tweak Hearing Focus Plus T OTC Hearing Aid User Manual

June 16, 2024
tweak Hearing

tweak Hearing Focus Plus T OTC Hearing Aid

tweak-Hearing-Focus-Plus-T-OTC-Hearing-Aid-PRO

Product Information

The Focus+T OTC is an over-the-counter hearing aid designed for individuals who are 18 years and older. It is not recommended for individuals under the age of 18, as they should seek specialized care from a doctor, preferably an ear-nose-throat doctor (ENT). The device is intended to assist individuals with hearing loss and improve their ability to hear and communicate.

Specifications:

  • Product Name: Focus+T OTC
  • Age Requirement: 18 years and older
  • Intended Users: Individuals with hearing loss

Warnings:

  1. If you are younger than 18, do not use this product. Seek specialized care from a doctor.
  2. If you experience pain or discomfort when inserting the device, remove it and follow the instructions carefully. Contact the manufacturer if the issue persists or consult with a hearing healthcare professional.
  3. This device is not intended for hearing protection. If you are in a loud environment, use appropriate hearing protection instead of wearing the device.
  4. If any part of the hearing aid gets stuck in your ear, do not attempt to remove it with tweezers or cotton swabs. Seek immediate medical help to avoid injury to your eardrum or ear canal.

Caution:

  • Turn down the volume or remove the device if the sound output is uncomfortably loud or painful. Adjust the volume settings if necessary.
  • If you consistently need to lower the volume, further adjustments may be required. Consult with a hearing healthcare professional for assistance.

Product Usage Instructions

Step 1: Insertion

  1. Ensure the device is clean and free from any debris.
  2. Gently insert the hearing aid into your ear canal, following the provided instructions.
  3. If you experience pain or discomfort, remove the device and re-insert it, ensuring proper alignment.

Step 2: Volume Adjustment

  1. Start with the volume set at a comfortable level.
  2. If the sound output is too loud or uncomfortable, lower the volume using the device controls.
  3. If you consistently need to lower the volume, consult with a hearing healthcare professional for further adjustments.

Step 3: Regular Maintenance

  1. Keep the device clean by gently wiping it with a dry, soft cloth.
  2. Avoid exposing the device to moisture or extreme temperatures.
  3. Store the device in a safe and dry place when not in use.

FAQ:

  • Q: Can individuals under the age of 18 use this hearing aid?
    A: No, this hearing aid is only intended for users who are 18 years and older. Individuals under 18 should seek specialized care from a doctor, preferably an ENT.

  • Q: What should I do if I experience pain or discomfort when inserting the device?
    A: If you experience pain or discomfort, remove the device and carefully re- insert it, following the provided instructions. If the issue persists, contact the manufacturer or consult with a hearing healthcare professional.

  • Q: Can I use this device for hearing protection in loud environments?
    A: No, this device is not intended for hearing protection. If you are in a loud environment, it is recommended to use appropriate hearing protection such as earplugs instead of wearing the device.

  • Q: What should I do if a part of the hearing aid gets stuck in my ear?
    A: Do not attempt to remove it with tweezers or cotton swabs. Seek immediate medical help to avoid injury to your eardrum or ear canal.

  • Q: What should I do if I consistently need to lower the volume?
    A: If you find yourself consistently needing to lower the volume, it may be necessary to consult with a hearing healthcare professional for further adjustments to ensure optimal settings for your needs.

  • Q: How should I maintain the device?
    A: Keep the device clean by gently wiping it with a dry, soft cloth. Avoid exposing the device to moisture or extreme temperatures. Store the device in a safe and dry place when not in use.

Warnings / Cautions

  • WARNING: If you are younger than 18, do not use this.
    You should go to a doctor, preferably an ear-nose-throat doctor (an ENT) because your condition needs specialized care. Over-the-counter hearing aids are only for users who are age 18 or older.

