Starkey RIC 13, RIC 312 Hearing Aid Operations Manual

Made for iPhone ® RIC

(Receiver-In-Canal)

O P E R A T I O N S M A N U A L

Hearing Instrument

Size 13 Battery - Orange

Instrument Controls

Push Button Controls p. 14

Made for iPhone RIC and TruLink are compatible with iPhone 6s Plus, iPhone 6s, iPhone 6 Plus, iPhone 6, iPhone 5s, iPhone 5c, iPhone 5, iPhone 4s, iPad Air

2, iPad Air, iPad (4th generation), iPad mini 3, iPad mini with Retina display, iPad mini, iPod touch (5th generation) and Apple Watch. Use of Apple Watch requires iPhone 5 or later.

Table of Contents

Overview

4

Preparation

6

11

Operation

14

User Controls

Volume Control

Volume Control Indicators

Memory Change

Mute

18

19

20

Directional Settings

21

Adjustment

26

27

Cell Phone Use

Hearing Instrument Care

33

36

Troubleshooting Guide

Tips for Better Communication 38

Safety Information 41

FDA Information 44

FCC Information 53

Made for iPhone RIC 13 Overview

Features, Controls and Identification

Your hearing instrument controls include:

1. Hearing Instrument

2. Cable

3. Receiver

4. Microphones

5. Push Button (user control)

6. Battery Compartment (on/off control), location of serial number

7. Retention Lock

8. Location of manufacturer’s name and model name

9. Location of left/right side receiver indicator

10. Instant Fit Earbud

11. Location of left/right side instrument indicator

12. Custom Earmold (optional)

13. RIC Custom Power Earmold (optional)

4

Made for iPhone RIC 13 Overview

5

4

1

2

3

8

10

6

7

9

11

12

13

5

Preparation

Batteries

Your hearing instrument uses a battery as its power source. This battery size can be identified by the orange (13) color code on the packaging.

To insert or replace the battery:

1. Use the nail grip on the battery door.

2. Open the battery door gently and remove the old battery.

3. Remove the colored tab from the new battery.

4. Align the battery’s “+” sign (flat side of the battery) with the “+” on the battery door.

5. Close the battery door.

RIC 13

1

3

5

6

2

4

Preparation

7

Preparation

Battery Indicators

An indicator will sound when the battery voltage is low. You have approximately

30 minutes* to replace the battery. An indicator may also sound just before the battery stops working.

* Actual time between low battery indicator and shutdown will vary depending on environmental noise levels and brand of battery used.

8

Preparation

Helpful Hints

• NEVER FORCE THE BATTERY

DOOR SHUT. This could result in serious damage. If the door will not close securely, check that the battery is inserted correctly.

• Do not open the battery door too far or damage is likely to occur.

• Dispose of used batteries immediately in the proper waste or recycling container.

• Batteries vary in size and performance. Your hearing professional is your best source for lifespan estimates and verification that you are using the proper size and type.

9

Preparation

WARNINGS

Batteries are dangerous if swallowed.

To help prevent the accidental ingestion of batteries:

Keep out of reach of children and pets

Check your medications before taking them – batteries have been mistaken for pills

Never put batteries in your mouth, as they can easily be swallowed

National Button Battery Ingestion

Hotline: 202-625-3333

10

Preparation

Insertion and Removal

To insert the earbud or earmold:

1. Hold the cable at the bend in front of the receiver with your thumb and forefinger. Gently insert the receiver into your ear canal.

2. Wrap the hearing instrument over the top of your ear, carefully placing it behind your ear.

3. Place the retention lock inside the bowl of your ear.

To remove the earbud or earmold:

• Remove the retention lock from the bowl of your ear.

• Remove the hearing instrument from behind your ear.

• Grasp the receiver with your thumb and forefinger. Gently pull out of your ear canal.

Do not pull with the hearing instrument case as this may damage the connection.

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Preparation

1 2

Preparation

Helpful Hints

• Minor irritation and/or inflammation may occur as your ear becomes accustomed to having an object in it; if so, please contact your hearing professional.

• If an actual allergic reaction occurs, alternative earmold materials are available; contact your hearing professional.

