllabic) 12 / 70 Input/Output response, measured in a 2cc coupler at the reference test gain @ 2 KHz Input/Output Response - HP Ref.Test.Gain @ 2 kHz 2cc coupler Input [dB SPL] Technical specifications 65...
- Page 66 Ultra Power (UP) models (US only) Additional technical data Latency, mid frequency delay (2 kHz) Attack/release time (2 kHz syllabic) 12 / 70 Input/Output response, measured in a 2cc coupler at the reference test gain @ 2 KHz Input/Output Response - UP Ref.Test.Gain @ 2 kHz 2cc coupler Input [dB SPL] 66 Technical specifications...
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Page 67: 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 68 Apple performance standards. Apple is not responsible for the operation of this device or its compliance with safety and regulatory standards. © 2024 GN Hearing A/S. All rights reserved. Beltone 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.
- Page 69 Notes Additional information 69...
- Page 70 Notes 70 Additional information...
- Page 71 Notes Additional information 71...
- Page 72 Manufacturer according to FDA: Manufacturer according to Health Canada: Beltone Beltone Canada 8001 E Bloomington Freeway 2 East Beaver Creek Road, Building 3 Bloomington, MN 55420 Richmond Hill, ON L4B 2N3 Canada 1-800-BELTONE 1-800-387-3744 beltone.com beltone.ca...
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Questions and answers
Are there other adjustments beside sound enhancer and nouse
The Beltone Serene offers additional adjustments, including volume control, program changes, and mute functions through remote controls. It also provides tinnitus management with the "Tinnitus Breaker Pro," allowing users to adjust volume, frequency shaping, and choose between white noise variations or a Nature Sound. Additionally, wireless accessories enable streaming and control via a mobile app.
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how tocontrol volume