  • This OTC hearing aid is for users who are 18 and older. People who are younger than 18 with hearing loss should see a doctor, preferably an ENT, because they may need medical testing and management. Hearing loss can affect speech and learning, so professional fitting and continuing care are also important.

  • WARNING: When to See a Doctor
    If you have any of the problems listed below, please see a doctor, preferably an ear-nose throat doctor (an ENT).

    • Your ear has a birth defect or an unusual shape. Your ear was injured or deformed in an accident.
    • You saw blood, pus, or fluid coming out of your ear in the past 6 months.
    • Your ear feels painful or uncomfortable.
    • You have a lot of ear wax, or you think something could be in your ear.
    • You get dizzy or have a feeling of spinning or swaying (called vertigo).
    • Your hearing changed suddenly in the past 6 months.
    • Your hearing changes: it gets worse then gets better again.
    • You have worse hearing in one ear.
    • You hear ringing or buzzing in only one ear.
  • WARNING: This hearing aid should not cause pain when inserting it. Remove this device from your ear if it causes pain or discomfort when you insert or place it. To try again, make sure to follow the instructions. If you feel pain or discomfort again, contact the manufacturer. If your pain or discomfort doesn’t go away, contact your hearing healthcare professional. You can also report this to the FDA as an adverse event according to the instructions that appear later.

  • Caution: This is not hearing protection.
    You should remove this device if you experience overly loud sounds, whether short or long-lasting. If you’re in a loud place, you should use the right kind of hearing protection instead of wearing this device. In general, if you would use ear plugs in a loud place, you should remove this device and use ear plugs.

  • 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 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 farther into your ear, injuring your eardrum or ear canal, possibly seriously.

  • Note: If you remain concerned, consult a professional.
    If you try this device and continue to struggle with or remain concerned about your hearing, you should consult with a hearing healthcare professional. Also if you experience side effects from wearing the hearing aids, contact a hearing healthcare professional. Possible side effects may be: dizziness, tinnitus, perceived worsening of hearing loss, nausea, headache, skin reaction, or excessive ear accumulation.

  • 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 counselling can help them get more out of their devices. If you have hearing loss in both ears, you might get more benefit from using hearing aids in both, especially in situations that make you tired from listening—for 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 device, 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.

SYMBOL DESCRIPTIONS

Congratulations
Congratulations on your Tweak® purchase. Tweak Focus+T is an over-the-counter (OTC) hearing aid. We know your new Tweak will soon be indispensable to you. With amazing sound quality, Focus+T delivers both confidence and comfort so that you never miss a moment! Focus+T is a sophisticated OTC hearing aid utilizing innovative, patented technology. This unique device allows you to select and set your desired amplification profile from a range of acoustic alternatives. Developed by an audiologist in conjunction with a team of acoustic engineers, Tweak Focus+T OTC can help you hear better in group settings, restaurants, theatres, meetings, and other environments where you have difficulty hearing. Read entire user manual before using Tweak OTC hearing aids. Doing so will ensure you know how to operate the hearing aids correctly. Download a copy of this manual at www.tweakhearing.com/support

If you still have questions about using these Tweak OTC hearing aids, call us at 1-888-815-3240 or visit www.tweakhearing.com

Intended Use
Tweak Focus+T OTC hearing aids are intended to address perceived mild-to- moderate hearing loss in people aged 18 or older.

Indications for Use
Tweak Focus+T OTC hearing aids are intended to address perceived mild-to- moderate hearing loss in people aged 18 or older. OTC hearing aids offer cost savings for consumers who wish to buy lower cost hearing aids without professional services.