• Severe swelling, discharge from the ear, excessive wax or other unusual conditions warrant immediate consultation with a physician.

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3

13

Operation

Power On & Off

To turn ON:

Insert a battery and completely close the battery door. Your instrument has a power-on delay which may require a few seconds. You may hear a tone indicating that your instrument is powered on.

To turn OFF:

Open the battery door until the battery is no longer touching the battery contacts.

User Controls

Your hearing instrument’s user control may have been customized by your hearing professional. Ask your hearing professional how the user control on your instrument is set.

Available User Control Functionality

The user control on your hearing instrument can respond differently depending on how long you activate (press) the button.

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Operation

Your instrument is capable of having one function assigned to a short press

(press and release) and one function assigned to a long press (press and hold).

The options selected below indicate how your particular user control is configured.

Assigned User Control Settings

Short Press

(Press and Release)

Long Press

(Press and Hold)

Volume

Control

Memory

Change

Mute

Multiflex

Tinnitus Level

Volume Control

Power On Volume Level

Your hearing instrument has been set to a specific volume level by your hearing professional. If sounds are generally too loud or too soft, please contact your hearing

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Operation professional for advice and adjustment.

If your hearing instrument has been set up with a user adjustable volume control, temporary volume adjustments can be made.

Your hearing instrument will always power-on to the same volume setting (Volume Home) determined by your hearing professional.

Sprinkler Volume Control

If your user control is configured as a sprinkler volume control, each time you activate the user control, the volume of your hearing instrument changes.

Sprinkler volume control is configured by default to automatically decrease in volume before it increases. To make sounds louder, activate the user control. Repeat this motion until you are at the minimum setting. The next time you activate the user control, the volume will increase one step. Continue to

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Operation activate the user control until you reach the desired loudness.

NOTE:

If 10 minutes or more have passed since the last volume change, the volume will automatically decrease before it increases.

Up/Down Volume Control

If your user control is configured as a dedicated up/down volume control, each time you activate the user control, the volume of your hearing instrument always changes in a specific direction (either up or down). For example, a short press and release may increase the volume while a long press and hold may decrease the volume in your hearing instrument.

Some user controls can be set for the Right instrument to increase volume and the Left instrument to decrease volume. Ask your hearing professional if this setting would benefit you.

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Operation

Volume Control Indicators

Your hearing professional may enable audible indicators, which highlight the current volume position.

Volume Level

Volume Max

Volume Step(s)

Volume Home

(Power on volume level)

Volume Step(s)

Volume Min

Tone

5 Beeps

Click

3 Beeps

Click

Single Tone

Length of Tone

.....

–

...

–

—

Memory Change

Your hearing professional may create multiple memories within your hearing instrument. These additional memories can be accessed by activating the user control on your hearing instrument.

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Operation

If your user control is configured for memory changes, each time you activate the user control, the memory of your hearing instrument will increment through the available memories.

Memory Indicators

Your hearing professional may enable an audible indicator, which is presented while making a memory change. The indicator defaults to a voice saying “One, Two, Three or Four” to identify which memory your instrument is in.

Mute

Long Press Mute

If your hearing instrument is configured with mute functionality, a long press and hold of the user control will mute your hearing instrument. If enabled by your hearing

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Operation professional, you may hear an indicator prior to the hearing instrument muting. To unmute your hearing instrument, long press and hold the user control until audio is restored.

Multiflex Tinnitus Level Control

Your user control can also adjust the level of your Multiflex Tinnitus stimulus. Please refer to the section labeled Multiflex

Tinnitus Technology (on page 24) for further information.

Directional Settings

Your hearing instrument may have a directional microphone to help improve speech understanding in noisy situations.

Ask your hearing professional about your particular directional settings.

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Operation

Landline Telephone Use

Some hearing instruments can be customized with features to help you effectively communicate on the telephone.

Ask your hearing professional about your telephone solution.

My hearing instruments have the following landline telephone setting(s):

Automatic Telephone Memory and

Automatic Telecoil. See below.

Manual Telephone Memory and

Manual Telecoil. See next page.

(Memory # _________________ ).