Box contents

tweak-Hearing-Focus-Plus-T-OTC-Hearing-Aid- \(2\)

Contents shown represent a single hearing aid. A pair of hearing aids includes 10 sound domes/tip, 4 sound tubes, and 8 batteries.tweak-Hearing-Focus-
Plus-T-OTC-Hearing-Aid- \(3\)

Accessories Description
Tweak Focus+T OTC hearing aid Amplifies sounds picked up by the microphones
Sound tubes Size 2B, left and right. Connects your dome to the hearing aid;

sound travels through the tube and dome into the ear canal.
Sound domes/tip| Multiple sizes. Attaches to sound tube; helps to guide sound into the ear
Batteries| Size 312 zinc-air battery powers the hearing aid
Carrying case| Store your hearing aids inside when they’re not in use
Cleaning lines| Used to remove wax from inside the sound tube
Focus+T OTC manuals| User guide, quick start guide, and warranty

Components

Components Description
Sound post Amplified sounds exit the hearing aid through sound post; sound

tube attaches to the sound post, and sound travels through the tube and dome into the ear canal.
Microphones| Pick up sounds to be amplified by the hearing aid
Program button| Changes listening mode
Rocker switch| Decreases or increases volume
Battery compartment door| Where battery is located; door serves as ON/OFF for the hearing aid.
Tube connector head| Attachment point for sound tube
Thin sound tube| Connects to the hearing aid and carries sound to the dome and into the ear canal
Vented dome| Attaches to the sound tube; helps to guide sound into the ear
Retaining lock| Sets in the bowl of the ear to keep sound tube and dome positioned correctly

Preparing for use

Focus+T comes with two standard tubes (size 2B, left and right). Tubes are marked with red lettering for the right ear and blue lettering for the left ear. There are a variety of tips included with your hearing aid. The sleeve tip will work for most users. However, for more bass sound use a vented or closed dome. tweak-Hearing-Focus-Plus-T-OTC-Hearing-Aid-
\(5\)

When choosing the proper tip, the goal is to get a comfortable fit and secure enough to keep tip in the ear. Larger tips will create a more snug fit and increase the bass sounds (lower frequencies) and reduce feedback.

Domes/Tips Description
Closed dome Closed domes do not have holes in them and are used when the

hearing aid seems too quiet. They can also help to prevent your hearing aids from “whistling” at higher volumes.
Open dome| Open domes have holes in them, to prevent the ears from feeling blocked. This type of dome can help in cases where your own voice seems too loud or the hearing aid seems too noisy.
Sleeve tip| The sleeve tip fits most users. Try it first.

Connecting the Tube and Dome/Tip

  1. Choose either the left or right sound tube.
  2. Align the sound tube connector end with the sound post on the hearing aid, then push the tube straight onto the sound post. Be sure it is securely fastened to the sound tube before inserting it in your ear.
  3. Choose the tip to use with the sound tube.
  4. Align the dome/tip with the end of the sound tube and push the dome straight on.

Dome/Tip Insertion Depth
The dome/tip should be completely in the ear canal without touching the eardrum. Proper insertion of the dome/tip is key to getting adequate loudness with no feedback (“whistling”). For adults, the length of the ear canal varies from 0.9” to 1.1”. The maximum insertion depth is 0.37”. While wearing the hearing aid, the distance from the dome/tip to the eardrum is at least 0.53”. This is greater than the lower limit of 0.39” as specified by OTC guidelines, meaning there is more space between the dome/tip and eardrum.tweak-Hearing-
Focus-Plus-T-OTC-Hearing-Aid- \(8\)

Inserting a battery

battery: size 312 zinc-air (brown tab)

  1. Lift the notch at the edge of the battery compartment and swivel open the door of the battery compartment.
  2. Remove the brown-coloured tab on a new battery. Wait one minute for the battery to activate.
  3. Notice the “+” on the edge of the battery door to assist you in finding the proper orientation. Insert the battery with the positive “+” side facing up.
  4. Gently close the battery door. It should close easily; do not force the door closed.
    If resistance is experienced while closing the battery door, make sure the battery is inserted properly as it may be upside down. When the battery door is completely closed, your Tweak is on, ready for operation.
    Always discard used battery door closed tweak is OFF tweak is ON batteries. Small batteries can be harmful if swallowed. Keep batteries out of reach of pets and small children. In case of ingestion, seek medical attention immediately or call the National Battery Ingestion Hotline at 202-625-3333 For more info visit https://www.poison.org/battery

Battery information

  • Low Battery Warning
    You will hear three sets of double beeps every 10 minutes, which indicates it’s time to change the battery.
    Once the voltage drops below 0.95V, Tweak emits six sets of double beeps, then shuts down. Remove and replace the battery immediately.
    Dispose of batteries in an environmentally friendly way by federal and state requirements.