None

Automatic Telephone Memory and Automatic Telecoil

These options activate the telephone memory automatically when used with a hearing instrument compatible telephone.

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Operation

To use, place the telephone receiver on your ear as you normally would and the hearing instrument will automatically select the telephone memory. It might be necessary to move the telephone receiver slightly to find the best reception. Once the telephone is removed from the ear, the hearing instrument will switch back to the last used memory.

NOTE: Consult with your hearing professional if your instrument does not switch to the telephone memory automatically, if it is enabled.

Manual Telephone Memory and Manual Telecoil

Manual access allows you to switch the hearing instruments into a telephone or telecoil memory, as needed. Ask your hearing professional which memory you should access for manual telephone use.

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Operation

Landline Telephone Tips

Some hearing instruments work best by holding the phone close to, but not fully covering your ear. In some instances, if you encounter whistling (feedback), tilt the receiver at an angle until the whistling stops. Additionally, the hearing instrument in the non-phone ear (ear opposite the phone) may switch to a telephone setting to reduce background sounds. Your hearing professional can provide instructions and techniques for your specific needs.

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Multiflex Tinnitus Technology

Introduction

Multiflex Tinnitus Technology can be used as a part of a tinnitus treatment program.

Multiflex Tinnitus Technology plays a tinnitus stimulus through the hearing instrument. The tinnitus stimulus is programmed according to your hearing loss, and your hearing professional can adjust the settings of the tinnitus stimulus to meet your needs.

Sprinkler Tinnitus Stimulus Control

If your user control is configured as a sprinkler stimulus control, each time you activate the user control, the stimulus level in your hearing instrument changes.

Sprinkler stimulus control is configured by default to automatically decrease in level before it increases. To make the stimulus level louder, activate the user control.

Repeat this motion until you are at the minimum setting. The next time you activate the user control, the level will increase one

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Multiflex Tinnitus Technology step. Continue to activate the user control until you reach the desired loudness.

NOTE:

If 10 minutes or more have passed since the last stimulus level change, the level will automatically decrease before it increases.

Up/Down Tinnitus Stimulus Control

If your user control is configured as a dedicated up/down stimulus control, each time you activate the user control, the stimulus level in your hearing instrument always changes in a specific direction (either up or down). For example, a short press and release may increase the stimulus level while a long press and hold may decrease the stimulus level in your hearing instrument.

Some user controls can be set for the Right instrument to increase stimulus level and the

Left instrument to decrease stimulus level.

Ask your hearing professional if this setting would benefit you.

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Adjustment

Adjusting Your Hearing Instrument

Your Made for iPhone hearing instrument and

TruLink ™ are compatible with iPhone 6s Plus, iPhone 6s, iPhone 6 Plus, iPhone 6, iPhone 5s, iPhone 5c, iPhone 5, iPhone 4s, iPad Air 2, iPad

Air, iPad (4th generation), iPad mini 3, iPad mini with Retina display, iPad mini, iPod touch (5th generation) and Apple Watch. Use of Apple

Watch requires iPhone 5 or later.

To adjust your hearing instrument with your iOS device:

• For best performance, ensure that the iOS device is running iOS 9 or higher.

• Download the TruLink Hearing Control app from the App Store ® or use the native iOS on your device (see Pairing

Your Hearing Instrument to the iOS

Device section on the next page).

For more detailed information on hearing instrument functionality with the app, open the app and touch the i icon.

Detailed instructions are located there.

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Adjustment

Pairing Your Hearing Instrument to the iOS Device

To adjust your hearing instrument with your iOS device, you must ‘pair’ the two together so they can communicate. Please follow the instructions to ‘pair’ your iOS device and your hearing instrument.

IMPORTANT: Before completing the following steps, ensure Bluetooth ® is enabled on your iOS device. Within the Settings menu, go to Bluetooth and toggle to On .

1. Locate then tap the Settings icon on your iOS device.

2. Within the Settings menu go to

General > Accessibility > Hearing Aids.

3. While the iOS device searches for the hearing instrument, open and close the battery door on your hearing instrument

(this puts the hearing instrument into

‘pairing’ mode).

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Adjustment Adjustment

5. Tap on the Hearing Aid Name to connect the hearing instrument to the iOS device.

6. You will see two pairing requests

(one for each hearing instrument).

Select Pair for each request. These requests may be several seconds apart.

4a. If your name does not appear in the

“Devices List” within 5-7 seconds, tap

Accessibility in the upper left corner, then tap Hearing Aids.

4b. You will see your first name and hearing aid (e.g. “Matt Hearing Aids” or “Matthew H/As” depending on the length of the first name) when the iOS device first discovers the hearing instrument.

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7. Pairing is complete.

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Adjustment

You are now ready to use your iOS device to adjust your hearing instrument. You can adjust either with the native iOS controls or with the TruLink app.

To access the native iOS hearing instrument controls, triple-click the Home button on your iOS device. From this screen you can adjust the volume, select memory or use your iOS device as a remote microphone.

Select Start Live Listen to stream the iOS device microphone input directly into your hearing instrument. Point the iOS device microphone toward the audio source. To minimize background noise and provide the best signal, place the iOS device as close to the source as possible.

Right Volume/Left Volume allows you to increase and decrease volume for each hearing instrument individually.

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Adjustment

Turn off Adjust Independently to make changes to both hearing instruments simultaneously.

Normal indicates the name of a memory setting in the hearing instrument. You can select from any memories shown in the list to change the hearing instrument to that memory setting.

Cell Phone Use

Your hearing instrument is designed to work with iPhone. When the hearing instrument is paired and powered on, incoming phone calls will route automatically to your hearing instrument. When your hearing instrument is not powered on, incoming calls route only to iPhone.

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Adjustment iOS allows you to select a preference for how audio (call audio and media audio) is routed from iPhone to your hearing instruments.

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Hearing Instrument Care

Instrument Care

Keep your hearing instrument clean. Heat, moisture and foreign substances can result in poor performance.

• Use a cleaning brush or soft cloth to clean debris from around the user control, microphone and battery compartment; inspect the receiver, earbud or eartip, and wax guard regularly.

• Never use water, solvents, cleaning fluids or oil to clean your instrument.

Your hearing professional can provide further information on additional maintenance procedures for your hearing instrument, if needed.

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Hearing Instrument Care

Hear Clear ™ Receiver Wax Guards

The hearing instrument integrates disposable Hear Clear earwax protection.

The innovative wax guards prevent earwax accumulation in the hearing instrument receiver.

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Hearing Instrument Care

Helpful Hints

• When not wearing your hearing instrument, open the battery door to allow any moisture to evaporate.

• Do not take apart your hearing instruments or insert the cleaning tools inside them.

• When not in use, remove the batteries completely; place your hearing instrument in the storage container and store:

– In a dry, safe place

– Away from direct sunlight or heat to avoid extreme temperatures

– Where you can easily find them

– Safely out of reach from pets and children

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Hearing Instrument Care

Service and Repair

If, for any reason, your hearing instrument 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 instrument fail or perform poorly, check the guide on the next page for possible solutions. If problems continue, contact your hearing professional for advice and assistance. Many common problems may be solved right in your hearing professional’s office or clinic.

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Hearing Instrument Care

Troubleshooting Guide

SYMPTOM POSSIBLE

CAUSES

Not Loud

Enough

Inconsistent

Performance

Unclear,

Distorted

Performance

Dead

Low battery

Blocked earmold/earbud

Hearing change

Debris buildup

Low battery

Blocked earmold/earbud

Low battery

Blocked earmold/earbud

Defective hearing instrument

Low battery

Blocked earmold/earbud

SOLUTIONS

Replace battery

Clean or replace wax guard as needed

Contact your hearing professional

Clean both microphone and receiver with brush

Replace battery

Clean or replace wax guard as needed

Replace battery

Clean or replace wax guard as needed

Contact your hearing professional

Replace battery

Clean or replace wax guard as needed

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Tips for Better Communication

Your hearing professional will recommend an appropriate schedule to help you adapt to your new hearing instrument. It will take practice, time and patience for your brain to adapt to the new sounds that your hearing instrument provides. Hearing is only part of how we share thoughts, ideas and feelings.