  • Battery Tips

    • Open the battery door when not in use. This turns off the hearing aid.
    • Store batteries in original packaging. Do not remove the brown coloured tabs from the batteries until you’re ready to use them.
    • Do not use expired, unsealed, or corroded batteries.
    • Do not leave exhausted batteries in your Tweak.
      The average battery life is 5 to 7 days. Keep in mind some functions of the hearing aid (volume control, noise compression, etc.) require more energy than others which depletes the battery more quickly.

Wearing Tweak

  1. Place Tweak over your ear. The curve of the sound tube should rest on top of your ear comfortably, even with glasses.tweak-Hearing-Focus-Plus-T-OTC-Hearing-Aid- \(17\)
  2. Grab the loose end of the tubing and gently insert the tip into the ear canal.
  3. Position the retaining lock in the bowl of the ear.

When properly inserted, the tubing will lay close to the head around the front of the ear and into the ear canal. Check this by moving your finger down the tubing, into the ear.

If the tip doesn’t stay in your ear, you may need a different-length sound tube. Additional sizes are available at tweakhearing.com or by calling 1-888-815-3240

Tweak Setup

Selecting Your Amplification
With a fresh battery in your Tweak and wearing the hearing aid, you are ready to choose an amplification profile.

  1. Start out in a relatively quiet environment with someone speaking or the TV playing. The first time you turn Tweak on, it will be at the lowest amplification profile. How does it sound?
  2. To try the next level of amplification, press and release the upper portion of the rocker switch. You will hear two beeps, indicating you are now in Amplification Profile 2. What you are doing is sampling the available acoustic settings for quiet environments. There are six different profiles for you to try. Choose the one that sounds best to you–the most natural, most helpful volume level.
  3. Continue to press and release either the upper or lower portion of the rocker switch to try out the six different amplification profiles.
  4. Once you’ve made your decision, press and HOLD the rocker switch for six seconds, until you hear a long beep. This procedure locks in your chosen amplification profile. Three programs are now available: Quiet, Noise, and Telecoil.

Congratulations, your set up is now complete! Tweak remembers your preferred amplification profile from now on.

If you find you can’t get enough volume, call 1-888-815-3240 for additional options .tweak-Hearing-Focus-Plus-T-OTC-Hearing-Aid- \(23\)

To change programs
Press and hold the program button for one second. Once you release the button, you will hear a special sound that indicates which mode or “program” you have just entered.

In all three listening programs you can still make minor adjustments to the volume by quickly tapping the rocker switch.

Telecoil Information

Telecoil
Tweak Focus+T OTC hearing aids are equipped with a telecoil. The telecoil serves as a wireless receiver that converts electromagnetic signals from the telephone into sound. Once you switch the hearing aids to the telecoil program, sounds from the telephone can be heard through your hearing aids. Check your phone for “Hearing Device Compatible” labelling. This means it will work with a telecoil You can also use the telecoil program in looped environments such as airports, churches, and auditoriums. (Look for the symbol shown at right to know the area is looped.) Telecoils can be used with assistive listening devices as well.

Care

Cleaning the Exterior
You should inspect and clean your Tweak every day. To clean, gently wipe the surface with a soft, dry cloth or a moist non-alcohol disinfecting wipe. Do not allow water or liquid to enter any openings.
The daily use of a drying appliance by Dry & Store® is recommended to reduce moisture and wax buildup. www.dryandstore.com

Do not rinse or submerge these parts in water. There is risk of damage if a water drop becomes trapped in the tube. If this should occur, it will prevent sound from coming through the tube and may be harmful to Tweak’s electronics.

Cleaning the Tip and Tube

  1. Remove the sound tube from the case by twisting the tube connector from the sound post (turning counterclockwise).
  2. Wipe the exterior of the tube and tip.
  3. Thread the cleaning tool wire through the tube connector and out of the tip. Wipe end of wire and repeat as necessary to remove moisture and debris from the tube.
  4. Re-attach the sound tube by aligning the connector end with the sound post on the hearing aid case then turn the tube connector clockwise onto the sound post until snug.

Changing the Tube and Tip
The tube and tip should be changed periodically, typically two or three times per year. When the tube or tip become soft, discolored, kinked, or damaged, the tube can break and become detached from the device. Obtain replacements by calling 1-888-815-3240 or visiting tweakhearing.com

When you change the tip, make sure it is securely fastened to the sound tube before inserting it in your ear.

Extended Storage

  • If it is necessary to store your Tweak hearing aid for an extended amount of time, follow the steps below:
  • Remove the battery.
  • Clean your Tweak according to instructions in the Care section of this manual.
  • A full cycle in a Dry & Store* appliance is recommended before extended storage.
  • Place Tweak in an airtight container with a desiccant such as a Dry-Brik® or DryCaddy® Disc. Store in a cool dry place.

tweak tips

  • Correct

    • Place your Tweak OTC hearing aid in a Dry & Store drying appliance every night to remove moisture and prevent corrosion.
    • Always carry spare batteries.
    • Safely store Tweak when not in use. Keep out of reach of small children and pets.
    • In particular, dogs may be irritated by the feedback (“whistling”) sound and attracted by the owner’s scent. This often results in a chewed and/or ingested device.
  • Wrong

    • Don’t leave Tweak on the radiator, near a stove, in a sunny window, in a car or in any other hot place. Excessive heat or cold can damage the instrument.
      Don’t wear Tweak when using a hair dryer or when at the beauty salon, spa or barber.

    • Don’t apply hair spray when wearing your Tweak. It can damage the microphone or other components.

    • Don’t wear Tweak while taking a bath, shower, or while swimming.

    • Don’t store Tweak in the bathroom during  a shower or near a steam room, as moisture created by the steam may cause damage.

Troubleshooting

No Sound or Not Loud Enough

 | Ensure that the battery door is closed.
Replace the battery.
Make sure the tip is not clogged. See page 32 for cleaning instructions.
Make sure the hearing aid case and sound tube are clean and dry.
Make sure that the hearing aid case is positioned properly behind the ear, and that the tip is positioned properly in the ear canal.
Make sure the volume is turned up, by tapping the upper portion of the rocker switch.
Excessive ear wax can prevent sound from entering the ear. Contact your physician.
Changes in your hearing can affect how you hear with Tweak. Contact a hearing healthcare professional if you suspect any change in your hearing condition.
Your Tweak may need to be reset. See page 40 for instructions.
Whistling (“Feedback”)

 | Your Tweak has a best-in-class feedback management system. However, when your hand is near the device, you may hear a whistling noise, which is called “feedback.” This may be caused by amplified sound bouncing off your hand back into the instrument. The noise usually quits when you take your hand away.
If the whistling doesn’t stop once you’ve moved your hand away, ensure that the hearing aid case is positioned properly behind the ear, and that the tip is positioned properly in the ear canal.
Try adjusting the volume. Tap the lower portion of the rocker switch to decrease the volume.
Make sure the dome/tip and sound tube are not clogged with wax or other debris. See page 32 for cleaning instructions.
Your Tweak may need to be reset. See page 40 for instructions. Once reset, repeat steps on page 27 and choose a lower Amplification Profile. (Example: if you’re currently on Amplification Profile 3, consider Amplification Profile 2.)
If the above fails to reduce feedback, contact your place of purchase.
Sound is Distorted, Unclear, Intermittent or has Static Noise