Reading lips, facial expressions and gestures can help the learning process and add to what amplification alone may miss.

Please review the following simple communication tips:

For You

• Move closer to and look at the speaker

• Sit face-to-face in a quiet room

• Try different locations to find the best place to listen

• Minimize distractions

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Tips for Better Communication

• Background noises may be frustrating at first; remember, you have not heard them for a while

• Let others know what you need; keep in mind that people cannot “see” your hearing loss

• Develop realistic expectations of what your hearing instruments can and cannot do

• Better hearing with hearing instruments is a learned skill combining desire, practice and patience

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Tips for Better Communication

For Your Family and Friends

Your family and friends are also affected by your hearing loss. Request that they:

• Get your full attention before beginning to speak

• Look at you or sit face-to-face in a quiet room

• Speak clearly and at a normal rate and level; shouting can actually make understanding more difficult

• Rephrase rather than repeat the same words; different words may be easier to understand

• Minimize distractions while speaking

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Safety Information

Safety Information

INTENDED USE: An air conduction hearing instrument is a wearable sound-amplifying device intended to compensate for impaired hearing. Hearing instruments are available in multiple gain/output levels appropriate to treat hearing losses ranging from mild-to-profound.

Your hearing instruments are designed to comply with the most stringent Standards of

International Electromagnetic Compatibility.

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 instruments might cause interference with your medical

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Safety Information device, please contact your physician or the manufacturer of your medical device for information about the risk of disturbance.

Your hearing instruments should not be worn during an MRI procedure or in a hyperbaric chamber.

Your hearing instruments are classified as a

Type B applied part under the IEC 60601-1 medical device standard.

Your hearing instruments are not formally certified to operate in explosive atmospheres such as may be found in coal mines or certain chemical factories.

Your hearing instruments should be stored within the temperature and humidity ranges of -40°C (-40°F) to +60°C (140°F) and 10%-95% relative humidity.

Your hearing instruments are designed to operate beyond the range of temperatures comfortable to you, from very cold up to

50°C (122°F).

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Safety Information

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 electronic instruments on an aircraft. Your iOS device should be put into

Airplane Mode or turned off.

International Use

Be aware that operation during international travel may cause interference to other electronic devices, or other electronic devices may cause interference to your hearing instruments.

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FDA Information

Required Information

The following additional information is provided in compliance with U.S. Food and Drug Administration

(FDA) regulations:

WARNING TO HEARING AID DISPENSERS.

A hearing aid dispenser should advise a prospective hearing aid user to consult promptly with a licensed physician (preferably an ear specialist) before dispensing a hearing aid if the hearing aid dispenser determines through inquiry, actual observation, or review of any other available information concerning the prospective user, that the prospective user has any of the following conditions:

i. Visible congenital or traumatic deformity of the ear.

ii. History of active drainage from the ear within the previous 90 days.

iii. History of sudden or rapidly progressive hearing loss within the previous 90 days.

iv. Acute or chronic dizziness.

v. Unilateral hearing loss of sudden or recent onset within the previous 90 days.

vi. Audiometric air-bone gap equal to or greater than

15 decibels at 500 Hertz (Hz), 1,000 Hz and 2,000 Hz.

vii. Visible evidence of significant cerumen accumulation or a foreign body in the ear canal.

viii. Pain or discomfort in the ear.

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FDA Information

IMPORTANT NOTICE FOR PROSPECTIVE HEARING

AID USERS.

Good health practice requires that a person with a hearing loss have a medical evaluation by a licensed physician (preferably a physician who specializes in diseases of the ear) before purchasing a 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 which 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 affirming 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.

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FDA Information

Federal law restricts the sale of hearing aids to those individuals who have obtained a medical evaluation from a licensed physician. Federal law permits a fully informed adult to sign a waiver statement declining the medical evaluation for religious or personal beliefs that preclude consultation with a physician. The exercise of such a waiver is not in your best health interest and its use is strongly discouraged.

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.

CHILDREN WITH HEARING LOSS.

In addition to seeing a physician for a medical evaluation, a child with a hearing loss should be directed to an audiologist for evaluation and rehabilitation since hearing loss may cause problems in language development and the educational and social growth of a child. An audiologist is qualified by training and experience to assist in the evaluation and rehabilitation of a child with a hearing loss.

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FDA Information

For hearing 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 healthcare 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 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 patient’s hearing 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.

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FDA Information

Multiflex Tinnitus Technology generates a broadband white noise signal that varies in frequency and amplitude.

These characteristics are adjustable by the hearing professional and are specific to the prescribed therapy designed by the professional for the patient’s 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 professional.

WARNING TO HEARING CARE PRACTITIONER

A hearing care practitioner should advise a prospective sound generator user to consult promptly with a licensed physician (preferably an ear specialist) before using a sound generator if the hearing care practitioner 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:

i. Visible congenital or traumatic deformity of the ear.

ii. History of active drainage from the ear within the previous 90 days.

iii. History of sudden or rapidly progressive hearing loss within the previous 90 days.

iv. Acute or chronic dizziness.

v. Unilateral hearing loss of sudden or recent onset within the previous 90 days.

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FDA Information

CAUTION: If set to the maximum output level and worn for periods of time exceeding the following recommendations, the patient’s exposure to sound energy has the potential to exceed noise exposure limits. This instrument 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 professional can adjust the settings of Multiflex Tinnitus

Technology to meet your needs.

Multiflex Tinnitus Technology may provide temporary relief of your tinnitus.

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FDA Information

PRESCRIPTION USE ONLY

CAUTION: Federal law restricts this instrument to sale by or on the order of a doctor, audiologist or other hearing care practitioner licensed to dispense hearing instruments 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 practitioner. Your hearing professional will properly diagnose and fit the instrument to your personal needs and requirements. This should include its use in a prescribed tinnitus treatment program.

Your hearing professional will also be able to offer the appropriate follow-up care. It is important that you follow your hearing professional’s advice and direction regarding such care.

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 instrument.

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 instrument and seek a consultation with a medical, audiology or other hearing professional.

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FDA Information

As with any instrument, 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 instrument out of the reach of children and pets.

CAUTION: If set to the maximum output level and worn for periods of time exceeding the following recommendations, your exposure to sound energy has the potential to exceed noise exposure limits. You should not use your hearing instrument for more than sixteen

(16) hours a day if your instrument is set at the maximum output level, nor should you use your instrument if your hearing professional has set the instrument 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.

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FDA Inform ation

TECHNICAL DATA

Multiflex Tinnitus Technology Maximum Output = 87 dB

SPL (typical) when m easured in a 2cc coupler per ANSI

S3.22 or IEC 60118-7.

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REGULATORY NOTICES

RIC 13

FCC ID: EOA-24HALO2R13

IC: 6903A-24HALO2R13

RIC 312

FCC ID: EOA-24HALO2R312

IC: 6903A-24HALO2R312

FCC Information

FCC Notice

This device complies with part 15 of the FCC rules.

Operation is subject to the following two conditions: (1) This device m ay 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 user ’s authority to operate the equipment.

Hereby, Starkey ® Hearing Technologies declares that the products listed above are in compliance with the essential requirements and other relevant provisions of Directive

1999/5/EC. A copy of the Declaration of Conformity can be obtained from the addresses on the following page.

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FCC Information

Starkey Hearing Technologies

6700 Washington Ave. South

Eden Prairie, MN 55344 USA

Wm. F. Austin House, Bramhall Technology Park

Pepper Road, Hazel Grove, Stockport SK7 5BX

United Kingdom

Waste from electronic equipment must be handled according to local regulations.

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Notes

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0086

“Made for iPod,” “Made for iPhone,” and “Made for iPad” mean that an electronic accessory has been designed to connect specifically to iPod, iPhone, or iPad, respectively, 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.

Please note that the use of this accessory with iPod, iPhone, or iPad may affect wireless performance.

© 2016 Starkey Hearing Technologies. All Rights Reserved.

81960-007 1/16 BKLT2839-00-EE-XX

Apple, the Apple logo, iPhone, iPad, iPod touch, Apple Watch and App Store are trademarks of Apple Inc., registered in the

U.S. and other countries.