 | Replace the battery.
Make sure the tube and tip are not clogged. See page 32 for cleaning instructions.
Make sure the hearing aid is clean and dry. We recommend nightly use of a Dry & Store drying appliance to remove moisture and prevent corrosion.
If you are near an electromagnetic field (e.g. near a computer screen or fluorescent lights), step away to see if the static clears.
Your Tweak may need to be reset. See page 40 for instructions. Once reset, repeat steps on page 27 and choose a lower Amplification Profile. (Example, if you’re currently on Amplification Profile 3, consider Amplification Profile 2.)
Your Tweak may have a poor battery contact or may not be set up properly. Contact your place of purchase.

How to reset

After wearing Tweak for a while, you may decide you want to try a different Amplification Profile than the one you initially selected. However, if you simply want more bass sound, remove the vented dome tip and attach one of the closed dome tips instead. This may resolve the issue and resetting is no longer necessary.
Tweak may be reset by following these simple steps.

  1. With a battery inserted, open the battery door.
  2. Press and hold the upper or lower portion of the rocker switch.
  3. While still pressing and holding the rocker switch, close the battery door.
  4. Continue holding the rocker switch. Wait at least 14 seconds before releasing the rocker switch.
  5. Open the battery door.
  6. When you close the battery door again, Tweak is reset.

You may now proceed to select a new Amplification Profile. See page 27 for setup.

Technical information
Tweak Focus+T OTC hearing aid is manufactured by Intricon and distributed in the USA by Ear Technology Corporation.
1-888-815-3240 | [email protected] | Johnson City, TN 37601 USA

Tweak Focus+T OTC Specifications (program 4)|
---|---
 | Maximum Output Limit Value

Output Sound Pressure Level 90 (OSPL 90)

| 109 dB
Full-on Gain Value

Gain with 50 dB Sound Pressure Level (SPL) pure-tone input and volume set to full on.

| 34 dB
Total Harmonic Distortion Value| 0.4%
Self-generated Noise Value| 24.3 dB
Latency Value| < 15 ms
Upper Cutoff Frequency for Bandwidth Lower Cutoff Frequency for Bandwidth| < 6500 Hz

< 250 Hz

Warranty And Service

Warranty and Service–NORTH AMERICA
The manufacturer’s warranty period is 12 months. This warranty covers any defect in material or faulty production, specifically excluding batteries, tips, and tubes. Any warranties are invalidated if the Tweak OTC hearing aid has been tampered with or altered in any way, if the serial number has been altered or removed, or if any repairs have been made without authorization. The manufacturer reserves the right to repair or replace the instrument or any defective part, at the manufacturer’s expense, within the limits of the warranty. This warranty does not include a promise of specific listening improvement. Warranty service must only be performed by the manufacturer. Service performed by any unauthorized personnel voids all warranties. If service is needed, contact Tweak Hearing by calling 1-888-815-3240.

Repairs And Replacements
If your Tweak OTC hearing aid needs to be repaired or replaced during the warranty period, please contact us to arrange a return. We will accept any Tweak OTC hearing aid or accessory for repair/service for one (1) year after the date of purchase. Servicing or replacement after the warranty period has expired will be your responsibility.
contact us 1-888-815-3240 | [email protected]

Owner Information
See the warranty card for more details.

Owner information
Each Tweak OTC hearing aid has a serial number (S/N) located on the underside of the hearing aid. Record this serial number in the owner information section below.tweak-Hearing-Focus-Plus-T-OTC-Hearing-Aid-
\(40\)

tweakhearing.com
1-888-815-3240

Distributed by Ear Technology Corporation, USA
P.O. Box 1017, Johnson City, TN 37605 USA
Manufactured by Intricon Corporation
1260 Red Fox Road
Arden Hills, MN 55112 USA

[email protected]
www.tweakhearing.com

References

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